For those on Gilead 9451, 5885, peg/riba info 4 u..
For those of us on the Gilead trail with GS 9451 NS3 protease, GS 5885 NS5A, peg/intf. and riba you many find these new studies of some interest. I know these are different pharma co. and the preliminary studies for each individual drugs were for treatmeant-naive folks however these are from the same type class of meds and there is some positive data to check out. SVR results up to 86% in PILLAR and COMMAND-1 studies. So there is some data showing these class of meds have merit and are continuing on with clinical trails. Go check it out for yourself if interested.
"Bristol-Myers Squibb and Tibotec Pharmaceuticals are teaming up to carry out a Phase II clinical study evaluating the combination of their respective HCV candidates, daclatasvir (BMS-790052) and TMC435. BMS’s daclatasvir is an NS5A replication complex inhibitor, and Tibotec’s TMC435 is an NS3 protease inhibitor, which the Janssen-owned firm is developing in partnership with Medivir. Both drugs are currently in Phase III development by their respective firms."
From the PILLAR study - "Results from the final PILLAR analysis showed that TMC435 administered in combination with peginterferon alpha-2a and ribavirin (PR) resulted in significantly higher sustained virologic response (SVR) rates compared to placebo plus PR. In the two TMC435 treatment groups who received TMC435 75mg, between 75 and 82 percent of patients achieved SVR24, and in the two TMC435 treatment groups who received TMC435 150mg, between 81 and 86 percent of patients achieved SVR24. This is compared to 65 percent of patients in the placebo arm who achieved SVR24. In addition, 79 to 86 percent of patients in the TMC435 treatment arms had a shortened treatment duration of 24 weeks, compared to a 48 weeks treatment duration for patients who received placebo plus P/R. In TMC435 arms, 68 to 76 percent of patients achieved rapid virologic response [RVR; HCV RNA less then 25 (undetectable)], of whom 88 to 95 percent achieved SVR24. There were no significant differences for adverse events between TMC435 treatment groups and placebo."
For the COMMAND-1 study- "Bristol-Myers Squibb Company (NYSE: BMY) today announced interim results from a Phase IIb clinical trial (COMMAND-1) of 395 treatment-naïve, genotype 1 and 4 hepatitis C infected patients in which two doses of the investigational NS5A replication complex inhibitor daclatasvir (BMS-790052), in combination with peginterferon alfa and ribavirin (alfa/RBV), achieved higher virologic response rates through Week 12 than the alfa/RBV control group, with comparable rates of adverse events. The data were reported at the 62nd Annual Meeting of the American Association for the Study of Liver Diseases in San Francisco.
The primary efficacy endpoint reported in these interim results is the proportion of HCV genotype 1 patients who achieved undetectable viral load (HCV RNA <10 IU/mL) at Weeks 4 and 12 (extended rapid virologic response, or eRVR). Of the 365 patients with HCV genotype 1 in the study, 54% in each of the daclatasvir dose groups (20 mg and 60 mg) achieved eRVR vs. 14% in the control group. The proportion of HCV genotype 1 patients with undetectable viral load at Week 12 was 78% (115/147) and 75% (110/146) in the daclatasvir 20 mg and 60 mg groups, respectively, compared with 43% (31/72) in the control group. Serious adverse events occurred in 7.5% and 7.6% of patients in the daclatasvir 20 mg and 60 mg groups, respectively, and in 6.4% of patients in the control group.
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