A Study Comparing Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Dosed With Daclatasvir in Adults With HCV Genotype 3 Infection

• Status: Completed
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to compare the safety and efficacy of ABT-493/ABT-530 to the combination of sofosbuvir (SOF) and daclatasvir (DCV) in adults with genotype 3 (GT3) chronic hepatitis C virus (HCV) infection.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Sofosbuvir

Criteria

Inclusion Criteria:

• Male or female (of nonchildbearing potential, practicing total abstinence, sexually active with female partners only, or using allowed contraceptive methods) at least 18 years of age at time of screening.

• Screening laboratory result indicating HCV GT3 infection.

• Chronic HCV infection, defined as one of the following:

• Positive for anti-HCV antibody (Ab) or HCV RNA at least 6 months before screening; or

• A liver biopsy consistent with chronic HCV infection; or

• Abnormal alanine aminotransferase (ALT) levels for at least 6 months before screening.

• Hepatitis C virus treatment-naïve (i.e., participant had never received any anti-HCV treatment).

• Documented as noncirrhotic.

Exclusion Criteria:

• Female who was pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner was pregnant or planning to become pregnant during the study.

• Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could have precluded adherence to the protocol in the opinion of the investigator.

• Positive test result at screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus Ab (HIV Ab).

• Hepatitis C virus genotyping performed during screening indicated co-infection with more than one HCV genotype.

• Any cause of liver disease other than chronic HCV infection.

• Consideration by the investigator, for any reason, that the participant was an unsuitable candidate to receive ABT-493/ABT-530, SOF, or DCV.

• History of severe, life-threatening, or other significant sensitivity to any excipients of the study drug.

• Previous use of any anti-HCV treatment.