A Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir With Sofosbuvir With or Without Ribavirin in Adults With Chronic Hepatitis C Virus Infection
Phase 2
Completed
- Conditions
- Chronic Hepatitis C Virus Infection
- Interventions
- Registration Number
- NCT02292719
- Lead Sponsor
- AbbVie
- Brief Summary
The purpose of this study is to evaluate the safety and efficacy of Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) with sofosbuvir (SOF) with or without ribavirin (RBV) in adults with Genotype 2 Chronic Hepatitis C Virus (HCV) infection or Genotype 3 HCV infection with or without Cirrhosis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
- Chronic HCV infection prior to study enrollment.
- Screening laboratory results from the central clinical laboratory indicating HCV genotype 2 or 3 infection only (no mixed genotype).
- Absence OR presence of cirrhosis.
- If cirrhotic, need to have compensated cirrhosis and absence of hepatocellular carcinoma (HCC)
Exclusion Criteria
- Positive screen for hepatitis B surface antigen or anti-human immunodeficiency virus antibody
- Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse.
- Current enrollment in another clinical study, previous enrolment in this study, or previous use of any investigational or commercially available anti-HCV therapy (other than interferon, pegIFN, RBV, and or SOF) including previous exposure to telaprevir, boceprevir, ABT-450, or ombitasvir (ABT-267).
- Subjects without cirrhosis: Any current or past clinical evidence of cirrhosis.
- Abnormal lab tests.
- Females who are pregnant or plan to become pregnant or breastfeeding, or males whose partners are pregnant or planning to become pregnant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm D (GT2, noncirrhotic) Ribavirin (RBV) OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 6 weeks. Arm A (genotype [GT]3, noncirrhotic) OBV/PTV/r Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) 25/150/100 mg once daily (QD) and sofosbuvir (SOF) 400 mg QD for 12 weeks. Arm B (GT3, noncirrhotic) OBV/PTV/r OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and ribavirin (RBV; weight-based 1,000 mg or 1,200 mg daily divided twice daily \[BID\]) for 12 weeks. Arm C (GT2, noncirrhotic) Ribavirin (RBV) OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight- based 1,000 mg or 1,200 mg daily divided BID) for 8 weeks. Arm E (GT3, cirrhotic) OBV/PTV/r OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 12 weeks. Arm B (GT3, noncirrhotic) Ribavirin (RBV) OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and ribavirin (RBV; weight-based 1,000 mg or 1,200 mg daily divided twice daily \[BID\]) for 12 weeks. Arm E (GT3, cirrhotic) Ribavirin (RBV) OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 12 weeks. Arm C (GT2, noncirrhotic) OBV/PTV/r OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight- based 1,000 mg or 1,200 mg daily divided BID) for 8 weeks. Arm D (GT2, noncirrhotic) OBV/PTV/r OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 6 weeks. Arm F (GT3, noncirrhotic) OBV/PTV/r OBV/PTV/r (25/150/100) mg QD and SOF (400 mg QD) for 12 weeks. Arm A (genotype [GT]3, noncirrhotic) Sofosbuvir Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) 25/150/100 mg once daily (QD) and sofosbuvir (SOF) 400 mg QD for 12 weeks. Arm B (GT3, noncirrhotic) Sofosbuvir OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and ribavirin (RBV; weight-based 1,000 mg or 1,200 mg daily divided twice daily \[BID\]) for 12 weeks. Arm C (GT2, noncirrhotic) Sofosbuvir OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight- based 1,000 mg or 1,200 mg daily divided BID) for 8 weeks. Arm D (GT2, noncirrhotic) Sofosbuvir OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 6 weeks. Arm E (GT3, cirrhotic) Sofosbuvir OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 12 weeks. Arm F (GT3, noncirrhotic) Sofosbuvir OBV/PTV/r (25/150/100) mg QD and SOF (400 mg QD) for 12 weeks.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) 12 weeks after the last actual dose of study drug SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of study drug.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With On-treatment Virologic Failure Up to Week 12 On-treatment virologic failure was defined as confirmed increase of \> 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ LLOQ after HCV RNA \< LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment for 12-week and 8-week treatment or at least 26 days of treatments for 6-week treatment.
Percentage of Participants With Post-treatment Relapse Up to 12 weeks after the last actual dose of active study drug Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels \< LLOQ at the end of treatment.