Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Low-Dose Ribavirin QD in Subjects With Genotype 1a Chronic Hepatitis C Virus Infection

Phase 3

Completed

Interventions: Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir
Drug: ribavirin

Brief Summary: This study seeks to assess the safety and efficacy of treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir with low-dose ribavirin in non-cirrhotic, genotype 1a (GT1a) hepatitis C virus infected participants who are treatment-naïve or treatment-experienced with Interferon (IFN) or Pegylated Interferon (pegIFN) with or without Ribavirin (RBV).

Recruitment & Eligibility

Inclusion Criteria

Chronic hepatitis C virus (HCV) infection
Non-cirrhotic subjects
Screening laboratory results showing HCV Genotype 1a (HCV GT1a) infection
HCV treatment-naïve or if treated previously, only with interferon (IFN) or pegylated interferon (pegINF) with or without ribavirin (RBV)

Exclusion Criteria

Pregnant or breastfeeding women
Positive for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab)
HCV genotype of any subtype other than GT1a or unable to subtype
Prior or current use of any investigational or commercially available anti-HCV agents other than IFN, pegIFN or RBV. Subjects with previous participation in trials of investigational direct-acting antiviral agents (DAAs) may be enrolled if they can produce documentation that they received only placebo.
Current enrollment in another interventional clinical study or receipt of any investigational product within 6 weeks prior to study drug administration.

Arm && Interventions

Group	Intervention	Description
3-DAA + RBV 600 mg	ombitasvir/paritaprevir/ritonavir and dasabuvir	3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) plus RBV (ribavirin \[600 mg once daily\]) for 12 weeks.
3-DAA + RBV 600 mg	ribavirin	3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) plus RBV (ribavirin \[600 mg once daily\]) for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Hemoglobin < 10 g/dL During Treatment	up to 12 weeks	The percentage of participants with hemoglobin \<10 g/dL during treatment is provided.
Mean Change in Hemoglobin Values From Baseline to End of Treatment	Baseline (Day 1) to Weeks 2, 4, 8, and 12, and the Final Treatment Visit (up to 12 weeks)	The mean change in hemoglobin (g/L) from baseline to each study visit and to the final treatment visit (up to 12 weeks) is provided.
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)	12 weeks after the last actual dose of study drug	SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of study drug. The primary efficacy endpoint was noninferiority of the percentage of participants who achieved SVR12 in participants in the treatment arm 3-DAA + RBV 600 mg) for 12 weeks compared with the historical control rate for subjects treated with 3-DAA + weight-based RBV for 12 weeks.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With On-treatment Virologic Failure	Up to 12 weeks	On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA \< LLOQ during treatment; confirmed increase of \> 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of treatment.
Percentage of Participants With Post-treatment Relapse	From the end of treatment through 12 weeks after the last dose of study drug	Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug, excluding reinfection, among participants who completed treatment with HCV RNA levels \< LLOQ at the end of treatment.