MEXICO CITY--6 Aug--PRNewswire-AsiaNet/InfoQuest HIV-Infected Women and Non-Whites New to Antiretroviral Therapy Respond Similarly to Men and Whites 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 datapresented 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 of2007, 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 requirerefrigeration, 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 were similar. In addition, the proportions of whites and non-whites who achieved an undetectable HIV viral load were similar. Specifically, 72 percent of women and 78 percent of men, and 75 percent of non-whites and 77 percent of whites had undetectable HIV viral loads (less than 50 copies/mL) at 48 weeks. CD4+ cell count mean increases over 48 weeks were similar for females and males, independent of baseline CD4+ cell count, except among women with baseline CD4+ cell counts of fewer than 50 cells/mm3, who experienced statistically significant greater mean increases in CD4+ cell counts than males. In addition, CD4+ cell count mean increases over 48 weeks were similar for whites and non-whites. At 48 weeks, the overall rate of moderate to severe and related adverse events of diarrhea was 15.8 percent. A similar rate of diarrhea was observed in whites (17.8 percent), while non-whites experienced a rate of 9.7 percent. "This sub-analysis of M05-730 provides additional clinical information on race and gender response with Kaletra," said Joseph Gathe, Jr., M.D., clinical instructor, Department of Internal Medicine, Baylor College of Medicine. "The information can help physicians in making treatment decisions for the patient populations most affected by HIV." About the M05-730 Study -- 48-week Data Design and Primary Endpoints: -- M05-730 study is a 96-week Phase III open-label, randomized, multi-center, multi-country study that enrolled 664 ARV-naive patients with HIV-1 RNA >1000 copies/mL and any CD4+ T-cell count. Patients were randomized equally to lopinavir/ritonavir 800/200 mg once-daily soft gel capsule (SGC), 400/100 mg twice-daily (BID) SGC, 800 mg/200 mg once-daily tablet or 400/100mg twice-daily tablet for eight weeks. All patients also received emtricitabine (FTC) 200 mg once-daily and tenofovir disoproxil fumarate 300 mg once-daily. At week eight, all patients receiving SGC were switched to the tablet formulation of Kaletra, matching their previous dosing schedule of once- or twice-daily. -- The primary efficacy endpoint was the proportion of patients with HIV-1 RNA