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Lopinavir/Ritonavir Recommended in Initial Treatment Protocol Of HIV

ABBOTT PARK, Ill., Sept. 5 /PRNewswire-FirstCall/ -- A panel convened by the U.S. Department of Health and Human Services (DHHS) has recommended Kaletra® (lopinavir/ritonavir), in combination with zidovudine or stavudine plus lamivudine, as a preferred protease inhibitor (PI)-based regimen for the treatment of patients new to HIV therapy, according to new treatment guidelines released recently. The selection of a drug by the panel as part of a preferred regimen was based on treatment goals, which include viral suppression, immune restoration, and tolerability.

"Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents" were developed by the Panel on Clinical Practices for Treatment of HIV Infection, convened by the DHHS, and were first published in 1996.

"The updated guidelines simplify the way physicians approach HIV treatment today," said Dan Kuritzkes, M.D., Director of AIDS Research at Brigham and Women's Hospital and Associate Professor of Medicine at Harvard Medical School. "These guidelines give practitioners and patients the most updated guidance on constructing effective treatment regimens, based on solid clinical evidence."

The Kaletra-based regimen is one of only two regimens selected as preferred by the DHHS Panel for patients new to therapy and for whom a PI- based regimen was appropriate. The preferred regimens were selected from among the 19 antiretroviral medications currently approved by the FDA, which may be used in multiple possible combinations. The goal of the Panel's treatment recommendations is to provide evidence-based guidance for clinicians and other healthcare providers who treat adult and adolescent patients living with HIV.

"HIV care is perhaps the most rapidly evolving field in medicine," said John Bartlett, M.D., Chief, Division of Infectious Diseases, at the Johns Hopkins University School of Medicine and co-chair of the DHHS Panel. "The purpose of these treatment recommendations is to assist providers with decision-making for antiretroviral agents for patients with HIV."

"The Panel's recommendations regarding Kaletra are supported by significant clinical evidence regarding durable viral suppression and effective disease management," according to Scott Brun, M.D., Global Medical Director of Abbott's Antiviral Global Project Team. "Abbott is proud of the research on both lopinavir and ritonavir, and its contributions to patients who are living with this life-threatening disease."

Important Safety Information About Kaletra

In the United States, Kaletra is indicated in combination with other antiretroviral agents for the treatment of HIV infection. This indication is based on analyses of plasma HIV RNA levels and CD4 cell counts in controlled studies of Kaletra of 48 weeks duration and in smaller, uncontrolled dose- ranging studies of Kaletra of 72 weeks duration.

Kaletra should not be used with certain medications. Taking certain other drugs with Kaletra could create the potential for serious side effects that could be life threatening. Patients should always talk to their physician or health care provider before starting new medicines, including those without a prescription and herbal preparations.

Kaletra should not be taken if a patient has had an allergic reaction to Kaletra or any of its ingredients. Various degrees of cross-resistance among protease inhibitors have been observed. In patients with hemophilia, increased bleeding has occurred with PI use. Diabetes and high blood sugar have also occurred in some patients when taking protease inhibitors. 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, which should be monitored before and during therapy. Pancreatitis and liver problems including death have been reported in some patients taking Kaletra. It is unclear if Kaletra caused these problems because some patients had other illnesses or were taking other medications. Monitoring of liver enzymes in some patients should be considered, especially during the first several months of therapy.

Kaletra is not a cure for HIV infection. People treated with Kaletra may continue to develop illnesses associated with advanced HIV infection, including opportunistic infections. Kaletra has not been shown to reduce the risk of passing HIV to others through sexual contact or blood contamination. Patients should continue to practice safe sex and should not use or share dirty needles. In adults, the most commonly reported, Kaletra-related side effects of moderate to severe intensity are: abdominal pain, abnormal bowel movements, diarrhea, feeling weak/tired, headache and nausea.

Under accelerated review, the U.S. Food and Drug Administration approved Kaletra for marketing on September 15, 2000. Kaletra received full FDA approval on November 27, 2002. Abbott also has obtained marketing approval for Kaletra in Canada, Japan, the European Union, throughout Latin America and in additional countries around the world.

Kaletra is now the most prescribed protease inhibitor in the United States. For more information, please visit https://www.kaletra.com/ .

Source: Abbott Laboratories

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