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| |  Once-Daily Lopinavir/Ritonavir as Effective as Twice Daily Dosing in Treatment-Experienced HIV Patients: Presented at IAS By Charlene Laino CAPE TOWN, South Africa -- July 23, 2009 -- Once-daily lopinavir/ritonavir is just as effective and safe as the approved twice-daily dose as part of a combination antiretroviral regimen in treatment-experience HIV-positive patients, researchers reported on July 21 at the 5th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention. But the once-daily dose led to better adherence, said Roberto Zajdenverg, MD, Projeto Praça Onze, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil. Previous research has shown that once-daily and twice-daily lopinavir/ritonavir are equally effective in treatment-naïve patients. The present study (M06-802) was designed to determine if this held true for treatment-experienced patients. The study involved 599 patients with a viral load >1,000 copies/mL who were on antiretroviral therapy. Of the patients, 300 were randomised to once-daily lopinavir 800 mg plus ritonavir 200 mg and 299 were randomised to twice-daily lopinavir 400 mg plus ritonavir 100 mg. Both groups also received 2 nucleoside/nucleotide reverse transcriptase inhibitors that were chosen according to the patient’s treatment history and resistance profile. After 48 weeks of treatment, 55% of patients taking once-daily lopinavir/ritonavir had an undetectable viral load <50 copies/mL, compared with 52% of those taking the twice-daily dose (P = NS). CD4 cell count increases were also not significantly different: 135 cells/mm3 in the once-daily group versus 122 cells/mm3 in the twice-daily group. The drugs were given in pill bottles with electronic caps so the researchers could determine whether patients took their medication as prescribed. “In this manner, we were able to determine if once-daily dosing was associated with significantly better adherence than twice-daily dosing,” Dr. Zajdenverg said. A total of 78% in both arms completed the study, and most discontinuations were due to reasons other than adverse events. Five percent of patients taking the once-daily dose and 7% of those taking twice-daily doses dropped out due to side effects (P = NS). The most commonly reported side effects associated with lopinavir/ritonavir were diarrhoea (14% in the once-daily arm vs 11% in the twice-daily arm) and nausea (3% vs 7%, respectively). [Presentation title: Lopinavir/Ritonavir (LPV/r) Tablets Is Coadministered Once- (QD) or Twice-Daily (BID) With NRTIs in Antiretroviral-Experienced HIV-1 Infected Subjects: Results of a 48-Week Randomized Trial (Study M06-802). Abstract TUAB104]
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