Sprenger, Herman G., Langebeek, Nienke, Mulder, Paul G.H., Napel, Chris H.H. Ten, Vriesendorp, Robert, Hoepelman, Andy I.M., Legrand, Jean-Claude, Koopmans, Peter P., Van Kasteren, Marjo E.E., Bravenboer, Bert, Kate, Reinier W. Ten, Groeneveld, Paul H.P., van der Werf, Tjip S., Gisolf, Elisabeth H., and Richter, Clemens
Maintenance with a triple nucleoside reverse transcriptase Inhibitor (NRTI) regimen after successful induction with a dual NRTI/protease inhibitor (PI) combination may be advantageous, because of low pill burden, favorable lipids, and less drug interactions. This strategy to become free of PI-related problems without losing viral efficacy has not been formally tested. We performed a randomized, open-label, multicenter, 96-week comparative study in antiretroviral therapy (ART)-naive patients with CD4 50 copies per milliliter). Two hundred seven patients had similar baseline (BL) char- acteristics: median CD4 180 cells/[mm.sup.3], median VL 5.19 log10 copies per milliliter. One hundred twenty subjects (58%) met randomization criteria. Baseline VL differed significantly between dropouts and randomized subjects (median 5.41 versus 5.06 log10 copies per milliliter, p = 0.017), as did CD4 cells (median 160 and 200 cells/ram3, p = 0.044). Sixty-one subjects received TZV and 59 subjects continued NRTIs/PI. At week 48, 2 patients in the TZV group and 5 in the PI group did not have a sustained virologic suppression (log rank test; p = 0.379). CD4 counts increased significantly in both arms. In ART-naive patients, TZV maintenance had similar antiviral efficacy compared to continued standard ART at 48 weeks after baseline. Patients on successful standard ART can be safely switched to a NRTI-only regimen, at least for the tested time period. DOI: 10.1089/apc.2009.0236