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Long-term efficacy of darunavir/ritonavir monotherapy in patients with HIV-1 viral suppression: week 96 results from the MONOI ANRS 136 study

2011; Oxford University Press; Volume: 67; Issue: 3 Linguagem: Inglês

10.1093/jac/dkr504

1460-2091

M.A. Valantin, Sidonie Lambert-Niclot, Philippe Flandre, Laurence Morand‐Joubert, André Cabie, J.‐L. Meynard, Diane Ponscarme, F. Ajana, Laurence Slama, Angélique Curjol, Lise Cuzin, L Schneider, A M Taburet, Anne‐Geneviève Marcelin, Christine Katlama, Christine Katlama, M.A. Valantin, Claudine Duvivier, Philippe Flandre, Vincent Cálvez, Anne‐Geneviève Marcelin, Gilles Peytavin, A M Taburet, Christine Katlama, Claudine Duvivier, M.A. Valantin, Vincent Cálvez, Anne‐Geneviève Marcelin, Gilles Peytavin, S. Kolta, Philippe Flandre, Dominique Costagliola, Michèle Genin, M.- J. Commoy, A M Taburet, Marianne L’Hénaff, Arnaud Chéret, François Raffi, Rodolphe Garaffo, Diane Descamps, Geneviève Chêne,

HIV-related health complications and treatments

Long-term results at week 96 are needed to evaluate the capacity of the darunavir/ritonavir monotherapy strategy to maintain a sustained control of the HIV-1 viral load. MONOI is a prospective, open-label, non-inferiority, randomized, 96 week trial comparing darunavir/ritonavir monotherapy versus a darunavir/ritonavir triple-therapy strategy to maintain HIV-1 viral load suppression in HIV-1-infected patients. Clinical trial registration: NCT00412551. From 225 randomized patients, 219 patients reached the 48 week follow-up and 211 reached the 96 week follow-up (106 patients in the darunavir monotherapy arm and 105 in the darunavir triple-therapy arm). Baseline characteristics were well balanced between the two treatment groups. At week 96, in intent-to-treat analysis, 91/103 patients (88%, 95% CI 81–94) allocated to the darunavir/ritonavir monotherapy arm and 87/104 patients (84%, 95% CI 75–90) allocated to the darunavir triple-therapy arm achieved an HIV-1 viral load <50 copies/mL, with no statistical difference between the two groups. Throughout the 96 week follow-up, 66/112 patients (59%, 95% CI 49–68) and 79/113 patients (70%, 95% CI 61–78) consistently had HIV-1 RNA <50 copies/mL with darunavir/ritonavir monotherapy and darunavir/ritonavir triple therapy, respectively. The MONOI study establishes darunavir/ritonavir monotherapy as durable and efficacious for maintaining virological suppression in HIV-1 patients. Darunavir/ritonavir monotherapy should be considered as a (tailored) treatment option for standard triple-therapy patients who have had a substantial period of viral suppression.