22: Additional pharmacovigilance activities planned by the sponsor Additional activity Assigned Actions/outcome safety proposed concern of data Phase II/III Study HIV Assess safety of Phase II M14-004, "A cohort Randomized, subjects and dasabuvir in 3Q label Study to Evaluate with RBV for 2014 the Safety and Efficacy 12 and 24 weeks in HCV Phase of GT1-infected subjects with III HIV-1 co-infection and to cohort evaluate the percentage of in 3Q subjects achieving SVR12 2015 and (HCV RNA < lower limit of dasabuvir quantification [LLOQ] 12 with weeks following treatment) Ribavirin (RBV) in within the 12- and 24-week Adults with Genotype arms compared to the 1 Chronic Hepatitis C historical SVR rate of Virus (HCV) Infection pegIFN and RBV therapy in and Human the corresponding Immunodeficiency population. Virus, Type 1 (HIV-1) Coinfection (Turquoise-1)" Ongoing II Study Transplant Assess safety and efficacy 2Q "Open-label, subjects (percentage of subjects 2014 Phase 2 Study to achieving SVR12) of Evaluate the Safety paritaprevir and Efficacy of the with ritonavir (r) and Combination of /ombitasvir and dasabuvir with ribavirin and (RBV) for 24 weeks in HCV dasabuvir With or GT1 infected adult liver Without Ribavirin transplant recipients with (RBV) in Adult Liver recurrent HCV GT1 Transplant Recipients infection. with Genotype 1 Hepatitis CVirus (HCV) Infection" Ongoing Study in Child Pugh B Subjects with Evaluate safety and efficacy 4Q Subjects Child Pugh B (SVR12) in subjects with 2015 Child Pugh B. Planned
22: Additional pharmacovigilance activities planned by the sponsor Additional activity Assigned safety concern Actions/outcome proposed of data Phase II/III Study M14-004, "A Randomized, Study to Evaluate the Safety and Efficacy of and dasabuvir with Ribavirin (RBV) in Adults with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection and Human Immunodeficiency Virus, Type 1 (HIV-1) Coinfection (Turquoise-1)" Ongoing HIV subjects Assess safety of and dasabuvir with RBV for 12 and 24 weeks in HCV GT1-infected subjects with HIV-1 co-infection and to evaluate the percentage of subjects achieving SVR12 (HCV RNA < lower limit of quantification [LLOQ] 12 weeks following treatment) within the 12- and 24-week arms compared to the historical SVR rate of pegIFN and RBV therapy in the corresponding population. Phase II cohort in 3Q 2014 Phase III cohort in 3Q 2015 II Study "Open-label, Phase 2 Study to Evaluate the Safety and Efficacy of the Combination of and dasabuvir With or Without Ribavirin (RBV) in Adult Liver Transplant Recipients with Genotype 1 Hepatitis CVirus (HCV) Infection" Ongoing Transplant subjects Assess safety and efficacy (percentage of subjects achieving SVR12) of paritaprevir with ritonavir (r) and /ombitasvir and dasabuvir with ribavirin (RBV) for 24 weeks in HCV GT1 infected adult liver transplant recipients with recurrent HCV GT1 infection. 2Q 2014 Study in Child Pugh B Subjects Planned Subjects with Child Pugh B Evaluate safety and efficacy (SVR12) in subjects with Child Pugh B. 4Q 2015 label