Phase 3
Completed N=601
SOF (Sovaldi®) +RBV for 16 or 24 Weeks and SOF+RBV+Peg-IFN for 12 Weeks in Adults With Genotype 2 or 3 Chronic HCV Infection
Source: ClinicalTrials.gov NCT01962441 ↗Enrolled (actual)
601
Serious AEs
5.0%
Results posted
Feb 2016
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) — 71.9; 85.4; 92.9 percentage of participants
Summary
This study will assess the efficacy, safety, and tolerability of 16 or 24 weeks of sofosbuvir (Sovaldi®; SOF) + ribavirin (RBV), and 12 weeks of SOF+RBV+ pegylated interferon (Peg-IFN) in treatment-naive and treatment-experienced adults with chronic genotype 3 hepatitis C virus (HCV) infection, and treatment-experienced adults with cirrhosis and chronic genotype 2 HCV infection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
71.9; 85.4; 92.9 | — |
| PRIMARY Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
1.5; 1.5; 1.5 | — |
| SECONDARY Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
73.0; 85.9; 95.9; 71.9; 84.4; 93.4 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24 |
14.8; 20.1; 25.9; 53.3; 53.5; 67.0 | — |
| SECONDARY HCV RNA at Weeks 1, 2, 4, 8, and 12 |
2.13; 2.08; 1.81; 1.44; 1.45; 1.32 | — |
| SECONDARY Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12 |
-4.18; -4.15; -4.46; -4.86; -4.78; -4.96 | — |
| SECONDARY Percentage of Participants Experiencing On-Treatment Virologic Failure |
0; 1.5; 0 | — |
| SECONDARY Percentage of Participants Experiencing Viral Relapse |
26.7; 12.3; 4.6 | — |
Eligibility Criteria
Key Inclusion Criteria
- Male or female, age greater than or equal to 18 years.
- Confirmed chronic HCV infection.
- Subjects will have cirrhosis status assessment; liver biopsy may be required.
- Genotype 2 subjects must have cirrhosis of the liver to be eligible.
- Treatment-naive or prior treatment failure to ≥12 weeks of an interferon- based regimen that was not discontinued prematurely due to an adverse event
- Infection with HCV genotype 2 or 3 as determined at Screening
- Body mass index (BMI) greater than or equal to 18 kg/m^2
- Screening laboratory values within predefined thresholds.
- Liver imaging (e.g., ultrasound) within 6 months of Baseline/Day 1 is required in cirrhotic patients to exclude hepatocellular carcinoma (HCC). In the event of intrahepatic lesions, triple phase CT scan or MRI should be performed to exclude HCC.
- Subject must be of generally good health as determined by the Investigator.
Key Exclusion Criteria
- Prior use of any other inhibitor of the HCV nonstructural protein (NS)5B polymerase
- Pregnant or nursing female or male with pregnant female partner
- History of any other clinically significant chronic liver disease.
- HIV or chronic hepatitis B virus (HBV) infection.
- Malignancy with the exception of certain resolved skin cancers.
- Chronic use of systemically administered immunosuppressive agents.
- Clinically-relevant drug or alcohol abuse.
- History of solid organ transplantation.
- Current or prior history of clinical hepatic decompensation.
- History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol.
- Known hypersensitivity to interferon, RBV, the study investigational medicinal product, the metabolites, or formulation excipients.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01962441). 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.