Journal Articles Open Forum Infectious Diseases Year : 2023

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

Mireille Mpoudi-Etame
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Tamara Tovar Sanchez
Marwân-Al-Qays Bousmah
Centre population et développement
Institut Convergences Migrations [Aubervilliers]
Développement, Institutions et Modialisation
CV
Pierrette Omgba Bassega
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Justin Olinga
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Eric Mimbe
Michel Foalem
Camille Chiep
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Serge Edimo
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Marie Varloteaux
Raphaël Pelloquin
  • Function : Author
Nadine Lamare
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Sylvie Boyer
Centre population et développement
Martine Peeters
Jacques Reynes
Alexandra Calmy
Andrew Hill
Eric Delaporte
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Charles Kouanfack
A Ayouba
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A Agholeng
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C Butel
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B Granouillac
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A Lacroix
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S Leroy
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L Serrano
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T Tovar-Sanchez
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N Vidal
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C Kounfack
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P Fouda
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R Mougnoutou
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V Omgba
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S Tchokonte Ngandé
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B Ymele
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L Donfack
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A Kambi
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C Epoupa Mpacko
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M Fotso
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R Moukoko
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T Nké
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A Akamba
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S Lekelem
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S Ngono
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S Tongo Fotack
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M Tanga
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M Tsafack
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A Bissek
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L Ciaffi
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S Lem
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M Niba
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N Camille
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E Mpoudi-Ngolé
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E Ebong
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G Edoul Mbesse
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M Tongo
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P Huynh
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G Maradan
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M Nishimwe
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B Spire
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G Peytavin
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M Lê
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Y Yazdanpanah
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A Diallo
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I Fournier
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A Montoyo
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N Mercier
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V Petrov-Sanchez
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J Jean-Rassat
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C Rekacewicz
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C Perez Casas
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Abstract

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. Clinical Trials Registration. NCT02777229.

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Submitted on : Tuesday, June 4, 2024-10:02:48 AM

Last modification on : Wednesday, October 23, 2024-11:04:20 AM

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hal-04599949 , version 1 (04-06-2024)

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Mireille Mpoudi-Etame, Tamara Tovar Sanchez, Marwân-Al-Qays Bousmah, Pierrette Omgba Bassega, Justin Olinga, et al.. 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. Open Forum Infectious Diseases, 2023, 10 (12), pp.ofad582. ⟨10.1093/ofid/ofad582⟩. ⟨hal-04599949⟩

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