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Pharmasset Reports Positive Results from its HCV Clinical Programs
Date:1/6/2011

atigue; AEs were consistent in severity and frequency to historical Peg-IFN/RBV treatment. There were no clinically significant, treatment-emergent trends in any clinical laboratory parameters.  

PSI-7977 with Peg-IFN/RBV resulted in rapid viral suppression, with all HCV GT2 or 3 patients (n=24) achieving both a rapid virologic response (RVR) and remaining below the limit of detection through the end of treatment at week 12 (EOT). No patient exhibited viral breakthrough. These HCV GT2 or 3 patients are now being monitored for an additional 24 weeks to assess SVR at 12 weeks (SVR12) and 24 weeks (SVR24) after the discontinuation of therapy. Initial data have been submitted for presentation at an upcoming major scientific conference scheduled to take place during the first half of 2011.

In addition to the ongoing Phase 2b dose-ranging study, we recently announced the initiation of an exploratory Phase 2 study of PSI-7977 and RBV with 0-12 weeks of interferon in patients with HCV GT2 or GT3.  During the second quarter of 2011, we also expect to initiate a 24-week Phase 2b study of PSI-7977 with Peg-IFN/RBV.

PSI-938In late November 2010, we initiated Part 2 of a Phase 1 study that includes the first combination of a purine (PSI-938) and a pyrimidine (PSI-7977) nucleotide analog for the treatment of HCV. The cohorts within Part 2 are evaluating PSI-938 300mg QD as monotherapy and in combination with PSI-7977 400mg QD. The primary objective is to assess the safety, tolerability and pharmacokinetics of PSI-938 alone and in combination with PSI-7977. The secondary objective of Part 2 is to evaluate the short-term change in HCV RNA.

Preliminary results with PSI-938 300mg QD administered as monotherapy for 14 days demonstrate:

  • PSI-938 was generally safe and well tolerated over 14 days
  • There were no serious adverse events, and no dose modifications or discontinuations
  • There were no clinically significan
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  • SOURCE Pharmasset, Inc.
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