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Abacavir-lamivudine versus tenofovir-emtricitabine for initial HIV-1 therapy Sax PE; Tierney C; Collier AC; Fischl MA; Mollan K; Peeples L; Godfrey C; Jahed NC; Myers L; Katzenstein D; Farajallah A; Rooney JF; Ha B; Woodward WC; Koletar SL; Johnson VA; Geiseler PJ; Daar ESN Engl J Med 2009[Dec]; 361 (23): 2230-40BACKGROUND: The use of fixed-dose combination nucleoside reverse-transcriptase inhibitors (NRTIs) with a nonnucleoside reverse-transcriptase inhibitor or a ritonavir-boosted protease inhibitor is recommended as initial therapy in patients with human immunodeficiency virus type 1 (HIV-1) infection, but which NRTI combination has greater efficacy and safety is not known. METHODS: In a randomized, blinded equivalence study involving 1858 eligible patients, we compared four once-daily antiretroviral regimens as initial therapy for HIV-1 infection: abacavir-lamivudine or tenofovir disoproxil fumarate (DF)-emtricitabine plus efavirenz or ritonavir-boosted atazanavir. The primary efficacy end point was the time from randomization to virologic failure (defined as a confirmed HIV-1 RNA level > or = 1000 copies per milliliter at or after 16 weeks and before 24 weeks, or > or = 200 copies per milliliter at or after 24 weeks). RESULTS: A scheduled interim review by an independent data and safety monitoring board showed significant differences in virologic efficacy, according to the NRTI combination, among patients with screening HIV-1 RNA levels of 100,000 copies per milliliter or more. At a median follow-up of 60 weeks, among the 797 patients with screening HIV-1 RNA levels of 100,000 copies per milliliter or more, the time to virologic failure was significantly shorter in the abacavir-lamivudine group than in the tenofovir DF-emtricitabine group (hazard ratio, 2.33; 95% confidence interval, 1.46 to 3.72; P<0.001), with 57 virologic failures (14%) in the abacavir-lamivudine group versus 26 (7%) in the tenofovir DF-emtricitabine group. The time to the first adverse event was also shorter in the abacavir-lamivudine group (P<0.001). There was no significant difference between the study groups in the change from the baseline CD4 cell count at week 48. CONCLUSIONS: In patients with screening HIV-1 RNA levels of 100,000 copies per milliliter or more, the times to virologic failure and the first adverse event were both significantly shorter in patients randomly assigned to abacavir-lamivudine than in those assigned to tenofovir DF-emtricitabine. (ClinicalTrials.gov number, NCT00118898.)|*HIV-1/genetics/isolation & purification[MESH]|Adenine/adverse effects/*analogs & derivatives/therapeutic use[MESH]|Adolescent[MESH]|Adult[MESH]|Analysis of Variance[MESH]|Anti-HIV Agents/adverse effects/*therapeutic use[MESH]|CD4 Lymphocyte Count[MESH]|Deoxycytidine/adverse effects/*analogs & derivatives/therapeutic use[MESH]|Dideoxynucleosides[MESH]|Double-Blind Method[MESH]|Drug Combinations[MESH]|Drug Resistance, Viral[MESH]|Emtricitabine[MESH]|Female[MESH]|Fractures, Bone/chemically induced[MESH]|HIV Infections/*drug therapy/immunology[MESH]|Humans[MESH]|Lamivudine/adverse effects/*therapeutic use[MESH]|Male[MESH]|Middle Aged[MESH]|Organophosphonates/adverse effects/*therapeutic use[MESH]|RNA, Viral/blood[MESH]|Tenofovir[MESH]|Therapeutic Equivalency[MESH]|Time Factors[MESH]|Treatment Failure[MESH]|Viral Load[MESH]|Young Adult[MESH] |
