BACKGROUND: Before the initiation of long-acting (LA) cabotegravir and rilpivirine (CAB/RPV), oral lead in (OLI) is an option, intending to rule out potential (systemic) side effects. The desire of people with HIV (PWH) to skip this phase is often in contrast to the wish of health care professionals to ‘test’ the drug in a short acting form before administering the first LA dose. This study aimed to add to the understanding of the relevance of OLI with regards to persistence on CAB/RPV.
METHODS: Retrospective cohort study in PWH exposed to at least one dose of CAB/RPV orally (as OLI) and/or intramuscularly from January 2021 onwards. Persistence on CAB/RPV LA was compared between PWH, receiving at least one dose of CAB/RPV LA with or without OLI. Analysis was repeated after stratification for previous antiretroviral regimen (dolutegravir containing yes/no). Standard and modified log-rank tests (using Peto-Peto-Prentice weighing), were used to compare event-times in the overall and the early time on treatment, respectively.
RESULTS: 161 PWH were included into the analysis; 122 (75.8%) received OLI. While 8 (6.6 %) did not proceed to LA after OLI, in only one (0.8 %) a potential side effect was the reason. Times of persistence on CAB/RPV LA was not significantly different for PWH with and without OLI (p=0.769). Stratifying for ART prior to CAB/RPV yielded in similar results, whether the previous ART was dolutegravir containing (p=0.706, fig 1b) or not (p=0.380, fig 1c).
CONCLUSIONS: Rates of discontinuation during OLI was low and time of persistence on CAB/RPV LA was not significantly different between PWH with and without OLI. Therefore, if clinically nesessary, its omission seems to be safe in general. Particularly in the subgroup of PWH without prior DTG-containing ART, the validity of our findings might be limited by low sample size.