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Dolutegravir and lamivudine maintenance therapy in HIV-1 virologically suppressed patients: results of the ANRS 167 trial (LAMIDOL)

2018; Oxford University Press; Volume: 74; Issue: 3 Linguagem: Inglês

10.1093/jac/dky467

1460-2091

Véronique Joly, Charles Burdet, Roland Landman, Marie Vigan, Charlotte Charpentier, Christine Katlama, André Cabie, Aı̈da Benalychérif, Gilles Peytavin, Patrick Yéni, France Mentré, Anne-Laure Argoud, Imane Amri, D. Descamps, Yazdan Yazdanpanah, Cécile Goujard, Véronique Joly, Bao Phung, Jean Paul Viard, Laurence Weiss, Claudine Duvivier, Christine Katlama, Pierre Marie Girard, Jean‐Michel Molina, Philippe Morlat, Christine Jacomet, Lionel Piroth, André Cabie, Isabelle Poizot‐Martin, Jacques Reynes, Clotilde Allavena, Éric Billaud, David Boutouille, F. Raffi, Véronique Reliquet, Eric Roenthal, Alissa Naqvi, H. Aumaitre, Faouzi Souala, Louis Bernard, Noémie Biezunski, Faïza Ajana, Patrick Miailhes, Karine Amat, Aida Benalicherif, Babacar Sylla,

HIV/AIDS Research and Interventions

To evaluate the dolutegravir+lamivudine combination in virologically suppressed patients living with HIV.The ANRS 167 LAMIDOL trial was an open-label, single arm, multicentre trial assessing once-daily dolutegravir (50 mg)+lamivudine (300 mg) in virologically suppressed HIV-1 patients on first-line triple-drug regimens. The main criteria for inclusion in the trial were plasma viral load (pVL) ≤50 copies/mL for ≥2 years, CD4 nadir >200 cells/mm3 and WT HIV prior to treatment initiation. From week -8 (W-8) to day 0 (D0) (Phase 1), the current third agent was switched to dolutegravir. From D0 to W48 (Phase 2), patients received once-daily dolutegravir+lamivudine, except if intolerant or if pVL >50 copies/mL during Phase 1. Virological failure was defined as pVL >50 copies/mL in two consecutive samples. The study was designed to show that the strategy had an efficacy of ≥80%, assuming a 90% success rate with a type I error of 5% and a power of 90%.In total, 104 of 110 patients enrolled in Phase 1 were included in Phase 2. These 104 patients were 86% male, 72% MSM and 87% CDC stage A. Their characteristics were (median): age 45 years, CD4 nadir 339 cells/mm3, baseline CD4 743 cells/mm3 and duration of viral suppression 4.5 years. The overall success rate at W48 was 97% (95% CI: 94%-100%), meeting the design expectation/assumption. Three therapeutic failures occurred: one virological failure at W4, one lost to follow-up at W32 and one interruption of therapeutic strategy at W40 after a blip (pVL 59 copies/mL but control pVL <50 copies/mL). Three viral blips occurred in two additional patients. Neither M184V nor integrase resistance mutations were detected after failure or blips.Dolutegravir+lamivudine is a promising maintenance therapy in HIV-1-infected patients with controlled virological suppression.