Decay of HIV RNA in Seminal Plasma and Rectal Fluid in Treatment-Naive Adults Starting Antiretroviral Therapy With Dolutegravir Plus Lamivudine or Bictegravir/Emtricitabine/Tenofovir Alafenamide.
antiretroviral therapy
dolutegravir
rectum
semen
Journal
The Journal of infectious diseases
ISSN: 1537-6613
Titre abrégé: J Infect Dis
Pays: United States
ID NLM: 0413675
Informations de publication
Date de publication:
03 10 2023
03 10 2023
Historique:
received:
13
07
2023
accepted:
30
07
2023
medline:
5
10
2023
pubmed:
1
8
2023
entrez:
1
8
2023
Statut:
ppublish
Résumé
Decay of HIV in seminal plasma (SP) and rectal fluid (RF) has not yet been described for the antiretroviral combination of dolutegravir (DTG) + lamivudine (3TC). In this randomized multicenter pilot trial, males who were antiretroviral naive were randomized (2:1) to DTG + 3TC or bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). HIV-1 RNA was measured in blood plasma (BP), SP, and RF at baseline; days 3, 7, 14, and 28; and weeks 12 and 24. Of 25 individuals enrolled, 24 completed the study (DTG + 3TC, n = 16; BIC/FTC/TAF, n = 8). No significant differences were observed between groups for median decline in HIV-1 RNA from baseline at each time point or median time to achieve HIV-1 RNA <20 copies/mL in BP and SP and <20 copies/swab in RF. HIV-1 RNA decay patterns were compared in individuals receiving DTG + 3TC. Despite significantly higher percentages for changes from baseline in BP, median (IQR) times to HIV-1 RNA suppression were shorter in SP (7 days; 0-8.75) and RF (10.5 days; 3-17.5) than in BP (28 days; 14-84; P < .001). Comparable HIV-1 RNA decay in BP, SP, and RF was observed between DTG + 3TC and BIC/FTC/TAF. As shown with triple-drug integrase inhibitor-based regimens, rapid HIV-1 RNA suppression in SP and RF is achieved with DTG + 3TC, despite decay patterns differing from those of BP. EudraCT 2019-004109-28.
Sections du résumé
BACKGROUND
Decay of HIV in seminal plasma (SP) and rectal fluid (RF) has not yet been described for the antiretroviral combination of dolutegravir (DTG) + lamivudine (3TC).
METHODS
In this randomized multicenter pilot trial, males who were antiretroviral naive were randomized (2:1) to DTG + 3TC or bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). HIV-1 RNA was measured in blood plasma (BP), SP, and RF at baseline; days 3, 7, 14, and 28; and weeks 12 and 24.
RESULTS
Of 25 individuals enrolled, 24 completed the study (DTG + 3TC, n = 16; BIC/FTC/TAF, n = 8). No significant differences were observed between groups for median decline in HIV-1 RNA from baseline at each time point or median time to achieve HIV-1 RNA <20 copies/mL in BP and SP and <20 copies/swab in RF. HIV-1 RNA decay patterns were compared in individuals receiving DTG + 3TC. Despite significantly higher percentages for changes from baseline in BP, median (IQR) times to HIV-1 RNA suppression were shorter in SP (7 days; 0-8.75) and RF (10.5 days; 3-17.5) than in BP (28 days; 14-84; P < .001).
CONCLUSIONS
Comparable HIV-1 RNA decay in BP, SP, and RF was observed between DTG + 3TC and BIC/FTC/TAF. As shown with triple-drug integrase inhibitor-based regimens, rapid HIV-1 RNA suppression in SP and RF is achieved with DTG + 3TC, despite decay patterns differing from those of BP.
CLINICAL TRIALS REGISTRATION
EudraCT 2019-004109-28.
Identifiants
pubmed: 37526315
pii: 7234537
doi: 10.1093/infdis/jiad304
doi:
Substances chimiques
tenofovir alafenamide
EL9943AG5J
Lamivudine
2T8Q726O95
bictegravir
8GB79LOJ07
dolutegravir
DKO1W9H7M1
Heterocyclic Compounds, 3-Ring
0
Pyridones
0
Anti-Retroviral Agents
0
Drug Combinations
0
RNA, Viral
0
Emtricitabine
G70B4ETF4S
Anti-HIV Agents
0
Banques de données
EudraCT
['2019-004109-28']
Types de publication
Randomized Controlled Trial
Multicenter Study
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
919-925Informations de copyright
© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
Déclaration de conflit d'intérêts
Potential conflicts of interest. S. S. has received financial compensation for educational activities, as well as training courses, funds for research, travel grants, and nonfinancial support from Gilead Sciences, Janssen-Cilag, Merck Sharp & Dohme, and ViiV Healthcare. P. D. has received financial compensation for lectures, consultancy work, and educational activities, from Gilead Sciences, GSK, Ferrer International, Janssen-Cilag, Merck Sharp & Dohme, Roche, Thera Technologies, and ViiV Healthcare. A. C. has received financial compensation for lectures, consultancy work, and educational activities, as well as funding for research, travel grants, and nonfinancial support from Gilead Sciences, Janssen-Cilag, Merck Sharp & Dohme, Thera Technologies, and ViiV Healthcare. J. T. has received financial compensation for lectures, consultancies, and educational activities as well as research funding from Gilead Sciences, Janssen-Cilag, Merck Sharp & Dohme, and ViiV Healthcare. D. P. has received research grants and/or honoraria for advisory boards and/or conferences from Gilead Sciences, Janssen-Cilag, Merck Sharp & Dohme, and ViiV Healthcare. A. I. has received financial compensation for lectures, consultancy work, and educational activities, as well as funding for research, travel grants, and nonfinancial support from Gilead Sciences, Janssen-Cilag, Merck Sharp & Dohme, Thera Technologies, and ViiV Healthcare. All other authors report no potential conflicts.