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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of the Co-Administration of Ombitasvir/ABT-450/Ritonavir (Ombitasvir/ABT-450/r) With Sofosbuvir (SOF) With or Without Ribavirin (RBV) in Subjects With Genotype 2 Chronic Hepatitis C Virus (HCV) Infection or Genotype 3 HCV Infection With or Without Cirrhosis

Conditions
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Chronic Hepatitis C Virus Infection

Intervention / Treatment
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* Drug: OBV/PTV/r
* Drug: Sofosbuvir
* Drug: Ribavirin (RBV)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A (genotype [GT]3, noncirrhotic)<br>Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) 25/150/100 mg once daily (QD) and sofosbuvir (SOF) 400 mg QD for 12 weeks. | Drug: OBV/PTV/r<br>* Tablet<br>* Other names: TECHNIVIE;Drug: Sofosbuvir<br>* Tablet<br>* Other names: Sovaldi;|
| Experimental: Arm B (GT3, noncirrhotic)<br>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. | Drug: OBV/PTV/r<br>* Tablet<br>* Other names: TECHNIVIE;Drug: Sofosbuvir<br>* Tablet<br>* Other names: Sovaldi;Drug: Ribavirin (RBV)<br>* Tablet<br>|
| Experimental: Arm C (GT2, noncirrhotic)<br>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. | Drug: OBV/PTV/r<br>* Tablet<br>* Other names: TECHNIVIE;Drug: Sofosbuvir<br>* Tablet<br>* Other names: Sovaldi;Drug: Ribavirin (RBV)<br>* Tablet<br>|
| Experimental: Arm D (GT2, noncirrhotic)<br>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. | Drug: OBV/PTV/r<br>* Tablet<br>* Other names: TECHNIVIE;Drug: Sofosbuvir<br>* Tablet<br>* Other names: Sovaldi;Drug: Ribavirin (RBV)<br>* Tablet<br>|
| Experimental: Arm E (GT3, cirrhotic)<br>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. | Drug: OBV/PTV/r<br>* Tablet<br>* Other names: TECHNIVIE;Drug: Sofosbuvir<br>* Tablet<br>* Other names: Sovaldi;Drug: Ribavirin (RBV)<br>* Tablet<br>|
| Experimental: Arm F (GT3, noncirrhotic)<br>OBV/PTV/r (25/150/100) mg QD and SOF (400 mg QD) for 12 weeks. | Drug: OBV/PTV/r<br>* Tablet<br>* Other names: TECHNIVIE;Drug: Sofosbuvir<br>* Tablet<br>* Other names: Sovaldi;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | 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. | 12 weeks after the last actual dose of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With On-treatment Virologic Failure | 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. | Up to Week 12 | 
| Percentage of Participants With Post-treatment Relapse | 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. | Up to 12 weeks after the last actual dose of active study drug | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C Virus, Genotype 2, Chronic Hepatitis C, Genotype 3, Non-cirrhotic, Cirrhotic