LA-CAB/RPV for HIV With Adherence Challenges

Background: Long-acting cabotegravir–rilpivirine (LA-CAB/RPV), an injectable antiretroviral therapy (ART) for HIV, is approved for patients with viral suppression on oral therapy. Randomized trials are needed to determine the role of LA-CAB/RPV in persons with inadequate adherence to oral ART. Objective: To compare rates of treatment failure using LA-CAB/RPV versus standard oral therapy (SOT) in persons with HIV and adherence challenges. Design: Prospective, open-label, multisite randomized trial. Participants: Patients with HIV with nonadherence to oral ART (persistent HIV-1 RNA level of >200 copies per mL or loss to follow-up for >6 of the prior 18 months). Those with hepatitis B co-infection or rilpivirine or integrase strand transfer inhibitors (INSTIs) resistance mutations were excluded. Methods: In step 1, patients received 24 weeks of support and economic incentives to facilitate adherence to SOT containing 3 drugs, including a boosted protease inhibitor, INSTI, or both. more...