sample of HIV-1 infected sponsor should provide an paediatric patients assurance that draft protocols for these studies will be PBPK simulations of the effect provided to the TGA when they of potent CYP3A4 inhibitors become available. on COBI exposure GS-US-183-1004 - A Phase I, Multiple Dose Study to Evaluate the Pharmacokinetics of Cobicistat-Boosted Elvitegravir in Subjects with Decreased UGT1A1 Activity The sponsor should provide at least an electronic copy of the draft protocols for these studies to the TGA for review if they have not already been initiated. If they are not yet available the sponsor should provide an assurance that draft protocols for these studies will be provided to the TGA when they become available. 5. The for The sponsor states: This is acceptable. ‘Potential Medication Errors’ section of has reinstated “Gilead the AU-RMP previously the for ‘Potential accepted for Stribild has been Medication Errors’ removed from the updated section of the AU-RMP AU-RMP. The sponsor’s within Section 6, handling of this matter using Additional routine pharmacovigilance, Requirements for the routine risk minimisation and Safety Specification”. additional risk minimisation activities was previously considered satisfactory. Consequently the sponsor should reinstate such a section in a revised AU-RMP, which relates to the important identified risk: toxicity’, including ‘Renal updating this section with post marketing data. 6. The sponsor’s The sponsor states: This is acceptable, although it is correspondence, dated 16 has updated noted that Annex 9. of “Gilead ‘Details January 2013, states: Table 1-1.Risk additional risk minimisation (information relating to Minimisation measures’ has been added additional risk minimisation Measures for rather than Table 1-2. ‘Risk activities for the important Important Identified Minimisation Measures for identified risk: Risks within Part V of ‘Renal
sample of HIV-1 infected paediatric patients PBPK simulations of the effect of potent CYP3A4 inhibitors on COBI exposure GS-US-183-1004 - A Phase I, Multiple Dose Study to Evaluate the Pharmacokinetics of Cobicistat-Boosted Elvitegravir in Subjects with Decreased UGT1A1 Activity The sponsor should provide at least an electronic copy of the draft protocols for these studies to the TGA for review if they have not already been initiated. If they are not yet available the sponsor should provide an assurance that draft protocols for these studies will be provided to the TGA when they become available. sponsor should provide an assurance that draft protocols for these studies will be provided to the TGA when they become available. 5. The ‘Potential for Medication Errors’ section of the AU-RMP previously accepted for Stribild has been removed from the updated AU-RMP. The sponsor’s handling of this matter using routine pharmacovigilance, routine risk minimisation and additional risk minimisation activities was previously considered satisfactory. Consequently the sponsor should reinstate such a section in a revised AU-RMP, which relates to the important identified risk: ‘Renal toxicity’, including updating this section with post marketing data. The sponsor states: “Gilead has reinstated the ‘Potential for Medication Errors’ section of the AU-RMP within Section 6, Additional Requirements for the Safety Specification”. This is acceptable. 6. The sponsor’s correspondence, dated 16 January 2013, states: (information relating to additional risk minimisation activities for the important identified risk: ‘Renal The sponsor states: “Gilead has updated Table 1-1.Risk Minimisation Measures for Important Identified Risks within Part V of This is acceptable, although it is noted that Annex 9. ‘Details of additional risk minimisation measures’ has been added rather than Table 1-2. ‘Risk Minimisation Measures for
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