(Reuters Health) - (Reuters Health)—In anti-HIV combination therapy, use of a once-daily lopinavir/ritonavir formulation (Kaletra, Abbott) appears as effective as twice-daily dosing, and may help improve adherence, according to researchers.
Dr. Thomas J. Podsadecki of Abbott Laboratories, Abbott Park, Illinois and colleagues studied 190 antiretroviral-naive subjects with plasma HIV-1 levels above 1000 copies per mL.
As reported in the October 1st issue of the Journal of Acquired Immune Deficiency Syndromes, the patients were randomized to receive soft gelatin lopinavir/ritonavir capsules at a dose of 800/200 mg once daily or 400/100 mg twice daily. All also received tenofovir disoproxil fumarate (TDF) and emtricitabine once daily.
Through 48 weeks, virological responses were comparable, with 70% of the once-daily group and 64% of the twice-daily group achieving HIV-1 RNA levels below 50 copies per mL. Mean increases in CD4 count were similar.
The resistance profile was also similar. No patients showed resistance to the combination therapy or to TDF, but two of the once-daily and one of the twice-daily patients demonstrated emtricitabine resistance.
The most common drug-related adverse event was diarrhea, which was seen in 16% of the once-daily, and 5% of the twice-daily group.
Abbott spokesman, Chris G. Bona told Reuters Health that using a tablet as a vehicle offers patients more convenience than soft gel capsules and, in fact, "Kaletra is now only available in a once-daily tablet formulation, requiring a lower pill count, no refrigeration, and is better tolerated in patients."
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