August 25, 2010 investigator i confirm that i have read this protocol, p79770523, and agree to conduct this study in. 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. Donor dependence of cata and ces1 was assessed using. Pharmasset initiates phase 2b clinical trial of psi7977. In january 2010, pharmasset initiated a 28day phase iia study on psi 7977. Genotype and subtype profiling of psi7977 as a nucleotide inhibitor of hepatitis c virus article pdf available in antimicrobial agents and chemotherapy 566. In the p79770221 study, patients received sofosbuvir 100, 200 or 400 mg. Results of a 28day phase 2a study with psi7977 for the. 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. Mechanism of activation of psi7851 and its diastereoisomer psi7977.
A phase i, openlabel, singlesequence drugdrug interaction trial in. Sofosbuvir in combination with peginterferon alfa 2a and ribavirin for noncirrhotic, treatmentnaive patients with genotypes 1, 2, and 3 hepatitis c infection. Pdf mechanism of activation of psi7851 and its diastereoisomer. Psi7977 400 mg dose 2 x 200 mg tablets orally daily for 24 weeks. Pharmasset announces results of a 28day phase 2a study. 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. Pdf genotype and subtype profiling of psi7977 as a.
In january 2010, pharmasset initiated a 28day phase iia study on psi7977. 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. The study enrolled 63 chronic hcv infected patients. Subjects receive psi7977 400 mg qd with pegylated interferon and ribavirin pegifnrbv for a total of 12 weeks. In a phase iia clinical study of psi7977 in combination with soc, rapid. Pharmasset starts trial of hcv polymerase inhibitor psi. Gt 2a s282t showed only a very modest shift in 50% effective concentration ec50 for psi7977. 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. Genotype and subtype profiling of psi 7977 as a nucleotide inhibitor of hepatitis c virus article pdf available in antimicrobial agents and chemotherapy 566. Pharmasset initiates phase 2b clinical trial of psi 7977 for chronic hepatitis c genotypes 1, 2, and 3 pharmasset, inc. Inhibition of hepatitis c virus replicon rna synthesis by psi. The primary goal of the study is to determine the safety and tolerability of psi 7977 in combination with pegylated interferon and ribavirin.
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. Hcv infection interferes with the human immune system and could result in liver. Results are shown as foldchange relative to donor a. Pharmasset initiates phase 2a trial with psi7977, a. Psi7977 for treatment of chronic hepatitis c clinical. 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.
This document provides a more detailed evaluation of clinical findings. Overall efficacy and safety results of sofosbuvirbased therapies in. To describe the effect of therapeutic rescue defined as the addition of. The results of phase ii studies demonstrated that sofosbuvir once. In this study, we profiled the activity of psi 7977 and its ability to select for resistance using a number of different replicon cells. Genotype and subtype profiling of psi7977 as a nucleotide. Openlabeled study of psi7977 and rbv with and without peg. These results indicate that cata preferred psi7977 as a sub. It focused on evaluating different doses of psi 7977 in combination with pegasys peginterferon alfa 2a and copegus ribavirin. 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. Sofosbuvir in combination with peginterferon alfa2a and.
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