information provided in nonclinical and clinical Study response to these includes a evaluators’. will be consideration of the included in the relevance for the Risk when this Management Plan, and any document is next specific information needed updated. to address this issue in the RMP. For any safety considerations so raised, the sponsor should provide information that is relevant and necessary to address the issue in the RMP. The sponsor should The sponsor has prepared a This is acceptable. systematically identify and summary of the differences justify any differences between the safety concerns and between the summaries of missing information for these the safety concerns and similar products and concluded missing information for the that no changes to the summary similar products, Descovy of the safety concerns or and Genvoya. Any subsequent missing information are changes to the summary of required, apart from the the safety concerns and addition of safety in patients missing information for with severe renal impairment as Descovy as specified in the missing information. ASA must be entirely captured in a revised ASA to be provided to the TGA for review. In addition consideration must be given to proposing appropriate pharmacovigilance and risk minimisation activities for any new ongoing safety concerns, to be reflected accordingly in the revised ASA. The sponsor should provide The sponsor states Study This is acceptable. an assurance that the draft was planned to study protocol for the planned E/C/F/TAF in ARV clinical study of E/C/F/TAF HIV-1 infected in ARV patients from 6 to < 18 years of HIV-1 infected age. Virologically suppressed, patients from 6 to < 18 years HIV-infected children 6 to < 12 of age (GS-US-292-0113) will years of age are now being be attached to the ASA once it enrolled into Cohort 2 of the becomes available. ongoing, pediatric Study rather than Study Study has been renumbered as Study GS-US-292-1515 for administrative reasons. As younger children 6 to < 12 years of age are now being enrolled in Cohort 2 of Study Study GS-US-292-1515 is
information provided in response to these includes a consideration of the relevance for the Risk Management Plan, and any specific information needed to address this issue in the RMP. For any safety considerations so raised, the sponsor should provide information that is relevant and necessary to address the issue in the RMP. nonclinical and clinical evaluators’. Study will be included in the when this document is next updated. The sponsor should systematically identify and justify any differences between the summaries of the safety concerns and missing information for the similar products, Descovy and Genvoya. Any subsequent changes to the summary of the safety concerns and missing information for Descovy as specified in the ASA must be entirely captured in a revised ASA to be provided to the TGA for review. In addition consideration must be given to proposing appropriate pharmacovigilance and risk minimisation activities for any new ongoing safety concerns, to be reflected accordingly in the revised ASA. The sponsor has prepared a summary of the differences between the safety concerns and missing information for these similar products and concluded that no changes to the summary of the safety concerns or missing information are required, apart from the addition of safety in patients with severe renal impairment as missing information. This is acceptable. 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 (GS-US-292-0113) will be attached to the ASA once it becomes available. The sponsor states Study was planned to study E/C/F/TAF in ARV HIV-1 infected patients from 6 to < 18 years of age. Virologically suppressed, HIV-infected children 6 to < 12 years of age are now being enrolled into Cohort 2 of the ongoing, pediatric Study rather than Study Study has been renumbered as Study GS-US-292-1515 for administrative reasons. As younger children 6 to < 12 years of age are now being enrolled in Cohort 2 of Study Study GS-US-292-1515 is This is acceptable.
auspar-emtricitabine-161220.docx