A Study of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Sofosbuvir and Ribavirin in Direct-Acting Antiviral Agent Treatment-Experienced Adults With Chronic Hepatitis C Virus Infection
A Study of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Sofosbuvir and Ribavirin in Direct-Acting Antiviral Agent Treatment-Experienced Adults With Chronic Hepatitis C Virus Infection
The purpose of this study is to evaluate the safety and efficacy of
 ombitasvir/paritaprevir/ritonavir and dasabuvir with or without sofosbuvir (SOF) and
 ribavirin (RBV) in DAA treatment-experienced adults with Genotype 1 Chronic Hepatitis C Virus
 infection. This study will contain 2 parts.

 Part 1: Approximately 20 participants and at least 10 of the 20 participants previously
 treated with the combination of ombitasvir/paritaprevir/ritonavir and dasabuvir, with or
 without RBV, and experienced treatment failure.

 Part 2: Approximately 10 participants and all participants previously treated with
 SOF/ledipasvir and experienced treatment failure.
Efficacy, safety, and demographic analyses were performed separately for the 2 study parts
 using the intent-to-treat (ITT) population, which consists of all enrolled participants who
 received at least one dose of study drug.
Inclusion Criteria:

 -  History of previous direct acting antiviral (DAA) therapy failure; Part 2 only:
 history of previous direct acting antiviral (DAA) therapy failure and received at
 least 8 weeks of SOF/ledipasvir; participant must be treatment naïve to all other
 anti-HCV therapies

 -  HCV genotype 1 infection

 -  Females must be post-menopausal, of non-child bearing potential or practicing specific
 forms of birth control

 Exclusion Criteria:

 -  Positive screen for hepatitis B surface antigen or anti-human immunodeficiency virus
 antibody

 -  Discontinuation of the prior DAA treatment for reasons other than virologic failure

 -  Confirmed presence of hepatocellular carcinoma

 -  Abnormal lab tests