Phase 3 Study of Sofosbuvir and Ribavirin

Phase 3

Completed

• Conditions: Hepatitis C
• Interventions: Drug: Sofosbuvir; Drug: PEG; Drug: RBV

• Registration Number: NCT01497366
• Lead Sponsor: Gilead Sciences

Brief Summary

This study was to assess the safety and efficacy of sofosbuvir (GS-7977; PSI-7977) in combination with ribavirin (RBV) administered for 12 weeks compared with pegylated interferon (PEG)/RBV administered for 24 weeks in treatment-naive patients with Hepatitis C (HCV) genotype 2 or 3. Efficacy was assessed by the rate of sustained viral response (SVR) 12 weeks after the discontinuation of therapy (SVR12). This was a non-inferiority study, and if non-inferiority was demonstrated, the study was then allowed to test for superiority.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-19
• Study First Submitted QC: 2011-12-21
• Study First Posted: 2011-12-22
• Primary Completion: 2013-01
• Study Completion: 2013-04
• Disposition First Submitted: 2013-11-20
• Disposition First Submitted QC: 2013-11-20
• Disposition First Posted: 2013-12-06
• Results First Submitted: 2014-01-15
• Status Verified: 2014-03
• Results First Submitted QC: 2014-03-04
• Last Update Submitted: 2014-03-04
• Results First Posted: 2014-04-02
• Last Update Posted: 2014-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 527

Inclusion Criteria

• Chronic Genotype 2 or 3 HCV-infection
• Naive to all HCV antiviral treatment(s)

Exclusion Criteria

• Positive test at Screening for HBsAg, anti-hepatitis B core immunoglobulin M antibody (anti-HBc IgM Ab), or anti-HIV Ab
• History of any other clinically significant chronic liver disease
• A history consistent with decompensated liver disease
• History or current evidence of psychiatric illness, immunologic disorder, hemoglobinopathy, pulmonary or cardiac disease, seizure disorder or anticonvulsant use, poorly controlled diabetes, cancer, or a history of malignancy, that makes the subject unsuitable for the study.
• Participation in a clinical study within 3 months prior to first dose

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sofosbuvir+RBV	Sofosbuvir	Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
PEG+RBV	PEG	Participants were randomized to receive PEG+RBV for 24 weeks.
Sofosbuvir+RBV	RBV	Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
PEG+RBV	RBV	Participants were randomized to receive PEG+RBV for 24 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12)	Post-treatment Week 12	SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; \< 25 IU/mL) 12 weeks after study drug cessation.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities	Up to 24 weeks plus 30 days following the last dose of study drug
Percentage of Participants With Sustained Virologic Response 24 Weeks After Stopping All Study Drugs (SVR24)	Post-treatment Week 24	SVR24 was defined as HCV RNA \< LLOQ 24 weeks after study drug cessation.
Percentage of Participants With HCV RNA < LLOQ on Treatment	Up to 12 Weeks
Change From Baseline in HCV RNA	Baseline to Week 12
Percentage of Participants With Virologic Failure During Treatment	Baseline up to Week 24	Virologic failure was defined as either; * Viral breakthrough: HCV RNA ≥ 25 IU/mL after having previously had HCV RNA \< 25 IU/mL while on treatment, confirmed with 2 consecutive values or last available measurement; * Viral rebound: \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values or last available measurement; * Non-response: HCV RNA persistently ≥ 25 IU/ml while on treatment (through Week 12)
Percentage of Participants With Viral Relapse Following Treatment	Up to Post-treatment Week 24	Viral relapse was defined as HCV RNA ≥ 25 IU/mL in post-treatment after having achieved \< LLOQ at last on-treatment measurement, confirmed with 2 consecutive values or last available measurement.

Trial Locations

Locations (96)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Alabama Liver & Digestive Specialist; 🇺🇸 Montgomery, Alabama, United States

Franco Felizarta, MD; 🇺🇸 Bakersfield, California, United States

California Liver Institute; 🇺🇸 Beverly Hills, California, United States

Arrowhead Regional Medical Center; 🇺🇸 Colton, California, United States

SCTI Research Foundation; 🇺🇸 Coronado, California, United States

eStudy Site; 🇺🇸 La Mesa, California, United States

Peter J. Ruane, M.D. Inc.; 🇺🇸 Los Angeles, California, United States

eStudySite; 🇺🇸 Oceanside, California, United States

University of California, Davis - Health System; 🇺🇸 Sacramento, California, United States

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