PRNewswire- -December 18, 2001

"Although resistance may be observed with longer study, the fact that it has not yet been detected in naive patients treated with a Kaletra-based regimen through 96 weeks is encouraging," said Eugene Sun, M.D., vice president, anti-infective and antiviral drug development at Abbott Laboratories. "Kaletra continues to exceed our expectations in ongoing studies and in clinical practice since its approval last year."

Study M98-863 is a randomized, double-blind, Phase III study of 653 HIV treatment-naive patients taking either Kaletra (N=326) or nelfinavir (N=327), in combination with stavudine (d4T) and lamivudine (3TC). Patients with detectable HIV (>400 copies/mL) at Week 24 through Week 96 were identified, and of those with viral isolates that could be analyzed, none (0/40) in the Kaletra arm had protease inhibitor resistance to lopinavir, compared to 33 percent (28/84) of patients in the comparator arm. Additionally, resistance to 3TC was detected in 38 percent of viruses (15/40) from patients in the Kaletra arm, compared to 82 percent of viruses (69/84) from patients in the nelfinavir arm.

Observing Protease Mutation Patterns Associated with Lopinavir Resistance Abbott Laboratories is conducting additional studies, which are retrospective, observational and prospective, that are designed to collect information related to protease mutation patterns associated with lopinavir resistance. Results from these studies will enable HIV treaters to better understand patients' virologic response to subsequent therapies, should they become resistant to a Kaletra regimen.

"To date, resistance to Kaletra when used as the first PI-based regimen has not been identified in any of Abbott's ongoing clinical trials," said Barry Bernstein, M.D., medical director, antiviral drug development, Abbott Laboratories. "We hope the additional studies will provide us with information to better understand the potential resistance patterns of Kaletra."

Kaletra Regimen Suppresses HIV Through Three Years in Patients New to Treatment

In July at the International AIDS Society Conference, Abbott presented three-year follow-up data in antiretroviral naive patients taking Kaletra. In an ongoing open-label study of 100 patients, Kaletra, in combination with two nucleoside reverse transcriptase inhibitors (NRTIs), provided viral suppression through 132 weeks of treatment, with 79 percent of patients achieving undetectable viral levels (<400 copies/mL). These results were based on an intent-to-treat (ITT) analysis, where non-completers were considered treatment failures. By week 132, 17 patients discontinued the study. Of the 17 who discontinued, five were due to Kaletra-related side effects. The most common drug-related side effects of at least moderate severity were diarrhea, nausea, asthenia (feeling weak or tired) and headache. Additionally, this study was designed to evaluate different doses of Kaletra. At 48 weeks, all patients were converted to an open-label regimen with the approved dose of Kaletra in addition to other ARV therapy.

"We continue to be pleased with the long-term performance of the Kaletra- based regimen in this study," said Charles Farthing, M.D., Medical Director and Principal Investigater of the AIDS Healthcare Foundation. "At almost three years, patients continue to have their virus suppressed and are maintained on therapy."

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 a controlled study of Kaletra of 24 weeks duration, and in smaller open-label studies of Kaletra of 72 weeks duration. The 72-week studies were designed to evaluate different doses of Kaletra and had no comparator groups. At present, there are no results from controlled trials evaluating the effect of Kaletra on clinical progression of HIV.

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 healthcare provider before starting new medicines.

Kaletra should not be taken if a patient has had an allergic reaction to Kaletra or any of its ingredients. Cross-resistance to other protease inhibitors has been observed. Increased bleeding in patients with hemophilia, and diabetes and high blood sugar has 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. Pancreatitis and abnormal liver function have been reported in patients receiving Kaletra.

Kaletra is not a cure for HIV infection. People treated with Kaletra may continue to acquire 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 severity are: abdominal pain, abnormal stools, diarrhea, feeling weak/tired, headache, nausea and vomiting.

Abbott Laboratories 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 the leader in HIV diagnostics. Abbott retroviral and hepatitis tests are used to screen more than half of the world's donated blood supply. With Kaletra, Abbott has developed two protease inhibitors, and also offers nutritional products that meet the unique dietary needs of people living with HIV.

Under accelerated review, Kaletra was approved for marketing by the U.S. FDA on Sept. 15, 2000.

Abbott Laboratories is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceutical, diagnostic, nutritional and hospital products. The company employs 70,000 people and markets its products in more than 130 countries.

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

011218
PR011235

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2001. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .