Longest Study of Kaletra(R) (Lopinavir/Ritonavir) Based Regimen Demonstrated Favorable Resistance Profile for Patients Through Six Years of Initial HIV Therapy WASHINGTON, Nov. 1 /PRNewswire/ -- Study data presented showed no primary protease inhibitor (PI) resistance was reported in anti-retroviral-naive patients taking a Kaletra(R) (lopinavir/ritonavir)-based regimen through six years (300 weeks) of therapy. The data, presented at the 44th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), also showed the majority of patients taking Kaletra in combination with other antiretroviral agents maintained an undetectable viral load, (amount of virus in the blood) of less than 50 copies per milliliter, as measured by HIV RNA, through six years of therapy. "We have come a long way in treating HIV for many individuals," said Constance Benson, M.D., professor of medicine, University of Colorado Health Sciences Center, Division of Infectious Diseases. "Kaletra, as part of an initial treatment regimen, is a good example of how far we have come in being able to provide patients with long-term HIV treatment options that include durable viral suppression and a favorable resistance profile." Data from the randomized, uncontrolled, prospective Phase II study of 100 treatment-naive patients taking Kaletra in combination with lamivudine (3TC) and stavudine (d4T) show that of 18 patients out of 28, who met the criteria for resistance testing and who had resistance data available through 300 weeks, none demonstrated evidence of resistance to lopinavir (0/18) or stavudine (0/18). Three patients (3/18) demonstrated lamivudine resistance. In addition, 61 percent of patients (61/100) had an undetectable viral load (HIV RNA less than 50 copies per milliliter) and 63 percent (63/100) had HIV RNA less than 400 copies per milliliter, using an intent-to-treat analysis, which categorizes any patient who does not complete the study as a treatment failure. Of the 63 patients remaining on treatment at week 300, 100 percent (63/63) had HIV RNA less than 400 copies per milliliter. The low viral loads were accompanied by increases in CD4 cell counts. These data include patients with the most advanced disease (those with baseline CD4 cell count less than 50 cells per cubic millimeter). CD4 cell counts increased consistently over the 300-week period, with an average increase, from baseline, of 595 cells per cubic millimeter observed for all patients remaining in the study. Patients with the most advanced disease (n=16) had an average CD4 cell count increase of 568 cells per cubic millimeter. "There are few HIV clinical trials with six years of data, and we are encouraged that no primary protease resistance has been seen in patients taking Kaletra as part of their initial treatment regimen over the extended duration of this trial," said Scott Brun M.D., divisional vice president, Infectious Disease Development, Abbott. "Approaching six years of clinical study, a Kaletra-based regimen demonstrated its ability to meet the pressing needs in HIV therapy, long-term viral suppression, immunological benefit and tolerability." Patients in this open-label study, in which there was no comparator group, were given one of three doses of Kaletra in addition to the nucleoside analogues stavudine and lamivudine. After 48 weeks of therapy, all patients were converted to the same dose of Kaletra (400/100 mg twice-daily) with stavudine and lamivudine. Kaletra was generally well tolerated through 300 weeks of therapy. The most frequent adverse events were diarrhea, nausea and abnormal fat distribution. Non-fasting lipid elevations were reported. At week 300, Grade 3 total cholesterol elevation was observed in six percent of study patients. No Grade 4 total cholesterol elevation was observed. Grade 3 or Grade 4 triglyceride values were observed in 10 percent of patients. A minority of patients in this study employed appropriate lipid lowering agents to treat these elevations through week 300. A decrease in total cholesterol and triglycerides were observed in these patients. Additional Information About Kaletra Kaletra is always used in combination with other anti-HIV medicines to treat people with human immunodeficiency virus (HIV) infection. Kaletra should not be taken if you have had an allergic reaction to Kaletra or any of its ingredients, including lopinavir or ritonavir. Taking Kaletra with certain drugs can cause serious problems or death. Kaletra should not be taken with dihydroergotamine, ergonovine, ergotamine, and methylergonovine such as Cafergot(R), Migranal(R), D.H.E. 45(R), Ergotrate Maleate, and Methergine, as well as Halcion(R), Hismanal(R), Orap(R), Propulsid(R), Seldane(R), Versed(R), Rimactane(R), Rifadin(R), Rifater(R), Rifamate(R), Mevacor(R), Zocor(R), or products containing St. John's wort (Hypericum perforatum). Particular caution should be used when taking Viagra(R), since the interaction with Kaletra may result in an increase in Viagra-related side effects. Discuss all medicines, including those without a prescription and herbal preparations you are taking or plan to take, with your doctor or pharmacist. Pancreatitis and liver problems, which can be fatal, have been reported. Patients should tell their doctor if they have had liver disease such as hepatitis. In patients taking protease inhibitors, increased bleeding (in patients with hemophilia) and diabetes/high blood sugar have occurred. Changes in body fat have been seen in some patients receiving antiretroviral therapy. Some patients receiving Kaletra have had large increases in triglycerides and cholesterol. Varying degrees of cross-resistance among protease inhibitors have been observed. In clinical trials, the most commonly reported side effects of moderate or severe intensity were: abdominal pain, abnormal bowel movements, diarrhea, feeling weak or tired, headache and nausea. This is not a complete list of reported side effects. Kaletra oral solution contains alcohol. Kaletra does not cure HIV infection or AIDS and does not reduce the risk of passing HIV to others. About Abbott Abbott has been a leader in HIV/AIDS research since the early years of the epidemic. In 1985, the company developed the first licensed test to detect HIV antibodies in the blood, and remains a leader in HIV diagnostics. Today, Abbott retroviral and hepatitis tests are used to screen more than half of the world's donated blood supply. To treat those with HIV, Abbott scientists have developed two protease inhibitors. Kaletra is the protease inhibitor market share leader in Europe, and is the most prescribed protease inhibitor in the United States. Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 55,000 people and markets its products in more than 130 countries. Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com/. Outside of the U.S., health care professionals can access additional information on Kaletra at http://www.kaletra.com/. DATASOURCE: Abbott Laboratories CONTACT: Nicole Wesley, US Media, +1-847-935-9877, cell +1-847-772-3209, Media Outside the U.S., Michelle Johnson, +1 847-935-0011, or cell +1-312-213-6140, Financial Community, Larry Peepo, +1-847-935-6722 Web site: http://www.abbott.com/ Company News On-Call: http://www.prnewswire.com/comp/110328.html

Copyright