1. Five-Year Follow up of Once-Daily Therapy with Emtricitabine, Didanosine and Efavirenz (Montana ANRS 091 Trial)
- Author
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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, and Lecompte, T Doco
- 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.
- Published
- 2007
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