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| |  Once-Daily Lopinavir/Ritonavir Tablets Show Similar, Durable Efficacy as Twice-Daily Dosing: Presented at IAS By Ed Susman CAPE TOWN, South Africa -- July 22, 2009 -- A once-daily dosing tablet of the protease inhibitor lopinavir/ritonavir helps patients with HIV infection suppress viral loads to undetectable levels as effectively as twice-daily dosing over a 96-week period, researchers said here at the 5th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention. In the intention-to-treat population, 69.2% of 331 patients on the twice-daily regimen had no detectable virus using the 50-copies/mL assay compared with 64.9% of 333 patients on once-daily therapy, a difference that was not statistically significant (P = .249). “The efficacy of lopinavir/ritonavir once-daily continued to meet the protocol-defined criteria for noninferiority compared to twice-a-day dosing,” said Daniel Cohen, MD, Abbott Laboratories, Abbott Park, Illinois, in his poster presentation on July 20. “Comparable efficacy of once-daily dosing compared to twice daily dosing of lopinavir/ritonavir was also observed in subgroup analyses, regardless of baseline CD4-positive T-cell count or HIV-1 RNA level,” Dr. Cohen said. He also said that through the 96-week trial, researchers did not observe any clinically significant differences in safety or tolerability when the once-daily regimen was compared with twice-daily dosing. In the open-label, randomised trial, researchers had recruited patients who were antiretroviral treatment-naïve who had at least 1,000 copies/mL of HIV in serum. For the first 8 weeks of the study, all patients were on the liquid gel formulation of lopinavir/ritonavir and then all patients were switched to the tablet. All the patients were also treated with the nucleotide reverse transcriptase inhibitors tenofovir and emtricitabine. About 80% of the participants in the study were men, and more than 70% were white. Their mean age was about 39 years. “As previously noted with lopinavir/ritonavir therapy, increases in some lipid parameters were detected,” Dr. Cohen said. “These changes were largely unaffected by dose frequency with the exception of triglycerides and non-high-density lipoprotein cholesterol, which showed slightly smaller mean increases, and the low-density versus high-density ratio, which had a marginally greater mean decrease in once-daily subjects compared to twice-daily dosing.” Dr. Cohen concluded that the 96-week findings confirmed outcomes seen in 48-week studies that compared the dosing strategies and also found noninferiority with the once-daily regimen when compared with the twice-daily dosing. The study was sponsored by Abbott Laboratories. [Presentation title: Comparable Safety and Efficacy With Once-Daily (QD) Versus Twice-Daily (BID) Dosing of Lopinavir/Ritonavir (LPV/r) Tablets With Emtricitabine (FTC) + Tenofovir DF (TDF) in Antiretroviral (ARV)-Naïve, HIV-1-Infected Subjects: 96 Week Results of the Randomized Trial M05-730. Abstract MOPEB035]
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