NCT01329978

Sofosbuvir With Pegylated Interferon and Ribavirin Hepatitis C Virus (HCV) Genotypes 1,4,5,6

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 332 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	Sofosbuvir	Sofosbuvir (SOF) administered as a 400 mg tablet orally once daily
DRUG	RBV	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)
DRUG	PEG	Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2011-04-06
• Last updated: 2014-05-26
• Results posted: 2014-05-26

Locations

46 sites across 2 countries: United States, Puerto Rico