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| |  Abacavir-Lamivudine Combination Has Worse Clinical Outcomes Than Tenofovir DF-Emtricitabine Combination in Patients With High HIV-1 Loads LOS ANGELES -- December 2, 2009 -- Patients with high HIV loads who received the antiretroviral therapy combination of abacavir and lamivudine (Epzicom) were twice as likely to achieve virologic failure and within a shorter time than a similar group of patients who received a combination of tenofovir DF and emtricitabine (Truvada), reports a study published in the December 3 issue of the New England Journal of Medicine. The A5202 study examined the safety and efficacy of 4 once-daily antiretroviral regimens as initial therapy in 1,858 patients with HIV-1 infection and was led by principal study investigator Eric Daar, MD, Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, California. Among the 797 patients with high viral loads (>=100,000 copies/mL) who initiated therapy, those who received abacavir-lamivudine had twice as many virologic failures compared with a similar group of patients who received tenofovir DF-emtricitabine after a median of 60 weeks of treatment. The significant difference in efficacy prompted the data and safety monitoring board to halt the comparison in 2008, nearly 2 years earlier than planned. However, the researchers continued with patient follow-up. “The patients in the study all did quite well. But for those starting with high viral loads, there was a highly significant difference in outcomes that favoured those given [tenofovir DF-emtricitabine] compared to [abacavir-lamivudine],” said Dr. Daar. “There are many effective therapeutic options for the treatment of HIV-infected individuals and much ongoing research, like this study, to further refine and optimise the management of this disease.” The New England Journal of Medicine publication reports on the patients who were randomly assigned to receive 1 of 4 oral once-daily regimens: abacavir-lamivudine or tenofovir DF-emtricitabine with either efavirenz (Sustiva) or atazanavir (Reyataz) plus ritonavir (Norvir). The researchers assessed the patients’ medical condition at 4, 8, 16, and 24 weeks after they entered the trial, and every 12 weeks thereafter for the remainder of trial duration. Among patients with high viral loads who initiated therapy, viral failure occurred in 57 receiving abacavir-lamivudine and 26 patients receiving tenofovir DF-emtricitabine. The abacavir-lamivudine group also had a significantly shorter time to virologic failure and fewer adverse events than a similar group of patients who received tenofovir DF-emtricitabine. The researchers will continue to examine the relative safety and effectiveness of abacavir-lamivudine and tenofovir DF-emtricitabine in those patients with lower viral loads starting therapy. They will also assess the effect of the other 2 antiretroviral therapies: efavirenz and the atazanavir with ritonavir combination. “This study and others like it help guide physicians and their patients in determining the optimal therapy for each individual with the goal of providing the safest and most effective regimens possible,” said Dr. Daar.
SOURCE: New England Journal of Medicine
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