by Carolyn Chu, MD, MSc, AAHIVS, AAHIVM Chief Medical Officer
August 16, 2022
This study describes participants and outcomes of a compassionate use program involving long-acting cabotegravir plus rilpivirine. Patients (n = 35) were adult PWH with no key CAB or RPV-associated mutations and needed parenteral ART due to malabsorption syndrome, dysphagia, or psychological conditions preventing oral ART; had prolonged non-adherence to oral ART with progressive HIV disease; or had some other compelling reason for compassionate use. 66% received a 4-week oral lead-in and maintenance doses were administered every 4 weeks for all. 28/35 (80%) entered the program with viremia ≥ 50 copies/mL (median 60,300 copies/mL). At data cut-off, 22/35 (63%) achieved (16/28) or maintained (6/7) VL < 50 copies/mL (of the other patients, 2 had not yet received injections and 1 had initiated the program < 4 months before data cut-off). Out of 11 participants who had perinatally-acquired HIV, 8 experienced virologic suppression. 7 patients stopped LA CAB/RPV because of incomplete virologic response; at time of discontinuation, 6 had NNRTI resistance-associated mutations not observed at program initiation (2 of whom also had INSTI resistance-associated mutations). Although injection site reactions were the most commonly reported side effect, no participant discontinued LA CAB/RPV because of injection site reactions. 1 participant reported two pregnancies while receiving LA CAB/RPV and continued LA dosing (details available in Appendix S1).
Initial results of this LA CAB/RPV compassionate use program were presented at the International AIDS Conference in 2020, and additional details provided in this manuscript shed further light on the role of LA CAB/RPV for PWH with viremia who have been unable to achieve or maintain virologic suppression on oral ART. Safety-related outcomes were similar to those previously described in clinical trials. A few of the participants who experienced incomplete virologic response on LA CAB/RPV were able to transition to a protease inhibitor-based oral regimen with eventual virologic suppression. As observed in clinical trials, NNRTI and INI resistance-associated mutations may emerge in PWH who do not experience virologic suppression on LA CAB/RPV, and therefore close laboratory monitoring is warranted to ensure early detection of virologic failure and HIV drug resistance among PWH receiving LA CAB/RPV—this may be especially important for PWH with complex ART histories where complete information on pre-existing resistance associated mutations is not available and/or case scenarios involving known factors for potential virologic failure.
The author has no conflicts of interest to disclose.
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