International journal of antimicrobial agents · 2026
Real-world evaluation of HIV-1 reservoir and resistance in virologically suppressed people after 52 weeks of treatment with long-acting cabotegravir + rilpivirine.
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Marchegiani Greta, Antonucci Francesco Paolo, Bertoli Ada, Bellocchi Maria Concetta, Torre Giulia, Spalletta Daniele, Carioti Luca, Eizadi-Moghadam Hossein, Narducci Arianna, Vergori Alessandra, El Khalili Omar, Armenia Daniele, Ferrara Sergio, Ceccherini-Silberstein Francesca, Lo Caputo Sergio, Santoro Maria Mercedes
Аннотация
BACKGROUND: Although long-acting cabotegravir plus rilpivirine (CAB + RPV long-acting [LA]) has demonstrated high efficacy in clinical trials, real-world data on archived resistance and HIV-1 reservoir dynamics remain limited.
METHODS: Archived resistance profile and total HIV-1 DNA were assessed at baseline (BL) and over 52 weeks in 36 virologically suppressed participants who switched to CAB + RPV LA, followed at the Polyclinic of Foggia, Italy. Total HIV-1 DNA in whole blood was quantified by real-time PCR. Resistance and APOBEC-context mutations were assessed through the Stanford HIVdb algorithm.
RESULTS: At BL, participants had a median body mass index of 26.1 kg/m² and prior virological suppression (VS) of 8.5 y; none of them harboured A6 subtype. Thirty-four participants (94.4%) maintained VS after 52 weeks on CAB + RPV LA, with a stable total HIV-1 DNA (3.5 at BL vs. 3.7 log10 copies/10⁶ CD4 at week 52, P = 0.324). BL prevalence of non-nucleoside reverse transcriptase inhibitor (NNRTI) and integrase strand transfer inhibitor (INSTI) major mutations was 18.2% and 6.5%, respectively. NNRTI prevalence remained constant, while no major INSTI mutations were found at week 52. Excluding APOBEC-context mutations, NNRTI resistance prevalence was about 9% at both time points, while no INSTI major mutations were found. In the two participants who failed CAB + RPV LA, NNRTI resistance was detected at failure; they subsequently regained VS after treatment modification.
CONCLUSIONS: In this real-world study, stable HIV-1 DNA over 52 weeks of CAB + RPV LA treatment was observed. A substantial proportion of participants harboured NNRTI or INSTI major mutations, mostly APOBEC-context, without conferring true resistance. These findings emphasize the importance of a careful interpretation of proviral resistance.
METHODS: Archived resistance profile and total HIV-1 DNA were assessed at baseline (BL) and over 52 weeks in 36 virologically suppressed participants who switched to CAB + RPV LA, followed at the Polyclinic of Foggia, Italy. Total HIV-1 DNA in whole blood was quantified by real-time PCR. Resistance and APOBEC-context mutations were assessed through the Stanford HIVdb algorithm.
RESULTS: At BL, participants had a median body mass index of 26.1 kg/m² and prior virological suppression (VS) of 8.5 y; none of them harboured A6 subtype. Thirty-four participants (94.4%) maintained VS after 52 weeks on CAB + RPV LA, with a stable total HIV-1 DNA (3.5 at BL vs. 3.7 log10 copies/10⁶ CD4 at week 52, P = 0.324). BL prevalence of non-nucleoside reverse transcriptase inhibitor (NNRTI) and integrase strand transfer inhibitor (INSTI) major mutations was 18.2% and 6.5%, respectively. NNRTI prevalence remained constant, while no major INSTI mutations were found at week 52. Excluding APOBEC-context mutations, NNRTI resistance prevalence was about 9% at both time points, while no INSTI major mutations were found. In the two participants who failed CAB + RPV LA, NNRTI resistance was detected at failure; they subsequently regained VS after treatment modification.
CONCLUSIONS: In this real-world study, stable HIV-1 DNA over 52 weeks of CAB + RPV LA treatment was observed. A substantial proportion of participants harboured NNRTI or INSTI major mutations, mostly APOBEC-context, without conferring true resistance. These findings emphasize the importance of a careful interpretation of proviral resistance.