Subject: CDC Summary 1/22/93 Date: Fri, 22 Jan 1993 07:30:20 PST (256 lines) Note: Copyright 1992, Dan R. Greening. Non-commercial reproduction allowed. sold. Copyright 1992, Information, Inc., Bethesda, MD Archive-Number: 11 AIDS Daily Summary January 22, 1993 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. Copyright 1992, Information, Inc., Bethesda, MD ------------------------------------------------------------------------ "Study Finds DDC Effective by Itself Against AIDS" Los Angeles Times-- Washington Edition (01/22/93), P. A4 (Cimons, Marlene) A new study that is expected to be released today has found that DDC is as effective--and possibly more so--than DDI in AIDS patients who are unable to tolerate AZT, according to sources familiar with the research. The National Institute for Allergy and Infectious Diseases is scheduled to release the study, which is the first to demonstrate that DDC is beneficial when used alone. The study involved 467 patients and took place between December 1990 and September 1992. About two-thirds of the patients had been diagnosed as having full- blown AIDS, said sources. The study was sponsored by the institute's Community Programs for Clinical Research on AIDS, a research program based in primary health-care settings like private doctors' practices and substance abuse clinics. The researchers investigated disease developments, including the onset of AIDS-related illnesses and deaths, and found them almost the same among groups taking DDI or DDC. The study revealed that survival time was slightly longer among patients on DDC. There were 100 deaths in the DDI group, compared to 87 in the DDC group. A memo summarizing the research said, "DDC was found to be at least as efficacious as DDI in delaying disease progression, including death, and may provide a survival advantage." The findings could lead to a new treatment option for AIDS patients who cannot tolerate AZT. Food and Drug Administration Commissioner David A. Kessler said the agency would examine the data and "consider revising the [DDC] label," and would contemplate "urging insurance companies to pay for single agent use." ------------------------------------------------------------------------ "Doctor: 'Mystery AIDS' Defies Testing" Philadelphia Inquirer (01/22/93), P. A2 (Collins, Huntly) The mysterious AIDS-like illness found in the United States may be caused by an unusual variant of HIV that is not detectable by conventional laboratory tests, said a leading AIDS researcher yesterday. Dr. Jeffrey Laurence, head of AIDS research at Cornell University, said that the number of people with this variant appeared to be exceedingly small. There is no proof that the virus is transmitted from one person to another through blood or sexual intercourse the way HIV is, he added. Laurence, who spoke to medical staff at Hahnemann University in Philadelphia, was among a group of researchers who reported puzzling HIV cases at July's International AIDS conference in Amsterdam. The researchers found patients who tested HIV-negative in laboratory tests but who had AIDS-like symptoms, including severely depressed immune systems. Since the conference, the Centers for Disease Control has detected 68 such cases of the AIDS-like illness, known as idiopathic CD4 T-lymphocytopenia. Laurence reported five cases of the condition last summer, and has found 12 additional ones since that time. He said the mysterious cases may be caused by a virus that is similar to HIV-1. He based his belief on preliminary evidence from two patients. Pictures of the patients' cells, taken with an electron microscope, showed virus particles like HIV-1, said Laurence, and research demonstrated that the genetic makeup of the particles closely resembled that of HIV. While the virus is similar to HIV, it may be different enough not to be detected on conventional lab tests. Laurence urged that more advanced tests be developed. ------------------------------------------------------------------------ "Boost for AIDS Drugs" Financial Times (01/22/93), P. 8 (Abrahams, Paul) Stock shares for Burroughs Wellcome rose sharply last week after reports of a positive trial for AZT. The trial was conducted by the National Institutes of Allergy and Infectious Diseases, which compared AZT with DDI in HIV-infected patients with late-stage disease. The study demonstrated that AZT was more effective in delaying the progress of AIDS among patients who had not previously used the drug. The trial was conducted from October 1989 to May 1992 and involved 617 patients. Among the 380 AIDS patients who had not taken AZT before, 18 percent developed a new, previously undiagnosed, AIDS-related illness or died within a year, compared with 31 percent taking 750 mg of DDI, and 29 percent on a 500 mg dose. But for those who had used AZT for eight to 16 weeks before, DDI proved more effective. For this group, 33 percent taking AZT developed a new AIDS-related condition or died within a year, compared with 11 percent on 500 mg of DDI, and 17 percent on 750 mg. The study showed that the two drugs had mixed side-effect profiles. Those taking AZT were more likely than those on DDI to experience lowered blood cell counts. Those on a 750 mg dose of DDI were more likely to develop pancreatitis than those on a 500 mg dose or AZT. The trial suggests that combination therapy will play an increasingly important role in treating HIV-related disease. ------------------------------------------------------------------------ "France's Fabius Wants Trial to Clear His Name" Reuters (01/20/93) Paris--Former French prime minister Laurent Fabius asked to be tried by a parliamentary High Court to vindicate himself from a scandal in which 1,200 French hemophiliacs contracted HIV from contaminated blood. Fabius, who served from 1984 to 1986 and is currently first secretary of the ruling Socialist Party, said he hoped that judges would not decide that too much time had elapsed for a trial to be held. In 1985, the hemophiliacs were infected by HIV-tainted transfusions before controls to screen and purify the blood stocks were introduced. Last month, members of both houses of parliament decided that Fabius and two other former ministers should be tried by the High Court on charges of neglecting to assist persons in danger. A panel of judges will convene today to determine whether there are grounds for a trial. Fabius has argued that he was not responsible for the incident because scientific knowledge about AIDS was more limited at the time. He said that if a time limit is established by the judges considering his case, he will return to parliament to press his case for a trial. ------------------------------------------------------------------------ "Chiron Diagnostics Appoints Jean-Paul Bonn Vice ..." Business Wire (01/20/93) Emeryville, Calif.--Chiron Corp. announced Wednesday that it appointed Jean-Paul Bonn as vice president, sales and marketing, for Chiron Diagnostics. This appointment is significant because Bonn has previously coordinated European marketing and new business development of AIDS and hepatitis products for Ortho Diagnostic Systems Inc., a unit of Johnson + Johnson, which has a joint business in blood screening products for HIV and hepatitis with Chiron. Before joining Ortho, Bonn worked at E.I. Du Pont de Nemours + Co. Inc., where he held a series of management positions. Some of his responsibilities included the development of new tests for HIV and HIV-1/2, clinical evaluations, product registrations, and distribution agreements. William G. Gerber, president of Chiron Diagnostics, said, "Jean-Paul has a strong technical background and is particularly familiar with the research community and diagnostic market for hepatitis and AIDS in Europe." He added, "Our tests are designed to be used to monitor therapy by quantifying the amount of virus present in patients. We have begun the process of establishing the utility of these tests for hepatitis C, hepatitis B, and AIDS treatment with opinion leaders. Jean Paul is ideally suited to lead this effort, and has the added advantage of being able to work effectively with our colleagues at Ortho to coordinate these separate but complementary businesses." ------------------------------------------------------------------------ "Some Library Patrons Want Gay-Lesbian Magazine Removed" United Press International (01/21/93) Goshen, Ohio--The gay-lesbian magazine The Advocate has evoked controversy in a small Cincinnati-area community, where patrons of a local library want officials to remove the publication from library shelves. Dave Macksam, director of the Clermont County Public Library, said three people have filed written requests to have library staff examine the magazine. He said, "We try to look at reading interests on a community basis. It was the opinion of the staff at the branch that there was a reading audience for it." One of the complaints about The Advocate was that it was "inappropriate material" for the library. However, Barbara Galik, assistant university librarian for information and research services at Miami University and Northern Kentucky University, argued, "The articles in there are quite good. If you want up-to-date information on AIDS and AIDS research that is the place to get it. We've had no complaints." Betsy Gressler, president of Stonewall Cincinnati, a gay and lesbian group, said the magazine does not contain sexually explicit photos or advertisements, but does provide information on fashion, music, and books, and also shows positive homosexual role models. "In a lot of rural areas, having access to magazines such as The Advocate is the only link to the gay and lesbian community that a lot of people have. I think any attempt to have it removed is an attempt at censorship," said Gressler. ------------------------------------------------------------------------ "The Geography of AIDS" Atlantic Monthly (01/93) Vol. 271, No. 1, P. 90 (Gould, Peter and Kabel, Joseph) Recent technology has allowed computers to model maps of the progress of the AIDS epidemic, which can be helpful as a means of education. In the early years of the epidemic, geographic information was hard to obtain because doctors thought that disclosing it might threaten the confidentiality of people's medical records. But now, AIDS cases can be reported on an appropriate geographic basis without any possibility of revealing identities, and most states today publish data on AIDS cases by county or by zip code. Researchers give the computer the number of AIDS cases in each county; the computer gives complex formulas to predict their likely distribution throughout the county. Also, the colors on the AIDS map represent geometric steps, which can capture the great variation in incidence for each location. For example, a map of Ohio will show different colors for rates of AIDS cases. The prevalence of AIDS tends to intensify in confined areas before more remote locales are infected. But maps with a predictive capability have not yet been used in epidemiology in any systematic capacity, even though the ability to predict the course of epidemics could help health-care planners in many ways. Several hospitals and health-care facilities are already overwhelmed with AIDS cases, and planning new or expanded facilities requires decisions about where to obtain scarce medical resources. In addition, maps can be motivating when animated. Teenagers and young adults are very difficult to reach in educating behavioral change. Therefore, viewing an AIDS prevalence map might help them understand that the danger of AIDS is everywhere. ------------------------------------------------------------------------ "Delayed Trial of HIV Immune Globulin to Protect Infants of Infected Mothers Is Likely to Resume" Journal of the American Medical Association (01/06/93) Vol. 269, No. 1, P. 17 (Cotton, Paul) Abbott Laboratories will no longer pursue blocking a trial of a product that may prevent the transmission of HIV from infected mothers to their infants. The group has dropped its demands to be exempt from liability in the trials of HIV Immune Globulin (HIVIG). But it may still be a full year from when a National Institutes of Health- sponsored multicenter trial was supposed to start to when the trial actually does commence. Abbott sold all rights to its HIVIG to North American Biologicals Inc., of Miami, Fla., "including raw materials, some manufacturing equipment, the know-how, everything," as of Nov. 4, according to Abbott spokeswoman Traci Lance. Mark Rosenbaum, an attorney with the American Civil Liberties Union, said it was a "textbook case" of promissory estoppel contract law, except that in this case "thousands of infants' lives and the progress of AIDS research were at stake." He said that liability "never was the real reason" for blocking the trials, as the "so-called risk" was the same when Abbott first proposed the study as when the company raised the issue two years later. Abbott had said that it needed complete indemnification because HIVIG, purified antibodies from healthy persons infected with HIV, might possibly increase the chance of a baby becoming infected. Although Abbott sold everything to North American Biologicals Inc., the NIH is reviewing applications from at least one other producer of HIVIG, the New York Blood Center, to supply it for the trial. If North American Biologicals wins, the trial could begin in the spring because phase-1 studies of the former Abbott product are completed. ----------------------------------------------------------------------- "Cats and Toxoplasmosis Risk in HIV-Infected Adults" Journal of the American Medical Association (01/06/92) Vol. 269, No. 1, P. 76 (Wallace, Mark R. et al.) The presence of toxoplasmosis in an adult HIV-infected population is unusual and appears unrelated to cat ownership or exposure, write Mark R. Wallace et al. of the U.S. Naval Hospital in San Diego, Calif. Serial toxoplasma antibody results were available for 723 patients. A total of 70 patients (9.7 percent) were positive on their initial screen; the seronegative patients were tested annually for 1 to 5 years (mean duration of follow-up, 2.1 years). Only 13 patients (2.0 percent) who were initially seronegative acquired antibodies to Toxoplasma gondii. None of the patients who seroconverted developed clinical disease. A pet history was available on 12 of 13 patients who seroconverted; only one (8.3 percent) had owned or lived in a household with a cat during the period of seroconversion. The calculated attributable risk of cat ownership/exposure for toxoplasmosis seroconversion in this population is -2.9 per 100 persons annually. Cat owners who are initially seronegative for toxoplasmosis can be assured that their pets pose them no major risk for seroconversion and possible subsequent toxoplasmic encephalitis. But patients who own cats would continue to be advised to exercise reasonable caution while emptying or otherwise working with litter boxes, as close contract with cat feces is an established means of transmission in certain settings. Daily emptying of litter boxes in addition to prompt handwashing can serve to further prevent the risk of toxoplasmosis in those who empty litter boxes, the researchers conclude. ------------------------------------------------------------------------ "FDA OKs New Fast-Track Blood Infection AIDS Drug" American Medical News (01/18/93) Vol. 36, No. 3, P. 19 The first drug to treat a blood infection in patients with advanced AIDS has been approved by the Food and Drug Administration. The drug, rifabutin, has been on a fast track through the FDA since an advisory committee gave approval last February. Clinical tests have exhibited the efficacy of rifabutin in blocking or delaying Mycobacterium avium complex, or MAC, which occurs in about 25 percent of patients in late stages of AIDS. The trials, performed on 1,100 AIDS patients, revealed that the drug decreased the rate at which patients developed MAC by almost half. Its side effects include rash and gastrointestinal symptoms, muscle and joint aches, discolored urine, and a decrease in certain white blood cells, said the FDA.