Study to Assess the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of ABT-267 in HCV Infected Subjects

• Analysis of pharmacokinetic variables [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  Assess plasma concentrations of each drug and possible metabolites
  
  
• Safety of all treatment regimens [ Time Frame: Baseline to end of treatment (up to 12 weeks) ] [ Designated as safety issue: Yes ]
  Analysis of safety measures including but not limited to tabulation of adverse events, physical exam, vital signs, ECGs and clinical lab results (including chemistry, hematology and urine).
  
  
• Percentage of subjects achieving 24-week sustained virologic response (SVR24) following treatment with 3 DAAs and RBV in HCV genotype 1-infected treatment-naïve adults [ Time Frame: 24 weeks after last dose of study drug ] [ Designated as safety issue: No ]
  Assess the percentage of subjects achieving SVR24 (HCV RNA (Ribonucleic acid) < lower limit of quantitation (LLOQ) 24 weeks after last dose of study drug
  
  
• Development and persistence of resistance to DAA therapy [ Time Frame: 48 weeks after last dose of study drug ] [ Designated as safety issue: No ]
  Assesses the fold change from baseline and reference HCV samples in the half maximal effective concentration at various time points, and identify mutations at each amino acid position by population and/or clonal nucleotide sequencing compared to baseline and prototypic sequences and assess the development and persistence of viral resistance with various treatment regimens.
  
  

• Percentage of subjects with rapid virologic response (RVR) [HCV RNA < lower limit of quantitation (LLOQ) at CT Week 4] [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  Assess the percentage of subjects with HCV RNA < LLOQ 4 weeks after beginning therapy with 3 DAAs and RBV
  
  
• Percentage of subjects with continued early virologic response (cEVR) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  Assess the percentage of subjects with HCV RNA < LLOQ 12 weeks after beginning therapy with 3 DAAs and RBV
  
  
• Percentage of subjects with sustained virologic response 12 weeks post-dosing (SVR12actual) and the percentage of subjects with sustained virologic response 24 weeks post-dosing (SVR24actual) [ Time Frame: 24 and 36 weeks, respectively ] [ Designated as safety issue: No ]
  Assess the percentage of subjects with HCV RNA < LLOQ 12 weeks after the last dose of study drug and the percentage of subjects with HCV RNA < LLOQ 24 weeks after the last dose of study drug
  
  
• Percentage of subjects with extended rapid virologic response (eRVR) [ Time Frame: Week 4 through week 12 ] [ Designated as safety issue: No ]
  Assess the percentage of subjects with HCV RNA < LLOQ at combination therapy Study Week 4 through combination therapy Study Week 12
  
  
• Exploration of the exposure-response relationship between ABT-267 concentrations and antiviral efficacy [ Time Frame: 24 weeks after last dose of ABT- 267 ] [ Designated as safety issue: No ]
  Assess the percentage of subjects with HCV RNA < LLOQ 24 weeks after last dose of ABT-267 in each treatment arm
  
  

A study to evaluate the safety, tolerability, pharmacokinetics and antiviral activity of ABT-267 as 2-day monotherapy in subjects with chronic HCV infection. The study will also evaluate the safety and effect of experimental drugs ABT-267, ABT-450, ritonavir (ABT-450/r), ABT-333, and ribavirin (RBV) in subjects with chronic HCV infection. The study will test the safety and effects of combinations of these drugs in treatments up to 12 weeks.