Abbott Laboratories' Kaletra(TM)Continues To Suppress HIV After Nearly Two Years in Patients New to HIV Therapy
TORONTO, Sept. 17 /PRNewswire/ -- Data presented at the 40th Interscience Conference on Antimicrobial Agents and Chemotherapy show Abbott Laboratories' protease inhibitor (PI), Kaletra(TM) (lopinavir/ritonavir), used in combination with other antiretroviral therapy for the treatment of HIV, continues to provide effective viral suppression for almost two years in the majority of patients new to HIV therapy. After 96 weeks of therapy with Kaletra, 83 percent of patients (83 of 100) had undetectable levels of virus (<400 copies/mL). These data were based on an intent-to-treat (ITT) analysis, which captures data on all study participants. Participants with missing data at 96 weeks were considered treatment failures. This ongoing Phase II study (M97-720) was designed to evaluate different doses of Kaletra and had no comparator group.
Also presented at the meeting were results from another analysis of the same study from patients that continued on treatment at 96 weeks. On treatment analysis (OT) captures data for patients who remained on treatment and had results at a particular time point, therefore results from OT analyses are typically higher than results from ITT analysis. Of these patients, 96 percent (83 of 86) had undetectable levels of virus (<400 copies/mL). Only two percent (two patients) discontinued due to Kaletra-related
side effects. The total discontinuation rate was 14 percent. ``We are impressed with the results of this ongoing study,'' said Constance Benson, M.D., professor of medicine in infectious diseases, University of Colorado Health Sciences, Denver, and investigator in the study. ``These data speak to the 96-week response to Kaletra in patients who were new to HIV therapy.''
This study was conducted among 100 patients new to HIV therapy who were placed in two groups and were randomly assigned a blinded dose of Kaletra at the start of the study. Thirty-two patients in Group I received either a 200/100mg or 400/100 mg dose of lopinavir/ritonavir twice daily and 68 patients in Group II received either a 400/100 mg or 400/200 mg dose twice daily. All patients took Kaletra in combination with d4T (stavudine) and 3TC (lamivudine). Between weeks 48 and 72, patients in both groups converted to open-label 400/100 mg dosing of Kaletra twice daily. The most common side effects were diarrhea, nausea, asthenia (weakness) and headache.
``We are encouraged by the discontinuation rate in this study,'' said Eugene Sun, M.D., head of antiviral drug development at Abbott Laboratories. ``Even after two years, patients continue to experience viral suppression.''
Under accelerated review, Kaletra was recently approved by the U.S. FDA for marketing on Sept. 15, 2000. Abbott also has submitted applications seeking marketing approval in Australia, Brazil, Canada, Mexico, New Zealand, South Africa, Switzerland and in Europe. Regulatory submissions in other countries will follow throughout the year.
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. The72-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 have 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 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. 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 has been providing Kaletra to patients in markets worldwide since the fall of 1999 through an Early Access Program. The Early Access Program gives patients who do not have other viable treatment options access to this treatment. With the recent approval of Kaletra by the U.S. FDA, Abbott continues to provide Kaletra to patients in the United States who participated in the program during a two-month period while they obtain coverage for the medication. Kaletra will continue to be available through Abbott's Early Access Program in many countries other than the United States, where it is pending local regulatory approval and market availability.
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.In addition to conducting its own aggressive research to fight HIV and AIDS, Abbott continues its strategic alliance with Triangle Pharmaceuticals to develop and market promising antiviral drug therapies.
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