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HIV Patients Experiencing Moderate Side Effects Reported Improved

July 14, 2003
PARIS -- HIV patients experiencing moderate side effects on their antiretroviral (ARV) drug regimen reported an improvement in symptoms of depression and in overall tolerability when they substituted Abbott Laboratories' Kaletra(R) (lopinavir/ritonavir) for their current protease inhibitor (PI) or non-nucleoside reverse transcriptase inhibitor (NNRTI) in their treatment program. The data were presented today at the International AIDS Society (IAS) 2nd Conference on Pathogenesis and Treatment.

The data were gathered in the international PLATO (Performance of Lopinavir/ritonavir as an Alternative Treatment Option) trial, an open-label, randomized eight-week study. The study looked at the impact of substitution with Kaletra in the treatment regimen of patients experiencing a Grade 2 side effect on their current PI/NNRTI. Grade 2 side effects are those that result in moderate limitation in activity with no or minimal intervention/therapy required.

Patients enrolled in the PLATO study were randomized (4:1) to immediately substitute their PI/NNRTI with Kaletra at baseline (immediate substitution group), or defer the change until week four of the study (deferred substitution group). All patients remained on their original NRTIs.

These data looked at symptoms of depression, which was available for 588 patients in the study, as measured using the Center for Epidemiologic Studies Depression Scale (CES-D), a validated self-report questionnaire. Scores of 16 or higher on the CES-D have been correlated with depression.

A statistically significant (p=<0.001) mean reduction in depression score was seen by week eight in patients who substituted Kaletra for their PI/NNRTI at baseline. The prevalence of CES-D depression scores of 16 or greater at week eight ranged from 26 percent to 41 percent after substitution with Kaletra compared to a range of 41 percent to 51 percent on the baseline PI/NNRTI (nelfinavir, indinavir, indinavir/ritonavir, efavirenz, or another PI/NNRTI).

PLATO was conducted by 169 investigators in 14 countries, including Argentina, Brazil, England, Germany, Greece, Spain and the United States.

As many as one in three people with HIV may suffer from depression, according to the U.S. National Institute of Mental Health. Depression should be appropriately diagnosed and treated.

"Research shows that depression can decrease a patient's energy and may even contribute to the progression of HIV/AIDS. It is important to consider HIV drug regimens that help keep the virus undetectable and help minimize the barriers to treatment success that depression can create," said Jurgen Rockstroh, M.D., HIV Outpatient Clinic, Department of Medicine, University of Bonn, Germany.

The PLATO study also evaluated whether switching to Kaletra would positively impact tolerability while maintaining viral control (HIV RNA <400 copies/mL). Results show that at baseline, 91 percent of patients included in this analysis had plasma HIV RNA below 400 copies/mL. At week eight, 91 percent (intent-to-treat) to 97 percent (on-study) of patients who received Kaletra at baseline maintained and possibly improved their virologic control.

Patient reported data on overall tolerability to HIV treatment was measured using an augmented ACTG (AIDS Clinical Trials Group) Symptoms Distress Module and showed a statistically significant difference at week eight compared to baseline. No adverse events leading to discontinuation of study drug were observed in more than two percent of patients switched to Kaletra.

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 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.

About Abbott

Abbott Laboratories (NYSE:ABT) 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. 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, Norvir(R) and Kaletra(R).

Abbott Laboratories is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals, nutritionals, and medical products, including devices and diagnostics. The company employs more than 70,000 people and markets its products in more than 130 countries.

Abbott news releases and other information, including Kaletra (lopinavir/ritonavir) full prescribing information, are available on the company's Web site at .

Source: Abbott Laboratories

CONTACT: U.S. Media, Laureen Cassidy, +1-847-938-7743, or Media Outside the U.S., Brian Kyhos, +1-847-936-7988, or Financial Community, John Thomas, +1-847-938-2655, all of Abbott Laboratories

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