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.

Autor: Mpoudi-Etame M; Service Spécialisé d'Epidemiologie et Maladies Infectieuses, Hopital Militaire de Région No.1 Yaoundé, Yaoundé, Cameroon.; Site Agence Nationale de Recherche sur le Sida et Maladies Infectieuses Emergentes du Cameroun, Yaoundé Central Hospital, Cameroon., Tovar Sanchez T; TransVIHMI, Université de Montpellier, Institute de Recherche pour le Développement, Inserm, Montpellier, France., Bousmah MA; Aix Marseille Univ, Inserm, Institut de Recherche pour le Développement, Sciences Economiques et Sociales de la Santé et Traitement de l'Information Médicale, Institut Science de la Santé Publique d'Aix-Marseille, Marseille, France.; Université Paris Cité, Institute de Recherche pour le Développement, Inserm, Ceped, F-75006 Paris, France., Omgba Bassega P; Unité de prise en charge du VIH, Hôpital de District de la Cité Verte, Yaoundé, Cameroon., Olinga J; Site Agence Nationale de Recherche sur le Sida et Maladies Infectieuses Emergentes du Cameroun, Yaoundé Central Hospital, Cameroon., Mimbe E; Site Agence Nationale de Recherche sur le Sida et Maladies Infectieuses Emergentes du Cameroun, Yaoundé Central Hospital, Cameroon., Foalem M; Site Agence Nationale de Recherche sur le Sida et Maladies Infectieuses Emergentes du Cameroun, Yaoundé Central Hospital, Cameroon.; Faculty of Medicine and Pharmaceutical Sciences, University of Dschang, Cameroon., Chiep C; Site Agence Nationale de Recherche sur le Sida et Maladies Infectieuses Emergentes du Cameroun, Yaoundé Central Hospital, Cameroon., Edimo S; Site Agence Nationale de Recherche sur le Sida et Maladies Infectieuses Emergentes du Cameroun, Yaoundé Central Hospital, Cameroon., Varloteaux M; Site Agence Nationale de Recherche sur le Sida et Maladies Infectieuses Emergentes du Cameroun, Yaoundé Central Hospital, Cameroon., Pelloquin R; TransVIHMI, Université de Montpellier, Institute de Recherche pour le Développement, Inserm, Montpellier, France., Lamare N; Centre de Recherches sur les Maladies Emergentes et Ré-émergentes, Yaoundé, Cameroon., Boyer S; Aix Marseille Univ, Inserm, Institut de Recherche pour le Développement, Sciences Economiques et Sociales de la Santé et Traitement de l'Information Médicale, Institut Science de la Santé Publique d'Aix-Marseille, Marseille, France.; Université Paris Cité, Institute de Recherche pour le Développement, Inserm, Ceped, F-75006 Paris, France., Peeters M; TransVIHMI, Université de Montpellier, Institute de Recherche pour le Développement, Inserm, Montpellier, France., Reynes J; TransVIHMI, Université de Montpellier, Institute de Recherche pour le Développement, Inserm, Montpellier, France.; Service de Maladies Infectieuses, Centre Hospitalier Universitaire de Montpellier, Montpellier, France., Calmy A; Service des maladies infectieuses, Hôpital Universitaire de Genève, Geneva, Switzerland., Hill A; Department of Pharmacology and Therapeutics, University of Liverpool, Liverpool, United Kingdom., Delaporte E; TransVIHMI, Université de Montpellier, Institute de Recherche pour le Développement, Inserm, Montpellier, France.; Service de Maladies Infectieuses, Centre Hospitalier Universitaire de Montpellier, Montpellier, France., Kouanfack C; Unité de prise en charge du VIH, Hôpital de District de la Cité Verte, Yaoundé, Cameroon.; Faculty of Medicine and Pharmaceutical Sciences, University of Dschang, Cameroon.; Hôpital du Jour, Hôpital Central de Yaoundé, Cameroon.
Jazyk: angličtina
Zdroj: Open forum infectious diseases [Open Forum Infect Dis] 2023 Nov 20; Vol. 10 (12), pp. ofad582. Date of Electronic Publication: 2023 Nov 20 (Print Publication: 2023).
DOI: 10.1093/ofid/ofad582
Abstrakt: 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.
Competing Interests: Potential conflicts of interest. A. C. was a member of the WHO guideline panel in 2018 and 2019. The HIV Unit of Geneva University Hospitals (HUG) received unrestricted educational grants from ViiV, AbbVie, Gilead, and MSD, all of which also provided financial support to the LIPO group and metabolism (day hospital) in the HIV/AIDS Unit of HUG. J. R. has received personal fees and grants from Gilead, MSD, Pfizer, Tibotec-Janssen, and ViiV Healthcare for participation in advisory boards, educational programs, and conferences. All other authors report no potential conflicts.
(© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)
Databáze: MEDLINE
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