Kaletra impressive 48-week HIV reduction

US health care major Abbott Laboratories says that data from a trial of its protease inhibitor Kaletra (lopinavir/ritonavir) indicate that once- and twice-daily dosing regimens offer comparable benefits in terms of viral load reduction in HIV-1 infected patients. Specifically, 48-week results from the study, which is examining Kaletra in combination with tenofovir/emtricitabine, showed that the target viral load of less than 50 copies/ml was achieved by 77% and 76% of the two groups, respectively.

The trial, which was discussed at the 15th Conference on Retroviruses and Opportunistic Infections in Boston, USA, is a 96-week examination of the two Kaletra regimens in 664 ARV-naive patients with HIV-1 RNA of less than 1,000 copies/ml. Participants were randomized to receive once- or twice-daily doses of the drug in tablet or soft-gel capsule formulations in combination with daily tenofovir/emtricitabine. After eight weeks, all patients in the soft-gel group were switched to the equivalent tablet dosage of Kaletra.

In addition to the comparable viral load reductions, the two dosing regimens were similar in terms of the absence of protease and tenofovir associated-resistance. Both dosing schedules also demonstrated comparable tolerability, with 15% and 17% of the two groups, respectively, experiencing moderate to severe diarrhea.