Therapeutic drug monitoring and virological response at week 48 in a cohort of HIV-1 infected-patients switching to dolutegravir/rilpivirine dual maintenance therapy (ANRS-MIE-BIRIDER Study)
Résumé
AIM: Dolutegravir (DTG) and rilpivirine (RPV) dual therapy is now recommended as a switch option in virologically suppressed HIV patients. Literature suggests that virological failure with dual therapy could possibly relate to sub-therapeutic drug concentrations. In this study, we aimed at describing the DTG and RPV trough plasma concentrations (Cmin) and plasma HIV-1 RNA (VL) during maintenance dual therapy. METHODS: We performed a retrospective analysis of DTG and RPV Therapeutic Drug Monitoring in people living with HIV/AIDS (PLWHA) with dual therapy in 9 French centers. DTG and RPV trough plasma concentrations were estimated using a Bayesian approach to predict Cmin. The relationship between the pharmacokinetics of DTG and RPV and VL>50cp/mL was explored using joint non-linear mixed models. The frequency of subtherapeutic threshold (DTG Cmin below 640 ng/mL and RPV Cmin below 50 ng/mL) were compared between PLWHA presenting VL>50 cp/mL or not during the study. RESULTS: At baseline, 209 PLWHA were enrolled in the study. At week 48, 19 people living with HIV/AIDS (9.1%) discontinued their treatment and 15 PLWHA (7.1%) exhibited VL>50 cp/mL. Six PLWHA out of 15 (40.0%) with VL>50 cp/mL during the follow-up had at least one Cmin below the respective thresholds while only 26/194 patients (13.4%) without virological replication had at least one concentration below the threshold (p=0.015). CONCLUSION: A majority of PLWHA receiving DTG/RPV maintenance dual therapy demonstrated VL<50 cp/mL but virological replication was more frequent in people living with HIV/AIDS with subtherapeutic Cmin.
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