Background
Lenacapavir (LEN), an HIV-1 capsid inhibitor, combined with broadly neutralizing antibodies teropavimab (TAB) and zinlirvimab (ZAB) is under investigation as a twice-yearly (Q6M) HIV-1 treatment in a Phase 2 open-label study (NCT05729568). We describe W52 patient-reported outcomes (PROs) for treatment preference/satisfaction, and health-related quality of life (HRQoL).
Methods
This study enrolled virologically suppressed (HIV-1 RNA <50 copies/mL) adults on oral antiretroviral therapy (ART) for ≥12 months with HIV-1 highly susceptible to TAB and ZAB. Participants were randomized 2:1 to switch to subcutaneous LEN 927 mg (+ LEN oral loading) plus intravenous TAB 2550 mg and ZAB 2550 mg Q6M, or continue baseline (BL) daily oral ART. PRO assessments included: HIV Treatment Preference Questionnaire (HIVTPQ), HIV Treatment Satisfaction Questionnaire – Status (HIVTSQstatus), and HIV Dependent Quality of Life (HIVDQoL) questionnaire. Analyses were conducted using descriptive statistics and complete-case analysis for LEN, TAB, and ZAB participants who completed BL, W26, and W52 questionnaires, with Wilcoxon signed-rank tests applied to continuous data.
Results
Of 53 participants receiving LEN, TAB, and ZAB, 85% were male, 53% White, 91% from the US, and mean (SD) age was 44 (14) years; 42/53 participants completed ≥1 of 3 PRO questionnaires at BL, W26, and W52. At W52, 32/42 (76%) participants receiving LEN, TAB, and ZAB preferred this over daily oral ART (HIVTPQ: strong, n=29; moderate, n=3), with 38/42 (91%) stating LEN, TAB, and ZAB would improve adherence compared with daily oral ART. Mean (SD) HIVTSQstatus score statistically significantly increased from 58 (8) at BL to 62 (8) at W52 (n=41; p=0.03); concepts for which the greatest proportion of LEN, TAB, and ZAB participants felt “very satisfied” at W52 were ‘control’ of their HIV-1 (37/41; 90%), ‘flexibility’ of treatment (33/41; 80%), and ‘understanding’ of their HIV-1 (33/41; 80%) (Figure). HIVDQoL scores improved from the switch from oral ART at BL to W52, with 34/37 (92%) and 36/37 (97%) participants receiving LEN, TAB, and ZAB reporting good–excellent HRQoL at BL and W52, respectively, and 6/37 (16%) and 14/37 (38%) reporting excellent HRQoL.
Conclusions
Consistent with W26 results, participants had moderate-to-strong preferences for the first all-injectable twice-yearly treatment over daily oral ART, along with increased treatment satisfaction and improved HRQoL through W52 after switching to LEN, TAB, and ZAB from daily oral ART.
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