Phase 3
Completed N=527
Phase 3 Study of Sofosbuvir and Ribavirin
Source: ClinicalTrials.gov NCT01497366 ↗Enrolled (actual)
527
Serious AEs
2.0%
Results posted
Apr 2014
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12) — 67; 67 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12) |
67; 67 | — |
| SECONDARY Number of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities |
3; 29; 7; 3; 33; 80 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response 24 Weeks After Stopping All Study Drugs (SVR24) |
66.8; 65.4 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ on Treatment |
43.7; 6.6; 92.0; 31.5; 99.6; 66.9 | — |
| SECONDARY Change From Baseline in HCV RNA |
-4.26; -2.19; -4.60; -3.19; -4.64; -4.04 | — |
| SECONDARY Percentage of Participants With Virologic Failure During Treatment |
0.4; 7.4 | — |
| SECONDARY Percentage of Participants With Viral Relapse Following Treatment |
30.5; 22.6 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01497366). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.