Bristol-Myers, Gilead Seek AIDS Cocktail to Match Success in Hepatitis C
.
Today bloomberg published an article on the aspirations of Bristol-Myers and Gilead ; the two drug companies are hoping to find the same success with HCV they have with their top selling oral combination for AIDS.
.
Quoted from the article:"The new antiviral combinations are oral drugs, not injections, and may have the potential to cure patients who haven’t benefitted from the older products, Liang said. “Both clinicians and patients would prefer drugs that lack the side effects of interferon and ribavirin,” said Alexandra Makarova, an analyst at Decision Resources, a research company in Burlington, Massachusetts, in a telephone interview. “If the combination of direct antivirals will allow doctors to exclude interferon and ribavirin, it could spoil the party for those regimens.” Optimal Combination Research hasn’t identified the optimal oral combination for hepatitis C. Initial reports show treatment with just one pill or low-dose combinations aren’t enough to keep the virus in check, and investigators are building more, and more-powerful, combinations. The U.S. Food and Drug Administration, which initially rejected efforts to study treatments without interferon and ribavirin, has now let trials begin".
.
.
.Telaprevir /VX-222 .
.As for the latest news on Vertex's Telaprevir/VX-222 combination, Michelle Fay Cortez writes: "Adding ribavirin alone delayed or reduced the breakthrough virus, the study found. Vertex stopped a low-dose combination of telaprevir and its experimental drug VX-222 after the virus broke through during the first month of treatment. A higher-dose combination is undergoing tests".
.(excerpt)
Oct 25, 2010 "Vertex today announced the initiation of a Phase 3b clinical trial to evaluate twice-daily dosing of telaprevir (1,125 mg; BID) compared to three-times-daily dosing of telaprevir (750 mg; q8h) in combination with pegylated-interferon and ribavirin for people with genotype 1 hepatitis C. Patient screening for enrollment in the study is expected to start in November 2010.
.
Additional details on this trial were provided today in a separate press release. Ongoing Phase 2 Trial Evaluating Combination Regimens of VX-222 and Telaprevir Vertex announced today that it has modified its clinical trial evaluating telaprevir dosed in combination with Vertex's lead HCV polymerase inhibitor, VX-222. The company will discontinue Arm A of this study as a result of patients meeting a pre-defined stopping rule related to viral breakthrough during the first four weeks of dosing. Arm A was designed to evaluate a two-drug regimen of VX-222 (low dose; 100 mg) and telaprevir (1,125 mg) both dosed twice daily without pegylated-interferon and ribavirin. The additional three arms of the study are continuing without modification, and no viral breakthrough has been reported in these arms. This Phase 2 proof-of-concept trial began dosing patients in August 2010 and is designed to evaluate safety and SVR rates using 12-week response-guided regimens of telaprevir/VX-222-based combination therapy in people with genotype 1 hepatitis C. The trial is continuing to evaluate treatment regimens that include four-drug regimens of telaprevir, VX-222, pegylated-interferon and ribavirin, as well as a two-drug regimen of only telaprevir (1,125 mg) and a higher dose of VX-222 (400 mg), both dosed twice daily. Trial sites have now completed patient recruitment, which Vertex expects will enable it to reach the initial target enrollment of 100 patients for the study. Vertex expects to obtain on-treatment clinical data from this trial in the first half of 2011 and SVR data in the second half of 2011" Read In Full.....
.
Also See Blog : Vertex;VX-222 and Telaprevir, Vertex disclosed rebound in viral load in phase IIb study
.
.Also mentioned in the article from bloomberg were BMS-790052 and BMS-650032, protease inhibitor, GS-9256, with a second new drug, GS-9190.
,'
No comments:
Post a Comment