This article was just published in the Lancet
The introduction of direct-acting antiviral (DAA) medicines in 2013 revolutionised the treatment of chronic hepatitis C virus (HCV) infection. The efficacy of DAA therapy is impressive—in many clinical trials HCV cannot be detected by sensitive laboratory assays in more than 90% of people who complete DAA therapy, and observational studies have documented similar results.1, 2 High efficacy combined with low rates of adverse events have led WHO to include DAAs in the WHO Model List of Essential Medicines.3 Several countries, including Australia, Georgia, Iceland, and Morocco, have started national DAA-based treatment programmes to eliminate HCV infection, and WHO has called for the expansion of HCV therapy with DAAs as part of its global hepatitis elimination strategy.4
HCV is an important contributor to global mortality, causing an estimated 399 000 deaths each year worldwide, and as HCV treatment expands, it is anticipated that mortality from HCV infection will decline.5 However, because the annual risk of death from HCV infection is low and the DAAs were introduced only recently, there are limited data on how these drugs affect mortality. Clinical trials that evaluate the efficacy of DAAs do not assess mortality as an outcome but rather a surrogate outcome called the sustained virological response (SVR). An SVR is defined as the absence of detectable HCV by nucleic acid testing of blood samples obtained 12–24 weeks after completion of HCV therapy. An SVR is deemed equivalent to a cure because once an SVR is achieved, it is maintained in more than 99% of patients, even after years of follow-up.6 Also, an SVR is associated with resolution of cirrhosis in about half of patients with cirrhosis followed-up clinical trials.7
However, documenting in a clinical trial that DAAs result in an SVR is not the same thing as showing that they reduce mortality or morbidity. A recent systematic review by Jakobsen and colleagues8 from the Cochrane Hepatobiliary Group sought evidence from clinical trials of HCV therapies to assess this issue. The authors reviewed randomised clinical trials that used SVR as the primary outcome in people receiving DAA therapy compared with those either not treated or treated with other regimens (primarily interferon-based therapy). Jakobsen and colleagues concluded that DAAs were effective in producing an SVR (relative risk 0·44, 95% CI 0·37–0·52); however, the analysis did not find a reduction in morbidity or mortality after DAA therapy. At first sight, this conclusion seems to contradict systematic reviews of observational data that show that people who have an SVR after treatment with interferon and ribavirin had a 50% (95% CI 37–67) reduction in overall mortality and 76% (95% CI 69–82) reduction in the incidence of hepatocellular carcinoma as compared with people who were treated but did not achieve an SVR.9, 10 The reduction in overall mortality was even greater (81% [95% CI 72–87]) when persons with an SVR were compared with those not treated.9 Other studies have shown improvements in extrahepatic manifestations of HCV infection and quality of life among people with an SVR after DAA treatment.11, 12 Data on the effect of DAA therapy are also beginning to be reported from national programmes that are scaling up HCV therapy. In England where HCV therapy increased by 48% in 2015, compared with 2014, there were reductions in the incidence of HCV-related cirrhosis (42%), liver transplantations (32%), and deaths (8%).13
Observational studies are biased towards showing an effect of treatment since treatment decisions are based on the likelihood of a successful outcome, and people achieving an SVR may be predisposed to a better outcome for reasons unrelated to the treatment. However, the magnitude and consistency of health benefits across studies and outcomes support the conclusion that HCV therapy resulting in an SVR substantially reduces mortality and morbidity.
How to explain these apparently contradictory results? An important difference between the studies reviewed by Jakobsen and colleagues is the duration of follow-up, which was short at an average of 34 weeks compared with an average of more than 5 years in the other reviews.9, 10 Simply put, the clinical trials included in the systematic review by Jakobsen and colleagues were not designed to answer the question posed by the authors about the effect of DAA treatment on morbidity or mortality. These studies generally followed up patients for only 24–48 weeks after the completion of DAA therapy, and the risk of HCV-related disease and death during such a short period is extremely low because the harmful effects of chronic HCV infection take years to develop. In fact, no morbidity was reported, and only 16 deaths occurred among the 2996 patients enrolled in all the DAA trials that were assessed by Jakobsen and colleagues. Thus, the statistical power to show a difference between the two groups is very low. In addition, the non-intervention groups in many of the studies included in Jakobsen and colleagues' systematic review did in fact receive HCV therapy, primarily an interferon-based regimen, which would minimise any mortality benefit of DAA therapy. Finally, Jakobsen and colleagues' study included early, less effective DAA regimens that were discontinued or withdrawn before marketing. They propose that, to resolve definitively whether DAA therapy reduces morbidity and mortality, randomised clinical trials with a non-treatment comparator group be done with clinically relevant outcomes such as death. Clearly, with the ready availability of safe and effective DAAs and ample evidence showing the health benefits of achieving SVR, such a study design is unethical and would be unacceptable to institutional review boards and harmful to patients' health. Several organisations, such as patients' groups and international hepatology associations, have expressed their concerns about the methods and conclusions of the Jakobsen review.14, 15, 16
People who are knowledgeable in the field of HCV therapy can readily ascertain the limitations of the approach taken in the systematic review by Jakobsen and colleagues and will be able to place their results in the proper context relative to other data that document the health benefits of DAA therapy. But for some patients, health-care providers, and decision makers who may be less knowledgeable about HCV therapy, this type of analysis, especially as reported in the mainstream media,17 could lead to conclusions that DAA therapy has no benefit, resulting in decisions to decline to prescribe or take DAA therapy or to decline to approve budgets for DAA treatment programmes, particularly in view of their expense. This would be a tragic outcome, as it would lead to preventable deaths. Public-health policy makers who must decide on budget allocations for HCV treatment cannot wait for perfect data on mortality endpoints, since the types of trials that would generate these data will never be done. Rather, they must assess available, albeit imperfect, data from observational studies and trials using surrogate outcomes that are reliably predictive of clinically important outcomes. Based on the fact that DAA therapy is safe and effective in achieving SVRs, that the SVRs are durable in most patients, that HCV-induced liver damage improves after SVR, and that observational data show a large reduction in morbidity and mortality, health-care decision makers and providers can take comfort that the evidence is strong in favour of treatment. A more definitive assessment of impact on morbidity and mortality will take time, but this should not be used as a reason for denying HCV therapy and delaying efforts to eliminate HCV infection.
About 1 in 5 patients taking Direct Acting Antivirals will get insomnia. Here is a post of mine from some years ago about how to manage it.
Insomnia is a common and often frustrating problem. Part of the reason it's frustrating is that, unless an accurate diagnosis of the root cause(s) is made, treatments tend to be temporary band aid solutions and rapidly lose their effectiveness.
Do you have an underlying medical problem?
There are a range of medical condition that can cause insomnia.
Chronic pain, sleep apnoea or a need to urinate frequently caused by an enlarged prostate gland can all cause insomnia.
Diseases like arthritis, cancer, heart failure, lung disease, gastroesophageal reflux disease (GERD), overactive thyroid, Parkinson's disease and Alzheimer's disease have all been implicated.
Mental health problems like stress, anxiety and depression can also cause problems.
Many of these issues are amenable to treatment, and by fixing the root cause, sleep patterns can return to normal.
Are your medications to blame?
- SSRI antidepressants
- ACE inhibitors
- Cholinesterase inhibitors
- H1 antagonists
Note that you should consult with your doctor before stopping any prescribed medications.
Are your daily habits contributing?
There are many habits and work patterns that promote poor sleep
- Not enough light at midday and too much light (device screens) at night
- Shift work - this scrambles your body clock (circadian rhythm)
- Eating late in the evening
- Fluids in the evening (we were all trained as children to wake up and not wet the bed)
- Excess caffeine, nicotine and other stimulant (ie Red Bull) consumption
- Using stimulants in the afternoon and evening
- Not getting enough exercise
- Too much alcohol - although alcohol is a sedative it prevents entry into deep sleep
Could your sleep hygiene be improved?
If you use your bedroom for other activities than sleep and sex you are missing the opportunity to program your thinking along the lines of go to bed, go to sleep.
You will sleep better if:
- You have got a good dose of daylight during the day, and less light at night
- Your bedroom is pitch black
- Your bedroom is quiet
- You bedroom is not too hot, not too cold
- You have a comfortable mattress
- You have a comfortable pillow - not too high or too low, too soft or too firm - get one that's just right (and remember they wear out over time)
- You have enough blankets so you're not too hot when you go to bed, but also don't wake up freezing when it cools off in the early morning
What can my doctor do for me?
For a start, any doctor worth his/her salt can discuss everything with you and look for root causes. It's always best to fix the source(s) of problems.
A simple plan (from Dr Margaret Hardy)
- Work out average amount of actual sleep per night from sleep diary
- Choose a regular wake-up time
- Set a regular bedtime by subtracting average sleeping hours from the planned wake-up time
- Review at weekly intervals and, if tired, increase time in bed by going to bed 30 minutes earlier
Your doctor can also provide medications including:
- Melatonin (which re-sysncs your body clock and is thus really good for shift work and jetlag
- First generation sedating antihistamines (promethazine, doxylamine)
- Benzodiazepines (temazepam, zopiclone, zolpidem and many others) which are good for short term (particularly stress related insomnia). Long term you become first tolerant (needing ever increasing doses) and then addicted (needed the medication or you won't be able to sleep)
- Antidepressants like amitriptyline and mirtazipine which are used (usually in low doses) not to treat depression but for their common sedating side effect. Their advantage over benzodiazepines is that tolerance is far less of an issue, so they can be used longer term.Don't despair. Most people can get
Don't despair. Most people can get a far better nights sleep with a few simple changes.
Talk to your doctor, or see one of our expert GPs online from the convenience of home.
Dr James Freeman
Yesterday the Guardian published an article called 'Miracle' hepatitis C drugs costing £30k per patient 'may have no clinical effect'
The problem with this sensationalist headline is that while it is reporting what was said by the Cochrane Collaboration what they looked at was trial specifically designed to test SVR rates, and not specifically designed to look at long-term outcomes.
Here is a commentary from Dr Andrew Hill and the study to which he refers which was presented at AASLD in 2015 and published in Clinical Infectious Diseases.
There is some really interesting stuff happening in the "reverse liver fibrosis" realm.
Here is state of the art in 2009 (great review of the mechanism) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2702953/ where we had no clear candidates, and
Here is state of the art in 2015 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4703795/ where we have literally hundreds of candidates (coffee and milk thistle (silymarin) and resveratrol are in there), and
Here is the state of the art in 2016 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4754444/ in an article called Promising Therapy Candidates for Liver Fibrosis
I like this bit from the conclusion:
Since both animal experiments and clinical studies have revealed that liver fibrosis, even early cirrhosis, is reversible, treating patients by combined therapies on underline etiology and fibrosis simultaneously might expedite the regression of liver fibrosis and promote liver regeneration.
Here is a copy of the generic hep c medication presentation given by Dr James Freeman at EASL 2017 today.
Mostly the presentation followed the slides.
The last words, with the last slide were "I want everyone to join the club, not the hep c buyers club, this club, the hep C cure club."
“The Liver Meeting”, or AASLD 2011, was taking place at the great, glass-fronted Moscone West Convention Center in downtown San Francisco. Almost 9,000 people were there – family doctors, hepatologists, gastroenterologists, academics, drug salesmen, public health officials – all networking, trudging the escalators, wandering the beige exhibit halls, trying to stay on top of an avalanche of medical information. Across five days in early November, no fewer than 2,200 liver-related scientific abstracts were being presented, at sessions that ran from 6.30am until 9pm. Specialists in hepatitis C, an awkward, under-recognised health problem, were used to finding their way to the back rooms, the less-glamorous receptions.
Many felt it was time the disease moved up the agenda. Since it was identified in 1989, “Hep C” or “HCV” to those who work on it, has only confounded those who underestimate it. Transmitted through blood, the virus is now thought to infect around 2.5 per cent of the world’s population, or 170 million people. Of those, around a quarter will develop liver cirrhosis, or cancer, within a decade or two. In the UK, deaths from hepatitis C have trebled since 1996 and more than 200,000 people are infected. No one knows what to do about the coming demand for liver transplants. For the past decade at least, scientists have used phrases such as “gathering storm” and “silent epidemic” to try to bring attention to the subject.
There has also been a torrent of new data to keep up with. Despite its orphan status, the sheer numbers of people infected with hepatitis C have made it the subject of hundreds of millions of dollars of medical research – particularly by pharmaceutical companies, working on a new generation of drugs. And AASLD, as the world’s premier liver event, has become the occasion when information on those drugs – known as “direct-acting antivirals” – is often shared for the first time. In recent years, hepatitis C delegates had got used to turning up to must-see presentations that were filled way beyond capacity.
One look at the 2011 programme told conference-goers that a session on the Sunday afternoon – “HCV: Refining the Use of Direct-Acting Antivirals” – was going to be mobbed. Room 2001, on the second floor of the convention centre, only held about 400 people. Dr Ed Gane, a 51-year-old hepatologist and transplant specialist from New Zealand, who was to give the fourth of six presentations in the session, arrived about 10 minutes before it was due to begin. “It was packed to the gunwales,” he told me. Conference staff began setting up a video link to adjoining rooms to cope with the spillover.
The cognoscenti were there to hear Gane. An unshowy, respected doctor, he had been working on hepatitis C since the early 1990s, and for the past year, had been carrying out a clinical trial of a particularly promising new drug developed by a small American pharmaceutical company called Pharmasset. The drug was known by its laboratory name, “PSI-7977”, and today, Gane was to give an update on the trial, called ELECTRON.
An article with the title: Importation of generic hepatitis C therapies: bridging the gap between price and access in high-income countries just made it into the Lancet print edition:
There is a PDF of it here
This article about the rationale for using generic hepatitis C medication has just been published in Liver International in their section "Debates in Hepatology".
James A. D. Freeman1 and Andrew Hill2
1 GP2U Telehealth, Hobart, Tas., Australia
2 St Stephens AIDS Centre, Chelsea and Westminster Hospital, London, UK
Liver Int. 2016; 36: 929–932. DOI: 10.1111/liv.13157
Hepatitis C, hepatitis B, HIV, TB and malaria are the five major causes of infectious disease death worldwide. In a breakthrough that rivals the invention of penicillin, drugs that cure hepatitis C, with minimal side effects and high success rates, have reached the market, but, in what must be one of the greatest tragedies of modern times, these life-saving medications are not being deployed on a mass scale. Pharmaceutical patents are gifted to private corporations by governments for the dual purposes of protecting R&D expenditure and encouraging innovation. Unfortunately the monopoly pricing power these patents provision currently lacks adequate checks and balances, is open to abuse, and is quite clearly being abused. The sort of legislative changes required to deliver on the original goals of pharmaceutical patents will take years or even decades to eventuate. Parallel importation of generic medication offers hope to the millions of patients with HCV unable to afford access to vastly overpriced originator medications. Doctors prescribing and monitoring patients taking generics can take comfort from the fact that the REDEMPTION trial results show, like the HIV generics that came before them, that HCV generics deliver robust clinical results.
Read the full article at: http://onlinelibrary.wiley.com/doi/10.1111/liv.13157/full
To find out more about generic hepatitis C medication please visit our forum where you can read the stories of patient successfully accessing and treating their hepatitis C with affordable generic medication.
Another US State Foots the Hepatitis C Bill - Where can you turn for therapy if you're not from Delaware?Written by Marko
Added pressure will not be enough
Ever since Obama Administration and lawsuits assumed office, most States are considered to be under pressure from the Delaware's case. For instance, Harvard Law School's Center for Health Law and Policy Innovation had threatened litigation to abandon money in response to policies that limits treatment of sick patients with expensive new medications.
However, many US citizens are waiting for their respective State to come up with a legislation that would cover the high costs of Hepatitis C treatment. Delaware is not an insulated case; but there is a long way from legislation to actual treatment. Hepatitis C patients are advised to seek treatment as quickly as possible in order to prevent further liver decay - and by far quickest method of getting Hepatitis C medicines with a considerable discount is by using Fix Hep C Buyers Club.
Hepatitis C patients can talk with Dr. Freeman about procuring the following medicines:
- sofosbuvir + ledipasvir (Harvoni®)
- sofosbuvir (Sovaldi®)
- daclatasvir (Daklinza®)
- ribavirin (Ibavyr®)
Hepatitis C overviewOver three million Americans are likely to be infected with hepatitis C, a bloodborne virus spread viа blood аnd bоdу-fluid contact ѕuсh аѕ blood, ѕеmеn, bоdу fluid, IV drug abusers ѕhаring needles or ѕоmеоnе uѕing tainted needles. Hераtitiѕ C uѕеd tо be thе mоѕt соmmоn tуре оf hераtitiѕ аcquirеd thrоugh blood trаnѕfuѕiоnѕ until a tеѕt fоr it bесаmе аvаilаblе in thе 1980ѕ.
Hераtitiѕ C саuѕеѕ inflаmmаtiоn оf the liver rеѕulting in liver damage that саn lead tо cancer. It аlѕо соmmоnlу lеаdѕ tо chronic livеr inflаmmаtiоn аnd ѕlоwlу dаmаgеѕthе livеr оvеr a lоng period оf time bеfоrе lеаding tо cirrhosis оf thе liver, that means scar tiѕѕuе rерlасing normal, healthy tiѕѕuе in rеѕult оf blocking thе flоw оf blood thrоugh the livеr and preventing it from frоm working аѕ it ѕhоuld.
Delaware Hepatitis C coverageThe Delaware State issue can be likened to that of New Jersey in that evidence is still required prior to liver damage approval treatment.
The new initiative policy permits a specific severity restrictions by July 1 and holds a requirement for patients on drugs abuse, thus bring in line with medical standard recommended for treatment and prevention of such infectious diseases.
Other changes will occur, for all hepatitis C-infected patients on Medicaid in Delaware who are eligible. The treatment new legislation takes effect on Jan. 1, 2018. The change as announced on Tuesday at Harvard was confirmed by a spokeswoman from Delaware Department of Health and Human Services that the State will definitely change its policy.
This initiative policy changes has already been embarked by other states. As it stands, an advisory committee set in Pennsylvania recommended that the state Medicaid initiative policy should treat all patients in that regard; a decision yet to be confirmed.
For all other patients, it is best to seek help using Fix Hep C Buyers Club. Contact us today and get your medications within a month.
Мы рады представить некоммерческий проект «ГЕПАТИТКА», созданный группой активистов для поддержки, помощи и общения людей, затронутых вирусными гепатитами B, C и D.
Начало этого проекта было положено в марте 2012 года пациентом из Москвы во время того, как он проходил курс лечения гепатита С пегилированнымиинтерферонами и рибавирином. Чтобы облегчить проживание сложных побочных эффектов, связанных с лечением, молодой человек начал взаимодействовать с людьми, затронутыми гепатитом С. Он делился своим опытом, рассказывал, как передается гепатит С, мотивировал лечиться, а не ждать развития фиброза, пояснял, как можно поддержать человека на лечении, организовывал совместное времяпровождение и он-лайн взаимодействие людей, связанных с гепатитом С. Вокруг него образовывалось сообщество людей, связанных с гепатитом С. Сообщество разрасталось, вышло за пределы Москвы и в октябре 2013 года его товарищ из Минска, замотивированный на лечение гепатита С, создал группу в социальной сети фейсбук. Этой группе далось запоминающееся название – ГЕПАТИТКА.
В 2015 году проект переформатируется, благодаря присоединению к работе и разносторонней поддержке коллег из ITPCru. Весной 2015 года в группе ГЕПАТИТКА в фейсбуке начала появляться информация о прорыве в лечении хронического гепатита С в виде появления на рынке препаратов для лечения гепатита С с принципиально новым принципом действия, с почти 100% эффективностью, легких по переносимости и с сокращенным сроком лечения. ГЕПАТИТКА была одним из первых ресурсов, где появились новости по доступу к лечению ВГС в мире новыми безинтерфероновыми схемами, где были опубликованы перечни доступных безинтерфероновых генерических препаратов для лечения ВГС с указанием цен и производителей. Ресурс подкреплял новостную информацию о препаратах переводенными на русский язык международными клиническими рекомендациями по лечению новыми схемами, а также результаты КИ по ним. При этом составом координатором ГЕПАТИТКИ было принято решение поддерживать исключительно традиционные мировые методы диагностики и лечения. Благодаря выкладываемой информации, постоянной работе с пациенстким сообществом и опыту первопроходцев, кто уже не мог откладывать лечение и воспользовался новыми препаратами, появилось много информации о ходе лечения новыми препаратами в режиме он-лайн, и как следствие, много возможностей расширения доступа к лечению гепатита С для всех нуждающихся и очевидная необходимость развития проекта ГЕПАТИТКА в разных направлениях.
На июнь 2016 года проект представлен в следующих ресурсах:
- закрытая группа фейсбук (3477 участников): https://www.facebook.com/groups/NAHCV/
- закрытая группа в ВКОНТАКТЕ (475 участников): https://vk.com/gepatitkaru
- сайт http://gepatitka.ru/, где доступен пациентский форум, а также последние мировые рекомендации по лечению ВГС и бесплатное медицинское консультирование по вопросам хронических гепатитов в режиме он-лайн.
На сегодня проект ГЕПАТИТКА координируется небольшой группой активистов из Москвы, Санкт-Петербурга и Минска. В планах стоит расширение развития в регионах ВЕЦА, в проекте на ежедневной основе задействованы активисты из РФ, Украины и Латвии. В проект вовлечены два медицинских специалиста, практикующих гепатолога, из Германии и России.
Добро пожаловать всем, кто затронут вопросами гепатитов на площадки проекта ГЕПАТИТКА. Вы сможете найти много полезной информации и общения там.
Dear all, especially Russian speaking audience,
We are pleased to present a non-profit project "GEPATITKA" for the Russian audience. Project was created by a group of activists to support and to coordinate communication between people, affected by viral hepatitis B, C and D.
Project started in March 2012 while a patient from Moscow (Russian Federation) was undergoing pegylated interferon and ribavirin treatment for hepatitis C. In order to handle tough side effects and not to stay alone with his condition, he started to share his experience with others, started to learn more about HCV and to share his knowledge. Very soon a community of patients grew around him. He treated his HCV and continued his activities to help others. He motivated his friend from Belarus to start treatment as well and in October 2013 the project appeared on-line, on FACEBOOK, and got it name – GEPATITKA (Gepatit means Hepatitis in Russian).
In 2015 the project GEPATITKA was reformatted (got a new structure), due to the joining of ITPCru. GEPATITKA started to spread out information about new landscapes in HCV treatment, about the DAA appearance in the world with almost 100% efficiency, easy portability and a reduced period of treatment. GEPATITKA was one of the first resources in the EECA region, where information about PEG-IFN-free regimens was published and lists with DAA generics with prices and producers appeared. Project supports its publications with the international clinical guidelines, and only traditional methods of HCV diagnosis and treatment. Due to the strong informational work and very attentive and intense approach to the patient’s community project GEPATITKA became very popular in the Russian speaking countries, especially in Russia, Belarus and Ukraine.
In June 2016 GEPATITKA project is presented in the following resources (only in Russian language):
- Private group on Facebook (more than 3500 participants): https://www.facebook.com/groups/NAHCV/
- Private group in a Russian social network VKontakte (around 500 participants): https://vk.com/gepatitkaru
- at the web site GEPATITKA: http://gepatitka.ru/
This web site provides not only the latest world updates for HCV treatment and free medical consultations for chronic hepatitis in the online mode, but also a platform for the patient’s forum.
Today GEPATITKA project is being coordinated by a small group of activists from Moscow, Saint Petersburg and Minsk (Belarus). They plan to expand in the EECA regions. A number of volunteers, who are affected by hepatitis, from Russia, Ukraine and Latvia are involved in this project on a daily basis. Two medical specialists, hepatologists from Germany and Russia answer questions on the web site free of charge on the daily basis.
Resources of GEPATITKA are very friendly and patient - oriented and warmly welcomes everyone who is affected by hepatits.
Efforts are being done to expand the insurance coverage to all Hepatitis C patients but it is an uphill battle. It is our hope that in some years, insurance companies will include Hepatitis C coverage in the majority of healthcare plans; however, Hepatitis C patients can't afford to wait for years on end to get the medicines.
FixHepC Buyers Club works much quicker. We can supply every Hepatitis C patients, regardless of fibrosis score, with an affordable Hepatitis C drugs (sofosbuvir, ledipasvir, daclatasvir, ribavirin). For everybody in need of Hepatitis C drugs, please do contact Dr. Freeman via email or phone and you will be able to discuss the proper course of treatment and how to obtain the medications.
Washington Judge Orders Medicaid to Save All Hepatitis C Patients
A federal judge has ordered Washington state’s Medicaid provider to cover expensive hepatitis C drugs for all patients with the liver-destroying disease, not just those who are sickest. Up till now, the coverage included only the patients with the most problematic fibrosis score. This has left thousands of patients in Washington alone without the access to the medications; not many could fetch up more than $80,000 for the medicines.
U.S. District Court Judge John C. Coughenour granted a preliminary injunction Friday that forces the state Health Care Authority (HCA) to halt a 2015 policy that restricted access to the drugs based on a fibrosis score, a measure of liver scarring.
Fibrosis ScoreHepatitis C drugs are expensive; so much so that many of health insurance companies would go down if they had to cover the expenses of all Hepatitis C patients.
This is why a sieve was created to determine which Hepatitis C patients need the medicines the most. The state of liver plays a key role in this selection process. Fibrosis score is used to get a basic understanding in how good a shape a liver is, and the decision process for many health insurance companies is as follows:
- 'Good' Fibrosis Score - No insurance coverage of Hepatitis C drugs
- 'Bad Enough' Fibrosis Score - Insurance covers Hepatitis C drugs
FixHepC Buyers Club - We Cure Everybody Regardless of Fibrosis ScoreWe all know that Hepatitis C is a deadly disease if left untreated. Why should only patients with a bad fibrosis score get the medical coverage? This is exactly what Washington Judge John C. Coughenour pointed out. Eventually, even people with the best fibrosis score will have their liver damaged beyond repair and looking for help then will be too late.
FixHepC has organized itself as a safe establishment to procure the necessary Hepatitis C medications to every patients.
- 'Bad' Fibrosis Score - We will help you get the medications (patients with bad fibrosis score need it the most)
- 'Good' Fibrosis Score - We will help you get the medications (patients with good fibrosis score will have their liver damaged in years to come - the time to act is now!)
The Washington CaseThe injunction was a response to a class-action lawsuit filed in February on behalf of two clients of Apple Health — and nearly 28,000 other Medicaid enrollees with hepatitis C.
The two patients, a 53-year-old Seattle woman and a 47-year-old Lakewood man, were prescribed the drug Harvoni to treat their hepatitis C infections. But they were denied the drug, which costs about $95,000 for a 12-week treatment, because of its cost, the complaint said.
The injunction orders HCA to begin covering Harvoni “without regard to fibrosis score.” The judge ruled that the agency’s policy was not consistent with existing state and federal Medicaid requirements that drugs be dispensed based on medical need.
“For people who have been living with this disease and feeling like there’s no hope if they can’t get this cure, this is life-changing,” said Ele Hamburger, a lawyer with the firm Sirianni, Youtz, Spoonemore and Hamburger, which filed the lawsuit. Co-filers included Columbia Legal Services and the Center for Health Law and Policy Innovation at Harvard Law School.
It’s not clear how soon Medicaid patients with hepatitis C may begin filling prescriptions for Harvoni and other direct-acting antiviral drugs. The ruling orders all parties to report back within 60 days.
HCA officials are reviewing the injunction, a spokeswoman said. But the state Medicaid director, MaryAnne Lindeblad, estimated in a letter to the U.S. Senate last fall that paying for hepatitis C treatment for all Medicaid clients in Washington would be three times the agency’s current $1 billion drug budget.
Medical guidelines had previously supported limiting the drugs to the sickest patients, but that changed last year. Experts in liver treatment and infectious disease now agree that drugs such as Harvoni should be used to treat all patients, including those with mild disease.
Time to Act is NowWaiting for your liver to have a bad enough fibrosis score for insurance company to cover Hepatitis C costs is literally playing with your own life.
We can help you to get the Hepatitis C medications within a month. Send us an email and we will help you get over Hepatitis C once and for all.
What Happened to the Indian Official that Rejected the US Drug Company Gilead’s Patent Application in 2015?
It appears that being a man of honour is less valued than it should be.
Hardev Karar, I salute you as a man of honour and integrity.
Dr James Freeman
End of Hepatitis C Tourism?For more than a year, Hepatitis C patients who could not afford the high price tag of the novel Hepatitis C drugs in their respective countries, could go to India and buy the medicines they needed to get well for about $2,000. This window that cured thousands and thousands of patients is about to close, as the result of Indian patent office ruling on drug Sovaldi (400mg sofosbuvir).
Gilead Sciences, the pharmaceutical company that makes Sovaldi, failed to show the inventiveness and novelty sufficient to grant a patent on Sovaldi. Since they did not wish to lose such a big market as India, they gave licences to 11 generic manufacturers in India to produce and distribute the low-cost sofosbuvir pills as their plan B (getting a patent being a plan A).
According to Reuters, Gilead appealed against the ruling that refrained Indian patent office from giving them a patent on sofosbuvir molecule. In a dramatic change of heart, Indian patent office just gave Gilead what they wanted all along - a patent. With the plan A in play now, Gilead might choose and forgo plan B - this would mean that there would be no more low-cost sofosbuvir pills to import from India and would leave millions to choose between fetching out more than 80,000$ for the original medicine, or face the lethal consequences of untreated Hepatitis C.
Fix Hep C Buyers Club supply of Hep C drugs is not affectedThe Fix Hep C Buyers Club remains one of the strongest providers of low-cost Hepatitis C medicines. Since sofosbuvir the buyers club provider is supplied from China, not India, the supply chain will not be affected and every Hepatitis C patient can seek help they need by contacting us (click here).
Why did the Indian patent office change its mind?In direct contradiction to its earlier order, the Controller General of Patents, Designs and Trademark granted American pharmaceutical company Gilead Sciences the patent for the blockbuster Hepatitis C drug Sofosbuvir (brand name Sovaldi) in India. An application for the same patent was first rejected in January 2015 as lacking inventiveness and novelty.
On Monday, however, the patent office dismissed all pre-grant oppositions and stated that it found, “claimed compounds are novel, inventive and patentable under Patents Act.” The decision is a major blow to the access to drug movement, said Leena Menghaney, South Asia head of Médecins Sans Frontières (MSF). “There has been excessive pressure building up on the Indian government to dilute the independent functioning of the patent office to ensure that patent claims are granted far more easily to U.S. firms. In the process, the patent office has completely ignored recent proceedings in the U.S. against Gilead regarding the same application which have been found to infringe two of Merck’s patents, clearly defeating Gilead’s claim that its application on the drug was novel,” added Ms Menghaney.
How obtaining a patent works
“These are very scary times for the patient communities globally who rely on affordable generic medicines coming from India. The government’s “Make in India” campaign seems to be only for foreign companies and not for Indian generic industry which has been the lifeline for people across the world,” said Loon Gangte with the Delhi Network of Positive People
Gilead, in a statement, welcomed the move, but said it will have no impact on availability of the compound, which is already licensed to 11 generic manufacturers in India for distribution in 101 developing countries.
Sofosbuvir patent issue goes beyond patent officeAnother key application on sofosbuvir is pending before the Kolkata patent office and several oppositions to its grant have been filed by patient and public interest groups. Stating that the case had been decided outside the merit of the technical and legal issues, Tahir Amin Co-Founder and Director of Intellectual Property Initiative for Medicines, Access & Knowledge (I-MAK) said that the organisation would appeal against the decision. “The Indian patent office has had to deal with a lot of external influences around this case, especially since the initial decision last year. Clearly the decision has been taken outside the realm of the patent office. The decision has not been reasoned properly and there are a lot of discrepancies. The interpretation of the law as it is intended has not been applied and we will be appealing against it.”
Get your Hepatitis C medicines today at Fix Hep C Buyers ClubPharmaceutical companies are trying ever harder to restrain the production of low-cost Hepatitis C medicines on all fronts. For them, a Hepatitis C patient is worth $80,000 or more. For us at Fix Hep C Buyers Club, Hepatitis C patient is worth saving because we consider it morally a right thing to do; this is why we have obtained a legal and safe way for Hepatitis C patients to obtain the medicines they need for less than $2,000. Please do contact us with the nature of your disease and Dr. Freeman will advise you on the best way of treatment, and what is even more important, we will deliver the treatment to your doorstep as soon as possible.
The irony of the problem is that in 2013 we have discovered a wonder drug to cure Hepatitis C patients, with about 95% cure rate. However, in 2014 we were faced with an all-time high death cases due to Hepatitis C virus. How can this be?
"Not everyone is getting tested and diagnosed, people don't get referred to care as fully as they should, and then they are not being placed on treatment," said Dr. John Ward, director of CDC's division of viral hepatitis.
Report on 2014 Hepatitis C related deaths by CDCOne of the reasons may lie in better reporting. CDC gathers information about Hepatitis C related deaths via computerised reporting system; in 2014, 40 states reported their Hepatitis B cases and 37 states disclosed statistical number about their Hepatitis C patients.
According to CDC report, the reported cases of acute Hepatitis C virus infection increased dramatically. While during the years 2006-2010 there were less than 1000 reported cases of infection per year, the number quickly rose to above 2000 cases per year in 2013 and 2014. That is more than 100% increase in less than 5 years. No doubt better reporting is in part responsible for the statistical increase; albeit that does not diminish the ever rising increase in HCV incidence.
New US Hepatitis C NumbersUp till the CDC report that came out on 4th of May 2016, the rough consensus on the number of HCV infected patients in the US was about 3.2 million. Now the number is more likely closer to 3.5 million, a nearly 10% increase in all Hepatitis C patients. What is more, the epidemiologic studies show that at least 4.6 million people in the US are HCV-positive. All of these people do not suffer from Hepatitis C; however, a very large majority has high probability of suffering the consequences of Hepatitis C.
Who are the new Hepatitis C patients?Using the statistical data from all the reporting states, CDC pointed out the demographics of people who's incidence of getting Hepatitis C is increasing the most. Here is a profile of a person now most likely to be infected by HCV:
- Young white persons
- Non-urban area residents (especially in Midwestern and Eastern states)
- History of injectable drugs use
- Use of opioid agonists such as oxycodone
Overall, factoring in the under-reporting and under-ascertainment, CDC estimates more than 30,000 people got infected with HCV in 2014 alone.
Hepatitis C related deathsAn average age of Hepatitis C patient that succumbs to the disease is 59 years. What is concerning is that there has been a drastic increase in Hepatitis C related deaths in adults aged 55-64 years old.
2007 marks the year when Hepatitis C related deaths (15,106) exceeded the number of HIV/AIDS related deaths (12,734). From that point on, we see Hepatitis C deaths gaining momentum while HIV/AIDS patients are doing better than before.
In 2014, almost 20,000 US citizens died from Hepatitis C; more than half of those were in the 55-64 years range. Baby boomers -- those born from 1945 to 1965 -- carry the greatest burden associated with the disease, as many have been unknowingly living with it for years.
You can access the full commentary on CDC report on Hepatitis C here.
Steve is 58 years old and had Hepatitis C for 10 years. With all the rumors about these new direct acting antivirals (DAA) treatment being so successful, he and his doctor make a decision to start sofosbuvir-based treatment of his genotype 1 Hepatitis C condition.
During the treatment Steve's well-being in being improved and after 3 months the tests show he is Hepatitis C free. He is giddy and excited about it like a little child and tells everybody that a decade-long fight with Hepatitis C is finally over and he had won. He even throws a party to commemorate the moment.
Now meet SVR. It is a clinical parameter that stopped Steve's breath. 4 weeks after treatment the same doctor that said he is cured of Hepatitis C, says that he is in fact not free of Hepatitis C at all. His viral load, which was zero when he finished the full treatment, was now up and rising. How can this be?
This is a story some Hepatitis C patients go through. After being told there is no HCV detected in their blood after treatment, the standard check up shows signs of Hepatitis C coming back, and the doctors are saying something in the terms that the measure of true cure rate of the medications is SVR. SVR4, SVR8, SVR12 and so on. Many patients are a bit confused when it comes to grasping the difference between successful treatment and SVR parameter. This is why today we will explain what does SVR mean; knowing this will make it easier for patients to better understand Hepatitis C and how it may 'come back' shortly after finalized treatment.
Difference between cure rate at the end of the treatment and 4-24 weeks after the treatmentAfter every treatment, especially as costly as above $80,000 Hepatitis C treatment (for the low-cost medications you can contact us), there is one thing every patient wants to hear - 'You are cured.'
In the case of Hepatitis C, the majority of people hear those exact words. In fact, even when the above 95% cure rate DAA treatment was not available and the golden standard of treatment was interferon, many patients heard those words.
Hepatitis C virus comes back.
In actuality, the SVR and cure rate have a lot to do with our method of detecting the presence of HCV.
During and after treatment, the HCV RNA viral load is measured - with the treatment working successfully, the viral load goes to zero and we interpret this result as being cured. In fact, however, having zero viral load only means that the current method of detection that works by identifying HCV's genetic material - RNA in viruses - has not detected any HCV RNA. To be even more correct, the levels of genetic RNA material of HCV in the blood was below the limit of detection of the method for measuring HCV presence.
Cure rate at the end of treatmentDuring the sofosbuvir-based treatment, patients take pills orally, the therapeutic DAA are absorbed into the bloodstream and from there they go wherever the blood goes and even beyond - into liver cells for example. However, the majority of the medication is circulating in the blood and it is in the blood that they have the greatest effect. At the end of the treatment, we look at blood for HCV, and upon finding none of it, we might say there is no detectable Hepatitis C.
However, HCV can be, for the lack of a better word, sneaky. In some cases, it 'hides' from the bloodstream only to be detected at a later time when it multiplies enough to start slipping into the bloodstream.
The great thing about the novel DAA treatment is that it 'finds' every virus there is and helps destroy it. In the case of older interferon treatment, it was very successful at eliminating the HCV in blood stream but the recurrence rate was high. 12 weeks after treatment, SVR12 or sustain virological release 12 weeks after treatment, was not 100%. It was closer to 50%; this is why we say that interferon successfully cures Hepatitis C only in about 50% of cases.
The DAA-based therapeutics such as sofosbuvir, ledipasvir, ribavirin and daclatasvir always include two distinct therapeutic molecules to scoop out all HCV. Let's say that sofosbuvir reaches and helps destroy 99% of the virus, it's counter part molecule - let's say daclatasvir - takes care of the remaining 1%. If that 1% would be allowed to survive the treatment, it wouldn't be detectable in the bloodstream right after treatment; however, after some weeks, it would multiply enough to be detectable. Detecting it would be a medical confirmation of Hepatitis C recurrence.
Luckily, with the new treatment, the number of patients who have zero load immediately after treatment and who retain this zero load even after 4 and 12 weeks, is very great. We talk about above 90% SVR4 and SVR12.
SVR4, SVR12 and SVR 24Generally speaking, the likelihood of Hepatitis C coming back a long time after treatment (SVR24) is extremely low (1%). The majority of patients where recurrence is happening is discovered 4 weeks after the end of treatment (SVR4). Here is a graph from Dr. Freeman's presentation, depicting the percentage of cure rate immediately after treatment versus 4 weeks after treatment.
As we can see from the graph, immediately after treatment (EOT) every patient except for 1 was 'cured'. However, the more realistic cure rate is depicted by SVR4 - this means the percentage of patients who were free of Hepatitis C 4 weeks after treatment. As seen from the results, the blood samples of a total of 8 patients have been positive on HCV RNA 4 weeks after treatment. These are the unfortunate, Steve's which brought the cure rate down to 94.4%.
Why is SVR important?Obviously the higher SVR4 or SVR12 a certain cure has, the better it is. Nonetheless, high SVR or high cure rate comes with some perks as well.
According to studies by Pearlman and Traub from Center for Hepatitis C, SVR-achieving patients saw a 'histologic regression of both necroinflammation and fibrosis '; this means the liver responded positively to being cured. What is more, patients with SVR were found to have less liver-related complications such as hepatocellular carcinoma, which translates to less liver-related deaths. According to an up-to-date statistics, about 500,000 people die from Hepatitis C or Hepatitis C related diseases annually.
Another interesting discovery by Pearlman and Traub is that successfully getting rid of HCV, which is associated with the increased insulin resistance, decreases the chances of getting Type II diabetes. This is also why HCV should be treated as soon as possible; the occurrence of other disease and liver damage can be reduced.
Here below is Dr. Freeman's presentation with added explanations. You can download full version of REDEMPTION-1 clinical trials below (see attachment).
The True Scope of Hepatitis CAs Dr. Freeman neatly put it, the discovery of the modern Hepatitis C drugs that consist of DAA rivals the invention of penicillin by Alexander Fleming in 1928. What is interesting in this analogy, is that penicillin became widely used only in 1942 during the WWII. The DAA treatment is currently available to anyone - with deep enough pocket. Out of estimated 150 million Hepatitis C patients, only 500,000 are treated with the DAA annually. That is less than 1%.
Of the Top 5 major causes for infectious disease, Hepatitis C just might be the one that is known the least. However, with the revolutionary DAA treatment making headlines, Hepatitis C awareness is slowly building momentum and the true scope of problems connected with Hepatitis C are becoming more obvious every day; as is the problem of the high prices of branded Hepatitis C treatments.
Top 5 Major Causes of Infectious Diseases:
- Hepatitis B Virus (HBV)
- Hepatitis C Virus (HCV)
We have had effective treatments for all of these diseases except Hepatitis C for more than a decade. It was in late 2013 that first DAA molecule called sofosbuvir was launched which should in effect greatly improve the world's Hepatitis C statistics by curing Hepatitis C patients. After all, the new Hepatitis C treatments have a cure rate of about 95% with minimal side effects.
Here are some up-to-date statistics on Hepatitis C as presented by Dr. Freeman:
- We have 150 million patients infected with Hepatitis C virus
- We have about 500,000 death connected with Hepatitis C and Hepatitis C related disease
- Even with the effective DAA treatment discovered, we treat only 500,000 patients per year
"If we have 150 million patients, why do we treat only 0.5 million of them? Especially with another 0.5 million patients dying every year."
The answer is pretty obvious as well.
How Big Pharma prices Hepatitis C medicinesThe problem is the high cost of treatment.
Big Pharma is apt to increase prices of innovative drugs; nonetheless, the Hepatitis C treatment area is another problem altogether because of the very extremes Big Pharma went to price Hepatitis C treatments that are of questionable innovation and are not based on production costs of manufacturing DAA-based pills.
Here is an illustration by Dr. Freeman about how the new standard sofosbuvir-based Hepatitis C treatment costs, and what are the actual production costs for making it.
From the graph above, it is clear that Hepatitis C treatment pricing has nothing to do with the cost of ingredients. Pharmaceutical companies spend $100 to produce Hepatitis C drugs, and sell it for outstanding $84,000 (US price). This incredible margin indirectly translates to 500,000 death every year.
Paradoxically, the discovery of an effective Hepatitis C cure brought more problems than it solved due to how Big Pharma operates.
There is a way around Big Pharma. One of the main objectives of REDEMPTION-1 clinical trials is to provide a scientific basis for treatment with the generic DAAs. It was designed to prove a patient can be cured using the low-cost generic DAA as effectively as with $84,000 priced branded medicines.
Generic DAA and the legality of obtaining itGeneric DAAs are basically the main therapeutic ingredients that branded Hepatitis C medicines are made of. It is important to understand that DAAs hold all of the therapeutic effect; pharmaceutical companies usually add sugars and other non-therapeutical ingredients to transform DAAs in powder form into a pill; a product most of us are used to.
According to the study, generic DAAs such as sofosbuvir, ledipasvir and daclatasvir are being mass produced for 1% of the current US price of final products. By using these DAAs for treatment, we can forgo 99% of costs connected with Hepatitis C treatment. However, in many cases legality of using the low-cost generic DAA is put under question. These issues are very important when it comes to obtaining low-cost treatment and were addressed at the International Liver Congress 2016 in Barcelona.
Dr. Freeman pointed out that according to the governing laws of Australia, the UK and other countries, an individual patient has the right to import the maximum of 3-months worth of supply of medicines intended exclusively for personal use.
In the pharmaceutical industry, usually the Big Pharma has patents on therapeutic molecules lawfully giving them monopoly power and privileges. The Hepatitis C treatment are no exception; DAAs such as sofosbuvir, ledipasvir and daclatasvir are all protected by patents.
Nonetheless, World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) provides a basis why importing Hepatitis C medicines such as generic DAAs is legal.
According to Article 60 of the said agreement known as De Minimis Imports, the following is stated:
"Members may exclude from the application of the above provisions small quantities of goods of a non-commercial nature contained in travellers' personal luggage or sent in small consignments."
The quotes article states that the TRIPS laws exclude the import of small quantities of non-commercial goods. A Hepatitis C patient travelling out of China with generic DAA pills in his backpack for personal use is an example of practical application of De Minimis Imports article. This also provides a legal basis for fixhepc.com to provide Hepatitis C patients with access to medications and helps them by discussing the treatment on-line.
REDEMPTION-1 Clinical TrialsIn order to start the REDEMPTION-1 clinical trials, two key elements were needed:
- Credible generic DAAs as treatment.
- Hepatitis C patients as subjects.
Generic DAAsGeneric DAAs were obtained and their quality was evaluated with advanced pharmaceutical techniques such as HPLC, NMR and Mass Spectrometry. To a trained eye, the results obtained (included below) prove that the obtained sofosbuvir DAA has a molecule structure expected from sofosbuvir molecule. This confirms the validity of the generic DAAs used in the REDEMPTION-1 trials.
The peaks in the NMR spector above correspond to specific hydrogen (H) atoms within the molecule of sofosbuvir and confirm the structure of the whole molecule. NMR is a standard technique for obtaining the molecule structure of small therapeutic molecules such as DAAs.
Hepatitis C PatientsIn order to determine the effectiveness of the obtained generic DAAs, Hepatitis C patients were recruited via http://fixhepc.com/ website. With the help of Dr. Freeman, more than 400 patients were assisted in making a personal importation of the affordable Hepatitis C medications.
As one can clearly see, the patients from all over the world were included in the trials. Each of them were given an assistance in legally importing the verified generic DAA treatment for an affordable price.
Using the gp2u.com.au Telemedicine Platform each patient was assessed in three stages:
- Before treatment
- During treatment
- After treatment (determining the cure rate via sustain virological release (SVR))
It is well known that there are 6 genotypes of Hepatitis C virus and each of them is treated in a respective manner with a selection of generic DAA. From the poll of over 400 Hepatitis C patients, Dr. Freeman presented the statistical data about the patients involved in the trials.
The statistical data above reveals that the average age of Hepatitis C patient in the trials was 54.4 years. About half of the patients were naive - meaning they received no previous Hepatitis C treatment, and about 30% of them have already suffered liver cirrhosis.
The most predominant genotypes in the trials were genotype 1 (63.9%) and genotype 3 (27.5%), and the most predominant manner of treatment was sofosbuvir+ledipasvir (45.8%) and sofosbuvir+daclatasvir (42.6%).
REDEMPTION-1 Trials ResultsThe objective of the trials was to evaluate the safety and efficacy of generic DAA treatment and compare them with published data from Phase III clinical trials of existing branded Hepatitis C treatments.
The main parameter for measuring the efficacy of Hepatitis C treatment is the decrease in the viral load over time.
In the graph below, we can see the comparison of how quickly does the HCV viral load decrease in patients treated with the generic DAA. Added to the graph are the results of Phase III clinical studies of how quickly did the HCV viral load decreased in patients using branded medicines.
Reading the graph, it is important to see that when Log Viral Load reaches 1, there is no more HCV virus present (since log(1)=0). The results of REDEMPTION-1 trials clearly indicate that the decrease in viral load in patients treated with generic DAA is as quick, or in some cases even quicker, than in patients treated with branded medications. This confirms the premises that the efficacy of generic DAA treatment is comparable to that of the treatment with branded medications.
Here is a more detailed look of how generic DAA treatment combination sofosbuvir+daclatasvir is fighting off HCV in patients with genotype 1 and genotype 3.
As we can see, the viral load of genotype 1 patients has decreased to 0 (Log Viral Load = 1) faster. In average, it took about 14 days of treatment for genotype 1 patients to be free of HCV. For genotype 3 patients, the zero viral load was achieved in about 30 days.
In both cases, the sofosbuvir+daclatasvir combo was proven to be very effective in curing Hepatitis C.
What was the cure rate in REDEMPTION-1 Trials?A parameter that is observed when we want to determine if a patient is cured of Hepatitis C, is the viral load (HCV RNA). If we cannot detect the genetic material RNA of HCV in the performed test (this means that the content of HCV RNA is below the lower limit of quantification (LLOQ)), we count such a patient as cured.
However, some patients who show zero viral load at the end of treatment (EOT), will in some weeks again suffer from Hepatitis C. Some of HCV viruses were not destroyed and evaded detection; without treatment they will multiply and we will again see their presence via measuring the viral load.
In the graph below, we see the efficacy of treatment at 2 distinctive time points:
- At the end of treatment (left columns)
- 4 weeks after the end of treatment (right columns)
At the end of the treatment, the resulting cure rate for the most prominent treatment regimens was 99.6%. Out of 236 patients treated, only 1 still showed a non-zero viral load at the end of the treatment. The viral load of the rest 235 patients was zero.
4 weeks after treatment, however, some patient experienced the Hepatitis C recurrence. From the data for GT1 above, we can see that the treatment combo sofosbuvir+ledipasvir went from being 99.2% successful to being 93.7%. This means that in 5.5% of patients treated in such a way, Hepatitis C came back.
On the other hand, sofosbuvir+daclatasvir combo was more successful - the cure rate after 4 weeks fell to 97.3% from 100%. Essentially, only 1 patient with GT1 treated in such a manner suffered from Hepatitis C recurrence.
The main result of REDEMPTION-1 Trials - EFFICACYThe REDEMPTION-1 trials main objective is to scientifically prove that the generic DAA medicines patients can purchase for about $1,000 are equally successful in curing Hepatitis C as branded medications for which the US patients have to pay $84,000 or more.
The overall cure rate was observed via parameter SVR12 - sustain virological release measured 12 weeks after the end of treatment. It is a consesus that SVR12 is a true measure of Hepatitis C medication efficacy.
In the graph below are the cure results of branded medications for each genotype.
Here are the cure results as obtain with generic DAA treatment in REDEMPTION-1 trials.
By comparing the above graphs, we can see that the cure rates in branded medicines treatment and low-cost generic DAA treatment are very similar.
This is the confirmation of REDEMPTION-1 trials objective.
Accordingly, we see less than 6% difference in cure rates between branded medicines and low-cost generic DAA; what is more, in more cases the treatment with generic DAA has proven to be even more successful than with the branded medications.
The main result of REDEMPTION-1 Trials - SAFETYDr. Freeman also addressed safety evaluation of the generic DAA treatment. As you can see from the presentation slide below, the safety profile of patients included in the study was comparable to the findings of Phase III clinical studies for respective branded medications.
Conclusions of REDEMPTION-1 TrialsThe successful REDEMPTION-1 trials have proven that the Hepatitis C treatment with the generic DAA is as effective and safe as with branded medications.
In order to summarize the results of the trials, Dr. Freeman pointed out 3 very important things to remember:
- Generic cure for Hepatitis C is as effective as branded medications, and it only costs $1,000.
- Given $200 costs of production of sofosbuvir+daclatasvir API, the possibility of $200 Hepatitis C cure is now (not in the future)
- There are 150 million Hepatitis C patients in the world. Without low-cost affordable treatment the future of majority of Hepatitis C patients looks like this (check the photo below)
The successful trial is being praised all over the news. Here are some stories about how the REDEMPTION-1 trials might influence Hepatitis C treatment in the future.
Dr. Freeman of FixhepC Buyers Club gave one of the most convincing presentations by tackling the most important issue in Hepatitis C treatment today - the high prices of branded drugs coming from Gilead Sciences, Abbvie, BMS and MSD. From the data gathered during large-scale clinical trials with DAA treatments, it is evident, as Dr. Freeman himself pointed out, that patients who cannot afford more than $80,000 for branded Hepatitis C drugs can be treated with DAA with equal success rate. The upside of DAA treatment is the low cost - Hepatitis C patients from all over the world can be cured for as little as $1000.
By proving the generic DAA treatments to be as successful as branded treatment, Dr. James Freeman defined a clear role of generic medicines in Hepatitis C treatment area.
Dr. Freeman's IdeaThe International Liver Congress was always a very notable event; however, in recent years the interest and people coming to the event started picking up tremendously. Obtaining a new Hepatitis C cure is a part of the reason why; the other part is that by inventing a very successful Hepatitis C cure, this treatment area became very profitable for everybody who is selling branded Hepatitis C treatments.
One look at the table of the most expensive prescription drugs in the US will tell you why Hepatitis C treatment sell, and they sell for ridiculously high prices.
However, for everybody who can afford Hepatitis C treatments like Sovaldi and Harvoni, there are at least 10 people in the US and around the world who cannot even phantom how to raise $80,000 for the treatment without which they will in all probability die.
Generic Hepatitis C marketThe secrets of the success of modern Hepatitis C treatments are the newly found active molecules in branded medicines. These active molecules, which carry all the therapeutic effect, are known as direct-acting antivirals or DAA for short. Because how the Big Pharma works, the DAA such as sofosbuvir, ledipasvir and daclatasvir are readily available in pharmaceutically-based manufacturing companies in India and China.
Dr. Freeman's idea was simple but has a profound effect: Why not use these low-cost DAA, from which branded Hepatitis C treatments are made off, to treat Hepatitis C?
With the redemption trials, Dr. Freeman went out to establish how well do the DAA cure Hepatitis C in comparison with branded drugs such as Sovaldi and Harvoni. The upside, of course, is a huge reduction in Hepatitis C treatment cost. If the DAA work, a patient with Hepatitis C would no longer be asked to pay more than $80,000 for the treatment; he or she will have an alternative option to be treated with DAA for about $1,000. In such a way, millions of Hepatitis C patients all over the world can get an access to the treatment because of it's financial availability.
DAA Redemption TrialsThe purpose of DAA redemption trials was to establish how well do the DAA treat Hepatitis C. We know the cure rate of the majority of branded Hepatitis C treatments is above 90% according to respective Phase III clinical trials done by Gilead Sciences, Abbvie, MSD and BMS.
For the purposes of the trials, the low-cost DAA such as sofosbuvir, ledipasvir, daclatasvir and ribavirin were legally imported and tested with modern analytical techniques such as HPLC, NMR and mass spectrometry. Patients involved in redemption trials came from all over the world - US, UK, Australia, Canada, Europe, SE Asia and Africa.
“Our interim data suggests a potential solution for Hepatitis C patients in areas where treatment access has been restricted as a result of the high prices demanded for branded treatment,” said Dr. James Freeman, the lead author of the study. “At the price level of generic direct-acting antivirals, treating the entire global Hepatitis C epidemic could be financially feasible. Furthermore, if a patient is cured of Hepatitis C, there is evidence for improved survival, and lower risks of liver cancer and liver cirrhosis and cured patients could return to work, delivering further economic benefits to society.”
Trial's results clearly indicate that generic DAA treatment is successful in overall 95% cases in patients with the most common genotype 1. More importantly, this is in line with how well branded medications performed in their respective Phase III clinical trials. This serves as a proof that being treated with banded medication will yield the same results as with generic DAA treatment - however, by choosing the later, you will save $80,000. Not only that, all the patients who cannot afford to fetch up $80,000 will now have an excellent fighting chance by choosing the $1,000 DAA treatment.
The cure rate for sofosbuvir + ledipasvir (branded medicine: Harvoni) in genotype 1 Hepatitis C patients is 93%.
The cure rate for sofosbuvir + daclatasvir (branded medicine: Sovaldi + Daklinza) in genotype 1 Hepatitis C patients is 97%.
“Across all genotypes, the SVR rate was 94% after treatment with generic DAAs. This indicates that generic DAAs can deliver the same success rates as branded equivalents, but at a price which is 1/100th of the current cost,” explained Dr. James Freeman.
The Implications of Successful DAA Redemption TrialsAbout 15 years ago, instead of Hepatitis C, we were dealing with high prices and resulting lack of availability for HIV drugs. People were dying not because of the lack of treatment but because the treatment was too expensive for most of them to afford.
Today everybody infected with HIV is treated with very effective and affordable treatment.
If there was one defining moment in history that changed our view of HIV from a deadly disease to an easily-treatable one, it was a 2004 Lancet published study that proved the same for HIV as Dr. Freeman demonstrated for HCV - Generic medications work as effectively as the originator's medication for a fraction of the cost.
Because of the impact factor the International Liver Congress has, we don't need only to hope for Hepatitis C to be as easily treatable as HIV in 15 years - we can count on it. From an average patient to the US Senate, everybody is pushing for lower cost of Hepatitis C drugs; but as of yet the Big Pharma could not be reasoned with.
Thankfully to Dr. Freeman we don't need Big Pharma to lower the costs any more; now we have a definitive proof that the low-cost generic DAA treatment is equally successful as the drugs Big Pharma wants to sell for above $80,000. We can do it for $1,000 and in such a way we can help everybody - not only 6-figure income people in the US, but a farmer in Australia or a sheep herder in Egypt as well.
“There is a clear role for generic treatments such as these for people with Hepatitis C across the world. The implications of increased availability of these drugs could be enormous, presenting more people with the possibility of a ‘cure’ for what is often a debilitating condition,” said Professor Laurent Castera, EASL Secretary General.
We will give you an inside scoop on the details of the study from Dr. Freeman's presentation in our next blog post. If there is one thing to remember from all of this, it is that when Dr. Freeman was done with the presentation a few light bulbs went off above scientific and medical experts heads - the idea that we can cure the whole planet of Hepatitis C, and we can actually afford to pay for it is a reasonable one.
In the video below you can see the highlights from the International Liver Congress 2015. The video for 2016 highlights is currently in production.
Gilead is a hedge fund under the guise of a pharmaceutical company. They want drugs that will treat diseases that are problems in wealthy, industrialized nations. Don't look for them to come up with a cure for malaria, ebola or Zika-there is just not enough money in it for them to be interested.
They will continue to tend the geese that lay the golden eggs until, like Australia, they are forced to "make the deal". Then they will cook and eat them.
In the US, insurers are relaxing restrictions because of legal pressure brought about by patients over denial of treatment. This will force substantial rises in the cost of health insurance for everyone, with Gilead getting the money. Health insurance companies don‘t go broke. They have reserve funds, and when they have to tap into them one year, they raise the premiums the next to cover the shortfall.
Widespread acceptance of affordable generics is the only way Greediad will have its hand forced. Dr. Freeman's EASL presentation on the stellar findings of the REDEMPTION clinical trials tomorrow could be a major first step.
We are in a high stakes poker game here. The insurance companies are the "house”- Gilead, the well-funded, card-counting professional gambler.
We are the chips.
According to clinical studies done on 300 patients in Egypt, the new Hepatitis C combo is 100% successful in curing Hepatitis C. What is more, DNDi predicts this medicine will be available in the US, Europe and Japan for - brace yourself - less than $300.
$300 instead of $80,000 for curing Hepatitis CHepatitis C was not a big market for pharmaceutical industry prior to 2013. Gilead Sciences, a pharmaceutical giant, launched Sovaldi (400mg sofosbuvir) in December 2013; this is when everything changed. Hepatitis C became one of the most important therapeutic areas for Big Pharma.
Sovaldi was a stellar achievement and raised the cure rate in Hepatitis C patients from 50% to over 90%. But what made the headlines was it's price point - $80,000 for a single treatment. This transformed Hepatitis C treatment area to one of the most lucrative and profitable areas Big Pharma can find themselves in.
The extreme pricing of Sovaldi led to the extreme pricing of other Hepatitis C medicines which were launched after Sovaldi. Viekira Pak, for example, was launched by AbbVie with a price $83,320 per treatment. In fact, if you check the most expensive drug on the planet list, you're bound to find all Hepatitis C drugs on it and not one of them has a price tag less than $50,000 per treatment.
This is why DNDi's study is so important. It seems that the drug combo they develop is working even better than what Big Pharma came up with, and they are willing to give it to patients for mere $300. This is more than 99% price reduction in Hepatitis C treatment.
DNDi is a non-profit organisation and factors only the manufacturing costs and the costs of running the DNDi into the final cost of medicines. This is how the $300 price tag can be achieved. One has to ask if Gilead has the same costs, why does it charge $94,500 for Harvoni in the US? That means that $300 goes to the manufacturing, and $94,200 is counted as net profit from each and every patient.
By now pretty much everybody knows the story about how Martin Shkreli lifted the prices of HIV medications from $13.50 to $750 per pill. DNDi is doing just the opposite; they will try to reduce $1,000 per pill standard to $3.50 per pill.
Ravidasvir and Sofosobuvir combo clinical study in EgyptDNDi teamed up with Egyptian pharmaceutical company Pharco Pharmaceuticals to conduct clinical studies in Egypt. 300 genotype 4 Hepatitis C patients were included in the study, and the cure rate is between 98%-100%. This showed principle investigators that one does not need to use ribavirin in order to successfully cure genotype 4 Hepatitis C.
DNDi is of an opinion that the new Hepatitis C drugs for $300 will be available in Egypt within 12 months. On the other hand, they are starting to conduct clinical trials in Malaysia and Thailand where patients have different underlying genetic characteristics. Upon successful trials, we are be expected to see Hepatitis C cure for $300 within 18 to 24 months. The drugs will be available in developing countries as well as developed countries. However, bringing such low-priced medicines to markets dominated by pharmaceutical giants such as Gilead Sciences, Abbvie, BMS and MDS might be challenging.
What are Hepatitis C patients to do?An average Hepatitis C patient should right now be asking the following question 'Do I buy Harvoni for $94,500 or wait two years and buy this new Hepatitis C combo for $300?'. The difference is ground-breaking.
Patients are currently paying more than $1,000 per pill of Sovaldi or Harvoni, and they usually need 84 of them. Pharco Pharmaceutical is expected to produce and sell the drugs that have the same or even better effect on Hepatitis C for $3.50 per pill.
The answer what to do: it depends from patient to patient. The most basic idea is to consult with your doctor about waiting for the new medication. It might suit your wallet, but if your liver deteriorate too much during this period, the size of the wallet won't matter any more.
Sovaldi was originally priced at $36,000 - Why do Hepatitis C patient have to pay more than $80,000 for it?Written by Marko
Let us look at a list of the most expensive drugs in the US. There are top 10 on the list; can you guess how many of them are Hepatitis C treatments?
We will explain an extraordinary story why all of these Hepatitis C drugs found their way on the list. In 2011, the highest expected price point for Hepatitis C cure was $36,000. Now patients are paying more than $80,000 for the privilege. What happened?
The real prices of the most expensive drugs in the US.
As you can see in this summary by Medscape, 5 out of 10 most expensive drugs in the US are Hepatitis C treatments. Gilead Sciences takes the 1st and the 2nd price with their extremely highly priced sofosbuvir-based treatments Sovaldi and Harvoni.
How Sovaldi Came to the US MarketSovaldi and Harvoni are marketed by a pharmaceutical giant Gilead Sciences. They were the ones who got the market authorisation approval by the FDA in December, 2013, and launched Sovaldi - the first all-oral Hepatitis C cure. Without a doubt, the first effective Hepatitis C cure was a game changer. It didn't only change how we perceived Hepatitis C but how we see pharmaceutical industry as a whole. The reason? Just look at the current Sovaldi price point - above $80,000 per a single treatment.
Pharmaceutical companies often try to justify high costs of drugs because of all the research and development that went into finding the innovative new drugs. Admittedly, R&D costs are high and rising, but Gilead Sciences was a bit shy to use R&D costs and innovation as an excuse for the extreme pricing of Sovaldi. Why?
R&D Costs for Sovaldi were very lowThe reason is because Gilead Scienced didn't do all the R&D job themselves; they didn't even do the majority of it. The necessary R&D was done by Pharmasset, a pharmaceutical company that was bought by Gilead because of its wonderful sofosbuvir molecule (Sovaldi consists of 400 mg sofosbuvir pills). Pharmasset has done the majority of work, and in their SEC filing in 2011 they projected that when the sofosbuvir-based drug will be finished and launched, 'a U.S. base rate of $36,000 per course of treatment' will be applicable. So how did we come to $80,000 price tag for Sovaldi?
If there was a single identifiable moment when Hepatitis C patients should scream at the tops of their lungs, it was the 2011 purchase of Pharmasset by one Gilead Science Inc.. Gilead paid $11.2 billion for a company with the ground-breaking Hepatitis C molecule. All they had to do, is just bring the research to conclusion, launch it and Hepatitis C patients would be well off, knowing they have an affordable medicine.
Instead, Gilead Sciences made a giant correction in the price of new Hepatitis C treatment. They raised what was supposed to be $36,000 cure into $80,000 cure. Given that patients don't really have a choice, Gilead put their bets on a sole premise that patients would rather pay $80,000 than die. And it paid off in a big way.
Gilead Sciences stock after Pharmasset purchase
When Gilead bought Pharmasset, its shares were trading below $20 and the company's market capitalisation was less than $30 billion. Gilead was a small-to-middle-player in the biotech industry.
In two years it took for Gilead to turn sofosbuvir molecule into Sovaldi medication, its shares were trading 300% higher at $80, and had a market capitalisation near $100 billion. Sovaldi has single-handedly made Gilead Sciences into a biotech giant it is today.
What has Gilead actually done?
Bought another company and harvested the fruits of their labor. It's just like a normal person going to the store, buying a dishwasher and selling the washed dishes for $1,000 a plate. Gilead just brought it home in a big way.
Lack of InnovationThe key active ingredient that goes into Sovaldi and Harvoni is sofosbuvir; this is why Pharmasset was bought for $11.2 billion. In hindsight, combined Sovaldi and Harvoni sales will probably peak over $20 billion in sales - if Gilead has done something right, it was its purchase of Pharmasset.
Sofosbuvir enables Hepatitis C treatments to be even more than 95% successful in curing Hepatitis C. However, despite the miracle effect, the molecule is not something all that new. If a medical chemist would compare sofosbuvir with acyclovir, standard antiviral, he would see some difference but practically the same bone structure of the molecule. Sofosbuvir is just a bit tweaked, that's all.
Acyclovir (left) and Sofosbuvir (right) - Molecules are different but the principle of how molecular structure affects Hepatitis C is the same
In the developed world, this tweaking means innovation. However, India did not find the Gilead's new sofosbuvir molecule all that different from other similar antiviral active ingredients. They stated that Gilead failed to showcase a significant innovation and this is why India did not grant patent rights to Gilead for their Hepatitis C drugs. Gilead had to struck a deal with Indian pharmaceutical companies to generate its Hepatitis C drugs and sell it for about $1,000. One has to ask - if they can sell Sovaldi for $1,000 and still turn a sizable profit, why are they selling Sovaldi for more than $80,000 in the US? How much profit are they making by selling drugs to people who would die without them?
The best way to get rid of Hepatitis C is of course to get the treatment with DAAs such as sofosbuvir, ledipasvir, daclatasvir and ribavirin. FixHep C Buyers Club offers these treatments for less than $2,000, with a kind help of Dr. Freeman; the original price of these medications can cost up to $100,000.
Here are some ideas how to help yourself if you are suffering from Hepatitis C.
18 Ways To Cope With Hepatitis C
- Join a support group. Talking to other people about the same problems is a very effective method to cope with any disease. Many HIV, addicts, alcoholics and so on are finding it as a means of acceptance, and Hepatitis C patients are recommended to find local Hepatitis C meetings and attend them.
- Stay away from alcohol, tobacco, excess caffeine and illicit drugs. If you can’t quit, cut back or ask for help.
- Keep your vaccinations current. Be immunized against hepatitis A and B.
- Aim for 7 to 9 hours of sleep every night.
- Strive to be as physically active as you can be on a regular basis. There are many choices, such as walking, bicycling, gardening, dancing, swimming, stretching, Yoga, Tai Chi or strength training. Just keep moving.
- Maintain a healthy weight.
- Eat a low fat, high fiber diet. Include fruit, vegetables, and whole grains. Avoid trans-fatty acids and saturated fats.
- Balance rest and activity.
- Cultivate a positive attitude.
- Avoid or reduce stress.
- Engage in activities that give you pleasure and make you laugh.
- Choose activities that stimulate your brain.
- Engage your spirit in meaningful ways, such as meditation, a walk in the woods, prayer.
- Learn to laugh at yourself.
- Drink at least 8 glasses of water every day.
- Maintain friendships and social contacts.
- Help others. Volunteer your time.
- Remind yourself of the things in your life to be grateful for or that you appreciate.
Picking some things from this list might help you to keep a positive outlook as well as keeping your body healthy.
Where does India come in in the pharmaceutical industry?This is how drug industry works.
New drugs are being developed by big pharmaceutical corporations in the developed world (mostly the US and Europe). When such originator drugs are launched, they are usually very expensive and patients and healthcare insurances have to pay even 100s of dollars per dollar of costs of actually making the drug.
Hepatitis C treatment area is a great example of that: Gilead Sciences developed an active molecule sofosbuvir (in hindsight, they bought a company that developed sofosbuvir, and invested in clinical studies to bring it to the market). They registered a drug called Sovaldi that consists of 400mg sofosbuvir pills, and they are selling a single such pill for about $1000 in the US. The manufacturing costs to create such pill are a lot less than $10. But, after all, this is how pharmaceutical industry works.
India - 'A pharmacy for the developing world'India is special because they enable access to expensive drugs by creating generic versions of such drugs. This is why India is dubbed 'A pharmacy for the developing world'. They are known to produce low-cost medicines that are also being sold for low prices. Gilead may produce low-cost medicines (they will pay pennies on the dollar for production costs) but you'll never see them selling it for low prices.
Patents are how big pharmaceutical corporations secure monopoly in the drug business and is the reason why they can sell drugs at such high prices. What makes India so special is not only that they are capable of producing drugs; it is that they have a special patent law that is not so much in favour of big corporations than in the rest of the world - and this is exactly the law that Europe and the US want them to change.
Indian patent law is designed specifically to prevent ever greening. Ever greening is the practice of pharma business big players to extend or get new patents on old drugs - in many times by making small changes in the active molecule or package it is some new way. In such a way, the drug effectiveness is not significantly increased - but the company sales of the drugs are huge because they can get a patent for it as a novel drug and sell it at high prices. Well, that can't be done in India.
Here is an example of ever greening. AstraZeneca, the second biggest pharmaceutical company in the UK, has been selling a drug containing omeprazole for some years (omeprazole is a treatment for acid reflux in the stomach). When a patent on omeprazole was about to expire and the drugs they were selling for lets say $50 would be reduced to $10 due to generic competition, they 'invented' a new active molecule called esomeprazole. This is how they could not only maintain $50 drug prices, but even increase the price to lets say $70.
The problem? Look at the difference between the drugs.
One does not need to be an expert in drug design to see that the molecules are practically identical; there is just a bit of a difference in the middle of the molecule (S-O bond). The treatment effects of both molecules are comparable; albeit esomeprazole was proven to be slightly better. AstraZeneca sold esomeprazole up till 2015 - at that point they were selling about $5 billion of esomeprazole per year. Without it, they would lose tens of billions of dollars that would remain in the pockets of their patients.
India's free trading agreement with EuropeIn Hepatitis C world, the story of Australian Greg Jefferys is well known. He was a Hepatitis C patient who couldn't afford $100,000 for the medicine Gilead Sciences was selling. He is one of the first who flew to India, bought generic Sovaldi for $1,200 and got cured. This is an example how every Hepatitis C patient can benefit from India's drug industry, and of course how the big corporations in the developed world can fail in extorting huge sums of money from people who know will die without the drugs the big pharma is selling.
With the recent renewal of India's free trade agreement with Europe, the practices of India's patent law offices are coming into question. If these laws would be changed to the laws in developed countries, there would be no more low-cost medicines for patients. There would be no more cheap Sovaldi and Harvoni for Hepatitis C patients.
The good news is that India is now likely to bow down to Europe.
'People will die' if India bows to EuropeThe statement was made by Gregg Jefferys who experiences the first hand the harshness that big pharma possess and the solution that India's generic pharmaceutical industry presents.
Dr. Prabhash Ranjan, Prof. of Trade Law at South Asia University, is of an option that the patent law is not likely to be changed in India. India simply has too much to lose. Because of all the benefits of low-cost medicines, India is reaping a lot of success with the so-called 'Hepatitis C tourism' - welcoming people from all around the world who can't pay $100,000 for Hepatitis C drugs. They come to India for a week or two, get the drugs for $1000 or so, and are cured within 3 months.
We will let you know how everything turns out. In the meantime, be sure to contact us and get the Hepatitis C drugs from India while the loophole is still open.
Rates of newly confirmed Hepatitis C patients in two age groups: The young (15-24 years) and everybody else, in Massachusetts (2002-2009)
If we look at the 'All other age groups' curve, we see that the rate of people newly infected with Hepatitis C is steadily dropping from 0.18% of the population to 0.12%.
The disconcerting curve is the second curve. We see that the incidence of Hepatitis C patients in the US state of Massachusetts rose for almost 100% in 7 years. This indicated that there is a new wave of Hepatitis C patients on the horizon; the upside here is that by properly informing our youth about the dangers of injecting illegal drugs via needles - this is the most common way of Hepatitis C transmission - we can drastically decrease the incidence of new Hepatitis C patients.
Hepatitis C infection is not slowing down - it is speeding upAccording to the article published in Oxford Journals, the rate of young people below the age of 30 contracting Hepatitis C was steadily increasing during 2006 to 2012. Here are some interesting results based on national surveillance in the US:
- 13% annual increase in reported Hepatitis C cases for young people in non urban areas
- 5% annual increase in reported Hepatitis C cases for young people in urban areas
- In 75% of cases, patients admit they used illicit injectable drugs via needle (opioids)
The survey data was gathered by Centers for Disease Control and Prevention for 34 states, and 634 people were interviewed about drug use.
Drug use is propelling the rise of Hepatitis CLooking at the CDCP data, one will find out that it's not Hepatitis C that is the issue - it is improper drug use.
The most common transmission of Hepatitis from person to person is via sharing an injectable needle. With more than 50% of Hepatitis C patients being infected in such a way, it is a major source of recovery if we tap into it in the right way. Namely, if we remove the infected needles out of equation, Hepatitis C spread can be stopped very effectively.
However, the problem is that more and more young people are using injectable drugs. This issue is being addressed for many decades now but the results, as we clearly see from the numbers of people still injecting themselves with opioids, are disconcerning . While stopping drug use is a very important cause, it is not necessarily needed to stop the spread of Hepatitis C.
Clean needles may be enoughHepatitis C is something drug users may not be concerned about at first because it's effects will show only after 10 years or more. Nonetheless, the core of the problem with Hepatitis C are 'infected needles'. These are needles that were used by a Hepatitis C positive person at first but were later used by a Hepatitis C negative person without prior sterilization - in such a way, we get two patients from one patient, and the chain reaction continues.
One way to break the chain reaction that is currently happening in the US is to provide clean needles. Many do see it as a kind of an incentive that even promotes drug use, but with regard to Hepatitis C, the solution, if implemented correctly, was of much benefit. There are no chances people will get infected if they use clean needles.
Another solution is to 'tag' Hepatitis C patients, similarly to HIV positive patients. However, this approach is met with ethical dilemmas and even if it were implemented thoroughly would not yield as effective results as complete stop of drug use.
Toll paid by the society for illegal drug use by 15-24 year oldsAccording to demography of the US, there are more than 40 million American aged between 15 and 24 years old. As we have seen from graph above, the incidence between 2002 and 2009 rose from about 0.06% to 0.012%. How many more young Americans are suffering from Hepatitis C?
If you do the maths, you see that there are more than 20.000 additional cases of future chronic Hepatitis C patients, just due of the new increase.
Considering the high costs of treatment (for example Harvoni, most prominent Hepatitis C medication, costs $94,500 for standard treatment in the US), these additional cases alone will cost more $1 billion to treat. Now this is a subsancial figure that can make you think twice before injecting yourself with a non-sterilized needle.
In the developed world, the newly discovered treatment is already taking effect and the number of Hepatitis C patients finally started to decrease. However, the most problematic countries that produce more and more Hepatitis C patients without a systematic healthcare system eliminating the HCV, are third world countries. Today we will look at the example of just such a country - Pakistan.
Pakistan is the country where the number of Hepatitis C patients is increasing at an alarming rate. These five practices speak all about it.
1. Injecting a silent killerAdministering interferon through intra-vascular injection is still a common mode of treatment in Pakistan. It is embedded deep down in medical culture and practices. In rural areas, the predominant symbol of doctor is the person holding a mighty injection. In many ways, this image of a doctor is interesting and opposite to the universal image of doctor wearing a white coat and holding a stethoscope around her neck.
In injection practice, alarming thing is not the injection itself but unhygienic reuse of syringes. There are cases where doctors have had limited supply of syringes for a whole week. This unhygienic practice let the infected person transfer the hepatitis virus silently to the other person.
Doctor-to-patient transmission is something the developed world is not immune to as well. A few weeks ago we wrote a story about a UK based NHS doctor who potentially infected more than 8,000 patients with HCV.
Spread of Hepatitis C all over the world
2. Quakes are part of problem not part of solutionQuakes are a sort of physicians in Pakistan. They do not study medicine or surgery but they do practice both. They are mostly working or retired paramedics but they act like real doctors and start their own clinics. Quakes are least concerned about preventive measures and hygienic standards.
They administer infected syringes, use non-scientific methods and prescribe sub-standard medicines. In many ways, quakes create an environment where infected person transfer the virus to other healthy person. These self-styled doctors do not recommend their patients basic tests and administer injection at their own whims. Many patients with chronic hepatitis C have had a history of quake treatment at an early stage.
3. Blood transfusion is a serious thing!In Pakistan, the practice of blood transfusion is not controlled as in the developed world. With the exception of few hospitals in big cities, most of the hospitals in the country lack facilities to storage donor blood.
Central blood bank is not effective enough to cater the demands of the whole country. When patients is a critical situation, the relatives have to procure blood on their own. This critical situation puts the question of hepatitis C free blood aside and results in unchecked transfusion of infected blood to the patient- leading to more cases of hepatitis C.
4. Desi Dawai (herbal treatment) does not work for every diseaseThere is a general misconception in hepatitis C treatment. People take interferon treatment as an unwelcome approach for two reasons.
First, it is a complicated and prolonged.
Second, it is costly and patients have to go for many costly tests during the treatment. Patient prefers to go for herbal medicines, as herbal treatment is less costly and patient-friendly. This method of treatment brings temporary relief in some cases but destroys the liver completely leading to complete liver failure.
5. Diagnosis requires proper testsA huge chunk of the population does not have access to sophisticated virus tests. They even do not know until the last stage that they have been carrying a virus for more than 20 years. The silent killer remains hidden in the body of a patient until it turns into a monster and becomes fatal.
Why is Africa special as far as Hepatitis C is concernedIn Africa alone the figures are at an astonishing thirty-two million infections making it the highest reported data in the world. With these statistics, HCV remains highly prevalent and infectious in nature with the virus infection remaining under-reported and under-diagnosed in Africa apart from a few countries like Egypt who have reliable data.
Prevalence of Hepatitis C in Africa
An estimated prevalence in Africa is at 5.3% with Egypt having a prevalence of 17.5%. Egypt has one of the highest reported prevalences. This is a result of Egypt's government not agreeing to use a somewhat expensive diagnostic tests to determine if donor blood is infected with HCV. In the US, for example, these kinds of tests have been around from 1992 and are vital for limiting the spread of the disease.
The prevalence of the HCV appears to increase with age as the highest reported cases are those people who are aged forty years and above.
As you see in the photo on your right, the majority of African countries have troubles coming up with a tangible figure as far as HIV prevalence rates are concerned. Getting these information for HPV are even more elusive.
Problem of not testing donor blood for HPVHCV is transmitted by various methods such as blood and blood products, organs and tissues, unsafe medical procedures, intravenous drug injection, sexual intercourse, through body piercings and vertical transmission i.e. mother infecting a fetus. A problematic method of transmission is by blood donation.
There are analytical tests that can detect the HPV in donor blood. However, in Africa, only a small percentage (about a fifth of all blood sampled) is tested for the HCV. This is due to the costs involved in laboratory testing.
Spread of HPV in AfricaThe populations that are at most risk are those who intravenously inject themselves with drugs, HIV/AIDS patients who are undergoing the hemodialysis procedure, organ transplantation and blood transfusion patients and surprisingly even the medical staff themselves can be infected if they acquire injuries caused by used needles. Other groups of people at risk include sexually active adults with several partners and children who are born to infected mothers. Also, the data available on HCV disclose that patients with the chronic liver disease tend to have a high prevalence.
In Africa, many of way of Hepatitis C transmission are not controlled. Not testing donor blood is just a tip of the iceberg; the unprotected sex due to lack of condoms and so on are only increasing the chances of HPV spreading.
HIV/AIDS has a higher prevalence in Africa as well making a pathway for HPV to spread. On the other hand, the lack of needles and systemic check of drug use is sprouting more and more cases of HPV via needle injections.
What is being done to prevent HPV spread in Africa?The primary prevention strategies of the HCV include testing and proper testing of blood, plasma, tissue, semen and organ donors. The virus can also be inactivated by-products derived from blood plasma. However, the strategies that work in the developed world are very rarely used in Africa.
HCV awareness campaigns and counselling services that reduce the risks to exposure and infection control practices should also be implemented in Africa. Hopefully with so much funds being generated by the big corporations who sell Hepatitis C medicines, at least some part will go to helping less fortunate.
Gilead Sciences has partly done that by giving licenses to produce generic version of Sovaldi and Harvoni but in Africa stopping the spread is the real issue.
The spread of HPV is a vicious circle. Luckily the spread is not as quick as in other viruses (especially those who spread by inhalation) but the number are steadily rising despite us having the cure for Hepatitis C. Africa should be calling for a systematic solution but as in many other cases, doing something systematic and long-lasting in Africa is very far fetched.
"There are some evidence that another virus (Hepatitis C?) is present in the liver."
This is the quote about Hepatitis C from 1980s. About 30 years later, we found a very successful cure consisting of sofosbuvir, ledipasvir, daclatasvir and ribavirin treatment options, for a lethal disease. Let us have a look at a brief history of Hepatitis C.
History of Hepatitis C TreatmentIt is almost impossible to know how long has Hepatitis C virus been around - we don't even have blood samples from lets say 50 years ago which could confirm the existence of HCV in 1960s.
Ancient History of Hepatitis CThe nature of many viruses inclines us to a conclusion that Hepatitis C virus has been around for a very long time. In fact, a close relative of HCV called HGV/GBV-C originated in primates about 35 million years ago, according to some theories.
Some scientist predict that the subforms of Hepatitis C (genotypes) originated about 500 years ago in West Africa.
Nonetheless, the spread of disease hundreds of years ago was much slower than today. Hepatitis C is a transmitted via blood-to-blood contact, and 500 years ago there were no blood transfusions or needle injections which are the leading cause of Hepatitis C transmission in today's world.
Hepatitis A and B - The first suggestion there might be Hepatitis CIn 1960s and 1970s, scientists developed blood tests to identify hepatitis B (1963) and hepatitis A (1973), but many of the blood samples taken for post-transfusion illness tested negative for hepatitis A and hepatitis B. However, in addition to A and B, a virus in the liver was discovered. Because it was neither Hepatitis A or B virus, the newly discovered virus was named NANB Hepatitis. This stands for non-A non-B Hepatitis.
Evidence suggest that more than 90% of patients diagnosed with NANB were actually Hepatitis C patients.
Discovery of Hepatitis C virus and Blood TestingThe virus itself was identified in 1989. The discovery is credited to the investigators from the Centers for Disease Control.
A year later, the screening of blood banks began but the method of Hepatitis C virus detection in blood used for transfusion was perfected in 1992. From that point on, only 1 blood bag out of 2 million is statistically infected with Hepatitis C.
However, prior to 1992, there was no way of detecting Hepatitis C in donated blood and it is speculated that about 1 blood bag out of 200 was infected by Hepatitis C. Due to these blood transfusion prior to 1992, an approximate 300,000 Americans were infected by Hepatitis C via transfusion. These include many war veterans.
Particularly the generation of Baby Boomers were infected by receiving the Hepatitis C infected blood.
Discovery of first Hepatitis C treatment - Interferon
The first Hepatitis C treatment was actually discovered earlier than 1989. In 1957, scientist discovered a treatment that was used more than 50 years for Hepatitis treatment - interferon. Primarily developed against Hepatitis A and B, it was also used to treat Hepatitis C patients.
The general treatment protocol was to inject 3 million units of interferon, three times a week for 48 weeks. Sustained virological response rates (negative viral load 6 months post-treatment) were approximately 9% for genotype 1 and 30% for genotypes 2 and 3.
Interferon name actually comes from its ability to 'interfere' with viral replication. The interference is not only useful against HCV but against other viruses as well.
Inclusion of Ribavirin to Hepatitis C treatmentIn 1998, FDA approved Rebetron - a treatment for Hepatitis C that included not only interferon but ribavirin antiviral drug molecule as well. This drastically increased the cure rate to about 30% for genotype 1 and 60% for genotype genotypes 2 and 3.
However, the cure rate was only 50%. Compared to sofosbuvir-based regimen of today, interferon is a much inferior treatment and is likely not going to be used for Hepatitis C treatment anymore.
During the following years, there has been some improvement in Hepatitis C treatment such as pegylated interferon and addition of some antiviral molecule to the regimen. However, the big breakthrough came with the DAA - direct acting antivirals such as sofosbuvir, ledipasvir and daclatasvir.
Hepatitis C Treatment Breakthrough2012 was a year for DAAs. Several new Hepatitis C treatment candidates were very promising in Phase III clinical trials, yielding an outstanding 90-100% cure rates. Several pharmaceutical companies were involved in drugs development, each with its own DAA and regimen.
In 2013, the FDA has approved the first modern Hepatitis C treatment and the golden age for Hepatitis C treatment discovery started. Here are all the drugs that were recently approved for treatment of various genotypes of chronic Hepatitis C.
- Sovaldi (sofosbuvir) by Gilead Sciences
- Harvoni (sofosbuvir and ledipasvir) by Gilead Sciences
- Olysio (simeprevir) by Janssen
- Daklinza (daclatasvir) by Bristol-Myers Squibb
- Viekira Pak (ombitasvir, paritaprevir, ritonavir and dasabuvir) by AbbVie
- Zepatier (elbasvir and grazoprevir) by Merck Co.
The problem and the reason why so much media is featuring the stories about Hepatitis C, is the price of the treatment. Not a single of drug above cost less than $50,000 in the US. Even US Senate became involved but the prices are still extremely high.
From interferon injections to a pill-a-day regimen
From Hepatitis C discovery to a cure in less than 25 yearsHepatitis C is a serious disease and HCV is a very resilient type of virus. However, it took our combined science less than 25 years to discover and develop the cure - with Sovaldi being approved by FDA in 2013, we finally got a formidable medication against HCV.
With only the cost being the major problem, we do welcome you to contact us at FixHepC Buyers Club and we will help you get Hepatitis C medications for a very affordable price.
In January 2016, Merck joined the Hepatitis C treatment market with the launch of Zepatier, a new and effective Hepatitis C treatment. While the Zepatier's cure rates for genotypes 1 and 4 are very comparable with other existing treatments such as Harvoni and Viekira Pak, Zepatier has one thing going for it - a lower price point for treatment. Will the lower Zepatier cost be enough to bring down the cost of other Hepatitis C treatments?
Zepatier cost vs the cost of other Hepatitis C treatmentsIf the voices of patients, doctors and even the US Senate have no effect on how big pharma is pricing Hepatitis C treatments - because this is how capitalism works - will the introduction of Zepatier decrease these prices by presenting major competition? According to general capitalistic economics, the added competition will have a net effect on lowering the prices across the board. But this is pharmaceutical industry with its specifics - can we still count on economic laws to work here?
Let us take a look at the Hepatitis C treatment prices.
As we see from the graph, the first treatment Sovaldi's price point is $80,000, followed by Harvoni's $94,500 price point - to date, Harvoni cost of standard treatment is the highest. When AbbVie introduced Viekira Pak at $83,319 per treatment, the price of Harvoni didn't decrease - primarily because Harvoni has an advantage over Viekira Pak due to simpler regimen.
Daklinza, introduced by BMS, also didn't manage to decrease the prices of other Hepatitis C treatments. However, the introduction of Zepatier with the lowest price point for modern Hepatitis C treatment at $54,600 might at least do something to decrease the costs. As we see, Zepatier cost is more than 40% lower than that of Harvoni, while the medications can arguably considered as very similar in effect.
What has been done thus far to decrease Hepatitis C treatment costs?Gilead Sciences, producer of Sovaldi and Harvoni, and the main player in Hepatitis C treatment market has thus far take two measures to react to the overwhelming pressure from all sides as far as the treatment cost reduction is concerned.
1. Gilead offers co-pay program for Hepatitis C patients covering 25% of Harvoni cost
2. Gilead gave licences to several Indian companies to produce generic Sovaldi and Harvoni to be sold in the third world countries
A good news is that majority of Hepatitis C patients can qualify for the Harvoni co-pay program. The price is reduced but it is still more than $70,000 per treatment. Generic Sovaldi and Harvoni are sold for less than $2,000 in India but one has to travel there to get them - this is where FixHepC Buyers Club steps in and helps patients to get it in a convienent way without the need to travel to India and bargain with the doctors and sellers there.
How can Zepatier lower cost effect Hepatitis C treatment prices in the near future?After Harvoni, Viekira Pak and Daklinza, two very successful Hepatitis C treatments were launched with a notably lower price point. However, Gilead remained unyielding and did nothing about the existing price of Sovaldi and Harvoni, despite the introduction of competition. This may be because Sovaldi and Harvoni have a strategical advantage over the new competition - Viekira Pak has a complex regimen (a patient has to take multiple pills per day) and Daklinza usually involves the use of sofosbuvir (an active ingredient in both Harvoni and Sovaldi), making both of them a tad bit inferior competitors.
Zepatier is the one we have been waiting for that can change the game. Not only does Zepatier offer a high cure rate for naive patients, the clinical research has revealed that in some patients who were already being unsuccessfully treated with interferon, Zepatier might have better clinical results than both Sovaldi and Harvoni - making Zepatier a contender to be reckoned with.
On top of this, Zepatier price of treatment is $54,600 in the US. In a normal economy, when you have two very comparable goods such as Harvoni and Zepatier, with one being much cheaper than the other, people will opt to go for the cheaper version. In this case, the only way for Harvoni to still be competitive, is to reduce it price and make it more comparable with the price of Zepatier.
Nonetheless, this is the pharmaceutical industry where things are not as simple as they might seem. Harvoni, being already launched for about two years, has build up a reputation as a safe and effective Hepatitis C cure. Zepatier is a new-comes - less known but cheaper. Only time will tell how this plays out but it is a hope of most of Hepatitis C community that the lower cost of Zepatier will help decrease the cost of Sovaldi, Harvoni, Viekira Pak and Daklinza due to the increased competition.