Twice-Yearly Lenacapavir for HIV Prevention in Men and Gender-Diverse Persons

New England Journal of Medicine, Journal Year: 2024, Volume and Issue: unknown

Published: Nov. 27, 2024

BackgroundTwice-yearly subcutaneous lenacapavir has been shown to be efficacious for prevention of HIV infection in cisgender women. The efficacy preexposure prophylaxis (PrEP) men, transgender women, and gender-nonbinary persons is unclear.MethodsIn this phase 3, double-blind, randomized, active-controlled trial, we randomly assigned participants a 2:1 ratio receive every 26 weeks or daily oral emtricitabine–tenofovir disoproxil fumarate (F/TDF). primary analysis compared the incidence group with background screened population. secondary that F/TDF group.ResultsAmong 3265 who were included modified intention-to-treat analysis, infections occurred 2 (0.10 per 100 person-years; 95% confidence interval [CI], 0.01 0.37) 9 (0.93 CI, 0.43 1.77). population (4634 participants) was 2.37 person-years (95% 1.65 3.42). significantly lower than both (incidence rate ratio, 0.04; 0.18; P<0.001) 0.11; 0.02 0.51; P=0.002). No safety concerns identified. A total 2183 (1.2%) 3 1088 (0.3%) discontinued trial regimen because injection-site reactions.ConclusionsThe twice-yearly F/TDF. (Funded by Gilead Sciences; PURPOSE ClinicalTrials.gov number, NCT04925752.)

Language: Английский

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Efficacy and safety of long-acting cabotegravir compared with daily oral tenofovir disoproxil fumarate plus emtricitabine to prevent HIV infection in cisgender men and transgender women who have sex with men 1 year after study unblinding: a secondary analysis of the phase 2b and 3 HPTN 083 randomised controlled trial

The Lancet HIV, Journal Year: 2023, Volume and Issue: 10(12), P. e767 - e778

Published: Nov. 9, 2023

BackgroundInjectable cabotegravir was superior to daily oral tenofovir disoproxil fumarate plus emtricitabine for HIV prevention in two clinical trials. Both trials had the primary aim of establishing efficacy long-acting injectable pre-exposure prophylaxis (PrEP) compared with PrEP. Long-acting PrEP associated diagnostic delays and integrase strand-transfer inhibitor (INSTI) resistance. This report presents findings from first unblinded year Prevention Trials Network (HPTN) 083 study.MethodsThe HPTN randomised controlled trial enrolled HIV-uninfected cisgender men transgender women at elevated risk who have sex men, 43 research sites Africa, Asia, Latin America, USA. Inclusion criteria included: a negative serological test screening study entry, undetectable RNA levels within 14 days age 18 years or older, overall good health as determined by laboratory evaluations, creatinine clearance 60 mL/min higher. Participants were randomly allocated receive After unblinding, participants remained on their original regimen awaiting an extension study. infections characterised retrospectively central laboratory. Here we secondary analysis safety year. The outcome incident infection. Efficacy analyses done modified intention-to-treat population using Cox regression model. Adverse events across treatment groups time periods (blinded vs unblinded). is registered ClinicalTrials.gov, NCT02720094.FindingsOf 4488 contributed person-time blinded analysis, 3290 between May 15, 2020, 14, 2021. Updated incidence phase 0·41 per 100 person-years 1·29 (hazard ratio [HR] 0·31 [95% CI 0·17–0·58], p=0·0003). 0·82 2·27 (HR 0·35 [0·18–0·69], p=0·002). Adherence both products decreased after unblinding. Additional group included on-time injections; three one more delayed detected reinitiation; 11 than 6 months last injection. Infection exposure INSTI generally consistent previous reports; hypertension requires further investigation.InterpretationLong-acting retained high during open-label follow-up, near-identical HR reduction unblinding period. Extended follow-up defined period emergence resistance.FundingDivision AIDS National Institute Allergy Infectious Diseases, ViiV Healthcare, Gilead Sciences.

Language: Английский

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Lenacapavir: a giant step forward in HIV prevention—but a missed opportunity for achieving equity and access

BMJ, Journal Year: 2024, Volume and Issue: unknown, P. q2254 - q2254

Published: Oct. 14, 2024

Language: Английский

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Factors Associated with HIV Risk Perception Among Cisgender Female Sex Workers in Brazil

Archives of Sexual Behavior, Journal Year: 2025, Volume and Issue: unknown

Published: Jan. 22, 2025

This study evaluated the association between HIV risk perception and sociodemographic behavioral characteristics among cisgender female sex workers in five regions of Brazil. A cross-sectional, multicenter using respondent-driven sampling was used. Sex over 18 years age who reported commercial past four months were included. All participants completed a questionnaire with factors. In addition, offered rapid antibody test. Unweighted bivariate analyses multivariable logistic regression models used to evaluate Overall, 794 HIV-negative included (mean = 34.44 [SD 6.49]). Most brown/pardo (59.47%), from social class D–E (82.24%), medium education (57.12%). women perceived themselves be at low moderate (68.26%), 7.56% no risk, 24.18% high for infection. Those frequently or always had sexual intercourse under influence alcohol 2.36 times higher probability having compared those never alcohol. The data this aid better understanding its impact on behaviors workers. Although majority considered HIV, some vulnerability prevalent.

Language: Английский

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Socio‐economic status and adherence to HIV preventive and therapeutic interventions: exploring the mediating role of food insecurity among men who have sex with men and transgender and non‐binary persons from Brazil

Journal of the International AIDS Society, Journal Year: 2025, Volume and Issue: 28(3)

Published: March 1, 2025

Brazil offers free-of-charge antiretroviral therapy (ART) for people living with HIV (PLWH) as well oral pre-exposure prophylaxis (PrEP) through its national health system. Adherence to ART and PrEP is essential achieving the expected benefits of virologic suppression prevention acquisition, respectively. has experienced worsening social inequalities, exacerbated by COVID-19 pandemic, leading increases in food insecurity especially among vulnerable populations. We explored whether mediated association socio-economic status on adherence ART/PrEP. Adult men who have sex (MSM) transgender non-binary persons (TGNB) (May-September/2021) voluntarily participated a cross-sectional online study advertised dating apps media. Participants reporting use participants HIV-negative daily were eligible analysis. Self-report was measured WebAd-Q instrument (3-items/past week) plus visual analogue scale. number days person took past week. The 8-item Brazilian Scale Food Insecurity (EBIA) used measure (higher scores indicate more severe insecurity). Two structural equation models assess direct indirect effects variables PLWH using PrEP. In total, 1230 ART, 991 individuals median age 37 years (HIV negative: 34 years), most cismen (98%). More reported moderate/severe (21.7%; 12.9%). (measured WebAd-Q, 7 days) 55.7% (PrEP adherence: 93.3%). two models, had an effect that insecurity: higher associated lower insecurity, adherence. Our findings suggest provision support could help at vulnerability acquisition improving their or PrEP, ultimately populations decreased transmissions.

Language: Английский

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Profiles of Willingness to Use Pre-Exposure Prophylaxis Modalities among Brazilian, Mexican and Peruvian Sexual and Gender Minorities: A Cross-Sectional Online Survey (Preprint)

Published: April 12, 2025

Despite recent advances, pre-exposure prophylaxis (PrEP) scale-up remains slow in Latin America. Understanding PrEP modality preferences can help design effective implementation. The aim of this study was to describe willingness use different modalities among sexual and gender minorities (SGM) aged 18+ years from Brazil, Mexico Peru, factors associated with four modalities. We conducted a cross-sectional online survey 2021. used multivariate Poisson regression estimate prevalence ratios, identifying differences daily oral, event-driven monthly oral bimonthly injectable PrEP. Models for each were adjusted age, country, race, education, income, HIV risk score, testing, perception. Among 27,589 individuals who initiated the survey, 16,951 included (Brazil: 61.3%; Mexico: 29.5%; Peru: 9.3%). Mean age 32 years, 67.8% had more than secondary education. Most respondents willing (74.4%), (65.8%), (60.2%), while only 38.0% Across modalities, higher those increased perception high exposure. Willingness lower Peruvian all except Participants education Our results suggest preference long-acting formulations SGM Further research is needed address gaps understanding prevention guide potential users selecting most suitable available.

Language: Английский

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Baseline variables associated with subsequent HIV seroconversion among gay, bisexual and other men who have sex with men and transgender women: a prospective, multicenter PrEP demonstration study (ImPrEP)

The Lancet Regional Health - Americas, Journal Year: 2025, Volume and Issue: 46, P. 101098 - 101098

Published: April 25, 2025

Language: Английский

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The rising tide of HIV among young men who have sex with men in Brazil: insights from the Conectad@s study

The Lancet Regional Health - Americas, Journal Year: 2024, Volume and Issue: 36, P. 100798 - 100798

Published: June 15, 2024

Young gay, bisexual, and other men who have sex with (YMSM) in Latin America experience disproportionately high rates of HIV. While new case numbers stabilised demographics, the incidence HIV this particular group continues to rise. We estimated prevalence sexually transmitted infections (STI) identified correlates diagnoses among YMSM Brazil.

Language: Английский

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Preparing for the Implementation of Long-Acting Injectable Cabotegravir for HIV Pre-Exposure Prophylaxis Within the Brazilian Public Health System (ImPrEP CAB Brasil): Qualitative Study

JMIR Public Health and Surveillance, Journal Year: 2024, Volume and Issue: 10, P. e60961 - e60961

Published: Oct. 24, 2024

Background Although long-acting, injectable cabotegravir (CAB-LA) pre-exposure prophylaxis (PrEP) has proven efficacious for HIV prevention in clinical trials, research is needed to guide effective implementation real-world settings. Formative work with community members and health care providers (HCPs) important provide insight into the needs contexts of specific populations reveal potential barriers facilitators projects. Objective We aimed describe results from formative develop an package CAB-LA PrEP within ImPrEP CAB Brasil study. Methods study same-day delivery young sexual gender minority (SGM) groups (aged 18-30 years) 6 existing oral public clinics. conducted prepare through mobilization, process mapping HCPs experience CAB-LA, focus group discussions (FGDs) SGM (n=92) (n=20) identify initial perceptions implementation, refine mobile (mHealth) educational tool, evaluate acceptability using a text message appointment reminder intervention WhatsApp. FGDs were recorded, transcribed, systematically coded, analyzed thematic categorization by trained researchers qualitative data analysis program ATLAS.ti (version 7). Results A mobilization team comprising 34 leaders collaborated creating prototype mHealth tool contributed planning peer education activities. created 3 maps each site visit, follow-up visits, laboratory flow. The main challenge identified was extended duration clinic visits due numerous tests counseling steps required. Proposed solutions included having point-of-care rapid instead additional staff. Barriers training HCPs, support adherence injection appointments, stigma or discrimination against persons PrEP. WhatsApp reminders highly acceptable indicating their choice adherence. Content on cultural appropriateness language overall clarity material refinement tool. Conclusions Structured generated refinements context-specific materials plans launch Ongoing monitoring will use Summative evaluations are measure effectiveness reminders.

Language: Английский

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Preparing for implementation of long-acting injectable cabotegravir for HIV pre-exposure prophylaxis within the Brazilian public health system: The ImPrEP CAB Brasil Study

Research Square (Research Square), Journal Year: 2023, Volume and Issue: unknown

Published: Nov. 20, 2023

Abstract Introduction Although long-acting injectable cabotegravir (CAB-LA) PrEP has proven efficacious for HIV prevention in clinical trials, additional research is needed to guide effective implementation real world settings. Methods ImPrEP CAB-Brasil an study of same-day delivery CAB-LA young sexual and gender minorities (SGM; aged 18-30 years) six existing oral public health clinics. We conducted formative prepare the through (1) community mobilization; (2) process mapping; (3) focus group discussions with SGM (N=92) professionals (N=20) identify facilitators barriers request feedback on mHealth education decision support tool WhatsApp appointment reminder intervention. Results Community mobilization team collaborated developing prototype materials intervention PrEP-user making, participated protocol training sessions, contributed planning peer activities. created three maps each site describe initial visit, follow-up visits laboratory flow. The main challenge identified was duration clinic due a high number counseling steps necessary. Proposed solutions included point-of-care rapid tests (with training) instead addition more staff perform counseling. Identified professionals, creating stigma-free environment, ensuring adherence injection appointments. educational video messages showed acceptability by both providers. Content analysis appropriateness language overall clarity material refinement component. Conclusions Structured work members providers generated important refinements context-specific plans launch Continuous monitoring mapped processes will help further delivery. Summative evaluations are measure effectiveness reminders. Trial Registration ClinicalTrials.gov NCT05515770 (29-AUG-2022)

Language: Английский

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