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AZT PATIENT POPULATION EXPANDS TO OVER 600,000 BASED ON RESULTS IN ASYMPTOMATIC HIV-INFECTED PATIENTS; BURROUGHS WELLCOME SAYS IT CAN MEET THE DEMAND

Executive Summary

Retrovir (zidovudine, AZT) efficacy results in asymptomatic HIV-infected individuals will expand the potential treatment population for the antiviral drug to over 600,000, Assistant Secretary of Health and Acting Surgeon General James Mason, MD, predicted at an Aug. 17 press briefing. "Just two weeks ago, we were able to announce findings that zidovudine significantly slows the progression of HIV infections in people with early AIDS related complex, an estimated 100,000 to 200,000 individuals. Today's announcement raises the total of people who can benefit from early use of AZT to some 600,000," Mason said. In addition to the "early use" potential beneficiaries of AZT, the Centers for Disease Control's July report estimates 102,000 people with full-blown AIDS in the U.S. * "We believe that we can meet the expected immediate demand," VP-Research David Barry said, "but I caution you by saying we don't believe the immediate demand is 600,000 patients." Barry said the company "will have sufficient warning to be able to expand whatever manufacturing [capability] that we have to meet the expected demand." On Aug. 18 the company said it had not yet stepped up production of the drug. Discussing the most recent efficacy findings of a study conducted by the National Institute of Allergy and Infectious Diseases in collaboration with Burroughs Wellcome, NIAID Director Anthony Fauci, MD, said that in asymptomatic HIV-infected individuals "with fewer than 500 T4 cells [per mm], the rate of progression to AIDS or severe ARC for those receiving treatment was roughly half the rate for participants who received placebo." Fauci reported that, based on the study results, a Data and Safety Monitoring Board recommended Aug. 16 "that the placebo arm of the study be halted for participants with fewer than 500 T4 cells and that [those] participants should be offered AZT." NIAID will continue the study for the remaining patient group "because the data from this study have shown that the short term risk of developing AIDS is negligible in asymptomatic persons with more than 500 T4 cells," Fauci said. The trial was conducted in 32 units of NIAID's AIDS Clinical Trials Group and coordinated by Paul Volberding, MD, of the University of California -- San Francisco, and San Francisco General Hospital. It included 3,200 HIV-positive volunteers, 1,300 of which had a T4 cell count of less than 500. The group of 1,300 was split into three roughly equal groups: a placebo arm; a low dose 500 mg/day arm; and a high dose 1500 mg/day arm. Of the placebo group, 38 progressed to severe ARC or AIDS, while 17 in the low dose group and 19 in the high dose group progressed to AIDS/ARC. * The adverse reactions observed in the trial showed that "toxic side effects were minimal to participants receiving either 500 mg per day or 1500 mg per day," Fauci pointed out. "With the exception of nausea that occurred in approximately 3% of the volunteers, virtually no differences in side effects were observed in persons receiving lower dose and persons receiving placebo," Fauci said. The study is the second major AZT trial to show a benefit in HIV-infected patients. The first trial, also conducted by NIAID, showed that AZT had a beneficial effect in early ARC patients with T4 cell counts between 200 and 500 ("The Pink Sheet" Aug. 7, T&G-2). Asked about the government's plans to share the costs of the drug for use in the asymptomatic group, HHS Secretary Sullivan said: "Based upon these findings today, . . . I have directed our officials in Medicare to begin reimbursement for the use of the drug." Furthermore, the Secretary said that HCFA will match all Medicaid funds paid out by the states for the drug under the new indication. However, Sullivan explained: "this is a preliminary decision." In order for "this [new indication] to be reimbursable under the usual mechanism under the law with which we have to operate, the FDA would have to examine these new findings and make a determination that this is an appropriate application for this drug." He noted that "this order that I am issuing today does in no way prejudice the future findings of the FDA," which will "take a minimum of several weeks, maybe several months." Reflecting on the study results, Fauci said: "I think this is a very important step in the scientific confirmation of what we had been hoping for -- that when one treats early, one can in fact go from what had previously been thought to be an inevitably lethal disease, at least within the framework of the time frame of this study, to have a disease that looks like it can be controllable over time . . . We are dealing here now with a controllable disease."
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