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Once-Daily Lopinavir-Ritonavir Treatment Gains FDA Nod

ABBOTT PARK, Ill., May 2 /PRNewswire-FirstCall/ -- Abbott announced today that it received U.S. Food and Drug Administration (FDA) approval to market a once-daily dosing regimen for Kaletra(R) (lopinavir/ritonavir), a protease inhibitor used in combination with other anti-HIV medications, for the initial treatment of HIV. The new dosing regimen for Kaletra offers physicians and patients increased flexibility in managing their individual HIV treatment without sacrificing the proven efficacy of the twice-daily dosing option, in patients new to HIV therapy. This new dosing option is available in both liquid and soft gel capsule formulations.

"We are pleased to be able to provide patients with a once-daily, Kaletra- based regimen, as an alternative that provides comparable efficacy to the twice-daily dosing option in initial treatment of HIV," said Scott Brun, M.D., divisional vice president, Infectious Disease Development, Abbott. "The once- daily regimen provides enhanced flexibility for people living with HIV."

Approval for the new regimen is based on data from a clinical study conducted in 190 patients new to HIV therapy which evaluated the effectiveness of the once-daily and twice-daily Kaletra doses, both administered in combination with once-daily tenofovir and emtricitabine, over a period of 48 weeks. Results demonstrated comparable virologic responses (HIV RNA less than 50 copies per milliliter) between the once- and twice-daily dosing groups. Kaletra once-daily was generally well tolerated. In both the once- daily and twice-daily arms, the most frequent drug-related adverse events of moderate or greater intensity reported were diarrhea and nausea, although diarrhea was observed more frequently in the once-daily arm.

"The aim of HIV treatment research is to enhance patient choice and convenience without sacrificing efficacy. A Kaletra once-daily dosing regimen is an important component in initial HIV treatment options," said Joseph Gathe, Jr., M.D., F.A.C.P., lead investigator and clinical instructor at Baylor College of Medicine, and Chief of Infectious Diseases at Park Plaza Hospital in Houston, Texas.

About Kaletra
According to the updated guidelines released by a panel convened by the U.S. Department of Health and Human Services (DHHS) in April 2005, "Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents," Kaletra, in combination with zidovudine or stavudine plus lamivudine, are recommended as the preferred PI-based regimens for the treatment of patients new to HIV therapy. Kaletra is the most prescribed protease inhibitor in the United States. For more information, including Kaletra (lopinavir/ritonavir) full prescribing information, please visit .

Kaletra is always used in combination with other anti-HIV medicines to treat people with human immunodeficiency virus (HIV) infection. Once-daily administration of Kaletra is not recommended in therapy-experienced patients and has not been evaluated in children.

Kaletra should not be taken if a patient has 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) and Versed(R). In addition, Kaletra should not be taken with 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), Cialis(R) or Levitra(R) since the interaction with Kaletra may result in an increase in their related side effects. Patients should discuss all medicines, including those without a prescription and herbal preparations that they are taking or plan to take with their physician or pharmacist.

Once-daily Kaletra should not be administered in combination with Sustiva(R), Viramune(R), Agenerase(R), Viracept(R), Tefretol(R), Phenobarbitol and Dilantin(R).

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.

Source: Abbott

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