Tolerability and Virologic Outcomes after Transition from Long-Acting Injectable ART to Oral ART.

The tolerability of oral antiretroviral therapy (ART) administered after discontinuation of long-acting injectable (LAI) cabotegravir (CAB) + rilpivirine (RPV), during the period of residual injectables persistence, has not been described. Limited data are available on the oral ART regimens used after all-cause LAI discontinuations and on their effectiveness. This analysis was conducted in Surveillance Cohort Long-Term Toxicity of Antiretrovirals, an active, multicenter, prospective, observational pharmacovigilance cohort that monitors antiretroviral safety and development of adverse reactions. In the cohort, 75/682 people living with HIV (PWH) discontinued LAI, the majority due to adverse events (AEs). No worsening or new AEs were observed after initiation of oral ART, even among PWH who discontinued CAB + RPV due to systemic symptoms. All patients were switched to a single-tablet regimen, with 34.7% receiving a non-nucleoside reverse transcriptase inhibitor (NNRTI)-containing regimen. Among individuals who discontinued LAI for reasons other than virologic failure (VF), all those previously on NNRTI-and/or integrase inhibitor (INSTI)-based oral ART resumed regimens containing the same drug classes. After discontinuation due to VF, a protease inhibitor-based regimen was newly introduced in 4/10 PWH. Within 6 months, HIV-RNA was ≤50 copies/mL in 96.0% and ≤200 copies/mL in 98.7% of participants. The overlap between the residual CAB + RPV and the oral therapy was well tolerated; most individuals restarted their previous oral regimen, and virological suppression remained high 6 months after resuming oral ART.