Same-day initiation of oral pre-exposure prophylaxis among gay, bisexual, and other cisgender men who have sex with men and transgender women in Brazil, Mexico, and Peru (ImPrEP): a prospective, single-arm, open-label, multicentre implementation study.

BACKGROUND: Although gay, bisexual, and other cisgender men who have sex with men (MSM) and transgender women have the highest HIV burden in Latin America, pre-exposure prophylaxis (PrEP) implementation is poor. We aimed to assess the feasibility of same-day oral PrEP delivery in Brazil, Mexico, and Peru. METHODS: Implementation PrEP (ImPrEP) was a prospective, single-arm, open-label, multicentre PrEP implementation study conducted in Brazil (14 sites), Mexico (four sites), and Peru (ten sites). MSM and transgender women were eligible to participate if they were aged 18 years or older, HIV-negative, and reported one or more prespecified criteria. Enrolled participants received same-day initiation of daily oral PrEP (tenofovir disoproxil fumarate [300 mg] coformulated with emtricitabine [200 mg]). Follow-up visits were scheduled at week 4 and quarterly thereafter. We used logistic regression models to identify factors associated with early loss to follow-up (not returning after enrolment), PrEP adherence (medication possession ratio ≥0·6), and long-term PrEP engagement (attending three or more visits within 52 weeks). This study is registered at the Brazilian Registry of Clinical Trials, U1111-1217-6021. FINDINGS: From Feb 6, 2018, to June 30, 2021, 9979 participants were screened and 9509 were enrolled (Brazil n=3928, Mexico n=3288, and Peru n=2293). 543 (5·7%) participants were transgender women, 8966 (94·3%) were cisgender men, and 2481 (26·1%) were aged 18-24 years. There were 12 185·25 person-years of follow-up. 795 (8·4%) of 9509 participants had early loss to follow-up, 6477 (68·1%) of 9509 were adherent to PrEP, and 5783 (70·3%) of 8225 had long-term PrEP engagement. Transgender women (adjusted odds ratio 1·60, 95% CI 1·20-2·14), participants aged 18-24 years (1·80, 1·49-2·18), and participants with primary education (2·18, 1·29-3·68) had increased odds of early loss to follow-up. Transgender women (0·56, 0·46-0·70), participants aged 18-24 years (0·52, 0·46-0·58), and those with primary education (0·60, 0·40-0·91) had lower odds of PrEP adherence. Transgender women (0·56, 0·45-0·71), participants aged 18-24 years (0·56, 0·49-0·64), and those with secondary education (0·74, 0·68-0·86) had lower odds of long-term PrEP engagement. HIV incidence was 0·85 per 100 person-years (95% CI 0·70-1·03) and was higher for transgender women, participants from Peru, those aged 18-24 years, Black and mixed-race participants, and participants who were non-adherent to PrEP. INTERPRETATION: Same-day oral PrEP is feasible for MSM and transgender women in Latin America. Social and structural determinants of HIV vulnerability need to be addressed to fully achieve the benefits of PrEP. FUNDING: Unitaid, WHO, and Ministries of Health in Brazil, Mexico, and Peru. TRANSLATIONS: For the Portuguese and Spanish translations of the abstract see Supplementary Materials section

Performance of HIV pre-exposure prophylaxis indirect adherence measures among men who have sex with men and transgender women: Results from the PrEP Brasil Study.

IntroductionEfficacy of daily emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) for PrEP is strongly dependent on the adherence. We examined the concordance between indirect adherence measures and protective drug levels among participants retained through 48 weeks in the PrEP Brasil Study.MethodsPrEP Brasil was a prospective, multicenter, open-label demonstration project evaluating PrEP provision for men who have sex with men (MSM) and transgender women (TGW) at higher risk for HIV infection within the setting of Brazilian Public Health System. Three indirect adherence measures were obtained at week 48: medication possession ratio (MPR), pill count and self-report (30-days recall). Tenofovir diphosphate (TFV-DP) concentration in Dried Blood Spot (DBS) was measured at week 48. Areas under (AUC) the receiver operating characteristics (ROC) curve were used to evaluate the concordance between achieving protective drug levels (TFV-DP≥700fmol/punch) and the indirect adherence measures. Youden's index and distance to corner were used to determine the optimal cutoff points for each indirect adherence measure. We calculated sensitivity, specificity, negative (NPV) and positive (PPV) predictive values for the found cutoff points. Finally, Delong test was used to compare AUCs.Results and discussionFrom April, 2014 to July, 2016, 450 participants initiated PrEP, 375(83.3%) were retained through 48 weeks. Of these, 74% (277/375) had TFV-DP ≥700fmol/punch. All adherence measures discriminated between participants with and without protective drug levels (AUC>0.5). High indirect adherence measure was predictive of protective drug levels (PPV>0.8) while low indirect adherence measure was not predictive of lack of protective drug levels (NPVConclusionsLow-burden measurements such as MPR and self-report can be used to predict PrEP adherence in a public health context in Brazil for MSM and TGW retained through 48 weeks. Clinical Trial Number: NCT01989611

High pre-exposure prophylaxis uptake and early adherence among men who have sex with men and transgender women at risk for HIV Infection: the PrEP Brasil demonstration project

Submitted by Fábio Marques ([email protected]) on 2018-03-23T16:18:41Z No. of bitstreams: 1 ve_Brenda_Hoagland_etal_INI_Lapclin_2017.pdf: 574693 bytes, checksum: 20ff4d29c13be82fa4c627eb0091d518 (MD5)Approved for entry into archive by Raquel Dinelis ([email protected]) on 2018-04-12T14:49:49Z (GMT) No. of bitstreams: 1 ve_Brenda_Hoagland_etal_INI_Lapclin_2017.pdf: 574693 bytes, checksum: 20ff4d29c13be82fa4c627eb0091d518 (MD5)Made available in DSpace on 2018-04-12T14:49:49Z (GMT). No. of bitstreams: 1 ve_Brenda_Hoagland_etal_INI_Lapclin_2017.pdf: 574693 bytes, checksum: 20ff4d29c13be82fa4c627eb0091d518 (MD5) Previous issue date: 2017Fundação Oswaldo Cruz.Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz.Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz.Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.School of Medicine, Universidade de São Paulo, Brazil.School of Medicine, Universidade de São Paulo, São Paulo, Brazil.School of Medicine, Universidade de São Paulo, Brazil.School of Medicine, Universidade de São Paulo, São Paulo, Brazil.Fundação Oswaldo Cruz.Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz.Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Denver, Aurora, CO, USA.Fundação Oswaldo Cruz.Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz.Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.San Francisco Department of Public Health, Bridge HIV, San Francisco, CA, USA.Fundação Oswaldo Cruz.Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz.Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Introduction: The efficacy of pre-exposure prophylaxis (PrEP) in preventing sexual acquisition of human immunodeficiency virus (HIV) is well established. Little is known about the feasibility of PrEP implementation in middle-income settings with concentrated epidemics among men who have sex with men (MSM) and transgender women (TGW). Methods: PrEP Brasil is a prospective, multicentre, open-label demonstration project assessing PrEP delivery in the context of the Brazilian Public Health System. HIV-uninfected MSM and TGW in 3 referral centres in Rio de Janeiro and São Paulo were evaluated for eligibility and offered 48 weeks of daily emtricitabine/tenofovir for PrEP. Concentrations of tenofovir diphosphate in dried blood spot samples (DBS) at week 4 after enrolment (early adherence) were measured. Predictors of drug levels were assessed using ordinal logistic regression models considering the DBS drug level as a 3 level variable (<350 fmol/ punch, ≥350–699 fmol/punch and ≥700 fmol/punch). Results: 1,270 individuals were assessed for participation; n = 738 were potentially eligible and n = 450 were offered PrEP (PrEP uptake was 60.9%). Eligible but not enrolled individuals were younger, had lower HIV risk perception and had lower PrEP awareness. At week 4, 424 participants (of the 450 enrolled) had DBS TFV-DP concentrations, 94.1% in the protective range (≥350 fmol/punch, consistent with ≥2 pills per week), and 78% were in the highly protective range (≥700 fmol/punch, ≥4 pills per week). Participants with ≥12 years of schooling had 1.9 times the odds (95%CI 1.10–3.29) of a higher versus lower drug level than participants with <12 years of schooling. Condomless receptive anal intercourse in the prior 3 months was also associated with higher drug levels (adjusted OR = 1.78; 95% CI 1.08–2.94). Conclusions: The high uptake and early adherence indicate that PrEP for high-risk MSM and TGW can be successfully delivered in the context of the Brazilian Public Health System. Interventions to address disparities on PrEP awareness and HIV risk perception among the younger and less educated are urgently needed in order to maximize the impact of this prevention strategy on the reduction of HIV infection among MSM and TGW in Brazil

PERFIL DE PACIENTES EM USO DE TERAPIA DUPLA COM DOLUTEGRAVIR E LAMIVUDINA, COORTE RETROSPECTIVA DE VIDA REAL

Introdução: O uso a longo prazo dos antirretrovirais (ARVs) e suas toxicidades são um desafio no atual manejo de pessoas vivendo com HIV/aids (PVHA). Com ARVs mais potentes e com maior barreira genética, a terapia dupla (TD) está atualmente recomendada em várias situações. Métodos: Análise retrospectiva realizada até agosto/2022 em PVHA atendidas no CRT DST/AIDS, São Paulo, utilizando TD baseada em Dolutegravir (DTG) 50 mg + Lamivudina (3TC) 300 mg ≥ 365 dias. Dados foram capturados dos prontuários e inseridos na plataforma REDCAP juntamente a verificação de dispensas de ARVs pelo Sistema de Controle Logístico de Medicamentos (SICLOM). Resultados: Em um total 8849 pacientes ativos na instituição, identificamos 383 elegíveis à inclusão e análise. Características da população: homem cisgênero 294 (76,1%), brancos 284 (74,1%), ensino superior completo 171 (44,6%), mediana de idade 56,9 anos, mediana de idade no diagnóstico 38 anos, tempo médio de infecção pelo HIV 16,9 anos, contagem linfócitos TCD4 >500 células 315 (82,2%). Identificamos 9 óbitos (2 doença cardiovascular, 2 COVID-19 e 5 sem dados), 371 vivos em seguimento e 3 sem dados. Em relação aos ARVs: tempo médio de exposição 13,5 anos, número médio de esquemas prévios 3,1 (1 naive, 249 um a três esquemas e 133 quatro ou mais), exposição prévia aos Inibidores de Integrase 218 (56,9%). Principais esquemas prévios a TD: Tenofovir (TDF) + 3TC + DTG 166 (43%), Abacavir (ABC) + 3TC + DTG 44 (11,4%), Zidovudina (AZT) + 3TC + DTG 32 (8,3%), TDF + 3TC + Efavirenz (EFZ) 30 (7,8%), ABC + 3TC + EFZ 29 (7,5%) e 82 outros esquemas. Principais razões para TD: comorbidade óssea 110, comorbidade renal 95, conveniência posológica 82, comorbidade cardiovascular 44, outros eventos adversos 40 (lipodistrofia, elevação de transaminases e dislipidemia) e 54 (14%) sem dados. Identificamos pacientes com mais de uma razão. Em relação a manutenção da TD: 371 (96,9%) mantiveram uso, 8 trocas de esquema (2 falhas virológicas, 1 otimização de TARV após blip sem confirmação de falha, 1 presença de M184V em genotipagem prévia e 4 motivos clínicos) e 4 sem dados. Tempo médio de uso de TD no momento da análise 2,4 anos. Não foi possível avaliar ausência de falha virológica prévia em toda população. Conclusão: Uso de TD com Dolutegravir e Lamivudina, pode ser uma opção segura em PVHA em supressão viral, em uso de terapia antirretroviral há vários anos, sem falha virológica prévia

Recent HIV infection and annualized HIV incidence rates among sexual and gender minorities in Brazil and Peru (ImPrEP seroincidence study): a cross-sectional, multicenter studyResearch in context

Summary: Background: HIV incidence estimation is critical for monitoring the HIV epidemic dynamics and the effectiveness of public health prevention interventions. We aimed to identify sexual and gender minorities (SGM) with recent HIV infections, factors associated with recent HIV infection, and to estimate annualised HIV incidence rates. Methods: Cross-sectional multicentre study in HIV testing services in Brazil and Peru (15 cities). Inclusion criteria: 18+ years, SGM assigned male at birth, not using pre-/post-exposure prophylaxis. We identified recent HIV infection using the Maxim HIV-1 LAg-Avidity EIA assay as part of a recent infection testing algorithm (RITA). Annualized HIV incidence was calculated using the UNAIDS/WHO incidence estimator tool. Multivariable logistic regression models were used to estimate factors associated with recent HIV infection. Trial registration: NCT05674682. Findings: From 31-Jan-2021 to 29-May-2022, 6899 individuals participated [Brazil: 4586 (66.5%); Peru: 2313 (33.5%)]; 5946 (86.2%) cisgender men, 751 (10.9%) transgender women and 202 (2.9%) non-binary/gender diverse. Median age was 27 (IQR: 23–34) years. HIV prevalence was 11.4% (N = 784/6899); 137 (2.0%) SGM were identified with recent HIV infection. The overall annualized HIV incidence rate was 3.88% (95% CI: 2.86–4.87); Brazil: 2.62% (95% CI: 1.78–3.43); Peru: 6.69% (95% CI: 4.62–8.69). Participants aged 18–24 years had higher odds of recent HIV infection compared to those aged 30+ years in both countries. Interpretation: Our results highlight the significant burden of HIV epidemic among SGM in large urban centres of Brazil and Peru. Public health policies and interventions to increase access to effective HIV prevention methods such as PrEP are urgently needed in Latin America. Funding: Unitaid, WHO (Switzerland), Ministry of Health from Brazil and Peru