Date: Tue, 19 Mar 1996 13:12:07 +0500 From: ghmcleaf{CONTRACTOR/ASPEN/ghmcleaf}%NAC-GATEWAY.ASPEN@ace.aspensys.com Subject: CDC AIDS Daily Summary 03/19/96 AIDS Daily Summary March 19, 1996 The Centers for Disease Control and Prevention (CDC) National AIDS Clearinghouse makes available the following information as a public service only. Providing this information does not constitute endorsement by the CDC, the CDC Clearinghouse, or any other organization. Reproduction of this text is encouraged; however, copies may not be sold, and the CDC Clearinghouse should be cited as the source of this information. Copyright 1996, Information, Inc., Bethesda, MD ************************************************************ "Panel Backs Retinitis Drug; Gilead Stock Recovers Some" "Testing Begins on AIDS Therapy Developed by Dr. Salk" "Experience of Doctor Vital To AIDS Patient" "Tuberculosis, Uncontrolled" "Impaired Immune Response After Hib Vaccination in HIV-Positive Infants" "Merck Discounts Its New Protease Inhibitor" "EEOC Permits Limited Disclosure of Employee HIV Status" "Faint Hope for Drug to Tackle Deadly Tuberculosis" "Routine Immunization in HIV: Helpful or Harmful?" "Europe's Drug Lottery" ************************************************************ "Panel Backs Retinitis Drug; Gilead Stock Recovers Some" New York Times (03/19/96) P. D5; Fisher, Lawrence M. Shares of Gilead Sciences Inc. dropped more than 20 percent Friday following news that the company's drug Vistide, being reviewed for treatment of cytomegalovirus (CMV) retinitis in AIDS patients, caused tumors in lab rats. By the end of the day, however, it was revealed that the drug had not caused cancers in monkeys or humans, and a Food and Drug Administration panel recommended the drug's approval. Experts expect the drug to be approved later this year, marking the first approval for Gilead and the first for a new class of drugs called nucleoside analogs. According to analysts, the market for Vistide may be limited by its severe side effects, namely kidney damage, though it can be lessened with the drug probenecid and intravenous hydration. Vistide's greatest advantage over foscarnet and ganciclovir, the two current drugs for CMV retinitis, is perhaps that a dose lasts longer, and a patient would thus require fewer infusions. "Testing Begins on AIDS Therapy Developed by Dr. Salk" Baltimore Sun (03/19/96) P. 2A Researchers at the University of California at San Francisco are set to begin testing in about 3,000 patients the drug Remune, an AIDS therapy developed by vaccine pioneer that attempts to boost the immune system. Often called a "therapeutic vaccine," Remune is the first immune system-based AIDS therapy to be tested at this level. "Experience of Doctor Vital To AIDS Patient" Washington Post--Health (03/19/96) P. 5; Colburn, Don A new study has found that AIDS patients of primary care doctors who are inexperienced at treating the disease die about a year sooner than those whose doctors are highly experienced. The study, conducted by researchers at the University of Washington, was based on the cases of 403 AIDS patients treated by primary care doctors at Group Health Cooperative of Puget Sound between 1984 and mid-1994. The 125 doctors were divided into three groups depending on their experience with AIDS, and researchers compared how long different doctors' patients survived after diagnosis. They concluded that experience is especially important in treating AIDS, a highly complex and relatively new viral infection. "Tuberculosis, Uncontrolled" New York Times (03/19/96) P. A22 In a New York Times editorial, the authors support spending to control tuberculosis (TB), now the leading infectious killer of adults despite available treatment. TB kills some three million people a year, and is the leading killer of people with AIDS, the editors note. Most TB cases are not treated, and once begun, treatment programs are often not completed, allowing drug-resistant strains to develop. Medicine must be taken for six months, and when health workers ensure that it is, under directly observed therapy, 95 percent of TB patients can be cured for only $11 per case in the developing world. The World Bank and the World Health Organization (WHO) have increased their budgets for TB, but most areas of the world are still inadequately treated. The WHO estimates that over the next 10 years, industrialized countries must spend $100 million a year to control TB--an investment which the editors claim "seems unconscionable" not to make. "Impaired Immune Response After Hib Vaccination in HIV-Positive Infants" Reuters (03/18/96) HIV-positive infants have a weaker response to vaccines because they are born with both humoral and cellular immunity impairments. Dr. Vicki B. Peters at Mount Sinai in New York and colleagues vaccinated 18 HIV-positive infants with a complete series of Haemophilus influenzae type b (Hib) vaccine, and a booster dose of another Hib vaccine. They found that HIV-positive infants had a lower immune response to the vaccines than healthy infants. Peters concluded HIV-infected infants may need additional doses of vaccine to provide long-term protective antibody response. "Merck Discounts Its New Protease Inhibitor" Reuters (03/18/96) Merck and Co. has announced plans to sell its newly approved drug Crixivan, or indinavir, at a discount. The cost of Crixivan will be $12 per day, compared to that of Roche's protease inhibitor Invirase, which sells for $15.89 per day. Merck said it will provide Crixivan free to some patients, and will help others find sources of reimbursement for the drug. "EEOC Permits Limited Disclosure of Employee HIV Status" Reuters (03/18/96) Employers can "allow" first-aid workers to be informed that an injured worker has AIDS only if the information is necessary to protect the employee's health, according to the Equal Employment Opportunity Commission's (EEOC) interpretation of the Americans with Disabilities Act. The EEOC noted, however, that first-aid workers should routinely attempt to protect themselves from exposure to blood or body fluids, so disclosure of an employee's HIV-positive status should not be necessary to protect the first aid worker. "Faint Hope for Drug to Tackle Deadly Tuberculosis" Reuters (03/15/96); Harris, Paul Glaxo Wellcome, one of the few major pharmaceutical companies working on the development of new drugs against tuberculosis (TB), says its research is in its early stages. According to Ken Duncan, head of Glaxo's Action TB research project--a five-year cooperation scheme with academic institutions--a new drug is "still a number of years off." Glaxo researchers are exploring several approaches to combating the disease, including the development of drugs to boost the body's immune system and attack the whole TB bacteria. Paul Nunn, chief of the World Health Organization's research and surveillance unit for TB, says he finds Glaxo's work encouraging, but criticizes the drug industry overall for ignoring certain compounds known to be effective in combating TB because of high development costs and the prospect of low profits. "Routine Immunization in HIV: Helpful or Harmful?" AIDS Clinical Care (02/96) Vol. 8, No. 2, P. 11; Singer, Mary; Sax, Paul Vaccines for pneumococcus, influenza, hepatitis B virus (HBV), and Haemophilus influenzae type-B (Hib) are recommended for patients with HIV, yet new evidence indicates that some vaccinations may stimulate HIV replication, note Mary Singer and Paul Sax of Brigham and Women's Hospital in AIDS Clinical Care. The use of vaccines has been reevaluated, however there is little conclusive data on their efficacy and potential harm. The authors note, for example, that HIV-infected individuals are at an increased risk for pneumococcal disease, but that the actual clinical efficacy of the vaccine in HIV patients is unknown. One study of pneumococcal and influenza vaccination in HIV found the pneumococcal vaccine to be cost-effective, but did not consider any adverse effects it could have on HIV progression. Influenza vaccination was not found to be as cost-effective. Meanwhile, between 35 percent to 80 percent of HIV patients are either immune to or are chronic carriers of HBV and are therefore not candidates for vaccination. Vaccination is recommended for those found to be HBV seronegative or not chronic carriers, even though the antibody response to the vaccine is suboptimal in HIV-infected people. Also, HIV patients have a higher incidence and severity of H. influenza infection, but the efficacy of the Hib vaccine is unknown. According to the authors Singer and Sax, further studies are needed to determine the efficacy of vaccines for people with HIV and the short-and long-term effects of immunization on viral load. "Europe's Drug Lottery" Journal of the International Association of Physicians in AIDS Care (02/96) Vol. 2, No. 2, P. 33; Alcorn, Keith Widely varying policies regarding the distribution of protease inhibitors within several European Union countries adversely impacts patients, contends Keith Alcorn in the Journal of the International Association of Physicians in AIDS Care. Alcorn notes that although German doctors can easily obtain the drug saquinavir from international pharmacies, doctors in the United Kingdom have had to wait for approval from the Medicines Control Agency of a compassionate release program. The bureaucracy in Spain, where local ethical agencies have delayed the approval of 3TC, can be even more cumbersome. Some patients at hospitals there have been waiting more than six months to receive the drug. In France, meanwhile, 3TC has been approved by the L'Authorisation Temporaire d'Utilisation, but only for patients who meet certain conditions, such as having CD4 counts over 50. According to Alcorn, the disparity in policies is the result of a system which is concerned only with bringing treatments to market, without any consideration to the compassionate use aspects of pharmaceutical availability.