RICARDO DE PAULA VASCONCELOS
Projetos de Pesquisa
Unidades Organizacionais
LIM/52 - Laboratório de Virologia, Hospital das Clínicas, Faculdade de Medicina
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- 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(2017) HOAGLAND, Brenda; MOREIRA, Ronaldo I.; BONI, Raquel B. De; KALLAS, Esper G.; MADRUGA, Jose Valdez; VASCONCELOS, Ricardo; GOULART, Silvia; TORRES, Thiago S.; MARINS, Luana M. S.; ANDERSON, Peter L.; LUZ, Paula M.; LEITE, Iuri da Costa; LIU, Albert Y.; VELOSO, Valdilea G.; GRINSZTEJN, BeatrizIntroduction: 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 Sao 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.
- Retention, engagement, and adherence to pre-exposure prophylaxis for men who have sex with men and transgender women in PrEP Brasil: 48 week results of a demonstration study(2018) GRINSZTEJN, Beatriz; HOAGLAND, Brenda; MOREIRA, Ronaldo I.; KALLAS, Esper G.; MADRUGA, Jose V.; GOULART, Silvia; LEITE, Iuri C.; FREITAS, Lucilene; MARTINS, Luana M. S.; TORRES, Thiago S.; VASCONCELOS, Ricardo; BONI, Raquel B. De; ANDERSON, Peter L.; LIU, Albert; LUZ, Paula M.; VELOSO, Valdilea G.Background PrEP Brasil was a demonstration study to assess feasibility of daily oral tenofovir diphosphate disoproxil fumarate plus emtricitabine provided at no cost to men who have sex with men (MSM) and transgender women at high risk for HIV within the Brazilian public health system. We report week 48 pre-exposure prophylaxis (PrEP) retention, engagement, and adherence, trends in sexual behaviour, and incidence of HIV and sexually transmitted infections in this study cohort. Methods PrEP Brasil was a 48 week, open-label, demonstration study that assessed PrEP delivery at three referral centres for HIV prevention and care in Rio de Janeiro, Brazil (Fundacao Oswaldo Cruz), and Sao Paulo, Brazil (Universidade de Sao Paulo and Centro de Referencia e Treinamento em DST e AIDS). Eligible participants were MSM and transgender women who were HIV negative, aged at least 18 years, resident in Rio de Janeiro or Sao Paulo, and reported one or more sexual risk criteria in the previous 12 months (eg, condomless anal sex with two or more partners, two or more episodes of anal sex with an HIV-infected partner, or history of sexually transmitted infection [STI] diagnosis). Participants were seen at weeks 4, 12, 24, 36, and 48 for PrEP provision, clinical and laboratory evaluation, and HIV testing. Computer-assisted self-interviews were also done at study visits 12, 24, 36, and 48, and assessed sexual behaviour and drug use. PrEP retention was defined by attendance at the week 48 visit, PrEP engagement was an ordinal five-level variable combining presence at the study visit and drug concentrations, and PrEP adherence was evaluated by measuring tenofovir diphosphate concentrations in dried blood spots. Logistic regression models were used to quantify the association of variables with high adherence (>= 4 doses per week). The study is registered with ClinicalTrials. gov, number NCT01989611. Findings Between April 1, 2014, and July 8, 2016, 450 participants initiated PrEP, 375 (83%) of whom were retained until week 48. At week 48, 277 (74%) of 375 participants had protective drug concentrations consistent with at least four doses per week: 183 (82%) of 222 participants from Sao Paulo compared with 94 (63%) of 150 participants from Rio de Janeiro (adjusted odds ratio 1.88, 95% CI 1.06-3.34); 119 (80%) of 148 participants who reported sex with HIV-infected partners compared with 158 (70%) of 227 participants who did not (1.78, 1.03-3.08); 67 (87%) of 77 participants who used stimulants compared with 210 (71%) of 298 participants who did not (2.23, 1.02-4.92); and 232 (80%) of 289 participants who had protective concentrations of tenofovir disphosphate at week 4 compared with 42 (54%) of 78 participants who did not (3.28, 1.85-5.80). Overall, receptive anal sex with the last three partners increased from 45% at enrolment to 49% at week 48 (p=0.17), and the mean number of sexual partners in the previous 3 months decreased from 11.4 (SD 28.94) at enrolment to 8.3 (19.55) at week 48 (p<0.0013). Two individuals seroconverted during follow-up (HIV incidence 0.51 per 100 person-years, 95% CI 0.13-2.06); both of these patients had undetectable tenofovir concentrations at seroconversion. Interpretation Our results support the effectiveness and feasibility of PrEP in a real-world setting. Offering PrEP at public health-care clinics in a middle-income setting can retain high numbers of participants and achieve high levels of adherence without risk compensation in the investigated populations.
- High pre-exposure prophylaxis uptake and early adherence among men who have sex with men and trans-gender women at risk for HIV Infection: the PrEP Brasil demonstration project (vol 20, 21472, 2017)(2018) HOAGLAND, Brenda; MOREIRA, Ronaldo I.; BONI, Raquel B. De; KALLAS, Esper G.; MADRUGA, Jose Valdez; VASCONCELOS, Ricardo; GOULART, Silvia; TORRES, Thiago S.; MARINS, Luana M. S.; ANDERSON, Peter L.; LUZ, Paula M.; LEITE, Iuri da Costa; LIU, Albert Y.; VELOSO, Valdilea G.; GRINSZTEJN, Beatriz
- Asymptomatic anorectal Chlamydia trachomatis and Neisseria gonorrhoeae infections are associated with systemic CD8(+) T-cell activation(2017) VIEIRA, Vinicius A.; AVELINO-SILVA, Vivian I.; CERQUEIRA, Natalia B.; COSTA, Dayane A.; COSTA, Priscilla R.; VASCONCELOS, Ricardo P.; MADRUGA, Valdez R.; MOREIRA, Ronaldo I.; HOAGLAND, Brenda; VELOSO, Valdilea G.; GRINSZTEJN, Beatriz; KALLAS, Esper G.Background: Oral preexposure prophylaxis (PrEP) has been established as a pivotal strategy in HIV prevention. However, bacterial sexually transmitted infections (STIs), such as Chlamydia trachomatis and Neisseria gonorrhoeae, are also highly prevalent. Although the presence of STI-related mucosal lesions is a known risk factor for HIV acquisition, the potential increase in risk associated with asymptomatic STIs is not completely understood. Recent data demonstrated higher T-cell activation is a risk factor for sexually acquired HIV-1 infection. We examined the effect of asymptomatic C. trachomatis and N. gonorrhoeae anorectal infection on systemic immune activation, potentially increasing the risk of HIV acquisition. Methods: We analyzed samples from participants of PrEP Brasil, a demonstration study of daily oral emtricitabine/tenofovir disoproxil fumarate HIV PrEP among healthy MSM, for T-cell activation by flow cytometry. We included 34 asymptomatic participants with anorectal swab for C. trachomatis and/or N. gonorrhoeae infection, whereas negative for other STIs, and 35 controls. Results: We found a higher frequency of human leukocyte antigen DR(+)CD3(+)CD8(+)T cells (1.5 vs. 0.9%, P<0.005) and with memory phenotype in the group with asymptomatic C. trachomatis and/or N. gonorrhoeae infection. Exhaustion and senescence markers were also significant higher in this group. No difference was observed in the soluble CD14 levels. Conclusion: Our findings suggest asymptomatic anorectal C. trachomatis and/or N. gonorrhoeae increase systemic immune activation, potentially increasing the risk of HIV acquisition. Regular screening and treatment of asymptomatic STIs should be explored as adjuvant tools for HIV prevention.