At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The ATOMIC Study: A Multicenter, Open-label, Randomized, Duration Finding Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 in Combination With Pegylated Interferon and Ribavirin in Treatment-Naive Patients With Chronic HCV Infection Genotype 1,4, 5, or 6
In Brief
A Phase 2 clinical trial evaluating Sofosbuvir, RBV, and 1 other intervention for Hepatitis C, Chronic. Completed, enrolled 332 participants across 46 sites in 2 countries.
Detailed Summary
The purpose of this study is to assess the safety, tolerability, and efficacy of sofosbuvir (GS-7977; PSI-7977) administered in combination with pegylated interferon and ribavirin (PEG/RBV) in treatment-naive patients with HCV genotypes 1,4,5,6, or indeterminate genotype.
Study Details
Timeline
Interventions
Sofosbuvir (SOF) administered as a 400 mg tablet orally once daily
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection