| Author | Marins, Luana M. S. | |
| Author | Torres, Thiago S. | |
| Author | Leite, Iuri da C. | |
| Author | Moreira, Ronaldo I. | |
| Author | Luz, Paula M. | |
| Author | Hoagland, Brenda | |
| Author | Kallas, Esper G. | |
| Author | Madruga, José Valdez | |
| Author | Liu, Albert Y. | |
| Author | Anderson, Peter L. | |
| Author | Grinsztejn, Beatriz | |
| Author | Veloso, Valdiléa G. | |
| Access date | 2019-09-12T15:25:28Z | |
| Available date | 2019-09-12T15:25:28Z | |
| Document date | 2019 | |
| Citation | MARINS, Luana M. S. et al. 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. Plos One, v. 14, n. 8, p. 1-12, Aug. 2019. | pt_BR |
| ISSN | 1932-6203 | pt_BR |
| URI | https://www.arca.fiocruz.br/handle/icict/35531 | |
| Sponsorship | This study was sponsored by the Brazilian Ministry of Health (Brasília, Brazil; #01/2013 BRA/K57), Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq; #402004/2012-4, #454931/2014-0), Secretaria de Vigilância em Saúde (SVS; #281/2013), Fundação Carlos Chagas Filho de Amparo à Pesquisa do Estado do Rio de Janeiro (FAPERJ; #E-26/110.261/2014), and Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP; #2012/51743-0). BG and PML are funded by the CNPq and FAPERJ. EGK is funded by FAPESP. Gilead Sciences donated the study drug and covered costs related to drug concentration assessment but had no role in study design, collection, analysis and interpretation of data, writing of the manuscript, or the decision to submit the manuscript for publication. | |
| Language | eng | pt_BR |
| Publisher | Public Library of Science | pt_BR |
| Rights | open access | pt_BR |
| Title | 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 | en |
| Type | Article | pt_BR |
| DOI | 10.1371/journal.pone.0221281 | |
| Abstract | Introduction: Efficacy 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. Methods: PrEP 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 discussion: From 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 (NPV<0.5). No significant differences were found between the adherence methods (p = 0.44). Conclusions: Low-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. | en |
| Affilliation | Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil. | pt_BR |
| Affilliation | Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil. | pt_BR |
| Affilliation | Fundação Oswaldo Cruz. Escola Nacional de Saúde Pública Sergio Arouca. Rio de Janeiro, RJ, Brasil. | pt_BR |
| Affilliation | Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil. | pt_BR |
| Affilliation | Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil. | pt_BR |
| Affilliation | Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil. | pt_BR |
| Affilliation | Universidade de São Paulo. Escola de Medicina. São Paulo, SP, Brasil. | pt_BR |
| Affilliation | Centro de Referência e Treinamento em DST/AIDS. São Paulo, SP, Brasil. | pt_BR |
| Affilliation | San Francisco Department of Public Health. Bridge HIV. San Francisco, CA, USA. | pt_BR |
| Affilliation | University of Colorado. Skaggs School of Pharmacy and Pharmaceutical Sciences. Aurora, CO, USA. | pt_BR |
| Affilliation | Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil. | pt_BR |
| Affilliation | Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil. | pt_BR |
| Subject | HIV | en |
| Subject | PrEP | en |
| Subject | Men who have sex with men | |
| e-ISSN | 1932-6203 | |
| xmlui.metadata.dc.subject.ods | 05 Igualdade de gênero | |
