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Abbott's Kaletra(R) Tablet Dosed Once-Daily or Twice-Daily Demonstrated Similar Clinical Results Across Race and Gender Lines
Date:8/5/2008

HIV-Infected Women and Non-Whites New to Antiretroviral Therapy Respond

Similarly to Men and Whites

MEXICO CITY, Aug. 5 /PRNewswire-FirstCall/ -- Initial treatment regimens containing once-daily or twice-daily dosing of Abbott's (NYSE: ABT) protease inhibitor Kaletra(R) (lopinavir/ritonavir) tablet provided similar results for controlling the virus (reducing the amount of HIV-1) and improving the immune system (increasing CD4 cells) in women compared to men and in non-whites compared to whites, according to 48-week data presented by Abbott today at the XVII International AIDS Conference (AIDS 2008).

A retrospective sub-analysis of study M05-730 at week 48 of 96 weeks offered data on the impact of gender and race on a Kaletra-based regimen. Women and non-whites have traditionally been underrepresented in HIV studies, although these patient groups increasingly account for the vast majority of HIV infections. According to the World Health Organization, by the end of 2007, 22.5 million of the total 33.2 million people infected with HIV lived in sub-Saharan Africa. Additionally, 15.4 million of the total number of HIV-infected patients worldwide are women.

"The results showed that regardless of gender or race, Kaletra dosed once-daily or twice-daily as part of a treatment regimen achieved consistent virologic suppression in patients new to antiretroviral therapy," said Scott Brun, M.D., divisional vice president, Infectious Diseases and Immunology Development, Global Pharmaceutical Research and Development, Abbott. "Additionally, the Kaletra tablet formulation is a convenient HIV treatment option that can be taken with or without food and does not require refrigeration, which is particularly important to patients in the developing world who are disproportionately affected by HIV."

M05-730 Analysis Results

Through 48 weeks, the proportions of males and females who achieved an undetectable HIV viral load wer
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