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Background: Kaletra is a coformulation of lopinavir (LPV), an HIV protease inhibitor, and ritonavir (r), which inhibits CYP3A, providing increased plasma levels of LPV. Clinical trials of LPV/r are ongoing in HIV infected patients with various levels of prior treatment experience. Data on long term outcomes, however, are limited.
Methods: One hundred antiretroviral (ARV) naïve patients were treated with d4T/3TC and one of 3 doses of LPV/r. After 48 weeks, patients began open-label treatment with LPV/r 400/100 mg BID with continued follow-up every 3 months.
Results: Mean baseline (BL) VL was 4.9 log10 copies/mL and mean BL CD4 count was 338 cells/mm3. At week 132, 83/100 patients remained on study drug. Five patients (5%) have discontinued therapy due to LPV/r related adverse events. The most common drug related adverse events (AEs) of at least moderate severity were diarrhea, nausea, asthenia, and headache. The mean increase from baseline to week 132 in CD4 cell count was 385 cells/mm3. Using an intent-to-treat analysis with noncompleters considered failures (ITT NC=F), 79/100 patients (79%) had VL < 400 copies/mL at week 132. Among patients enrolled long enough to have reached week 144, 35/43 (81%) had VL <400 copies/mL (ITT NC=F). Analyses using an ultrasensitive viral load assay (< 50 copies/mL) are in progress for the week 144 visit, and data will be presented on all 100 patients enrolled.
Summary: Kaletra based therapy demonstrated antiviral activity and was generally well tolerated in ARV naïve patients through 144 weeks.
Abstract provided by Abbott Laboratories
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