| Autor: |
Podzamczer, Daniel, Imaz, Arkaitz, Lopez-Lirola, Ana, Knobel, Hernando, Masiá, Mar, Fanciulli, Chiara, Hernández, Cristina, Lagarde, María, Gutierrez, Angela, Curran, Adrià, Morano, Luis, Montero-Alonso, Marta, Troya, Jesús, Rigo, Raúl, Casadellà, María, Navarro-Alcaraz, Antonio, Ardila, Fernando, Parera, Mariona, Bernal, Enrique, Echeverria, Patricia |
| Předmět: |
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| Zdroj: |
Journal of Antimicrobial Chemotherapy (JAC); Nov2023, Vol. 78 Issue 11, p2696-2701, 6p |
| Abstrakt: |
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. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
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