HIV Treatment Bulletin - Vol. 5, No. 7, August/September 2004

Abbott Laboratories has submitted a supplemental New Drug Application to both the US Food and Drug Administration (FDA) and a Marketing Authorisation variation to the European Medicines Agency (EMA), seeking approval of once-daily dosing for its protease inhibitor (PI) Kaletra® (lopinavir/ritonavir).

The submission package includes data from a clinical study in which once-daily Kaletra had comparable efficacy to twice-daily Kaletra, both dosed in a regimen containing tenofovir and emtricitabine, in treatment-naïve patients.

Among patients who participated in the study submitted, Kaletra was generally well tolerated. In the 48-week study comparing a Kaletra once-daily vs. twice-daily based antiretroviral regimen, the most frequent drug-related adverse events of moderate or greater intensity reported were diarrhoea and nausea.

Diarrhoea was reported more frequently in patients on once-daily therapy (16%) versus patients on twice-daily therapy (5%).

Source: Abbott press release

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