@misc{10481/84816,
year = {2023},
month = {8},
url = {https://hdl.handle.net/10481/84816},
abstract = {Background: This was a substudy of a Phase IV, randomized clinical trial (ClinicalTrials.gov identifier:
NCT04295460) aiming to compare the activity of dolutegravir/lamivudine versus dolutegravir plus tenofovir
alafenamide/emtricitabine (DTG + TAF/FTC) in the male genital tract.
Methods: Participants were asymptomatic adults without sexually transmitted diseases, treatment-naive people
living with HIV (PLWH), with CD4+ T cell counts >200 cells/mm3 and plasma HIV-1-RNA levels >5000 and
<500 000 copies/mL, randomized (1:1) to DTG + TAF/FTC or dolutegravir/lamivudine. Blood plasma (BP) and seminal
plasma (SP) were collected at baseline and Weeks 4, 8, 12 and 24. HIV-1-RNA was measured in BP and SP
using the Cobas 6800 system (Roche Diagnostics) with a lower detection limit of 20 copies/mL. The primary efficacy
endpoint was the proportion of subjects with undetectable SP HIV-1-RNA at Week 12 by intention-to-treat
analysis.
Results: Fifteen participants in the DTG + TAF/FTC and 16 in the dolutegravir/lamivudine arms were analysed,
with basal SP viral load of 4.81 (4.30–5.43) and 4.76 (4.09–5.23), P = 0.469, respectively. At Week 12, only one
participant in each treatment arm had a detectable SP HIV-1-RNA (DTG + TAF/FTC, 141 copies/mL; dolutegravir/
lamivudine, 61 copies/mL). Based on the estimated means, there was no significant difference in the decay
of HIV-1-RNA in both BP and SP over time between the two arms of treatment (F = 0.452, P = 0.662, and
F = 1.147, P = 0.185, respectively).
Conclusions: After 12 weeks of treatment, there were no differences in the percentage of undetectable SP
HIV-1-RNA in naive PLWH who started dolutegravir/lamivudine compared with DTG + TAF/FTC.},
organization = {Fundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla (FISEVI)},
organization = {ViiV Healthcare UK Ltd. The funders had no role in study design, data collection},
organization = {Instituto de Salud Carlos III},
organization = {(CP19/00159)},
organization = {PFIS contracts (FI19/00304)},
organization = {Ministerio de Ciencia e Innovación, Spain},
organization = {European Regional Development Fund ‘a way to make Europe},
publisher = {British Society for Antimicrobial Chemotherapy},
title = {Decay kinetics of HIV-1-RNA in seminal plasma with dolutegravir/ lamivudine versus dolutegravir plus emtricitabine/tenofovir alafenamide in treatment-naive people living with HIV},
doi = {10.1093/jac/dkad245},
author = {Saborido Alconchel, Abraham and Praena Fernández, Juan Manuel},
}