학술논문
Five-Year Follow up of Once-Daily Therapy with Emtricitabine, Didanosine and Efavirenz (Montana ANRS 091 Trial)
Document Type
Article
Author
Molina, Jean-Michel; Journot, Valérie; Furco, André; Palmer, Pierre; Castro, Nathalie De; Raffi, François; Morlat, Philippe; May, Thierry; Rancinan, Corinne; Chêne, Geneviève; Modaï, J; Decazes, J-M; Molina, JM; Madeleine, I; Sombardier, MN; Martinie, M; Séréni, D; Lascoux-Combes, C; Michon, C; Vinceneux, Ph; Delfraissy, JF; Goujard, C; Peretti, D; Rannou, MT; Galanaud, P; Boue, F; Colson, C; Rozenbaum, W; Girard, PM; Adda, N; Saimot, AG; Coulaud, JP; Landman, R; Matheron, S; Hoen, B; Derancourt, C; Drobacheff, C; Salard, D; Laurent, R; Estavoyer, JM; Beylot, J; Morlat, P; Lacoste, D; Bonarek, M; Bonnet, F; Bernard, N; Nouts, C; Trepo, C; Cotte, L; Schlienger, I; Rougier, P; Carre, C; Raffi, F; Bonnet, B; Allavena, C; Esnault, JL; Charonnat, MF; Sicot, M; Canton, P; Burty, C; Brel, F; May, T; Lecompte, T Doco
Source
Antiviral Therapy; April 2007, Vol. 12 Issue: 3 p417-422, 6p
Subject
Language
ISSN
13596535
Abstract
Background Once-daily combination therapy with emtricitabine, didanosine and efavirenz has been highly effective in clinical trials but its long-term efficacy and safety has not been previously reported.Methods This multicentre, single-arm, open-label trial enrolled 40 antiretroviral-naive HIV-1-infected patients who received a once-daily regimen of emtricitabine, didanosine and efavirenz. The objective was to assess the long-term effects of this combination on plasma HIV RNA levels, CD4+T-cell counts, safety and tolerability.Results After 5 years, 73% and 68% of patients had plasma HIV RNA levels <400 and <50 copies/ml, respectively, in an intent-to-treat, missing-equals-failure analysis. Genotypic resistance on treatment emerged in six patients. There was a significant increase in CD4+T-cell count of 294x106cells/l. Only six patients discontinued study treatment, because of non-severe adverse events. Lipodystrophy was infrequent, and lipid and glucose profiles were favourable with a significant increase in high-density lipoprotein cholesterol.Conclusions A convenient once-daily regimen of emtricitabine, didanosine and efavirenz provided durable antiretroviral response and was well tolerated through 5 years of therapy.