%0 Journal Article
%9 ACL : Articles dans des revues avec comité de lecture répertoriées par l'AERES
%A Mpoudi-Etame, M.
%A Sanchez, T. T.
%A Bousmah, Marwan-al-Qays
%A Bassega, P. O.
%A Olinga, J.
%A Mimbe, E.
%A Foalem, M.
%A Chiep, C.
%A Edimo, S.
%A Varloteaux, M.
%A Pelloquin, Raphael
%A Lamare, N.
%A Boyer, S.
%A Peeters, Martine
%A Reynes, J.
%A Calmy, A.
%A Hill, A.
%A Delaporte, E.
%A Kouanfack, C.
%A New Antiretroviral Monitoring,
%T Durability of the efficacy and safety of dolutegravir-based and low-dose efavirenz-based regimens for the initial treatment of human immunodeficiency virus type 1 infection in Cameroon : week 192 data of the NAMSAL-ANRS-12313 Study
%D 2023
%L fdi:010088881
%G ENG
%J Open Forum Infectious Diseases
%@ 2328-8957
%K dolutegravir ; efficacy-durability ; HIV-1 ; low-dose-efavirenz ; weight gain
%K CAMEROUN
%M ISI:001134222800001
%N 12
%P ofad582 [10 ]
%R 10.1093/ofid/ofad582
%U https://www.documentation.ird.fr/hor/fdi:010088881
%> https://horizon.documentation.ird.fr/exl-doc/pleins_textes/2024-02/010088881.pdf
%V 10
%W Horizon (IRD)
%X Background. A prospective study was extended to the new antiretroviral and monitoring strategies in HIV-infected adults in low-income countries (NAMSAL-ANRS)-12313 trial, a 96-week open-label, multicenter, randomized phase 3 trial comparing dolutegravir (DTG) 50 mg with efavirenz 400 mg (EFV400), both administered with tenofovir disoproxil fumarate and lamivudine (TDF/3TC) as first-line treatment for antiretroviral therapy (ART)-naive people living with human immunodeficiency virus type 1 (HIV). Noninferiority of DTG to EFV400 was demonstrated at 48-week and sustained at 96 weeks. Here, we present results at 192-week.Methods. Previous trial participants were reconsented and followed up on their initial randomization arm (1:1 DTG/TDF/3TC:EFV400/TDF/3TC). Assessments included changes in viral suppression, biological parameters, and new serious adverse events (SAEs).Results. Among the participants enrolled in the trial, 81% (499/613) were analyzed at week 192: 84% (261/310) on DTG/TDF/3TC and 78% (238/303) on EFV400/TDF/3TC. HIV RNA suppression was maintained in 69% (214/310) on DTG/TDF/3TC-based and 62% (187/303) on EFV400/TDF/3TC-based regimens (difference, 7.3% [95% confidence interval, -.20 to 14.83]; P = .057). Five (DTG/TDF/3TC = 2; EFV400/TDF/3TC = 3) new viral failures (World Health Organization definition) without related resistance DTG mutations and 24 new SAEs were observed (DTG/TDF/3TC = 13; EFV400/TDF/3TC = 11). Mean weight gain was +9.4 kg on DTG/TDF/3TC and +5.9 kg on EFV400/TDF/3TC. The percentage of participants with obesity increased from 6.9% to 27.7% on DTG/TDF/3TC (P < .0001) and from 8.3% to 16.7% on EFV400/TDF/3TC (P = .0033).Conclusions. Four-year follow-up of people with HIV on DTG- and EFV400-based regimens showed long-term efficacy and safety of both ARTs, markedly among participants on DTG/TDF/3TC with high baseline viral load. However, unexpected substantial weight gain over time was prominent among participants on DTG/TDF/3TC, which should be closely monitored.
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