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Clinical Trial
. 2023 Jan 20;18(1):e0279996.
doi: 10.1371/journal.pone.0279996. eCollection 2023.

Retention among transgender women treated with dolutegravir associated with tenofovir/lamivudine or emtricitabine in Argentina: TransViiV study

Claudia E Frola  1   2 , Inés Aristegui  1   3 , María I Figueroa  1 , Pablo D Radusky  1   4 , Nadir Cardozo  1   5 , Virginia Zalazar  1 , Carina Cesar  1 , Patricia Patterson  1 , Valeria Fink  1 , Ana Gun  1 , Pedro Cahn  1 , Omar Sued  1
Affiliations
Clinical Trial

Retention among transgender women treated with dolutegravir associated with tenofovir/lamivudine or emtricitabine in Argentina: TransViiV study

Claudia E Frola et al. PLoS One. .

Abstract

In Argentina, transgender women (TGW) have a high HIV prevalence (34%). However, this population shows lower levels of adherence, retention in HIV care and viral suppression than cisgender patients. The World Health Organization (WHO) recommends the transition to dolutegravir (DTG)-based regimens to reduce adverse events and improve adherence and retention. The purpose of this study was to determine retention, adherence and viral suppression in naïve TGW starting a DTG-based first-line antiretroviral treatment (ART) and to identify clinical and psychosocial factors associated with retention. We designed a prospective, open-label, single-arm trial among ART-naïve HIV positive TGW (Clinical Trial Number: NCT03033836). Participants were followed at weeks 4, 8, 12, 24, 36 and 48, in a trans-affirmative HIV care service that included peer navigators, between December, 2015 and May, 2019. Retention was defined as the proportion of TGW retained at week 48 and adherence was self-reported. Viral suppression at <50 copies/mL was evaluated using snapshot algorithm and as per protocol analysis. Of 75 TGW screened, 61 were enrolled. At baseline, median age was 28 y/o., HIV-1-RNA (pVL) 46,908 copies/mL and CD4+ T-cell count 383 cells/mm3. At week 48, 77% were retained and 72% had viral suppression (97% per protocol). The regimen was well tolerated and participants reported high adherence (about 95%). Eleven of the fourteen TGW who discontinued or were lost to follow-up had undetectable pVL at their last visit. Older age was associated with better retention. DTG-based treatment delivered by a trans-competent team in a trans-affirmative service was safe and well tolerated by TGW and associated with high retention, high adherence and high viral suppression at 48 weeks among those being retained.

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Conflict of interest statement

Co-author Omar Sued is a PLOS ONE Editorial Board member. However, does not alter the authors’ adherence to all the PLOS ONE policies on sharing data and materials.

Figures

Fig 1
Fig 1. Screening to week 48.
NOTE. (*) hyperamylasemia related to a prior history of alcohol abuse. (#) false-positive HIV test. LTFU, lost to follow-up. SAEs: suicide attempt (1) and death (1).
Fig 2
Fig 2. Time to last visit/medication dispensed curve.
See this image and copyright information in PMC

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