A Study Comparing Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Dosed With Daclatasvir in Adults With HCV Genotype 3 Infection
Condition: Chronic Hepatitis C; Hepatitis C Virus; Genotype 3 Hepatitis C Virus
MeSH terms: Hepatitis A; Virus Diseases; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: ABT-493/ABT-530; Sofosbuvir; Daclatasvir
Intervention description: Tablet; ABT-493 coformulated with ABT-530; Tablet; Tablet
Intervention MeSH terms: Sofosbuvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 506.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: interferon free; Hepatitis C; daclatasvir; Sovaldi; HCV; Hepatitis C Virus; Hepatitis C Genotype 3; Hep C; sofosbuvir; Chronic Hepatitis C; Daklinza

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.
    

Eligibility 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.