51. Switching to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) plus darunavir/cobicistat in heavily antiretroviral-experienced, virologically suppressed HIV-infected adults receiving complex regimens
- Author
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Gilead Sciences, Red Española de Investigación en SIDA, Fundació Lluita contra les Infeccions, Podzamczer, Daniel, Imaz, Arkaitz, López-Lirola, Ana, Knobel, Hernando, Masiá, Mar, Fanciulli, Chiara, Hernández, Cristina, Lagarde, María, Gutiérrez, Angela, Curran, Adrià, Morano, Luis, Montero-Alonso, Marta, Troya, Jesús, Rigo-Bonnin, Raúl, Casadellà, María, Navarro-Alcaraz, Antonio, Ardila, Fernando, Parera, Mariona, Bernal, Enrique, Echeverria, Patricia, Estrada, Vicente, Hidalgo-Tenorio, Carmen, Macías Sánchez, Juan, Prieto, Paula, Portilla, Joaquín, Valencia, Eulalia, Vivancos-Gallego, María Jesús, Rivero, Antonio, Gilead Sciences, Red Española de Investigación en SIDA, Fundació Lluita contra les Infeccions, Podzamczer, Daniel, Imaz, Arkaitz, López-Lirola, Ana, Knobel, Hernando, Masiá, Mar, Fanciulli, Chiara, Hernández, Cristina, Lagarde, María, Gutiérrez, Angela, Curran, Adrià, Morano, Luis, Montero-Alonso, Marta, Troya, Jesús, Rigo-Bonnin, Raúl, Casadellà, María, Navarro-Alcaraz, Antonio, Ardila, Fernando, Parera, Mariona, Bernal, Enrique, Echeverria, Patricia, Estrada, Vicente, Hidalgo-Tenorio, Carmen, Macías Sánchez, Juan, Prieto, Paula, Portilla, Joaquín, Valencia, Eulalia, Vivancos-Gallego, María Jesús, and Rivero, Antonio
- Abstract
[Objectives] To evaluate the efficacy and safety of the two-pill regimen bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) plus darunavir/cobicistat as a switching strategy in heavily treatment-experienced people living with HIV (PLWH)., [Methods] Multicentre, prospective, single-arm pilot clinical trial. Participants were virologically suppressed adults receiving a stable antiretroviral regimen of at least three pills from at least three drug families due to previous virological failures and/or toxicities with no documented resistance to integrase strand transfer inhibitors or darunavir (≥15 points, Stanford). Clinical and laboratory assessments were performed at 0, 4, 12, 24, 36 and 48 weeks. HIV-1 proviral DNA was amplified and sequenced by Illumina at baseline. Plasma bictegravir concentrations were determined in 22 patients using UHPLC-MS/MS. The primary study endpoint was viral load (VL)< 50 copies/mL at Week 48 (ITT)., [Results] We enrolled 63 participants (92% men) with median baseline CD4 count of 515 cells/mm3 (IQR: 334.5–734.5), 24 years on ART (IQR: 15.9–27.8). The median number of pills was 4 (range: 3–10). At baseline, proviral DNA was amplified in 39 participants: 33/39 had resistance mutations. Three participants discontinued owing to toxicity. At 48 weeks, 95% had VL < 50 copies/mL by ITT and 100% by PP analysis. A modest increase was observed in the bictegravir plasma concentration, and a significant decrease in estimated glomerular filtration rate was observed only at Week 4, probably related to interaction with renal transporters., [Conclusions] Our data suggest that BIC/FTC/TAF + darunavir/cobicistat is an effective, well-tolerated regimen that may improve convenience and, potentially, long-term success in stable heavily pre-treated PLWH.
- Published
- 2023