BACKGROUND:Once-daily, single-tablet regimens have transformed care for persons living with human immunodeficiency virus type 1 (HIV-1); however, challenges to adherence continue to limit effective treatment. Long-acting oral-drug combinations could offer new options with less frequent dose administration. METHODS:We conducted a phase 3, double-blind, randomized, active-controlled, noninferiority trial in 12 countries to evaluate the efficacy and safety of a switch to once-weekly oral islatravir-lenacapavir (ISL/LEN) from once-daily oral bictegravir-emtricitabine-tenofovir alafenamide (B/F/TAF) in adults in whom HIV-1 had been virologically suppressed for at least 6 months while they were receiving B/F/TAF. Participants were assigned in a 1:1 ratio to receive once-weekly ISL/LEN (2 mg/300 mg) or to continue once-daily B/F/TAF for 96 weeks; all received matched placebo for the alternative regimen. The primary end point was the percentage of participants with an HIV-1 RNA level of 50 copies per milliliter or higher at week 48, as determined by the Food and Drug Administration-defined snapshot algorithm. Noninferiority was determined at a margin of 4 percentage points. RESULTS:A total of 607 participants underwent randomization; 304 were assigned to the ISL/LEN group and 303 to the B/F/TAF group. A total of 21% of the participants were women, 31% were Black, 26% were Hispanic or Latine, and 15% were 65 years of age or older. At week 48, an HIV-1 RNA level of 50 copies per milliliter or higher was reported in no participants in the ISL/LEN group and 1 (0.3%) in the B/F/TAF group (difference, -0.3 percentage points; 95.002% confidence interval [CI], -1.4 to 0.8); an HIV-1 RNA level of less than 50 copies per milliliter was reported in 284 (93.4%) and 280 (92.4%), respectively (difference, 1.0 percentage point, 95% CI, -3.2 to 5.2). The mean change in the CD4+ T-cell count at week 48 was -10 cells per microliter with ISL/LEN and -18 cells per microliter with B/F/TAF (least-squares mean difference, 12 cells per microliter; 95% CI, -16 to 39). The trial regimen was discontinued owing to adverse events in 6 participants (2.0%) in the ISL/LEN group and 5 (1.7%) in the B/F/TAF group; serious adverse events occurred in 16 (5.3%) and 14 (4.6%), respectively. CONCLUSIONS:Among persons with virologically suppressed HIV-1, once-weekly oral ISL/LEN was noninferior to once-daily B/F/TAF in maintaining HIV viral load suppression. (Funded by Gilead Sciences and Merck Sharp and Dohme; ISLEND-1 ClinicalTrials.gov number, NCT06630286.).
Background Although Argentina provides access to no cost HIV care, treatment adherence and retention in care remain suboptimal. This study aimed to explore factors associated with self-reported adherence and appointment attendance over time. Method Participants ( N = 360) were people living with HIV (PLWH) that were lost to care (i.e., three missed pharmacy pickups in the last 6 months, or had not attended a physician visit in the last 12 months). Participants were recruited from seven HIV clinics in four urban centers in Argentina and re-engaged in care. Demographic variables, predictors, i.e., alcohol use, self-efficacy, motivation, patient-provider communication, insurance type (private/public), and outcomes, i.e., missed infectious disease (ID) specialist appointments, other missed clinic and lab appointments, and self-reported adherence were assessed over 2 years. A logistic regression and Poisson regression model within a generalized linear mixed model framework was used to analyze the association between predictors, treatment adherence outcomes, and interactions with time. Results Following re-engagement in care, increased alcohol use was associated with lower odds of antiretroviral therapy adherence over time, increased odds of missing ID specialist appointments, and missed clinic/lab appointments. Self-efficacy was associated with better medication adherence and fewer missed ID specialist appointments over time. Similarly, both motivation and patient/provider communication were associated with fewer missed ID specialist and clinic/lab appointments over time. Having private health insurance was also associated with less missed clinic/lab appointments. Conclusion Findings suggest alcohol use reduction interventions could improve treatment outcomes in this population. Additionally, interventions targeting patient-provider communication and patient self-efficacy and motivation may enhance retention following re-engagement in care.
INTRODUCTION:Real-world data on bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) showed high virologic suppression (VS) in treatment-naive (TN) and experienced (TE) people living with HIV (PLWH). The BIC-CD4 study aims to describe safety, persistence, and VS in PLWH who started B/F/TAF with CD4 <200/mm3, representing advanced HIV disease (AHD). MATERIALS AND METHODS:This retrospective, multisite, observational, open cohort study, included TN and TE PLWH who started B/F/TAF from October 2019 to January 2024 in three HIV clinics in Argentina. RESULTS:Of 3527 patients starting B/F/TAF, 250 (7%) had CD4 <200/mm3: 132 TN and 117 TE. The cohort was predominantly male (74%) with a median age of 43 years. For TN patients, 48-week persistence was 99%, VS was 83%, and median CD4 increased from 94 to 284/mm3. TE patients were divided into those with and without VS at baseline (TEU: treatment-experienced undetectable; TENU: treatment-experienced not-undetectable). Half of the TE patients corresponded to TENU subgroup which had lower CD4 counts and higher frequencies of exposure to efavirenz and atazanavir/ritonavir, ongoing toxicity, and virologic failure compared to TEU. At 48 weeks, VS rates for TEU and TENU were 98% and 89%, respectively. Overall persistence was >99% for both groups. Median CD4 counts increased in both TEU and TENU groups. No adverse events were reported. DISCUSSION:B/F/TAF demonstrated excellent persistence, safety, and adequate VS rates in PLWH with AHD, including both TN and TE patients, supporting its use in this population.
