Browsing by Author "Coelho, Lara"

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    Cabotegravir for HIV Prevention in Cisgender Men and Transgender Women
    (2021-08) Landovitz, Raphael; Donnell, Deborah J.; Clement, Meredith; Hanscom, Brett; Cottle, Leslie; Coelho, Lara; Cabello, Robinson; Chariyalertsak, Suwat; Dunne, Eileen F.; Frank, Ian; Gallardo-Cartagena, Jorge A.; Gaur, Aditya H.; Gonzales, Pedro; Tran, Ha V.; Hinojosa, Juan C.; Kallas, Esper; Kelley, Colleen F.; Losso, Marcelo H.; Valdez Madruga, J.; Middelkoop, Keren; Phanuphak, Nittaya; Santos, Breno R.; Sued, Omar; Valencia Huamaní, Javier; Overton, Edgar T.; Swaminathan, Shobha; del Rio, Carlos; Gulick, Roy M.; Richardson, Paul; Sullivan, Philip; Piwowar-Manning, Estelle M.; Marzinke, Mark; Hendrix, Craig; Li, Maoji; Wang, Zhe; Marrazzo, Jeanne; Daar, Eric; Asmelash, Aida; Brown, Todd T.; Anderson, Peter; Eshleman, Susan H.; Bryan, Marcus; Blanchette, Cheryl; Lucas, Jonathan; Psaros, Christina; Safren, Steven A.; Sugarman, Jeremy; Scott, Hyman; Eron, Joseph; Fields, Sheldon D.; Sista, Nirupama D.; Gomez, Kailazarid; Jennings, Andrea; Kofron, Ryan M.; Holtz, Timothy H.; Shin, Katherine; Rooney, James F.; Smith, Kimberly; Spreen, William; Margolis, David; Rinehart, Alex; Adeyeye, Adeola; Cohen, Myron; McCauley, Marybeth; Grinsztejn, Beatriz
    BACKGROUND Safe and effective long-acting injectable agents for preexposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) infection are needed to increase the options for preventing HIV infection. METHODS We conducted a randomized, double-blind, double-dummy, noninferiority trial to compare long-acting injectable cabotegravir (CAB-LA, an integrase strand-transfer inhibitor [INSTI]) at a dose of 600 mg, given intramuscularly every 8 weeks, with daily oral tenofovir disoproxil fumarate–emtricitabine (TDF–FTC) for the prevention of HIV infection in at-risk cisgender men who have sex with men (MSM) and in at-risk transgender women who have sex with men. Participants were randomly assigned (1:1) to receive one of the two regimens and were followed for 153 weeks. HIV testing and safety evaluations were performed. The primary end point was incident HIV infection. RESULTS The intention-to-treat population included 4566 participants who underwent randomization; 570 (12.5%) identified as transgender women, and the median age was 26 years (interquartile range, 22 to 32). The trial was stopped early for efficacy on review of the results of the first preplanned interim end-point analysis. Among 1698 participants from the United States, 845 (49.8%) identified as Black. Incident HIV infection occurred in 52 participants: 13 in the cabotegravir group (incidence, 0.41 per 100 person-years) and 39 in the TDF–FTC group (incidence, 1.22 per 100 person-years) (hazard ratio, 0.34; 95% confidence interval, 0.18 to 0.62). The effect was consistent across prespecified subgroups. Injection-site reactions were reported in 81.4% of the participants in the cabotegravir group and in 31.3% of those in the TDF–FTC group. In the participants in whom HIV infection was diagnosed after exposure to CAB-LA, INSTI resistance and delays in the detection of HIV infection were noted. No safety concerns were identified. CONCLUSIONS CAB-LA was superior to daily oral TDF–FTC in preventing HIV infection among MSM and transgender women. Strategies are needed to prevent INSTI resistance in cases of CAB-LA PrEP failure. (Funded by the National Institute of Allergy and Infectious Diseases and others; HPTN 083 ClinicalTrials.gov number, NCT02720094.)
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    Early Retention in Care Neither Mediates Nor Modifies the Effect of Sex and Sexual Mode of HIV Acquisition on HIV Survival in the Americas
    (https://doi.org/10.1089/apc.2018.0028, 2018-08-01) Coelho, Lara; Rebeiro, Peter F; Castilho, Jessica L; Caro-Vega, Yanink; Mejia, Fernando A; Cesar, Carina; Cortes, Claudia; Padgett, Denis; McGowan, Catherine C; Veloso, Valdiléa G; Sterling, Timothy R; Grinsztejn, Beatriz; Shepherd, Bryan E; Luz, Paula M; for the CCASAnet
    Early retention in care, sex, and sexual mode of HIV acquisition has been associated with mortality risk among persons living with HIV (PLWH). We assessed whether early retention in care mediates or modifies the association between mortality and sex and sexual mode of HIV acquisition among PLWH on antiretroviral therapy (ART) in the Americas. ART-naïve, adult PLWH (≥18 years) enrolling at Caribbean, Central and South America network for HIV epidemiology (CCASAnet) and Vanderbilt Comprehensive Care Clinic sites 2000–2015, starting ART, and with ≥1 visit after ART-start were included. Early retention in care was defined as ≥2 HIV care visits/labs ≥90 days apart in the first year of ART. Cox models assessed the association between early retention in care, sex, and sexual mode of HIV acquisition [i.e., women, heterosexual men and men who have sex with men (MSM)], and mortality. Associations were estimated separately by site and pooled. Among 11,721 included PLWH (median follow-up, 4.3 years; interquartile range, 2.0–7.6), 647 died (rate = 10.9/1000 person-years) and 1985 were lost to follow-up (rate = 33.6/1000 person-years). After adjustment for confounders, early retention in care was associated with lower mortality during subsequent years (pooled hazard ratio = 0.47; 95% confidence interval = 0.39–0.57). MSM had lower and heterosexual men had comparable mortality risk to women; risks were similar when adjusting for early retention in care. Additionally, no evidence of an interaction between early retention in care and sex and sexual mode of HIV acquisition on mortality was observed (p > 0.05). Early retention in care substantially reduced mortality but does not mediate or modify the association between sex and sexual mode of HIV acquisition and mortality in our population.