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

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.

• ACH-0143102 (Drug)
• Ribavirin (Drug)

Primary outcomes

• Sustained Virologic Response At 12 Weeks (SVR12) [12 weeks following the last dose]: 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.

Sex: All, ages: 18 Years to any

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.

Participant flow

Outcome results

• Sustained Virologic Response At 12 Weeks (SVR12) (Primary), Number, percentage of participants: ACH-0143102 Plus Ribavirin 50

Adverse events

Time frame: Adverse event data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up, for up to 36 weeks.

Other adverse events by term