Cabotegravir (CAB, GSK 1265744) is a Long-Acting (LA) injectable, in Phase 2 for treatment and prevention of HIV-1 infection. ÉCLAIR evaluated CAB LA injections for HIV PrEP. Secondary objectives include tolerability, satisfaction, and acceptability of CAB LA.
ÉCLAIR is a double-blind, randomised, multi-centre study in HIV-negative men, excluding males at high-risk of HIV-1. Participants were randomized (5:1) to QD oral CAB 30mg or placebo (PBO) for 4 weeks (W); thereafter IM injections (Inj) of 800mg CAB LA or PBO (saline) q12W x 3 cycles. Satisfaction, tolerability, and acceptability were self-assessed with Study Medication Satisfaction Questionnaire (SMSQ) with 11 items adapted from the HIV-Treatment Satisfaction Questionnaire and Study Medication Questionnaire (SMQ), which consists of 4 items evaluating adherence with study medication. SMSQ and SMQ were administered at W 6, 18, and 30 (1W after CAB LA inj).
ECLAIR randomized/treated 126 participants (CAB: 105; PBO 21). Eighteen withdrew from CAB: five during oral phase, six after oral but prior to inj, and seven during the inj phase. Of those receiving inj, 87/94 (93%) of CAB LA, and 20/21 (95%) PBO completed inj phase. AEs due to CAB included inj site pain (82%), headache (23%), and inj site swelling (20%). 1W following second inj, the majority of participants were more satisfied with IM CAB compared with once daily oral CAB, on all 11 items included in the SMSQ [figure below]. At 1W post third CAB LA inj, 64/86 (75%) of participants were satisfied with CAB IM, 21% neither satisfied nor dissatisfied and, 4% dissatisfied. Overall, 75/86 (87%) of participants reported as willing to recommend medication and 68/86 (79%) a willingness to continue with study medication. Tolerability of CAB LA inj showed 57/86 (66%) of participants were satisfied with side effects with 13% neither satisfied or dissatisfied and 55/86 (64%) were satisfied with the amount of pain/discomfort with 14% neither satisfied or dissatisfied. SMQ results show 73/86 (85%) of participants almost never found it difficult to comply with the q12W schedule.
Secondary endpoints from ECLAIR help interpretation of safety data and provide a robust participant-centred perspective. While CAB LA inj site pain was common, discontinuation was infrequent. Results suggest participants experienced a high level of overall satisfaction and cited preference for a LA inj based on dimensions such as convenience, flexibility and ease of use.