HIV AIDS INFORMATION

FDA OKs Abbott's Once-Daily HIV Drug
The Food and Drug Administration approved a once-daily version of Abbott Laboratories' (ABT) Kaletra, a protease inhibitor used in combination with other drugs for the initial treatment of HIV.

The health-care company said in a press release Monday that the new Kaletra dosing regimen will offer physicians and patients more flexibility in managing their HIV treatment, providing an alternative to the current twice-daily option. The new dosing option will be available in liquid and soft-gel capsule formulations.

Abbott said the FDA approval was based on data from a clinical study of 190 patients new to HIV therapy which compared the once-daily and twice-daily Kaletra doses, both administered in combination with once-daily tenofovir and emtricitabine, over a 48-week period.

The company said results showed comparable virologic responses between the dosing groups. Kaletra once-daily was generally well tolerated. The most frequent adverse effects reported in both dosing groups were diarrhea and nausea, although diarrhea was observed more frequently in the once-daily regimen.

According to Abbott, Kaletra is the most prescribed protease inhibitor in the U.S. It said a Department of Health and Human Services panel recommended a combination of Kaletra with zidovudine or stavudine plus lamivudine as the preferred protease-inhibitor based regimens for patients new to HIV therapy.