Safety and Efficacy of Grazoprevir and Elbasvir for GT1ang GT6 With and Without HIV

Inclusion Criteria

• •1. Men and women aged 18 years or older
• •2. Documented chronic HCV GT1 or GT6 (positive for anti-HCV antibody and HCV RNA at least 6 months prior to screening)
• •3. HCV RNA of at least 10,000 IU/ml
• •4. Cirrhosis defined by: liver biopsy showing cirrhosis METAVIR F4; or TE showing cirrhosis with a result of \>13.0 kPa
• •5. Treatment-naïve individuals for chronic HCV infection
• •6. Treatment-experienced individuals (Previous treatment failure with PEG-IFN plus RBV) for chronic HCV infection
• •7. HIV-infected participants enrolled in this study must meet following criteria:
• •7.1 Documented HIV infection 7.2 Naïve to treatment with any antiretroviral therapy (ART) or on HIV ART for at least 8 weeks prior to study entry using a dual nucleoside reverse transcriptase inhibitor (NRTI) backbone of tenofovir or abacavir and either emtricitabine or lamivudine plus raltegravir (or dolutegravir or rilpivirine) 7.3 CD4+ T-cell count \>200 cells/mm3 if on ART or \>500 cell/mm3 if ART treatment naïve 7.4 Undetectable plasma HIV-RNA at least 8 weeks prior to screening if on ART or \<50,000 copies/mL if ART treatment naïve
• •8. Agree to use two acceptable methods of birth control from at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study drug, or longer if dictated by local regulations (for female subject who is of childbearing potential or male subject with female sexual partner who is of childbearing potential).