Today the FDA approved what I pray is the cure for my illness 15-0 with nary a naysayer among them. Hepatitis C sufferers who failed the Interferon prophylaxis over the years now have one good shot at killing the dragon.
We’ve waited a long time-some as many as 16 years-for this day. How soon Gilead cranks up the pill machine is the only delay I see. Scientists actually created the first Interferon product in 1957 but didn’t understand how to employ it. They killed a lot of people before they diluted the dose down further and further. After the introduction of Ribavirin in pill form, the two-drug cocktail jumped from 39% success in fifty two weeks to almost 54%. With the latest addition of Telepravir/Bocepravir triple-drug regimen the cure rate has risen to 62% with an average of forty weeks.
In contrast, Sofosbuvir plus Ribavirin in oral form (pills) have a twelve week course for the most intractable genotypes (1A and 1B) with a reputed 97% rate and no relapses. Guess that tells you all you need to know. It won’t kill you and it works.
Genotypes 2 and 3, normally the ones most amenable to treatment with Interferon, are quite the opposite using the nucleotide protease inhibitors. We hope follow-on research will yield better results which are currently in the 69-72% range. Hell, that’s still better than the bug juice.
P.S. The Stock market closed too early to reflect the 3 PM FDA conference review board’s decision. However the stock did rise from 68.68 at 2:30 PM to $69.68 at the closing bell. This one will be interesting to watch. They are pretty much not only the frontrunners in this new race but indeed the only runners with an approved product.
asknod
brewerkelli
cspencer02
jamesaurora
kcraveiro
Laura
Veterans Claims Help 
I hate to be the angel of doom but I’m afraid it’s not so easy. Sofosbuvir was approved for all genotypes BUT….with Ribavirin, INF free for geno 2 and 3. The drugs were also approved for All geno types with the addition of Peg INF and Riba.
Genotyp 2 patients will take Sofosbuvir and Ribavirin for 12 weeks
Geno 3 patients will take Sofosbuvir and Ribavirin for 16 to 24 weeks and can include Interferon if desired. This is because Genotype 3 has a lower clearance rate and high relapse (about 1/3 relapse).
As for genotype 1 which most veterans have…
“Committee members also voted unanimously (15-0) that the available data support approval of sofosbuvir in combination with pegylated interferon and ribavirin for the treatment of chronic hepatitis C in TREATMENT-NAIVE adult patients with genotype 1 and 4 infection”. (SVR 90%)
The committee also discussed, but did not vote, on whether evidence supported sofosbuvir in combination with Interferon + Ribavirin for treatment of chronic hepatitis C in patients with GT 1 infection who are NONRESPONDERS to a prior course of Interferon+Ribavirin..
Studies did not directly analyze this patient population, but the FDA presented extrapolated data that suggested about 75% of treatment-experienced patients might respond positively to the therapy.”
My personal opinion….
As Dr Poordad form Cedairs once said, “Genotype 2’s will clear with anything, even holy water”. As for genotype 3, I cowrote a paper on Geno 3 so I spent lots of time researching it and I wouldn’t use Sofosbuvir by itself if they have any treatment negatives (i.e. obesity, cirrhosis, high viral load) As for treating Genotypes 1, they still need the interferon+Riba.
How long will it take for veterans to be able to get treated with this med regimen? Depends how long it takes us to get the veterans committee to give us funding.
You can understand my joy though. I can’t do Interferon and many others can’t either. Autoimmune disorders remove many of us from this option. Sofosbuvir is the only game in town for me. Genotype 3A is running 68% with riba/GS7977 in combo. That’s 68% better than 0%. I’ll take what I can get at this point. If it doesn’t work, then I’ll go to the back of the bus again and pray for another one to come down the pike.
When you’re ready to treat, invite me to watch over your case. I’ll bring in people who are experts on genotype 3. Can’t let anything happen to you.
BTW, I found out something that might help with claims. You see, if I put everything I found on gammaglobulin together, I can prove….
1. That the gammaglobulin was made from pooled prisoners blood and contained Hep B antigen. 2. That the gammaglobulin was used past its expiration date. 3. That the dose given to some of the men was enough for a horse. 4. That the gammaglobulin didn’t prevent hepatitis, all it did was make the hepatitis anicteric (without jaundice) and more difficult to identify. 5. That the VA knew by 1960 that gammaglobulin would make hepatitis infection be silent. No symptoms to write on medical records.
They knew because the Willowbrook trials had proved it.
Silvia
This is great news but I think patients will have to ask for it. Stock: The price per share is expensive. Someone should start a diversified Hepatitis mutual fund.
Once they start cranking it out I wonder how much longer it will take the VA to start treatments.
If the follow to form like the last rollout it took 8 to 10 months before the San Antonio hospital was proscribing the drug. Hope they speed this one up. I am still stage2 posttransplant but for all you autoimmune guys great good luck and fast tracks
Fabulous! That’s the one that we are waiting on!
YES!!! Lets go get it!!!