Psi 7977 phase 2a results pdf

The results of phase ii studies demonstrated that sofosbuvir once. Relative bioavailability of a 200 mg psi7977 tablet formulation to a 400 mg psi. Openlabeled study of psi7977 and rbv with and without peg. Pharmasset announces results of a 28day phase 2a study with psi 7977 for the treatment of chronic hepatitis c infection 94% or 93% of patients achieved undetectable hcv rna levels following 28 days. Results of a 28day phase 2a study with psi7977 for the. Pharmasset initiates phase 2b clinical trial of psi 7977 for chronic hepatitis c genotypes 1, 2, and 3 pharmasset, inc. Pdf genotype and subtype profiling of psi7977 as a. In the p79770221 study, patients received sofosbuvir 100, 200 or 400 mg. This study is to assess the safety and tolerability of sofosbuvir sof 400 mg with and without ribavirin rbv andor with and without pegylated interferon alfa2a. Vrus announced today that dosing has begun in a phase 2b study of psi 7977, a nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis c hcv. It focused on evaluating different doses of psi 7977 in combination with pegasys peginterferon alfa 2a and copegus ribavirin. August 25, 2010 investigator i confirm that i have read this protocol, p79770523, and agree to conduct this study in.

To describe the effect of therapeutic rescue defined as the addition of. The primary goal of the study is to determine the safety and tolerability of psi 7977 in combination with pegylated interferon and ribavirin. In this study, we profiled the activity of psi 7977 and its ability to select for resistance using a number of different replicon cells. Pharmasset starts trial of hcv polymerase inhibitor psi. Inhibition of hepatitis c virus replicon rna synthesis by psi. Genotype and subtype profiling of psi7977 as a nucleotide. Psi7977 for treatment of chronic hepatitis c clinical. Pharmasset initiates phase 2a trial with psi7977, a. Pharmasset announces results of a 28day phase 2a study with psi 7977 for the treatment of chronic hepatitis c infection 94% or 93% of pa. Sofosbuvir in combination with peginterferon alfa 2a and ribavirin for noncirrhotic, treatmentnaive patients with genotypes 1, 2, and 3 hepatitis c infection. Sofosbuvir in combination with peginterferon alfa2a and.

Subjects receive psi7977 400 mg qd with pegylated interferon and ribavirin pegifnrbv for a total of 12 weeks. Gt 2a s282t showed only a very modest shift in 50% effective concentration ec50 for psi7977. Overall efficacy and safety results of sofosbuvirbased therapies in. In january 2010, pharmasset initiated a 28day phase iia study on psi 7977. Mechanism of activation of psi7851 and its diastereoisomer psi7977. Psi7977 for treatment of chronic hepatitis c clinical trials arena. In a phase iia clinical study of psi7977 in combination with soc, rapid. Pdf mechanism of activation of psi7851 and its diastereoisomer. Cmethyluridine monophosphate, is the purified diastereoisomer of psi 7851 and is currently being investigated in phase 3 clinical trials for the treatment of hepatitis c. Our other clinical stage candidates include psi 7977, a chirally pure isomer of psi 7851, an unpartnered, next generation hcv nucleotide analog, that has completed initial phase 1 clinical studies which provided supportive safety and efficacy data to initiate a phase 2a trial, and racivir, for the treatment of hiv, which has completed a phase 2.

About the phase 2a trial the phase 2a trial is expected to enroll about 60 patients with chronic hepatitis c infection who have not been treated previously. Genotype and subtype profiling of psi7977 as a nucleotide inhibitor of hepatitis c virus article pdf available in antimicrobial agents and chemotherapy 566. Genotype and subtype profiling of psi 7977 as a nucleotide inhibitor of hepatitis c virus article pdf available in antimicrobial agents and chemotherapy 566. This document provides a more detailed evaluation of clinical findings. Pharmasset announces results of a 28day phase 2a study with psi 7977 for the treatment of chronic hepatitis c infection 94% or 93% of patients achieved undetectable hcv rna levels following 28 days of treatment with psi 7977 200mg or 400mg qd, respectively, in combination with pegasysr and copegusr. Pharmasset announces results of a 28day phase 2a study with psi 7977 for the treatment of chronic hepatitis c infection 94% or 93% of patients achieved undetectable hcv rna levels following 28. Pharmasset announces results of a 28day phase 2a study.

Donor dependence of cata and ces1 was assessed using. Hcv infection interferes with the human immune system and could result in liver. These results indicate that cata preferred psi7977 as a sub. Results are shown as foldchange relative to donor a. The study enrolled 63 chronic hcv infected patients. In january 2010, pharmasset initiated a 28day phase iia study on psi7977. Pharmasset initiates phase 2b clinical trial of psi7977.