The good news is that Gilead plans to launch generic versions of Harvoni and Epclusa in the USA. The bad news is the $24,000 USD price tag. Although this price is substantially lower than list price, the reality is that the VA negotiated a $25,000 price nearly a year ago, so the payers have been seeing this pricing for a while. The biggest bit of upside is that patients could save up to $2500 in out of pocket costs and that's got to be a good thing. Here is the full press release...
FOSTER CITY, Calif.--(BUSINESS WIRE)--Sep. 24, 2018-- Gilead Sciences, Inc.(NASDAQ: GILD) announced today plans to launch authorized generic versions of Epclusa® (sofosbuvir 400mg/velpatasvir 100mg) and Harvoni® (ledipasvir 90mg/sofosbuvir 400mg), Gilead’s leading treatments for chronic hepatitis C virus (HCV), in the United States, through a newly created subsidiary, Asegua Therapeutics LLC. The authorized generics will launch at a list price of $24,000 for the most common course of therapy and will be available in January 2019.
Since the launch of Gilead’s first HCV medication in 2013, the average price paid for each bottle of medicine in the United States has decreased by more than 60 percent off of the public list prices, across health insurers and government payers. Due to the complexity and structure of the U.S. healthcare system, however, these discounts provided by Gilead may not always translate into lower costs for patients. Further, existing contracts, together with laws associated with government pricing policies, make it challenging to quickly lower a product’s list price once it is on the market.
The authorized generics are priced to more closely reflect the discounts that health insurers and government payers receive today. Insurers will have the choice of offering either the authorized generics or the branded medications for both Epclusa and Harvoni. In the Medicare Part D setting, the authorized generics could save patients up to $2,500 in out-of-pocket costs per course of therapy. The authorized generics will also offer substantial savings to state managed Medicaid plans that do not currently benefit from negotiated rebates and that represent a significant number of people in need, potentially opening up access to our medications to beneficiaries who were previously denied coverage.
“Launching these authorized generics is the best solution available to us today to quickly introduce a lower-priced alternative to our HCV medications without significant disruption to the healthcare system and our business,” said John F. Milligan, PhD, President and Chief Executive Officer, Gilead Sciences. “This launch also will hopefully help increase transparency by more closely aligning our medications’ list prices with their cost. Our ultimate goal is to lower the list price of Epclusa – a medication we believe is of great importance given its clinical profile across genotypes – and Harvoni. We are committed to working with all of our partners in the healthcare system to help enable list price reductions of our HCV medications and find better solutions to reduce patients’ out-of-pocket costs.”
Beyond the company’s efforts to reduce patient costs, Gilead is continuing to pursue innovative collaborations and long-term financing models, such as a potential subscription model, that could not only expand access, but aim to eliminate HCV in the United States and around the world.
The stigma and stereotype associated with Hepatitis C says "you only get that from IV drug use". While you certainly can get it from IV drug use, the majority of my Baby Boomer patients didn't. How do I know? Well, of course, I can't know for sure how anybody caught any communicable disease, but when talking to the 3000+ patients I've helped access affordable generic medication there is a recurrent theme. That theme is "Hey doc, I never did drugs, I don't have any tattoos, and I've never had a blood transfusion, so how did I get HCV?" That led me to look for the answer. The real answer, not the stereotype.
The short answer is the medical or dental profession probably gave it to you, but how do I know that?
Well, for a start, we know the disease requires blood-blood contact for transmission and, outside of IVDU, tattoos and blood transfusions most of us don't share our blood with friends. So for people who have the disease, but don't have these risk factors, what other blood-blood exposures did they have? The answer to that is clear, they had two distinct exposure risks:
- Doctors giving vaccinations using reusable glass syringes, reusable needles, and multi-dose vials and jet guns for vaccinations.
- Dentists drilling and scraping away at damaged teeth using reusable tools.
Nowadays with disposable everything, it's easy to forget what medicine looked like in the 50s, 60s, 70s, 80s and (believe it or not) the early 90s.
As a young child in the 60s I followed my father around. He worked in Intensive care and I got to play with all sorts of cool stuff. Glass syringes, reusable needles, liquid mercury from the blood pressure machines (shudder). My father and the other staff routinely got blood all over their neatly pressed white lab coats with barely a glove or facemask to be seen. Surgeons used that stuff, but not the doctors and nurses in the rest of the medical world.
I was immunized several times in a gymnasium line up with all my school friends. It was a wham bam thank you ma'am type thing. I thought the jet gun was nifty as there was no needle but discovered it hurt more. As a medical student in the 80s I was aware of HIV but the notion of universal precautions was still a decade in the future. If we got blood on our hands we just washed it off. The world was very different and the acronym OH&S barely existed.
Here are some timelines:
400 B.C. Campaign Jaundice: Hippocrates (yes, the Hippocratic oath guy) described a condition he called “epidemic jaundice.”
8th century A.D.: Pope Zacharias quarantined men and horses with jaundice. This was meant to control the spread of the disease.
1861-1865: More than 40,000 cases of jaundice were recorded in the Union Army during the Civil War.
1942-1945 Hepatitis and World War II: Approximately 182,383 US service members were hospitalized for hepatitis during World War II. The disease was contracted in two different ways. An epidemic of hepatitis broke out among many service members who were vaccinated against yellow fever. The source of the infection was traced to the serum that was used in the vaccine. A different form of hepatitis, acute hepatitis, was found among soldiers who had received blood transfusions.
1951: Rothauser produced the first injection-molded syringes made of polypropylene, a plastic that can be heat-sterilized.
1956: New Zealand inventor Colin Murdoch was granted New Zealand and Australian patents for a disposable plastic syringe, it will catch on but will take time.
1964: Ansell manufactures the first disposable latex medical glove based on the production technique for making condoms, but universal use (as part of universal precautions) will take close to 3 decades to catch on.
1965: The hepatitis B virus was discovered by Dr. Baruch Blumberg.
1973: The hepatitis A virus was discovered at the National Institutes of Health by a team led by Steven Feinstone.
1973: Cases of hepatitis not caused by either hepatitis A or hepatitis B come to be called "non A, non B hepatitis".
1989: Hepatitis C virus (previously known as non A, non B) is discovered by scientists at a California biotechnology company called Chiron.
1991: A test for Hepatitis C in the blood supply becomes available.
1992: The Occupational Health and Safety Administration (OHSA) published its Bloodborne Pathogens Standard. Around this time, there was increased awareness regarding HIV, and OHSA implemented the rule to protect workers who would come in contact with bodily fluids. OSHA’s standard required employers to provide personal protective equipment, including disposable gloves, to these workers.
So, we know that Baby Boomers are more at risk of Hepatitis C than any other group? Why? It's actually pretty simple.
Some of the soldiers that returned to the USA from WWII came back with Hepatitis C. Poor medical hygiene spread it, and this spread was almost certainly by vaccination in the 1950s, NOT by IVDU in the 1960s and 1970s. Nice theory, but how can we be sure? One word - genomics. Here is the study, published in the most prestigious journal in the world "The Lancet".
Abstract here: https://www.thelancet.com/journals/laninf/article/PIIS1473-3099%2816%2900124-9/fulltext
Full text here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5245154/
Here it is in plain English, thanks to Sheryl Ubelacker from The Canadian Press.
Canadian researchers have determined the peak of the hepatitis C epidemic in North America occurred about 15 years earlier than previously believed, suggesting it wasn’t youthful indiscretions that put baby boomers at a high risk for the disease.
It was long thought that boomers who were infected with the blood-borne virus likely contracted the disease in their late teens or early 20s, due to such risky behaviours as IV drug use or sexual experimentation.
But a study by B.C. researchers found the peak of the hepatitis C epidemic occurred about 1950, when many baby boomers were young children and had plateaued by 1960 — well before the zenith of injection drug use at the end of that decade.
The oldest of the baby boomers were just 5 years old at the peak of the epidemic, the researchers say.
“The spread of hepatitis C in North America occurred at least 15 years earlier than it was suspected before, and if that is the case, the baby boomer epidemic ... cannot be explained by behavioral indiscretions on the part of the baby boomers,” said co-investigator Dr. Julio Montaner, director of the BC Centre of Excellence in HIV/AIDS.
“We suspect that this is more likely attributable to medical practices at the time,” said Montaner, explaining that hepatitis C hadn’t yet been identified and injections and blood transfusions were given employing reusable glass-tube syringes and metal needles, which were subject to contamination despite boiling.
“The baby boomers in North America ought to be offered hepatitis C screening,” he said, “not because they did anything wrong but because they are baby boomers, and so they were alive at a time in which the standard of care was such that we are all potentially at risk of having contracted hepatitis C.”
If you or a loved one have Hepatitis C, but can't get access to insurance-funded treatment, then maybe getting cured with generic HCV medication is worth a thought. Visit our home page to learn more about generic hepatitis C treatment.
For patients with Hepatocellular Carcinoma (HCC) the options are limited. Caught early enough RadioFrequency Ablation (RFC), TransArterial ChemoEmbolisation (TACE) or surgical resection can potentially be curative. For some patients with advanced disease a liver transplant may be an option, but what about everyone else?
Up until recently, Sorafanib was the mainstay of treatment and the only real option to slow down the progression of the HCC and give patients some extra months or years of time. Nivolumab (Opdivo) appeared in 2017 but remains prohibitively expensive for most patients.
A couple of months ago the New England Journal of Medicine published the Phase 3 results for Cabozantinib which has been shown to work where patients are failing Sorafenib.
Although it's not a cure it can add some precious time. While it is anecdotal, back in 2015, I had a patient who was failing Sorafenib and was rejected from this very trial having been fully worked up. He was shattered and asked for help. Given this drug was, at the time, very experimental we went through an extensive informed consent process, including enlisting the assistance of his oncologist who said "We really don't have much to lose..." As it turned out he did very well on the Cabozantinib and got 2 extra years of good quality life.
It's not a cure, but it does provide cause for hope, as we inch ever closer to more effective treatments for HCC.
Great News For Australian Patients - MAVIRET® (glecaprevir/pibrentasvir) PBS listed on 1 August 2018Written by Super User
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
Most of the messaging to people about Hepatitis C is boring with as much cut through as a blunt knife through a block of titanium. If you were born between A and B, if this, if that, etc. It's time to change the paradigm and speak to the simple reason for getting tested which is get treated and feel better.
Feeling Old & Tired?
We owe a debt of gratitude to Marty2Bulls who designed the butter(fly)man logo for us. You can check out Marty's work here: https://www.facebook.com/martytwobulls/
The other day, on Facebook, I witnessed a patient, looking for advice, be given some very poor advice. Where poor = wrong and potentially lethal. I provided some accurate commentary which was deleted, leaving a whole lot of no doubt well-meaning, but nevertheless incorrect information.
So the question to hand was "My father has sourced DAAs privately and has started taking them (< 2 weeks ago) - he has just been diagnosed with HCC and his doctor has recommended stopping the medication while TACE or RFA is done".
The short story is that the patient's doctor's advice was correct, and the Facebook advice to continue DAAs was wrong.
Here is an explanation in plain English.
Patients who do not have cirrhosis have a low risk of HCC and can just be treated. They also have a low risk of any problems on treatment and a high probability of cure meaning that in a number of countries no real medical oversight is required during or after treatment.
Patients who do have cirrhosis have an approximately 1/30 chance of developing HCC every year and as a result, need monitoring tests that typically only a doctor can order.
For patients with cirrhosis and who have already had an HCC their risk of getting another one is higher than the 1/30 for a patient with cirrhosis but no history of HCC.
Hep C causes the immune system to attack the liver - that's all the liver - normal liver and cancer liver. So when we treat with DAAs and get rid of the Hep C we make it easier for HCC to flourish.
Here are the rules:
- If you do not have cirrhosis you can just treat with DAAs and not worry too much about HCC or indeed on/post-treatment monitoring
- If you do have cirrhosis, but have never had HCC, you can treat with DAAs but you have a persistent risk of developing HCC and need regular (6 monthly) Ultrasound/CT/MRI
- If you do have cirrhosis, and have had an HCC treated with resection/TACE/RFA, you can treat with DAAs but need very close follow up (say 3 monthly US/CT/MRI) as your risk of a recurrence is significant
- If you have had a liver transplant DAA treatment itself is similar to 1 but the liver transplant needs monitoring and there are some drug-drug interactions to be aware of.
- If you have an active HCC you should defer DAA treatment until after transplant/resection/TACE/RFA because
- DAA success rates are around 74% in patients with HCC so there is a pretty high chance of treatment failure
- DAA treatment is likely to accelerate the progression of the HCC and being HepC free but dead of HCC is not a good outcome.
While rules are meant to be broken these rules have a good basis in fact. The full details of the current expert advice can be found here:
Facebook is great for peer group support, but if you have a serious medical condition - like Hep C and cirrhosis +/- HCC you really need expert local doctor care.
They say (who are they anyway?) "If it seems to good to be true it probably is". When it comes to generic Hepatitis C medication some people struggle with the idea that something like Harvoni® with a list price of $94,000 USD could be manufactured for under $1000 USD. Surely if the original costs $94,000 there must be something wrong with the more affordable generic. It's cheaper, they must have cut corners or something...
Well, the reality is that it does not cost very much to make a tablet of Harvoni® (about $1 to $2). Let's face it $1000 and is a lot of money for a single tablet, after all it will buy you a new iPhone and that's a lot more complicated than a pill. The $31,000 for a bottle of Harvoni® is the same as the price of a new car. And while $94,000 won't buy you a whole house in most places it is actually 1/2 the median price for a house in the USA. 3 Bottles of pills cost the same as 1/2 a house? Really?
Ok, I hear you say "So now I can understand that the price of Harvoni® represents outrageous price gouging, but that still does not prove the less expensive generics meet the required quality standard now does it?"
Fair point, and one that is answered by a set of tests called "bioequivalence" (BE). Bioequivalence testing starts with baseline things like high-quality factories, using high-quality active ingredients and putting them together into tablets under what is called GMP (Good Manufacturing Practice). GMP is a series of processes that provision QC (Quality Control) / QA (Quality Assurance). Ok, so now we have some tablets. They are in a nice bottle and have been made by experts. These experts have put their brand name on them but... that still does not prove those tablets are going to work the same. Why?
The why is because for a generic tablet to work the same as the originator it needs to have more than the same APIs (Active Pharmaceutical Ingredients) in the correct weights. These tablets also need to be formulated correctly to ensure that when a patient takes them (be it generic or originator) the product delivers the same blood levels to the patients. So how do we do that?
It's actually really simple. We recruit 24-60 volunteers. We give 1/2 of them the originator medication and the other 1/2 the generic. We then make 20 measurements of the blood levels over the next 12 hours. Then we wait a week for the drugs to wash out. Then we repeat the testing but the patients who had the generic first time around now get the originator, and the patients who got the originator now get the generic. This may then be repeated again (fully replicated).
A product is deemed to be bioequivalent if the blood levels at all time points demonstrate the statistical confidence interval (CI) fall within the range 80% - 125%.
Oh, I hear you say, "Does that mean a bioequivalent generic can have up to 20% less or 25% more drug in it?"
Not at all, because I said "confidence interval".
Ok, I hear you say, "WTF is a confidence interval?"
Glad you asked, although your eyes may glaze over!
Consider a coin toss. We toss it once and get a head. So our results are 100% heads. The actual result should be 50% heads (unless the coin is loaded). The confidence interval (technically a binomial confidence interval) is a measure of how confident we are in that 100% result. The confidence interval, in this case, is 2.5% - 100% so you can see we are not very confident. You may note that this range is wide but it does contain the actual value. Now if we toss the coin 3 times we might get 1 head and 2 tails. So we now have 33% heads and the confidence interval is 8.4% to 90%. The result is more realistic, the confidence interval is a little narrower but... Say we toss it 10 times and get 4 heads and 6 tails. Now we have 40% heads and the confidence interval is 12% to 73%. And finally, we toss the coin 100 times and get 49 heads and 51 tails. Now we have 49% heads and the confidence interval is 39%-59%. You can play with other numbers here: http://statpages.info/confint.html
What I want you to notice are 2 things. The more tests we do the more accurate the actual results become and the narrower the confidence interval becomes. With the 100 toss trial the 39% lower confidence interval is 22% lower than the expected 50% and the 59% upper confidence interval is 18% higher so it spans the confidence interval range on the actual value of 50% from 78% - 118% - you may note that this is similar to the bioequivalence threshold of 80% (-20%) to 125% (+25%).
What this means in practical terms is that when we test for bioequivalence the actual values at any point need to be very close together to meet the statistical confidence interval criteria and we need to do a lot of tests to narrow the CI range down. Here's what it actually looks like and as you can see these generic products are very very similar to the originator product. The key values of Cmax (Concentration maximum) and AUC (Area Under the Curve and a measure of total absorption) vary only by a low single digit % amount. Some are a little higher, some are a little lower. All are very similar in absolute and statistical terms.
The full details of our collation of BE testing results are available in the attached article from the Journal of Virus Eradication or online here: http://viruseradication.com/journal-details/Bioequivalent_pharmacokinetics_for_generic_and_originator_hepatitis_C_direct-acting_antivirals/
So you've made it! SVR at last. What now?
Here is a slideset from Clinical Care Options where Ira M. Jacobson, MD, and Paul Y. Kwo, MD, review optimal management of patients with HCV who have achieved SVR, including recommendations for HCV RNA and HCC monitoring.
These doctors are world leading experts so you're drinking from the source...
With HIV we observered that if we use 1 drug resistance develops rapidly, with 2 drugs it is slower, and with 3 drugs it virtually never happens, so it does not come as any great surprise that combining an NS3/4A drug with an NS5A drug and and NS5B drug works well.
We have previously seen Merck retreat Zepatier failures with Zepatier+Sofosbuvir and Abbvie retreat Viekira failures with Viekira+Sofosbuvir and in both cases very good 95% SVR12 results were achieved.
We have also seen Gilead follow the same strategy by adding the NS3/4A agent Voxilaprevir to the NS5A/NS5B Velpatasvir/Sofosbuvir in Epclusa to form Vosevii.
So what happens if you take the strongest NS3/4A inhibitor ever invented - Glecaprevir, and the strongest NS5A inhibitor ever invented - Pibrentasvir, and add in the strongest NS5B inhibitor ever invented - Sofosbuvir. Could it be we have the mythical "Perfectovir".
Abbvie have investigated this by dropping a lifeline to patients who failed G/P in their trials. Sadly they missed perfection with a 95% SVR12 (22/23) but the single patient who failed had previously failed both Harvoni and Maviret.
Anyway, for patients that have failed DAAs this is encouraging news. If we can cure 95% first time around, and then 95% of the 5% who relapsed that makes 99.75% overall and is awesome news.
The full presentation from CROI is available in the attachments to this blog post.
- Ravidasvir is a new NS5A inhibitor for HCV.
- Sofosbuvir + Ravidasvir with or without RBV has achieved very high SVR rates.
- Results are comparable for both patients with and without cirrhosis.
- Serious adverse events were noticed in very few treated patients.
Background & Aims
Although treatment of hepatitis C virus (HCV) and HCV-genotype-4 (GT4) has become very effective, it remains very expensive, and affordable options are needed, especially in limited resource countries. The aim of this study was to assess the efficacy and safety of the combination of ravidasvir (an NS5A inhibitor) and sofosbuvir to treat patients with chronic HCV-GT4 infection.
A total of 300 patients with HCV-GT4 infection were recruited in three groups: treatment-naïve patients with or without compensated Child-A cirrhosis (Group 1); interferon-experienced patients without cirrhosis (Group 2); and interferon-experienced patients with cirrhosis (Group 3). Groups 1 and 2 received ravidasvir 200 mg QD plus sofosbuvir 400 mg QD for 12 weeks and were randomized 1:1 to treatment with or without weight-based ribavirin. Group 3 patients received ravidasvir plus sofosbuvir with ribavirin and were randomized 1:1 to a treatment duration of 12 weeks or 16 weeks. The primary endpoint was sustained virologic response at 12 weeks post-treatment (SVR12).
A total of 298 patients were enrolled: 149 in Group 1, 79 in Group 2 and 70 in Group 3. SVR12 was achieved in 95.3% of all patients who started the study, including 98% of patients without cirrhosis and 91% of patients with cirrhosis, whether treatment-naïve or interferon-experienced. Ribavirin intake and history of previous interferon therapy did not affect SVR12 rates. No virologic breakthroughs were observed and the study treatment was well tolerated.
Treatment with ravidasvir plus sofosbuvir, with or without ribavirin, was well tolerated and associated with high sustained virologic response rate for HCV-GT4 infected patients with and without cirrhosis, regardless of previous interferon-based treatments.
This study evaluated efficacy and safety of the new oral hepatitis C drug ravidasvir in combination with the approved oral drug sofosbuvir in 298 patients infected with hepatitis C type 4. Our results showed that treatment with ravidasvir plus sofosbuvir, with or without ribavirin, was well tolerated and associated with high response rate in patients with and without cirrhosis.
Trial Registration number: ClinicalTrials.gov Identifier: NCT02371408.
A quick note on how to take your DAA medication. Read the package insert and follow the instructions with respect to with (or without) food.
For example, for Vosevii
Administration with food enhances the oral bioavailability of sofosbuvir, velpatasvir, and voxilaprevir. Relative to fasting conditions, mean sofosbuvir systemic exposure (AUC) increased by 64% to 144%, mean velpatasvir AUC increased by 40% to 166%, and mean voxilaprevir AUC increased by 112% to 435% when the combined sofosbuvir/velpatasvir/voxilaprevir formulation is administered with food.
Food enhances the absorption of all the ingredients. You get roughly 2 x as much Sofosbuvir, 2 x as much Velpatasvir and 3 x Voxilaprevir. To put this another way, if you take Vosevii WITHOUT food you will only get something like 1/2 the dose.
Note that this advice is equally applicable to Epclusa which is the same (just missing the Vox) and the ignoring this advice may cause your treatment to FAIL.
This advice also applies to Viekira and Mavyret which should be taken with food.
Sovaldi, Harvoni, Daklinza, and Zepatier can be taken with or without food.
In terms of food, think a real meal with some protein, fat and carbohydrate.
Once upon a time, there was an old man who used to go to the ocean to do his writing. He had a habit of walking on the beach every morning before he began his work. Early one morning, he was walking along the shore after a big storm had passed and found the vast beach littered with starfish as far as the eye could see, stretching in both directions.
Off in the distance, the old man noticed a small boy approaching. As the boy walked, he paused every so often and as he grew closer, the man could see that he was occasionally bending down to pick up an object and throw it into the sea. The boy came closer still and the man called out, “Good morning! May I ask what it is that you are doing?”
The young boy paused, looked up, and replied “Throwing starfish into the ocean. The tide has washed them up onto the beach and they can’t return to the sea by themselves,” the youth replied. “When the sun gets high, they will die, unless I throw them back into the water.”
The old man replied, “But there must be tens of thousands of starfish on this beach. I’m afraid you won’t really be able to make much of a difference.”
The boy bent down, picked up yet another starfish and threw it as far as he could into the ocean. Then he turned, smiled and said, “It made a difference to that one!”
If you'd like to make a difference to Hepatitis C please visit https://fixhepc.com/fixers
The combination of Sovaldi (Sofosbuvir) and Daklinza (Daclatasvir) was the world's first pan-genotypic Hepatitis C treatment. In the USA and Europe the $140,000 price tag of this combination means it has seen relatively little use, but in the world of generics it has seen extensive use because Daclatasvir is much cheaper to produce than either Ledipasvir (in Harvoni) or Velpatasvir (in Epclusa) so it provides the least expensive treatment option.
Ok, so it's more affordable, but is it as good as either Epclusa or Maviret? These are the new kids on the block, they are more expensive, so surely they are newer and must be better? Not really...
Abbvie conducted a trial called ENDURANCE-3 which demonstrated that Maviret - Glecaprevir + Pibrentasvir - (G/P) is "non-inferior" to the combination of Sofosbuvir + Daclatasvir (SOF/DCV). What is "non-inferior"? Well SOF/DCV achieved 97% SVR and G/P achieved 95% SVR12 in the difficult to treat GT3 population. Maviret is "non-inferior" is one way of phrasing it. SOF/DCV is "slightly superior" would be another way although this is not statistically significant.
Our REDEMPTION trials put the results for generic SOF/DCV in the range 93% (for GT3) to 100% (for GT2, GT5 and GT6) with 97% in GT1 and 95% in GT4 and are based on the results of over 1000 patients.
Published two days ago we have Generic daclatasvir plus sofosbuvir, with or without ribavirin, in treatment of chronic hepatitis C: real-world results from 18 378 patients in Egypt - where the overall results were 95.1%
So there you have it. We have 3 pan-genotypic options. They are all good, and all hit ~95%+ cure. Two are newer, more expensive, and have far less real-world proof. Strip off the marketing hype and if you were looking towards mass scale treatment SOF/DCV looks like the go-to medication because you can get the same cure rates for less cost, at least when using generics.
Recently I have been getting a number of enquires from patients who have just finished their tablets, all asking the same questions, so here is a quick primer. If you are looking for this sort of information you will find a lot more detail in our Frequently Asked Questions and on the Forum.
On treatment 99.5% of patients will drop to <15 on their HCV RNA. This is nice but does not prove cure. We need virtually zero viruses (less than 100 in total) to remain in your system to achieve cure.
When the tablets finish your body starts to remove the medication from your system. Within 24 hours there is less than 1/2, 48 hours 1/4, 3 days 1/8, 4 days 1/16, 5 days 1/32, 6 days 1/64, 7 days 1/128 and by this stage there is definitely not enough of the drugs left in your system to kill the virus.
So with the medicines now below effective levels one of two things happens.
- The virus starts to grow back because there is still some left, or...
- Nothing - ie the virus does not grow back because there is no virus left to grow back
If the virus has not grown back 4 weeks after the last tablet was taken and the HCV RNA PCR remains <15 then there is a 97% chance this will be permanent. We call this Sustained Virological Response (SVR) and because this one happened at 4 weeks we call it SVR4
If the virus has not grown back 12 weeks after the last tablet was taken and the HCV RNA PCR remains <15 then there is a 99.7% chance this will be permanent. We call this Sustained Virological Response (SVR) and because this one happened at 12 weeks we call it SVR12
If the virus has not grown back 24 weeks after the last tablet was taken and the HCV RNA PCR remains <15 then there is a 100% chance this will be permanent. We call this SVR24 but a better word is cure.
Please note this. Your Hepatitis C Antibody (HCV Ab) test will remain positive. Your body produces antibodies in response to infection and these persist for years. For example, if you have Hepatitis B vaccination you will have antibodies that persist for years, and often for life. Similarly to Hepatitis B without an exposure event (booster dose for Hep B, ongoing infection for Hep C) the levels of antibody will slowly fall over time, and may (after 5-10 years) fall below the level we use as a cut off, however, you should expect to remain antibody positive for many years. Cure is a negative HCV PCR RNA and the antibody remains as a marker of past infection.
This period of waiting can be stressful. Forums like https://fixhepc.com/forum can provide useful support.
With the SVR tests liver functions are normally conducted at the same time. These liver function results come back the next day, rather than a week later. If your liver functions remain similar to what they were on treatment (+/- 20%) you can be confident you have not relapsed. I have treated about 3000 patients and, as the statistics predict, seen over 100 relapses. In every case, the patient has been aware of the relapse before the results came back.
If you feel well you almost certainly are, but if you feel unwell it is worth noting that as well as over 100 relapses I have seen about 100 patients assigning every little twinge in their body to relapse (and they did not) so don't panic if you feel anxious - it's pretty normal. The result will be what it will be and worrying is about as effective as chewing bubble gum while trying to solve an algebra equation. If you do relapse it's possible to have another try and the results of take 2 are good although the costs of treatment do double.
It is normal to have some twinges from your liver. It's been suffering for years and now has the chance to recover. Some patients notice this.
In terms of getting pregnant, you should wait until 6 months after the tablets have finished. Ribavirin, in particular, is known to cause birth defects so you need to leave enough time for it to exit your system.
Finally, if you liver functions are not back to normal after treatment this should be looked into. A small percentage of patients with Hepatitis C also have another liver disease and we (as in doctors) have been assuming it is all due to the Hep C... Here is a list of things to look for if your LFTs do not normalise https://www.mayoclinic.org/symptoms/elevated-liver-enzymes/basics/definition/sym-20050830
Some time ago we saw some very bad science published. This suggested that treating Hepatitis C confers no benefits. While experts around the world expressed their firm view this was complete and utter rubbish here is something simple to understand. Get treated, get SVR and... you are far less likely to die of liver cancer.
This slide came from a presentation on Clinical Care Options entitled "Current HCV Therapy". The full slides are attached here:
This is just one of the reason treating your Hepatitis C sooner rather than later is a good idea. Push for coverage and appeal, but if you can't get access we know with 100% certainty that generic HCV medications deliver the same results - only the price is different (they are affordable).
KUALA LUMPUR/GENEVA – 13th November 2017 – Malaysian pharmaceutical company Pharmaniaga Logistics Sdn Bhd (Pharmaniaga), Egyptian pharmaceutical company Pharco Pharmaceuticals (Pharco) and non-profit research and development organization Drugs for Neglected Diseases initiative (DNDi) have signed a collaboration agreement to supply a new hepatitis C treatment regimen to be sold for US$300 in the public sector in Malaysia.
“It is estimated that there are around 450,000 people living with hepatitis C in Malaysia but most of them have been unable to access effective new hepatitis C treatment because of its very high price,” said Dato’ Farshila Emran, Managing Director of Pharmaniaga. “This agreement enables access to cheaper alternatives for patients in Malaysia, and we are proud to be embarking on this collaboration with DNDi and Pharco that would not have been possible without the Ministry of Health’s support.”
In partnership with the Malaysian Ministry of Health, DNDi is currently running clinical trials testing a potentially pan-genotypic treatment, combining the drug candidate ravidasvir, produced by Egyptian drug manufacturer Pharco Pharmaceuticals, with the existing hepatitis C medicine sofosbuvir. The clinical trial is ongoing in six hospitals and is co-sponsored by the Malaysian Ministry of Health, with initial results expected in early 2018.
“We applaud the Malaysian government in its efforts and commitment to make available affordable access to safe and effective treatments for hepatitis C,” said Jean-Michel Piedagnel, Head of DNDi South-East Asia. “The strategic investment from the Ministry of Health in helping develop a public health approach to the epidemic is remarkable.”
The agreement covers the supply of ravidasvir, once approved in Malaysia, and supply of sofosbuvir. A Government Use licence issued by the Malaysian Ministry of Domestic Trade, Co-operatives and Consumerism in September 2017 enables the importation of generic sofosbuvir in order to make this drug available in the public health system throughout the country at affordable prices.
“We hope that our collaboration with Pharmaniaga and DNDi to develop a treatment regimen that costs less than US$1 per day will lead to widespread access to safe, effective, and affordable treatment for hepatitis C patients in Malaysia and around the region,” said Dr. Sherine Helmy, CEO of Pharco Pharmaceuticals.
Currently a full 12-week course of treatment is available in Malaysia for around US$70,000. With the combination of generic sofosbuvir and ravidasvir, the cost for the same treatment will be made affordable with an almost 100% decrease in price.
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.
About 1 in 100 people, from all walks of life, have Hepatitis C so it is pretty common. Because it is a highly stigmatised disease, linked in the public mind to IV drug use, most patients choose to keep their diagnosis confidential. Despite the fact that the evidence shows most patients were infected too young to have been involved in IVDU, and many patients got it from blood transfusions, tattoos, and unsafe medical procedures, changing the stigma is probably an impossible task.
What this means is that having Hepatitis C is a very lonely experience for many people. Having to deal with the symptoms is one thing, but having to do it alone just adds to the burden. The good news is that help is out there!
One of the great things about the Internet is it allows people from across the globe to connect with other people with a common interest and with complete anonymity.
To find people like you, who have walked in your shoes and know how it feels, please visit the FixHepC forum - https://fixhepc.com/forum
You can browse the forum without logging in but to post you do need to create a login. Most people just use an anonymous email address to do that so there is no problem about maintaining your annonymity.
There are now highly effective treatments available with minimal side effects. For some patients, insurance and Medicaid can come to the rescue. For others, it might be a patient assistance program or the parallel importation of generics (these are the same medications but with a $1000 price tag for the whole treatment rather than a single pill). It is a cruel and unusual punishment to know that cure exists, but not for you.
Drop in to the FixHepC forum and find out how people just like you have navigated the varying processes that can see you get supported, treated and cured.
Just out of embargo for AASLD 2017 is the rather innocuous sounding Abstract 1078 which says, in brief, that these generic DAAs are inarguably proven the same as the originator DAAs.
Bioequivalent pharmacokinetics for generic and originator Hepatitis C Direct Acting Antivirals
Andrew M. Hill1, Loai Tahat2, Mohammed Khalil Mohammed3, Sanjay Nath4, Rabab Fayez Tayyem3, James A. Freeman5, Ismahane Benbitour7, Sherine Helmy6; 1Department of Translational Medicine, University of Liverpool, Liverpool, United Kingdom; 2Pharmaceutical Research Unit, Amman, Jordan; 3ACDIMA BioCentre, Amman, Jordan; 4Faculty of Medicine, Imperial College London, London, United Kingdom; 5GP2U Telehealth, Hobart, TAS, Australia; 6R&D Project Innovations, Pharco, Cairo, Egypt; 7BEKER Laboratories, Algiers, Algeria
Background: Mass production of low-cost generic directacting antivirals (DAAs) will be required to achieve targets of eliminating hepatitis C (HCV) by 2030. Gilead and Bristol-Myers Squibb have granted voluntary licenses to generic companies to mass-produce the DAAs sofosbuvir and daclatasvir at low cost. However generic manufacturers need to demonstrate bioequivalent pharmacokinetics for their generic DAAs compared to the originator versions, to fulfil World Health Organization standards for pre-qualification.
Methods: Randomised, single-dose, two-way, two-period pharmacokinetic studies were performed in 35-54 healthy volunteers, to compare generic forms of sofosbuvir and daclatasvir with the originator versions. Generics evaluated were from Pharco (Egypt), Beker (Algeria) and Hetero (India), versus originator sofosbuvir (Gilead) and daclatasvir (Bristol-Myers Squibb). All studies were conducted under Good Clinical Practice (GCP). Plasma concentrations of each DAA were assessed over 24 hours. Maximum concentration (Cmax) and Area Under the Curve (AUC) were calculated for each subject. Geometric mean ratios and associated 90% confidence intervals were used to compare each generic DAA with the originator version. Pre-specified limits for the 90% confidence intervals were 80% to 125% of the originator pharmacokinetic concentrations for AUC, and 69-145% for Cmax.
Results: Table 1 shows summary Geometric mean ratios for generic versus originator versions of sofosbuvir and daclatasvir. NB Results from Natco and Virchow came in after the deadline for AASLD submission, but are included here.
Table 1: Geometric mean ratio (90% confidence intervals) for generic versus originator HCV DAAs
|Sofosbuvir||Pharco||36||101.0 (88.1-115.7)||103.5 (97.6-109.7)|
|Sofosbuvir||Beker||35||95.4 (84.7-107.5)||98.5 (91.6-106.0)|
|Daclatasvir||Beker||35||35 104.1 (93.1-116.3)||103.0 (94.4-112.4)|
|Sofosbuvir||Hetero||54||95.7 (97.2- 105.2)||100.8 (96.2-
|Sofosbuvir||Natco||N/A||96.1 (81.0-114.0)||100.7 (94.2-107.8)|
|Daclatasvir||Natco||N/A||94.5 (83.1-107.4)||96.5 (87.1-106.8)|
|Sofosbuvir||Virchow||24||94.8 (83.3-107.9)||95.8 (86.9-105.7)|
All three (now expanded to 5) generic forms of sofosbuvir met pre-specified bioequivalence criteria. The Cmax and AUC of daclatasvir were bioequivalent in both cases. There were no serious adverse events observed.
Conclusions: The pharmacokinetics of generic sofosbuvir and daclatasvir were bioequivalent to the originator versions, in three independent single-dose PK studies. WHO pre-qualification of bioequivalent generic DAAs could then permit their export to high-burden countries for mass treatment programmes.
Disclosures: James A. Freeman - Advisory Committees or Review Panels: Pharco Pharmaceuticals, Beker Pharmaceuticals, Beacon Pharmaceuticals; Stock Shareholder: FixHepC, GP2U Telehealth
Ismahane Benbitour - Management Position: BEKER Laboratories
Sherine Helmy - Board Membership: Presidio Pharmaceuticals; Stock Shareholder: Pharco Pharmaceuticals
The following people have nothing to disclose: Andrew M. Hill, Sanjay Nath
Bye bye limitatio (and generics) - Open access to the new Hepatitis C medications for all Swiss patientsWritten by Super User
Switzerland has just announced that all limitations on access to the new DAAs will be abolished allowing treatment for all. Great news for Swiss patients. Here is an article from the Swiss Hepatitis C Association about it. If you are not lucky enough to live in Switzerland generic versions of the new medications are available for 1% of the originator prices. It's interesting to see that all the countries that have parallel imported generics at scale have managed to strike great pricing deals that allow things like this to happen. Australia, Canada, New Zealand, Italy, Switzerland... The list is growing.
Bye bye limitatio – People with hepatitis C are relieved
The rationing of hepatitis C drugs laid down by the Federal Office of Public Health (FOPH) about three years ago will be abolished as of 1 October 2017. For the first time, all patients can be treated regardless of the type of virus and disease progression.
The rationing of Gilead’s hepatitis C medicines will also be discontinued on October 1,2017. Harvoni and Epclusa can thus be prescribed to all hepatitis C patients for the first time, regardless of liver damage. This was after the rationing had already been abolished for Zepatier on July 1 and for Viekirax/Exviera on August 1 for all those affected with genotypes 1 or 4.
The abolition of rationing was accompanied by substantial price reductions, which are now also expected for Gilead products. Since Gilead’s Epclusa can be used for all 6 genotypes, all hepatitis C patients, regardless of their stage of development, can be treated and cured with a very high probability from October 1. This is excellent news for affected patients and represents an important step towards the elimination of hepatitis C in Switzerland.
This concludes a sad chapter in the history of the Swiss healthcare system. For years, leading representatives of the FOPH have claimed that it makes no sense to treat “healthy people”. As a result, thousands of people with hepatitis C were left untreated and continued to suffer from the symptoms of their disease for years. We welcome the latest developments and are extremely pleased with the change of heart in the FOPH. With the abolition of rationing, the core requirement of the SHCA patient organisation and the Positive Council, the “treatment of all HCV patients”, has finally been fulfilled.
This is the demand we have made since our petition to Federal Councillor Berset in July 2015.
The FOPH will boast of having achieved price reductions. This confirms our accusation that the Federal Office fought a price war on the back of the patients for years. This is ethically untenable and we warn against pursuing the same strategy for other life-threatening diseases. Under no circumstances should those affected be the victims of such price wars. We demand that our Parliament develops the necessary instruments to enable the Federal Office to conduct future price negotiations more constructively and transparently.
We would like to thank the experts of the Swiss Hepatitis Strategy, who have worked tirelessly with us to promote the well-being of those affected, and we regard the case of the limitation as a joint success for civil society.
We would also like to thank the industry, whose medicines have cured us and hopefully will now enable many other hepatitis C patients to lead a new life. Their willingness to compromise in the negotiations with the FOPH made it possible to abolish rationing.
What exactly is chronic HCV? In a nutshell, it refers to ongoing inflammation of your liver. But it can lead to symptoms throughout your body. Over time, living with this condition can cause your body to be especially vulnerable to serious health complications. Here is a great infographic from Healthline about the effects of Hepatitis C on your body.
Last week there was some celebrations after Under pressure, Gilead expands Sovaldi licensing deal to four middle-income countries.
So great news, right? Not exactly, because in order for a country to have PRACTICAL ACCESS the product needs to be registered for sale there.
Now Sovaldi hit the market in late 2013 and back in February 2015 Gilead announced Gilead is committed to increasing access to its medicines for all people who can benefit from them, regardless of where they live or their ability to pay and providing a list of 91 countries where generics would be available. That list has since been expanded to include 101 countries.
That was 2 and a half years ago, so surely Sovaldi must be available in all the original 91 by now, afterall, Sovaldi was fast tracked by the FDA with one of the most rapid approvals ever seen...
Nope. To date Sovaldi is only registered in 26 of those 101 countries, with applications filed in another 6. That's 32/101 countries filed in 2 1/2 years.
- Without filing, there can be no registration.
- Without registration, there can be no availability.
- Without availability, there can be no patients treated.
This is the reality behind Gilead's PR-access. It is PR, it is not access.
By Priti Krishtel
Last week, the FDA approved AbbVie’s Mavyret—a new hepatitis C virus (HCV) drug that treats all genotypes of the disease and cures more than 90% of patients within just 8 weeks of treatment. This has been reported as a threat to Gilead Sciences’ dominant position in the market, sparking rumors of a potential price war that could lower prices on the infamously expensive treatments.
There is reason to be tentatively optimistic. The initial published price on Mavryet was lower than expected at $13,200 per month—or $26,400 for a full course of treatment—appearing on the surface to be a significant discount from the $94,500 per-treatment course costs of Harvoni, Gilead’s market-leading treatment.
And while the published price is a step in the right direction to getting more people the treatment they need, it isn’t the whole story. The set Mavryet price is reflective of the current market conditions. With behind-the-scenes payer negotiations, the announced price on Mavyret is only an approximately 15% discount to the current net price paid for Gilead’s products.
While AbbVie’s pricing is now the lowest for a curative HCV drug, it is not a radical undercutting of Gilead prices. Millions of Americans with HCV—and tens of millions globally—are already blocked from getting treatment at the current exorbitant prices set by the pharmaceutical industry and the subsequent rationing of treatment approval by payers.
The United States is currently facing an HCV epidemic. There are an estimated 3.6 million Americans with HCV—and that number is expected to rise in the coming years. There is a cure, but every day 48 people in the United States die from HCV, the deadliest infectious disease in America. That’s because 2 out of every 3 Americans who have been diagnosed with HCV do not receive treatment, largely due to the high costs. States such as Louisiana and Pennsylvania are forced to ration treatment to the sickest of patients, and many insurers refuse to cover it because of the high price.
A week out from the FDA’s approval, it is not clear what the introduction of Mavyret will do to change this situation. What is clear, however, is that people should not die of an entirely treatable illness. One of the root causes of the unaffordability crisis is the fact that pharmaceutical companies such as Gilead over-patent drugs, including extending its market monopoly on Sovaldi for at least the next 2 decades.
Gilead’s initial price on Sovaldi has skewed what the market considered a fair price for HCV treatment. I doubt we would see this level of praise for AbbVie now if Gilead hadn’t launched this lifesaving medicine at $84,000 for a single course of treatment.
Until we address the core of the drug pricing problem—unjustified patents—pharmaceutical companies will be able to abuse the system to obtain monopolies on the market and charge astronomical prices that prevent people from getting access to disease-curing medicines.
About the Author
Priti Krishtel is co-founder and co-director of the Initiative for Medicines, Access & Knowledge (I-MAK), a US-based nonprofit group of scientists and lawyers working globally to get people lifesaving medicine. Prior to founding I-MAK, Krishtel obtained her law degree from New York University School of Law worked as a health attorney in the United States, Switzerland and India.
"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.
Here is a copy of the presentation, called "Practivism, it's the new black", given by Dr James Freeman at the International AIDS society meeting in Paris today.
Here is the text that went with the images.
Crisis, What Crisis?
This crisis. Look at this price comparison. I mean seriously?
We only have to look at Egypt to know these medications can be made affordably
Pricing negotiations are one sided and conducted by bandits
Our funders simply can not afford to cover the costs so…
We have rationing that sees only the sickest patients treated
And virtually nothing is being done for high burden populations like prisoners
And People Who Inject Drugs
Politicians pay lip service to the issue
Many advocacy groups are directly funded by Big Pharma*.
And in the Ukraine earlier this year generics were shot down by data exclusivity
Treatment rates are similar to infection rates
In short we are currently going nowhere fast.
Patients are stigmatized and don’t speak out so in the zeitgeist there is no crisis
But we desperately need a new balance between patent rights and patient lives
And now seven seconds of silence to remember those of us for whom treatment will come too late
One second for each patient who died during the time it's taken to give this presentation
Was it really only 50 years ago our Statesmen talked like this and the crowds came to listen?
What we call the “big picture” is really just the product of what each and every one of us chooses to do.
What we do as individuals, thinking globally but acting locally, exhibits a butterfly effect so I would like to suggest adopting this butterfly symbol and a simple slogan like "Wear if you care"