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| |  Epivir Delays HIV Disease Progression or Death NEW ORLEANS, La., Sept. 16, 1996 -- A 54 percent reduction in the rate of HIV disease progression or death was observed in patients who added Epivir(R) (lamivudine; 3TC), rather than adding placebo, to their current treatment regimen, according to a preliminary analysis of clinical trial data presented today at the 36th meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy. The data showed that the clinical endpoint (disease progression or dath) event rate in patients adding Epivir to their ongoing treatment regimen was 9 percent (80 of 935), while the event rate in patients adding placebo was 17 percent (81 of 482). Patients accepted into the study were already being treated with one of two combination regimens which contained Retrovir(R) (zidovudine; AZT), or with Retrovir alone. Approximately 60 percent of patients entered the study while receiving Retrovir alone. These data come from the recently discontinued CAESAR (an acronym for the countries with investigational sites: Canada, Australia, Europe and South Africa) study. The study was stopped in mid-July, nearly eight months early, on the recommendation of an independent Data Safety and Monitoring Board (DSMB) following a pre-planned interim analysis of trial data. The recommendation was made based on the fact that the data exceeded the pre- specified requirements for possible discontnuation due to the superior efficacy of one treatment arm. "The significant reduction in the risk of disease progression or death seen in these data reinforce the rationale for Epivir+Retrovir as a foundation for multiple-drug HIV treatment regimens," said Richard Kent, M.D., vice president and director of worldwide clinical research for Glaxo Wellcome. Patients recruited into the CAESAR study had CD4 cell counts of 25 to 250/mm3 and were already reeiving one of three "background" treatments -- Retrovir alone, Retrovir+ddl or Retrovir+ddC. Patients were then randomized to one of three arms: current background HIV therapy plus Epivir; current HIV therapy plus Epivir and an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI); or, current HIV therapy plus placebo. The median time on study at the time of trial discontinuation was approximately nine months. A the interim review, conducted on July 15, the DSMB evaluated data on 1,892 patients. The addition of the investigational NNRTI was not shown to provide any additional benefit to that seen with Epivir. All three arms were generally well tolerated with five percent of patients receiving current therapy plus placebo, three percent of patents receiving current therapy plus Epivir and the NNRTI, and two percent of patients receiving current therapy plus Epivir, withdrawing from the study due to adverse events. In clinical trials of Epivir+Retrovir, the most commonly reported side effects included headache (35%), nausea (33%), malaise and fatigue (27%), nasal congestion and runny nose (20%), diarrhea (18%), low white blood cell counts (7.2%) and anemia (2.7%). In addition, pancreatitis was observedin 15 percent of pediatric patients in clinical trials, especially in children with advanced HIV disease who had received prior nucleoside analogue therapy. Also, the addition of Epivir, or Epivir plus the NNRTI, to the background treatment regimens resulted n no additional clinical or laboratory side effects over the control arm. The CAESAR data were presented by Dr. Julio Montaner of St. Paul's Hospital in Vancouver, British Columbia, Canada. Since the approval of Epivir in November of 1995, Epivir+Retrovir has become a widely used combination regimen for the treatment of HIV and AIDS. In addition, this combination has emerged as a widely used foundation for three drug HIV regimens. Glaxo Wellcome is a world leader in developing new treatments for HIV disease and AIDS. In addition to Epivir and Retrovir, Glaxo Wellcome's HIV portfolio includes several products indicated for the treatment of HIV-related opportunistic infections. Epivir was discovered by BioChem Pharma of Laval, Quebec, Canada. BioChem Pharma licensed the rights to develop Epivir to Glaxo (now Glaxo Wellcome) in 1990.
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