A Randomized Trial of Simplified Maintenance Therapy with Abacavir, Lamivudine, and Zidovudine in Human Immunodeficiency Virus Infection

Opravil, Milos ; Hirschel, Bernard ; Lazzarin, Adriano ; Furrer, Hansjakob ; Chave, Jean-Philippe ; Yerly, Sabine ; Bisset, Leslie R. ; Fischer, Marek ; Vernazza, Pietro ; Bernasconi, Enos ; Battegay, Manuel ; Ledergerber, Bruno ; Günthard, Huldrych ; Howe, Colin ; Weber, Rainer ; Perrin, Luc

In: The Journal of Infectious Diseases, 2002, vol. 185, no. 9, p. 1251-1260

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    Summary
    This randomized study evaluated the efficacy and tolerability of continued treatment with protease inhibitor plus nucleoside-analogue combination regimens (n = 79) or a change to the simplified regimen of abacavir-lamivudine-zidovudine (n = 84) in patients with suppressed human immunodeficiency virus type 1 (HIV-1) RNA for ⩾6 months who did not have the reverse transcriptase 215 mutation. After a median follow-up of 84 weeks, virologic failure was 6% in the continuation and 15% in the simplified group (P = .081). Previous zidovudine monotherapy or dual therapy and archived reverse transcriptase resistance mutations in HIV-1 DNA at baseline were significant predictors of failure. Study treatment was discontinued because of adverse events in 20% of the continuation and 7% of the simplified group (P = .021). Simplification to abacavir-lamivudine-zidovudine significantly decreased nonfasting cholesterol and triglyceride levels; however, this switch strategy carries a risk of virologic failure when treatment history or resistance testing suggest the presence of archived resistance mutations to the simplified regimen