Ombitasvir/Paritaprevir/Ritonavir With or Without Dasabuvir in Adults With Genotype 1a or Genotype 4 Chronic Hepatitis C Virus (HCV) Infection, With Severe Kidney Impairment or End Stage Kidney Disease

• Percentage of participants with SVR12 in each arm [ Time Frame: 12 weeks after last dose ]
  SVR12 is defined as Hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ) 12 weeks after the last dose of study drug.
• Number of participants with Adverse Events [ Time Frame: Screening until 30 days after last dose ]

• Percentage of participants with on-treatment virologic failure in each treatment [ Time Frame: Up to 12 weeks after first dose ]
  On-treatment virologic failure is defined as quantifiable hepatitis C virus ribonucleic acid(HCV RNA) throughout the entire treatment period with at least 6 weeks of treatment, confirmed greater than the lower limit of quantification HCV RNA after previously having unquantifiable HCV RNA, or a confirmed increase from nadir of at least one log10 in HCV RNA during treatment.
• Percentage of participants with post-treatment relapse within 12 weeks following end of treatment in each arm [ Time Frame: Up to 12 weeks after last dose ]
  Virologic relapse after treatment is defined as confirmed plasma hepatitis C virus ribonucleic acid (HCV RNA) > the lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment.

• HCV
• Genotype 1a
• Genotype 4
• Chronic Kidney Disease
• Hepatitis C
• pegIFN
• IFN

• Drug: Ombitasvir/Paritaprevir/Ritonavir
• Drug: Dasabuvir

• Active Comparator: Genotype 1a
  Treatment with 3-DAA regimen
  Interventions:

  • Drug: Ombitasvir/Paritaprevir/Ritonavir
  • Drug: Dasabuvir
• Active Comparator: Genotype 4
  Treatment with 2-DAA regimen
  Intervention: Drug: Ombitasvir/Paritaprevir/Ritonavir

Inclusion Criteria:

• Chronic hepatitis C, genotype 1a infection or genotype 4 infection (HCV RNA level greater than 1,000 IU/mL at Screening).
• Females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control.
• Chronic kidney disease stage 4 or stage 5.

Exclusion Criteria:

• Females who are pregnant or breastfeeding
• Positive screen for hepatitis B Surface antigen or anti-Human Immunodeficiency virus antibody
• HCV genotype performed during screening unable to genotype or co-infection with any other HCV genotype, no mixed genotypes.
• Abnormal laboratory tests
• Current enrollment in another investigational study
• Prior treatment with a direct acting antiviral agent (DAA) containing regimen with the exception of interferon or pegylated interferon with or without ribavirin
• Current treatment with a direct acting antiviral agent (DAA) containing regimen
• Any evidence of liver cirrhosis or liver cancer