Pharmacovigilance plan The sponsor proposes routine and additional pharmacovigilance activities (as stated above). The additional pharmacovigilance activities are provided and include the following studies as shown in Table 4. Table 4: Ongoing studies proposed or in progress Study Objectives Safety concerns Status Date for addressed (planned, submission of started) Interim of reports (planned or actual) GS-US-337- To evaluate the safety of age planned April 2016 relative appropriate bioavailability paediatric SOF and safety of an formulation age-appropriate paediatric SOF formulation in healthy adult volunteers To evaluate the safety in children planned final study PK efficacy and report 2019 safety of LDV/SOF for 12 weeks in adolescents and children To evaluate the safety in patients started final study safety, efficacy with severe renal report July and PKs of impairment or end 2017 treatment with stage renal disease SOF + RBV for 24 weeks in subjects with chronic genotype 1 or 3 HCV infection and severe renal impairment To evaluate the safety in patients started March 2017 safety and with HCV/HIV efficacy of treatment with LDV/SOF ± RBV in subjects with HCV/HIV To evaluate the one cohort will started June 2016 safety and provide safety efficacy of information in
Pharmacovigilance plan The sponsor proposes routine and additional pharmacovigilance activities (as stated above). The additional pharmacovigilance activities are provided and include the following studies as shown in Table 4. Table 4: Ongoing studies proposed or in progress Study Objectives Safety concerns addressed Status (planned, started) Date for submission of Interim of reports (planned or actual) To evaluate the relative bioavailability and safety of an age-appropriate paediatric SOF formulation in healthy adult volunteers safety of age appropriate paediatric SOF formulation planned April 2016 To evaluate the PK efficacy and safety of LDV/SOF for 12 weeks in adolescents and children safety in children planned final study report 2019 To evaluate the safety, efficacy and PKs of treatment with SOF + RBV for 24 weeks in subjects with chronic genotype 1 or 3 HCV infection and severe renal impairment safety in patients with severe renal impairment or end stage renal disease started final study report July 2017 To evaluate the safety and efficacy of treatment with LDV/SOF ± RBV in subjects with HCV/HIV safety in patients with HCV/HIV started March 2017 To evaluate the safety and efficacy of one cohort will provide safety information in started June 2016 GS-US-337-
auspar-ledipasvir-sofosbuvir-171020.docx