Mpoudi-Etame M., Sanchez T. T., Bousmah Marwan-al-Qays, Bassega P. O., Olinga J., Mimbe E., Foalem M., Chiep C., Edimo S., Varloteaux M., Pelloquin Raphael, Lamare N., Boyer S., Peeters Martine, Reynes J., Calmy A., Hill A., Delaporte E., Kouanfack C., New Antiretroviral Monitoring. (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. Open Forum Infectious Diseases, 10 (12), ofad582 [10 p.]. ISSN 2328-8957.
Titre du document
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
Année de publication
2023
Auteurs
Mpoudi-Etame M., Sanchez T. T., Bousmah Marwan-al-Qays, Bassega P. O., Olinga J., Mimbe E., Foalem M., Chiep C., Edimo S., Varloteaux M., Pelloquin Raphael, Lamare N., Boyer S., Peeters Martine, Reynes J., Calmy A., Hill A., Delaporte E., Kouanfack C., New Antiretroviral Monitoring
Source
Open Forum Infectious Diseases, 2023,
10 (12), ofad582 [10 p.] ISSN 2328-8957
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.
Plan de classement
Santé : généralités [050]
;
Entomologie médicale / Parasitologie / Virologie [052]
Description Géographique
CAMEROUN
Localisation
Fonds IRD [F B010088881]
Identifiant IRD
fdi:010088881
