Phase 3
Completed N=421
Sofosbuvir and Ribavirin in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection
Source: ClinicalTrials.gov NCT01682720 ↗Enrolled (actual)
421
Serious AEs
2.9%
Results posted
Oct 2014
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) — 93.2; 27.3; 85.2 percentage of participants
Summary
This study will evaluate the safety, tolerability, and antiviral efficacy of GS-7977 with ribavirin (RBV) in participants with genotype 2 or 3 hepatitis C virus (HCV) infection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) |
93.2; 27.3; 85.2 | — |
| PRIMARY Adverse Events Leading to Permanent Discontinuation of Study Drug(s) |
1.2; 1.2; 0.4 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
93.2; 45.5; 87.2; 93.2; 27.3; 84.4 | — |
| SECONDARY Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse |
0; 0; 0.4; 6.8; 54.5; 14.0 | — |
Eligibility Criteria
Inclusion Criteria
- Age > 18 with chronic genotype 2 or 3 HCV infection
- HCV RNA > 10, 000 IU/mL at screening
- Subjects must be treatment naive or treatment experienced
- Presence or absence of cirrhosis; a liver biopsy may be required
- Healthy according to medical history and physical examination with the exception of HCV diagnosis
- Agree to use two forms of highly effective contraception for the duration of the study and 6 months after the last dose of study medication
Exclusion Criteria
- Prior use of any other inhibitor of the HCV NS5B Polymerase
- History of any other clinically significant chronic liver disease
- Evidence of or history of decompensated liver disease
- HIV or chronic hepatitis B virus (HBV) infection
- Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
- Chronic use of immunosuppressive agents or immunomodulatory agents
- History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study or not be in the best interest of the subject in the opinion of the investigator
Data sourced from ClinicalTrials.gov (NCT01682720). 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.