Safety and efficacy of deltoid intramuscular long-acting cabotegravir and rilpivirine, a case series

ObjectiveThe objective was to evaluate the safety, pharmacokinetics and efficacy of an alternative deltoid site for CAR-LA.DesignThis is a prospective cohort of people living with HIV (PLWHIV) switching for intramuscular long acting cabotegravir and rilpivirine (CAR-LA).MethodsClinical and biological data were collected at baseline, month 1 (M1), month 3 (M3), and every three months thereafter, when available.ResultsA total of 15 patients were enrolled between August 2022 and October 2024. Of these, 11 were transgender women, 1 cisgender woman, and 3 cisgender males. The median duration of plasma HIV-1-RNA (pVL) <50 copies/mL before switching to CAR-LA was 42 months. The main criterion for selecting PLWHIV was the presence of injected silicone in the gluteal region (12 out of 15 cases). Median duration of CAR-LA was 13 months. All patients maintained a pVL<50 copies/mL at M1 and M3. No virological failure was observed in the 13 patients who were followed up to M12. One PLWHIV discontinued deltoid injections due to low plasma concentrations at M2, while another discontinued due to non-adherence which led to cabotegravir resistance at M13. Three PLWHIV reported moderate pain at the injection site, with one discontinuing treatment at M12. All CAB and RPV plasma concentrations measured after deltoid CAR-LA were comparable with those obtained following gluteal CAR-LA phase 3 studies.ConclusionDeltoïd CAR-LA seems to be a reliable and well-tolerated alternative for PLWHIV with contraindications for gluteal injections.