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Pharmasset and Roche Obtain FDA Consent to Start a Phase 2b Study With R7128 in Treatment Naive HCV Patients
Date:1/12/2009

icated:

  • Results with R7128 500mg bid, 1000mg bid and 1500mg bid with SOC achieved a mean 3.8 log10 IU/mL (30% RVR, 6 of 20), 5.0 log10 IU/mL (88% RVR, 22 of 25) and 5.1 log10 IU/mL (85% RVR, 17 of 20) decrease in HCV RNA, respectively. Results with placebo with SOC indicated patients achieved a mean 2.9 log10 IU/mL decrease in HCV RNA and 18.75% (3 of 16) patients achieved RVR (<15 IU/ml).

In a harder to treat, non-responder, genotype 2 and 3 HCV patient population treated for 4 weeks:

  • Results with R7128 1500mg bid with SOC led to 90% of patients achieving an RVR (<15 IU/ml) compared to 60% in the standard of care arm.

In November 2008, Pharmasset, Roche and InterMune initiated the INFORM-1 trial to investigate the combination of R7128 with InterMune's R7227 (ITMN-191), a protease inhibitor in HCV patients in the absence of pegylated interferon and ribavirin. Patients will receive a maximum of 14 days of combination treatment, followed by Pegasys(R) plus Copegus(R) for a further 46 weeks. The aim of the study is to investigate the safety and antiviral activity of the combination.

About Pharmasset

Pharmasset is a clinical-stage pharmaceutical company committed to discovering, developing and commercializing novel drugs to treat viral infections. Pharmasset's primary focus is on the development of oral therapeutics for the treatment of hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV).

Pharmasset is currently developing three product candidates. Clevudine, for the treatment of chronic HBV infection, is enrolling Phase 3 clinical trials for registration in North, Central and South America and Europe. Clevudine is already approved for HBV in South Korea and marketed by Bukwang Pharmaceuticals in South Korea
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SOURCE Pharmasset, Inc.
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