A Study to Evaluate the Safety and Antiviral Effect of ABT-450/Ritonavir and ABT-530 Coadministered With and Without Ribavirin in Adults With Genotype 3 Hepatitis C (HCV) Infection

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and antiviral effect of ABT-450/r and ABT-530 coadministered with and without Ribavirin in adults with genotype 3 HCV infection.

Detailed Description
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Once the efficacy and safety data were obtained from participants administered ABT-450/r + ABT-530 + RBV weight-based (Arm 1) in Study M14-213, the decision was made to end this study before subjects were enrolled into Arm 2.

Official Title
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An Open-Label Pilot Study to Evaluate the Antiviral Activity, Safety, Tolerability, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-530, With and Without Ribavirin (RBV) in Treatment-Naïve Subjects With Genotype 3 Chronic Hepatitis C Virus (HCV) Infection

Conditions
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Chronic Hepatitis C, Hepatitis C Virus

Intervention / Treatment
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* Drug: ABT-450/ritonavir (r)
* Drug: ABT-530
* Drug: Ribavirin (RBV)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female (of non-child bearing potential) between 18 and 70 years of age with Body Mass Index ≥18 to <38 kg/m2. Chronic HCV genotype 3 infection prior to study enrollment and has never received antiviral treatment for HCV. Subject has plasma HCV RNA level > 10,000 IU/mL at Screening. Sexually active males must be sterile, have male partners only, or agree to use two effective forms of birth control for 7 months after stopping study drug. Exclusion Criteria: History of severe, life-threatening or other significant sensitivity to any drug. Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab). Prior therapy for the treatment of HCV. Any current or past clinical evidence of cirrhosis. Any cause of liver disease other than chronic HCV-infection. HCV genotype co-infection with any other HCV genotype. Use of contraindicated medications within 2 weeks or 10 half-lives of dosing.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABT-450/r and ABT-530 plus RBV<br>ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks. | Drug: ABT-450/ritonavir (r)<br>* Tablet<br>* Other names: ABT-450 also known as paritaprevir;Drug: ABT-530<br>* Tablet<br>* Other names: pibrentasvir;Drug: Ribavirin (RBV)<br>* Tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Subjects Who Achieve 12-week Sustained Virologic Response (SVR12) | SVR12 defined as hepatitis C (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug. | 12 weeks after last dose of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Subjects Who Achieve 24-week Sustained Virologic Response (SVR24) | SVR24 defined as HCV RNA LLOQ 24 weeks after last dose of study drug. | 24 weeks after last dose of study drug | 
| The Percentage of Subjects With Virologic Failure During Treatment | Percentage of subjects with quantifiable HCV RNA throughout the entire treatment period, confirmed quantifiable HCV RNA after previously having unquantifiable HCV RNA, or a confirmed increase of at least one log10 in HCV RNA during treatment. | Up to Treatment Week 12 | 
| The Percentage of Subjects With Post-Treatment Relapse | Percentage of subjects with confirmed quantifiable HCV RNA within 12 weeks of last dose among subjects with unquantifiable hepatitis C virus ribonucleic acid at the end of treatment. | Within 12 weeks after the last dose of study drug | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C, HCV, Interferon Free, Chronic Hepatitis C, Hepatitis C virus, Hepatitis C Genotype 3