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STUDY PROVIDES ADDITIONAL CONFIRMATION THAT AZT TREATMENT IMPROVES SURVIVAL OF PEOPLE WITH AIDS

 STUDY PROVIDES ADDITIONAL CONFIRMATION THAT AZT TREATMENT
 IMPROVES SURVIVAL OF PEOPLE WITH AIDS
 RESEARCH TRIANGLE PARK, N.C., March 4 /PRNewswire/ -- Survival time appears to be increased for AIDS patients who take Retrovir(R) brand zidovudine (AZT) therapy, according to a study published in the March 4 issue of the Journal of the American Medical Association.
 The study followed 271 persons from 23 AIDS treatment centers who were enrolled by Italy's National Registry of AIDS Cases beginning in July 1987. Enrollment of new patients ended in March 1988, and they were followed until September 1990. Of the total patients observed, 159 were treated with Retrovir and 112 were not. The untreated group consisted of patients who refused or had contraindications to therapy with Retrovir.
 Data from the Registry were examined to determine one-and two-year survival rates. According to the authors, "The estimated overall median survival time for zidovudine-treated patients was 22.1 months; their estimated one-and two-year survival rates were 85 percent and 46 percent, respectively. For patients who were not treated, the median survival time was 10.6 months, and estimated one-and two-year survival rates were 46 percent and 20 percent, respectively."
 Since improved survival of patients with AIDS and advanced ARC (CD4 cell count less than 200/mm3) was demonstrated in a 1987 study (Fischl M.A., New England Journal of Medicine, 1987) survival studies have generally been evaluated using comparisons with historical cohorts of untreated patients.
 Only one other study (Moore R.D., New England Journal of Medicine, 1991) has examined long-term survival among a large sample of patients with AIDS in comparison with a contemporary group of untreated patients. In that study, based on data from the Maryland Human Immunodeficiency Virus Information Systems, state residents who received treatment with Retrovir lived a median of 25.3 months compared to 6.3 months for those who did not receive therapy. The authors of that study concluded that treatment with Retrovir, and possibly other aspects of care associated with therapy with Retrovir, appeared to make a significant difference in survival for persons with AIDS.
 THE ITALIAN EXPERIENCE
 Although Retrovir has been licensed in Italy since 1987 and available free of charge to eligible patients, not all of those who were eligible for therapy were willing to comply with the strict treatment regimen which included a program of pharmacosurveillance. This created two natural cohorts of treated and untreated patients who were similar with respect to sex, age, risk behavior and immune status at time of diagnosis.
 Unlike populations followed in previous studies, the majority of individuals followed in Italy (69 percent) had acquired HIV infection through intravenous (IV) drug use. However, because medical care in Italy is government-funded, IV drug users were as likely to receive therapy with Retrovir as those who acquired HIV infection through other modes of transmission. Thus, in contrast to other countries where IV drug users are generally in lower socio-economic brackets and have less access to timely medical care, there were comparable survival outcomes between IV drug users and those who had acquired the disease in other ways.
 For patients receiving Retrovir, the mean elapsed time from AIDS diagnosis to initiation of therapy was 2.3 months and the mean daily dosage of Retrovir was 1000 mg. Prophylaxis against Pneumocystis carinii pneumonia was not common in Italy at the time, and only nine of the Retrovir-treated individuals received secondary PCP prophylaxis, compared with two of the untreated patients.
 "Zidovudine treatment was the best independent predictor of survival," the authors said. They added that CD4/CD8 ratio at diagnosis and gender were also independent predictors of survival, with female patients appearing to have a better survival than male patients.
 The authors acknowledged, however, that possible biases of the study include imperfect matching for clinical status and better overall medical care of treated patients.
 "Our findings strongly suggest that zidovudine treatment significantly improves the survival of patients with AIDS, even if this does not exclude the possible role of other medical care factors that can be associated with zidovudine therapy," the authors said. They added that a survival benefit persisted even after adjusting for PCP prophylaxis and CD4/CD8 ratio at diagnosis.
 The authors said the study also demonstrates that, if access to therapy with Retrovir is made possible, the survival probability of intravenous drug users with AIDS treated with Retrovir may be similar to that already reported for patients with AIDS who acquire HIV infection through other risk behaviors.
 THERAPY WITH RETROVIR
 Retrovir was the first antiretroviral drug released for use in adults and children with HIV infection, and it has been commercially available in the United States since March of 1987.
 The therapy slows the progression of HIV infection, allowing asymptomatic infected individuals with impaired immunity (CD4 cell count of 500 mm3 or less) to stay free of symptoms longer and delaying progression to advanced disease for those with early symptoms. In more severely ill patients, it prolongs life and reduces the risk and severity of the opportunistic infections associated with HIV.
 The incidence of adverse events associated with Retrovir is dependent upon the dose used and the stage of HIV infection during which therapy is begun. Earlier use and lower dosages are generally associated with a lower incidence of serious adverse events, particularly hematologic events. While depression of bone marrow function continues to be the most common laboratory adverse event associated with long-term therapy, patients are generally more tolerant of the lower dosage (600 mg/day) now recommended for the treatment of advanced disease.
 Retrovir currently is available for use in more than 70 countries worldwide. Lead author of the Italian study is Dr. Stefano Vella, of the Laboratory of Virology and Centro Operativo AIDS, Istituto Superiore di Sanita, Rome, Italy.
 Burroughs Wellcome Co. is a research-based pharmaceutical company headquartered in Research Triangle Park, N.C. The company is a wholly owned subsidiary of The Wellcome Foundation Ltd. of London. Wellcome last year devoted 38 percent of its $409 million research and development expenditures to antiviral and infectious disease research.
 -0- 3/4/92
 /CONTACT: Kathy S. Bartlett, 919-248-4302, or Sharon Bickus, 919-248-8611, both of Burroughs Wellcome Company/ CO: Burroughs Wellcome Company ST: North Carolina IN: MTC SU:


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