Abacavir–Lamivudine versus Tenofovir–Emtricitabine for Initial HIV-1 Therapy

• Published in: The New England journal of medicine Vol. 361; no. 23; pp. 2230 - 2240
• Main Authors: Sax, Paul E, Tierney, Camlin, Collier, Ann C, Fischl, Margaret A, Mollan, Katie, Peeples, Lynne, Godfrey, Catherine, Jahed, Nasreen C, Myers, Laurie, Katzenstein, David, Farajallah, Awny, Rooney, James F, Ha, Belinda, Woodward, William C, Koletar, Susan L, Johnson, Victoria A, Geiseler, P. Jan, Daar, Eric S
• Format: Journal Article
• Language: English
• Published: Waltham, MA Massachusetts Medical Society 03.12.2009
• Subjects: Acquired immune deficiency syndrome; Adenine - adverse effects; Adenine - analogs & derivatives; Adenine - therapeutic use; Adolescent; Adult; AIDS; Analysis of Variance; Anti-HIV Agents - adverse effects; Anti-HIV Agents - therapeutic use; Antibiotics. Antiinfectious agents. Antiparasitic agents; Antiretroviral drugs; Antiviral agents; Biological and medical sciences; CD4 Lymphocyte Count; Deoxycytidine - adverse effects; Deoxycytidine - analogs & derivatives; Deoxycytidine - therapeutic use; Dideoxynucleosides; Double-Blind Method; Drug Combinations; Drug Resistance, Viral; Drug therapy; Emtricitabine; Female; Fractures, Bone - chemically induced; General aspects; HIV; HIV Infections - drug therapy; HIV Infections - immunology; HIV-1 - genetics; HIV-1 - isolation & purification; Human immunodeficiency virus; Human viral diseases; Humans; Infectious diseases; Laboratories; Lamivudine - adverse effects; Lamivudine - therapeutic use; Male; Medical sciences; Middle Aged; Mutation; Organophosphonates - adverse effects; Organophosphonates - therapeutic use; Pharmacology. Drug treatments; RNA, Viral - blood; Tenofovir; Therapeutic Equivalency; Time Factors; Treatment Failure; Viral diseases; Viral diseases of the lymphoid tissue and the blood. Aids; Viral Load; Young Adult; Purine nucleoside; Antiretroviral agent; RNA-directed DNA polymerase; HIV-1 virus; Nucleotide analog; Tenofovir; Reverse transcriptase inhibitor; Nucleoside analog; Antiviral; Pyrimidine nucleoside; Emtricitabine; Immunopathology; Purine nucleotide; Acyclic nucleotide; Enzyme; Transferases; Enzyme inhibitor; Retroviridae; Lamivudine; AIDS; Organic phosphonate; Immune deficiency; Lentivirus; Infection; Virus; Medicine; Nucleotidyltransferases; Dideoxynucleoside; Viral disease; Abacavir; Human immunodeficiency virus; Comparative study
• ISSN: 0028-4793; 1533-4406
• DOI: 10.1056/NEJMoa0906768

In this prospective trial of fixed-dose, once-daily, nonnucleoside reverse-transcriptase inhibitors, patients with screening human immunodeficiency virus type 1 (HIV-1) RNA levels of 100,000 copies per milliliter or more were significantly less likely to have virologic failure if they were assigned to tenofovir DF–emtricitabine than if they were assigned to abacavir–lamivudine. These results may lead to changes in current practice and in guidelines for the initial treatment of HIV-1 infection. Patients with HIV-1 RNA levels of 100,000 copies per milliliter or more were significantly less likely to have virologic failure if they were assigned to tenofovir DF–emtricitabine than if they were assigned to abacavir–lamivudine Treatment guidelines for initial therapy for human immunodeficiency virus type 1 (HIV-1) infection recommend the use of two nucleoside reverse-transcriptase inhibitors (NRTIs) with a nonnucleoside reverse-transcriptase inhibitor or a ritonavir-boosted protease inhibitor. 1 , 2 The NRTIs abacavir–lamivudine and tenofovir disoproxil fumarate (DF)–emtricitabine can be given once daily, provide potent antiviral activity, and are infrequently associated with mitochondrial toxic effects, lipoatrophy, or neuropathy. 3 – 5 We conducted a multicenter, randomized, blinded equivalence study comparing the antiviral activity, safety, and tolerability of abacavir–lamivudine and tenofovir DF–emtricitabine given with efavirenz or ritonavir-boosted atazanavir. After a scheduled interim review, the data and safety monitoring board of . . .