MAVIRET® (glecaprevir/pibrentasvir) was listed on the PBS in Australia today.
- AbbVie is pleased to announce that MAVIRET is to be listed on the PBS on 1 August 2018 for the treatment of chronic hepatitis C virus (HCV) infection in adults.
- MAVIRET is a new 8 week pangenotypic treatment for treatment-naïve non-cirrhotic HCV adult patients.
- In clinical trials, MAVIRET demonstrated 98% cure* rate in the ITT population (n/N=943/965) and 99% in the mITT population‡ (n/N=943/952) in treatment-naïve, non-cirrhotic patients pooled across GT1-6 with 8 weeks of treatment3, and a 0.1% discontinuation rate due to adverse events
*Cure defined as HCV RNA below the lower limit of detection at 12 weeks post end-of-treatment (SVR12)
An estimated 9 out of 10 of the remaining people living with chronic HCV are treatment-naïve and non-cirrhotic and may be eligible for 8 weeks of therapy with MAVIRET
We have the power to FixHepC, but the real question is... Do we have the willpower?
This was how Dr James Freeman ended his presentation at the World Hepatitis Summit in Brazil.
You can watch the full presentation on YouTube.
In essence, if we applied the same effort to HCV as we do to HIV this epidemic could be over within a single year. Currently, we treat 18 million patients with one year's supply of multiple antiviral drugs. That would translate to 72 million 3 month treatment courses - enough to treat every man woman and child with HCV.
We still have the enormous challenge of finding those patients in time, but we clearly have the funding capacity and the industrial capacity to get it done.
One year, that's all it would take.
The slides are attached below:
Hepatitis C is a disease that can make you feel old before your time. While there is no doubt that treatment with the new generation of direct acting antivirals like Harvoni is by far the best option this is not available to everyone, either because they don't qualify under their insurance, don't have insurance, or can not afford the $1250 cost to get generic hepatitis c treatment.
This guest blog was written by the Outreach Team at Disability Benefits Help and outlines how you can get help if you have become too sick to work. This includes both financial support and the potential to access to subsidised treatment.
Qualifying for Social Security Disability Benefits With Hepatitis C
If you have been diagnosed with Hepatitis C and will be unable to work for at least one year, you might be eligible for Social Security disability benefits. The Social Security Administration (SSA) offers financial resources for people who are unable to work for an extended period of time due to a serious illness. Hepatitis C will not automatically qualify, and unfortunately, most people with the condition will not be approved. Severe cases will qualify though, meaning you could be eligible for payments to help with your daily living expenses, as well as access to health insurance to pay for your hepatitis treatments.
12 Months and Social Security Disability
Social Security disability benefits are never temporary. They’re only available for people who expect to have a disability that lasts at least a year. This means that if you’ve recently been diagnosed with hepatitis C and have a good prognosis with minimal liver damage and a strong treatment plan, you likely won’t qualify. You also will not qualify if you’ve had hepatitis C for years but your symptoms are managed well. The SSA will not consider you to be “disabled” unless you are completely unable to earn at least $1,170 per month (in 2017). If you expect to be finished with treatments within a few months, or your condition is well managed, it’s not advisable to apply for disability benefits.
Qualifying Via the Blue Book
For those with severe liver damage, medical qualification is possible and potentially guaranteed, depending on your liver function. The SSA evaluates all hepatitis C applicants under its own medical guide, known as the Blue Book. The Blue Book is a manual listing all potential disabling conditions, plus the symptoms you’d need to qualify. Hepatitis c would fall under Section 5.05: Chronic liver disease. Chronic liver disease is arguably the most complicated listing in the Blue Book. There are actually seven ways to qualify under this listing, and all require medical tests evaluating your serum levels, blood quality, and more. The Blue Book was written for medical professionals and is available entirely online, so please review the listing with your hepatologist! He or she can help you navigate the guide and determine if your hepatitis c meets any liver disease listings. If you require a liver transplant, rest assured that your liver disease will qualify. You will also automatically qualify for disability benefits for at least 12 months after a liver transplant surgery.
Starting Your Application
Most people can apply for Social Security disability benefits online. If you’d prefer, you can also apply in person at your closest office by scheduling an appointment at 1-800-772-1213. There are over 1,000 offices across the US.
You’ll usually hear back from the SSA within three to five months. If your application is denied, do not give up! The SSA has a thorough appeals process, which allows you to fight your claim. While just 30% of applicants are initially applied, nearly 70% are eventually approved after pursuing their claims further.
"To our knowledge, this is the first large-scale study to demonstrate the effect of newer DAA regimens upon survival. Treatment with 2 commonly used DAA regimens, PrOD and LDV/SOF, was associated with significant improvements in survival within the first 18 months of treatment, compared with demographically and clinically similar untreated HCV-infected controls. Treatment with either PrOD or LDV/SOF was associated with a 57% reduction in mortality, and attainment of SVR was associated with a 43% reduction in mortality….Benefits of treatment at a population level are expected to be substantial…..similar benefit can be expected with other DAA-based regimens"
Effect of Paritaprevir/Ritonavir/Ombitasvir/Dasabuvir and Ledipasvir/Sofosbuvir Regimens on Survival Compared With Untreated Hepatitis C Virus–Infected Persons
Adeel Ajwad Butt Peng Yan Tracey G. Simon Abdul-Badi Abou-Samra
Clinical Infectious Diseases, cix364, https://doi.org/10.1093/cid/cix364
Published: 20 July 2017
Interferon-based regimens are associated with a substantial survival benefit for persons infected with hepatitis C virus (HCV). Survival data with direct-acting antiviral agents are not available. We conducted this study to quantify the effect of paritaprevir/ritonavir, ombitasvir, dasabuvir (PrOD) and ledipasvir/sofosbuvir (LDV/SOF) regimens upon mortality.
In the Electronically Retrieved Cohort of HCV Infected Veterans (ERCHIVES), a well-established national cohort of HCV-infected Veterans, we identified HCV-infected persons initiated on PrOD or LDV/SOF, excluding those with human immunodeficiency virus, hepatitis B surface antigen positivity, hepatocellular carcinoma, or missing HCV RNA or FIB-4 scores. For each case, we identified a propensity score–matched control never initiated on treatment. Primary outcome was survival. Outcomes were assessed using frequency of events, Kaplan-Meier curves, and Cox proportional hazards regression analyses.
We identified 1473 persons on PrOD, 5497 on LDV/SOF, and 6970 propensity score–matched untreated persons. Treated persons were more likely to be obese and have cirrhosis, but less likely to have stage 3–5 chronic kidney disease (CKD), alcohol or drug abuse or dependence diagnosis, and anemia. The proportion of persons who died was higher in the untreated group compared with either treatment group (PrOD, 0.3%; LDV/SOF, 1.4%; untreated controls, 2.5%; P < .001). A significantly larger percentage of treated patients survived to 18 months of follow-up, compared with untreated controls (P < .001). In multivariable Cox regression analysis, treatment with either regimen (hazard ratio [HR], 0.43; 95% confidence interval [CI], .33–.57) and attainment of sustained virologic response (SVR) were associated with significantly lower mortality (HR, 0.57; 95% CI, .33–.99).
Treatment with PrOD or LDV/SOF and SVR are associated with a significant mortality benefit, apparent within the first 18 months of treatment.
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.
New age Hepatitis C medicines are more than just a medical wonder. They gave humanity an ability to save lives.
How good are we at saving those lives?
More people die of Hepatitis C than HIV/AIDS
Hepatitis C is a serious disease that ultimately results in death of patients. Approximately 500,000 people die from Hepatitis C and related illnesses in 2013 alone, more than 20,000 of them were US citizens. To put it in perspective: HIV/AIDS has longed been talked about as a very serious disease with a disastrous death toll. However, according to Dr. Laura J. Martin of WebMD nowadays more people die from Hepatitis C than from HIV/AIDS.
Today, there are more than 3.2 million of Hepatitis C patients in the US alone.
In late 2013, however, humanity had a break-through that should by all accounts drastically change lives of people living with Hepatitis C. A new drug, Sovaldi (400mg sofosobuvir), was approved in December 2013 on the US market.
With it, more than 90% of people with Hepatitis C can be cured. But are they really being cured?
Standard Interferon-based treatment
For any disease to be deemed a very problematic one, there are two conditions:
- Disease is serious (causes severe injuries or death)
- There is a lack of efficient cure
Polio, for example, was a very serious disease with a disastrous outcome. However, after discovering an efficient polio vaccine, the number of patient and number of death relating to polio was reduced dramatically.
Hepatitis C prior to 2013 was a very problematic disease because it caused death via liver cirrhosis and liver cancer, and the only treatment we had was 50% efficient.
Hepatitis C patients were put on 6-months long interferon-based treatment which consisted of injecting oneself with interferon and taking additional oral medicines such as ribavirin (antiviral molecule). Nonetheless, for 1 out of every 2 patients treated the treatment has been proven to be unsuccessful.
There was a need for an efficient cure. Newly-discovered sofosbuvir molecule was the answer.
New age Hepatitis C treatment - Sofosbuvir-based medications
With the launch of Sovaldi and Harvoni medicines by a company Gilead Sciences, humanity finally attained a very effective cure for Hepatitis C. Being an all-oral regimen, sofosbuvir pills are taken on a daily basis for 12-weeks (standard treatment), have mild side effects and, above all, more than 95% cure rate. This is what in pharmaceutical industry refer to as a game-changer. Now almost everyone can be cured and Hepatitis C suddenly became an easily curable disease.
Does anybody die of Hepatitis C now?
Simple answer is 'YES'. While the number of deaths has decreased from 500,000 per year, there are still hundreds of thousands of people dying every year. The reason: Hepatitis C.
But if we know Hepatitis C is so easily treatable nowadays, why are people still dying?
Pharmaceutical industry is a profitable business (Money>Patients)
When we spoke about Harvoni and Sovaldi being a game-changer in industrial industry, it was meant more in profits than in saving lives. Here are two simple reasons why people even in the developed world are still dying of Hepatitis C.
- Original Sovaldi (400mg sofosbuvir) costs $80,000 per treatment (US prices)
- Original Harvoni (90mg ledipasvir/400mg sofosbuvir) costs $94,500 per treatment (US prices)
With this in mind, let us calculate the US Hepatitis C market. If we know there are 3,2 million Hepatitis C patients, each in need of an $80,000 cure, the total comes to staggering number: Gilead Sciences is looking to sell more than $250 billion worth of Hepatitis C medicine to patients who can die without it.
Here is a horrifying realization. We have people who will die without the cure. We have the cure. But people who are dying cannot afford the cure because it is priced extremely high. 'What have we come to as a society?' is the right question here.
Way to get Hepatitis C medicines without having to pay massive sums of money
Gilead Sciences, company that markets Sovaldi and Harvoni, offered licences to Indian manufacturers to produce generic version of sofosbuvir-based medicines. In short, India refused to recognise a level of innovation for sofosbuvir molecule that would grant Gilead Sciences a patent and monopoly over Hepatitis C market in India.
This created a loophole. This loophole is now saving lives.
FixHepC Buyers Club to the rescue
All around the world there are Hepatitis C patients that will die without getting the cure - and they are not getting it because the prices of the drugs are so extremely high. This is where FixHepC Buyers Club comes in.
It is our mission to deliver life-saving Hepatitis C medicines to your doorstep for a negligible cost. We have set up a supply chain consisting of sofosbuvir production, packaging and distribution across the world. It is our hope this will bring down the Hepatitis C death toll under 100,000 and that in near future Hepatitis C death cases will be as few in number as possible with sofosbuvir-based medication.
We strive to deliver generic Harvoni anywhere on the planet for less than $2,000 per treatment in about 2-3 weeks. With this prices, we could cure all Hepatitis C patients in the US for less than $7 billion.
Are thing in Hepatitis C market likely to change?
Hardly. Pharmaceutical industry holds on to patents for drugs that last for 20- to 25-years. During this time, the prices of original Sovaldi and Harvoni will be extremely high, and Hepatitis C patients don't have 20 or more year to wait for patents to expire.
The thing with Hep C is that it's not about anonymous statistics, it's about real people. Here's the story of one patient, and his wife's journey through Interferon and failure and then to self initiated treatment and cure via the parallel import of generic DAA medications that was published in the Sydney Morning Herald and The Age:
Here is a letter to the editor that did not make the cut
Sunday 27th September 2015
(Ref: Hepatitis C drug buyers club aims to set up new source of support)
In 1961 JFK uttered the immortal lines "ask not what your country can do for you - ask what you can do for your country".
With the passage of time, the idea we should all put something back in seems increasingly lost.
We have at our fingertips the tools to rid the world of Hepatitis C and are separated from that only by corporate avarice.
Gilead Sciences are asking for more than the entire annual PBS medications budget, used to treat all Australians for all diseases, to treat a single disease forecast to kill half as many people as breast cancer by 2030.
If this medication pricing trend continues unabated you can foresee the day we invent a cure for cancer, but people still die because only a fortunate few can afford access.
Parallel importing is a tool that has been used before to level the playing field, most notably around the pricing of HIV medications. $1000 a tablet for something that costs $1 to produce and is available overseas for $10 does not make sense.
It’s time to draw a line in the sand and make it clear patient rights deserve equal protection to patent rights.
Dr James Freeman
A patient posted a link that contained a powerpoint presentation from Dr Andrew Hill, PhD. I asked Dr Hill if I could post it here and he said yes.
I turned that into a very quick YouTube movie, so you will probably have to pause it to read it. The attachments include the original PPT (and a PDF version) and two recent papers. Use the readmore to get to them.
Hepatitis Australia is using new data released from the Kirby Institute today showing only one per cent of people with hep C received treatment last year to push the government to list new hep C drugs without delay.
"It's time for action," said Kevin Marriott, Hepatitis Australia Acting CEO. "It's time of the federal government to make new therapies widely available, increase liver clinic capacity, upscale hepatitis C treatment and prevention programs and transform the lives of thousands of Australians."
New surveillance data from the Kirby Institute estimated some 230,470 people had chronic hepatitis C infection at the end of 2014. Around 80 percent had early to moderate fibrosis and 19 percent had severe fibrosis or hepatitis C related cirrhosis.
The estimated number of people with severe liver disease/hepatitis C related cirrhosis has more than doubled in ten years, according to the data.
Head of the viral hepatitis clinical research program at the Kirby Institute Professor Greg Dore said that without significant improvement in hepatitis C treatment rates, Australia would see a 245 percent increase in the rates of liver cancer and 230 percent increase in hep C-related deaths by 2030.
"Thousands of Australians are queuing up waiting for new medicines to be PBS listed. These treatments provide one of the great breakthroughs in clinical medicine in recent decades, with enormous potential to improve the lives of people living with hepatitis C," Professor Dore said.
Four new hep C medicines - Gilead's Sovaldi (sofosbuvir) and Harvoni (ledipasvir/sofosbuvir), BMS's Daklinza (daclatasvir)and AbbVie's Viekira Pak (paritaprevir with ritonavir, ombitasvir and dasabuvir plus ribavirin) - have been recommended for PBS listing but price negotiations with sponsors are ongoing. Professor Dore said previously, he suspected listing is more likely for sometime in 2016.
Mr Marriott said there is compelling evidence for the new medicines to be listed without delay before people progress to serious liver disease and die.
"Interferon-free therapies will allow the vast majority of people living with the hepatitis C virus to be cured, even where treatment has failed previously and without the terrible side-effects of existing treatments."
Originally published in Pharma in Focus. Reproduced with permission.