ongoing safety concerns, to be this population (see dosage and reflected accordingly in the revised administration)’. Furthermore a ASA. similar situation is observed with the use of Genvoya in hepatic impairment and it is noted that the missing information: in ‘Safety patients with severe hepatic impairment (CPT score C)’ is included in the summary of safety concerns for Genvoya. Consequently it is recommended that the missing information: in patients with severe ‘Safety renal impairment (estimated creatinine clearance below 30 mL per minute)’ should be included in the summary of safety concerns for Genvoya. It is acknowledged that routine risk minimisation is already applied for this new missing information and monitoring by routine pharmacovigilance will be sufficient. The ASA need only be revised accordingly, preferably before this application is approved. The sponsor should provide an The sponsor advises that This is acceptable. assurance that the draft protocol for the planned clinical study the planned clinical study of GS-US-292-0113 has been E/C/F/TAF in ARV renumbered as Study HIV-1 infected patients which is from 6 to < 18 years of age enrolling virologically will be attached to the suppressed, HIV-infected ASA once it becomes available. adolescents 12 to < 18 years of age only. Virologically suppressed, HIV-infected children 6 to < 12 years of age are now being enrolled into Cohort 2 of the ongoing, paediatric Study rather than Study GS-US-292-0113. The protocols for Studies GS-US-292-0106 and are attached to the ASA. Section 4: of the RMP’ of The sponsor states: This is acceptable. ‘Summary the ASA contains 6: has renamed the ‘summary ‘Gilead table of risk minimization measures’. and revised the This table summarises the classification of pharmacovigilance and risk pharmacovigilance minimisation activities for Australia. activities accordingly’. Consequently this table should be renamed accordingly. Furthermore all the additional pharmacovigilance
ongoing safety concerns, to be reflected accordingly in the revised ASA. this population (see dosage and administration)’. Furthermore a similar situation is observed with the use of Genvoya in hepatic impairment and it is noted that the missing information: ‘Safety in patients with severe hepatic impairment (CPT score C)’ is included in the summary of safety concerns for Genvoya. Consequently it is recommended that the missing information: ‘Safety in patients with severe renal impairment (estimated creatinine clearance below 30 mL per minute)’ should be included in the summary of safety concerns for Genvoya. It is acknowledged that routine risk minimisation is already applied for this new missing information and monitoring by routine pharmacovigilance will be sufficient. The ASA need only be revised accordingly, preferably before this application is approved. The sponsor should provide an assurance that the draft protocol for the planned clinical study of E/C/F/TAF in ARV HIV-1 infected patients from 6 to < 18 years of age will be attached to the ASA once it becomes available. The sponsor advises that the planned clinical study GS-US-292-0113 has been renumbered as Study which is enrolling virologically suppressed, HIV-infected adolescents 12 to < 18 years of age only. Virologically suppressed, HIV-infected children 6 to < 12 years of age are now being enrolled into Cohort 2 of the ongoing, paediatric Study rather than Study GS-US-292-0113. The protocols for Studies GS-US-292-0106 and are attached to the ASA. This is acceptable. Section 4: ‘Summary of the RMP’ of the ASA contains 6: ‘summary table of risk minimization measures’. This table summarises the pharmacovigilance and risk minimisation activities for Australia. Consequently this table should be renamed accordingly. Furthermore all the additional pharmacovigilance The sponsor states: ‘Gilead has renamed the and revised the classification of pharmacovigilance activities accordingly’. This is acceptable.
auspar-elvitegravir-160628.docx