Evaluation of Safety, Tolerability, and Antiviral Activity of ACH-0143102 Plus Ribavirin In Treatment-naive Hepatitis C Virus Infection Genotype 1b Participants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to evaluate the safety, tolerability, and efficacy of 12 weeks of treatment with ACH-0143102 and ribavirin in genotype 1b (GT1b), treatment-naive, hepatitis C virus (HCV) participants.

Detailed Description
-----------------
A Phase 1b, pilot study that evaluated the safety, tolerability, and antiviral activity of oral ACH-0143102 administered in combination with ribavirin for 12 weeks in treatment-naive participants with chronic HCV GT1b.

Official Title
-----------------
A Phase 1b, Open-label, Pilot Study to Evaluate the Safety, Tolerability, and Antiviral Activity of Oral ACH-0143102 Administered in Combination With Ribavirin for 12 Weeks in Treatment-naive Subjects With Chronic Hepatitis C Virus Infection Genotype 1b

Conditions
-----------------
Chronic Hepatitis C Infection

Intervention / Treatment
-----------------
* Drug: ACH-0143102
* Drug: Ribavirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females aged 18 years and older. Clinical diagnosis of hepatitis C with GT1b. Chronic hepatitis C treatment-naive participants. Interleukin 28B genotype CC. HCV ribonucleic acid > 10,000 international units/milliliter at screening. Female participants must be willing to use 2 effective methods of contraception during the dosing period and for 6 months after the last dose of ribavirin. Male participants must be willing to use an effective barrier method of contraception throughout the dosing period and for 6 months after the last dose of ribavirin. Male participants must agree not to donate sperm while enrolled in the study and for 6 months after the last dose of ribavirin. Willing to participate in all study activities and all study requirements. Exclusion Criteria: Body mass index > 36 kilograms/meter squared. Pregnant or nursing females. Clinically significant laboratory abnormalities at screening. Previous participation in a clinical trial with protease inhibitor and/or non-structural protein 5A inhibitor. Human immunodeficiency virus infection or other liver diseases. Positive hepatitis B surface antigen. Liver cirrhosis. Uncontrolled psychiatric disease. Clinical evidence of chronic cardiac disease. History of malignancy of any organ system within 5 years.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACH-0143102 plus ribavirin daily<br>ACH-0143102 loading dose (225 milligrams [mg]) on Day 1, followed by maintenance doses (75 mg) on Days 2-84, plus weight-based ribavirin as per label on Days 1-84. | Drug: ACH-0143102<br> <br> Drug: Ribavirin<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Virologic Response At 12 Weeks (SVR12) | To determine the incidence of the SVR12 after the completion of dosing with ACH-0143102 plus ribavirin, reported as hepatitis C virus ribonucleic acid less than the limit of quantification at that time point. | 12 weeks following the last dose |