"Interim Results from Phase 2 Combination Study of INCIVEK and VX-222
• In a separate press release issued earlier this week, Vertex announced results from an interim analysis of the two, four-drug (quad) arms of an ongoing Phase 2 clinical trial evaluating multiple 12- and 24-week response-guided regimens of Vertex's lead investigational hepatitis C virus polymerase inhibitor, VX-222, dosed in combination with INCIVEK. The study currently includes four treatment arms. Two of the arms are fully enrolled and are evaluating four-drug combinations of VX-222 (400 mg or 100 mg; BID), INCIVEK (1,125 mg; BID), pegylated-interferon and ribavirin. The third and fourth arms are three-drug treatment arms that are evaluating a twice-daily, all-oral, interferon-free regimen of INCIVEK (1,125 mg), VX-222 (400 mg) and ribavirin in people with genotype 1a or 1b chronic hepatitis C. Vertex expects to complete enrollment in the all-oral arms in the third quarter of 2011.
• Data from this study will be submitted for presentation at a medical meeting later this year."
"2. #LB-14: "VX-222/telaprevir in Combination with Peginterferon Alfa-2a and Ribavirin in Treatment-naïve Genotype 1 HCV Patients Treated for 12 Weeks: ZENITH Study, SVR12 Interim Analysis." November 7, 2011."
So apparently the interferon free triple involving 222 results are not ready yet. Any guesses as to which "medial meeting later this year" which is referred to above and the dates it will be presented?
This is a small study, but 222 made the difference. The chance of RVR improved from 58% w/o 222 in Advance to 85% with 222 here. The overall SVR12 is 90%. (SVR12 is as good as SVR24.) One can appreciate the potency of 222 by comparing this new data against the trial data without 222.
I would say the all-oral combo of T/222/Riba has a promise. My guess for the SVR % for the all-oral would be around 70. This would be for the patients who cannot tolerate interferon. It would be interesting to speculate on the effect of raising the 222 dose to 750mg from 400mg. In the earliest trial ViroChem used 750mg dosing. Since IFN is not in the mix, it may be OK to raise the dose back to 750mg.
"This would be for the patients who cannot tolerate interferon. "
Is there any quantitative data (numbers or percentage) of those who can not tolerate Interferon. If not, based on your extensive knowledge of these things can you guess a percentage range.
As to your estimate of 70% SVR for all oral, is that for the triple combo which includes 222, or do you believe with all oral compounds such as 7977, inhibitex, or others' orals the SVR will also be around 70%?
It seems to me if the all orals are going to have a lower SVR, if I were a doctor working with HCV patients I would not recommend a non interferon regiment (for its less side effects)unless the patient had gotten very very sick because of previous interferon use. If most doctors think that way and the SVR of all oral is going to be lower, there may not be that many patients who want to risk a lower SVR regiment.
Some may say most patients will start with all oral and if they do not achieve SVR then they could take an interferon contained regiment. It is my understanding that that is not wise because once you take one regiment and you don't achieve SVR, you will run the risk of developing mutants.
The news release today states the all oral treatment arms of the Zenith study will finish treatment in Dec 2011 with 12 week EOT interim results to be released in early 2012. Also the overall 93% cure rates with Quad Therapy, with half the patients being cured in 12 weeks, certainly validates the benefit of adding VX 222 to treatment with telaprevir+SOC. It alos suggests that the all oral regiemn (telaprevir+222+ribavirin) which has had no viral breakthrough or serious adverse effects reported to date, with just a month left to go in the treatment of all patients enrolled, will keep Vertex competitive in the race to develop an all-oral next generation hep C treatment regimen.
The results announced today regarding the HIV- Hep C coinfected patient study that is ongoing shows that TVR+SOC can more than double the SVR rates in this most difficult to treat supopulation of hep C patients. Hep C is the leading cause of death among patinets receiving treatment for HIV.