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

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

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.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Anti-Retroviral Agents / therapeutic use
  • Argentina / epidemiology
  • Emtricitabine / therapeutic use
  • Female
  • HIV Infections* / drug therapy
  • Heterocyclic Compounds, 3-Ring / adverse effects
  • Humans
  • Lamivudine / adverse effects
  • Prospective Studies
  • Pyridones / therapeutic use
  • Tenofovir / adverse effects
  • Transgender Persons*

Substances

  • Anti-Retroviral Agents
  • dolutegravir
  • Emtricitabine
  • Heterocyclic Compounds, 3-Ring
  • Lamivudine
  • Pyridones
  • Tenofovir

Grants and funding

The present study was funded by an Investigator Initiated Research Grant from ViiV Healthcare, GSK202037. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.