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Simplification Therapy with Once‐Daily Emtricitabine, Didanosine, and Efavirenz in HIV‐1–Infected Adults with Viral Suppression Receiving a Protease Inhibitor–Based Regimen: A Randomized Trial

2005; Oxford University Press; Volume: 191; Issue: 6 Linguagem: Inglês

10.1086/428091

1537-6613

Jean‐Michel Molina, Valérie Journot, Laurence Morand‐Joubert, Patrick Yéni, Willy Rozenbaum, Corinne Rancinan, Sandra Fournier, Philippe Morlat, Pierre Palmer, B. Dupont, Cécile Goujard, P. Dellamonica, Fidéline Collin, Isabelle Poizot‐Martin, Geneviève Chêne,

HIV/AIDS Research and Interventions

We assessed a once-daily combination to simplify therapy in patients infected with human immunodeficiency virus type 1 (HIV-1).A total of 355 adults with plasma HIV-1 RNA levels <400 copies/mL were randomly assigned to either switch to once-daily emtricitabine, didanosine, and efavirenz (n=178) or maintain their protease inhibitor (PI)-based regimens (n=177). The primary end point was sustained suppression of plasma HIV-1 RNA levels to <400 copies/mL.At week 48, the proportion of patients meeting the end point was 87.6% in the PI group and 90.5% in the once-daily group, with a treatment difference of -2.9% (upper bound of the 1-tailed 95% confidence interval, 2.6%). The proportion of patients with HIV-1 RNA levels <50 copies/mL was higher in the once-daily group (87%) than in the PI group (79%) (P<.05). Resistance mutations to efavirenz and emtricitabine were detected in all patients in the once-daily group who experienced virologic failure while receiving study medication. The proportion of patients discontinuing study medication because of adverse events was similar between the once-daily group (9%) and the PI group (10%) (P=.8).Substituting a convenient once-daily combination of emtricitabine, didanosine, and efavirenz for a PI-based regimen was well tolerated and associated with sustained virologic suppression.