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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

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

Edité par CCSD ; Oxford University Press -

International audience. 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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