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news.Roche has completed enrollment of the 12 week RG7128 Phase 2b study (PROPEL) of approximately 400 treatment-naive patients with hepatitis C virus (HCV) genotypes 1 and 4. The study remains blinded to Roche and Pharmasset.
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Pharmasset is a clinical-stage pharmaceutical company committed to discovering, developing, and commercializing novel drugs to treat viral infections.
Reportedly, Roche has started a 24 weeks Phase 2b study with RG7128 in combination with pegylated interferon and ribavirin in treatment-naive patients with HCV genotypes 1 and 4 to evaluate the safety and efficacy of RG7128 in combination with standard of care for longer durations.
Roche is expecting to complete patient recruitment for the trial in its second quarter. Additionally the company also said that the study could provide flexibility for combining RG7128 with direct acting antivirals which is currently in development with varying durations of therapy.
Earlier, RG7128 has showed antiviral activity with a 90% RVR in HCV genotypes 2 and 3 prior non-responders in a 28 day clinical study. Now, Roche is intending to begin Phase 2b study of RG7128 in combination with pegylated interferon and ribavirin in patients with HCV genotypes 2 and 3 later in 2010
Roche will start Inform-3 study as soon as the company and InterMune identify the optimal dose of ritonavir-boosted RG7227 with from ongoing studies. The company has also terminated it plan of conducting 28 day Inform-2 study, designed to evaluate the combination of RG7128 with RG7227, InterMune’s HCV protease inhibitor, with and without pegylated interferon and ribavirin.
Changes in Inform study will not create an impact on the primary registration pathway for RG7128, said that company.
Michelle Berrey, chief medical officer of Pharmasset, said: “We are pleased that our partner Roche has completed the enrollment of the initial Phase 2b study of RG7128, and we look forward to the announcement of data from the Propel study. We believe that the initiation of additional Phase 2b studies indicates Roche’s continued commitment to RG7128. We are also encouraged by Roche’s willingness to consider alternatives for potential combination with RG7128 in interferon-sparing combination studies.”
Pharmasset’s primary focus is on the development of oral therapeutics for the treatment of hepatitis C virus (HCV) and, secondarily, on the development of Racivir for the treatment of human immunodeficiency virus (HIV).