Unconventional use of injectable long-acting cabotegravir and rilpivirine against HIV-1 in PWH in clinical need: 52 weeks real-world data.

BACKGROUND

Long-acting Cabotegravir and Rilpivirine (LA CAB + RPV) shows potential advantages in heavily comorbid and even in viremic people with HIV (PWH). We assessed LA CAB + RPV durability in a cohort of PWH with a high comorbidity burden and adherence issues.

METHODS

Retrospective observational study in two Italian outpatient settings enrolling PWH who switched to LA CAB + RPV from February 2021 to January 2024 in presence of exclusion criteria enlisted in registrational trials or with other worrisome clinical risks. Kaplan-Meier (KM) was used to assess the probability of CAB/RPV discontinuation. Cox regression analysis was used to evaluate potential predictors of discontinuation.

RESULTS

We enrolled 74 PWH, with a median of 7 injections (IQR 5-9), a median age of 53 years (IQR 45-61), median time of exposure to antiretrovirals of 11 years (IQR 8-18) and median time from HIV diagnosis of 11.8 years (IQR 6.6-18.2). Eleven (14.9%) discontinued LA CAB + RPV mainly for injection-site pain. Of 53 PWH who were undetectable before switch, 37 maintained viral suppression at week 52. We registered only one virological failure at week 12. Twenty-one started injections with unsuppressed viral loads (median 66 cps/ml, IQR 40-215) and 10 (47.6%) achieved viral suppression. Overall probability of discontinuation was 14.9% at week 52. Younger age was protective against discontinuation (HR 0.93, 95%CI 0.88-0.99, p = 0.048).

CONCLUSIONS

Our results support the potential advantages in using LA CAB + RPV in PWH with adherence issues and comorbidities.