AIDS Treatment News
July 18, 1997

Contents:

• Health Insurance More Available: Federal Legislation Effective July 1
• Pediatric Trial of 141W94, Vertex Protease Inhibitor
• Pediatric 1592 Compassionate Use Program Begins
• World Wide Web AIDS Medical Information

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Health Insurance More Available: Federal Legislation Effective July 1 by John S. James

New Federal laws which became effective on July 1 will make it much easier for persons with preexisting medical conditions to change jobs without losing health insurance, and will also help some people who do not now have health insurance at all. The new legislation, the Health Insurance Portability and Accountability Act, became law on August 21, 1996, but many of its provisions were not effective until July 1. Some -- but not all -- of the protections of this law were already available through state law in California and some other states. (State laws may continue to provide additional protections beyond those of the Federal law.) Here we quote from the Conference Report, which was passed by both houses of Congress in early August 1996, which authoritatively explains the law. We added our own notes with explanations and additional information. There are many more details, and expert advice will be needed in some cases. But anyone with a serious illness should be aware of the major provisions of the law. Advertisement From the Conference Report: The Legislation Limits Exclusions for Preexisting Conditions. The bill prohibits employers offering health coverage and health insurers from limiting or denying coverage to individuals covered under a group health plan for more than 12 months for a medical condition that was diagnosed or treated during the previous 6 months. Once the 12-month limit expires, no new preexisting condition limit may ever be imposed on people maintaining their coverage, with no more than a 63 day gap, even if they change jobs or health plans. Employers and insurers must credit coverage of less than 12 months toward any preexisting condition exclusion under a new health plan. For example, an individual who has had coverage for six months when he or she changes jobs or health plans would face a maximum additional exclusion of 6 months, rather than the normal 12 months... The Legislation Prohibits Discrimination Against Employees and Dependents Based on Health Status. The bill prohibits employers offering health coverage to employees or dependents from excluding an employee or dependent from coverage, to drop an employee or dependent from coverage, or to charge an employee or dependent higher premiums based on that individual's health status, medical condition, claims experience, receipt of health care, medical history, genetic information, evidence of insurability (including domestic violence), or disability. Note: Employers do not have to offer health insurance at all. But if they do, their health insurer cannot exclude individuals based on their health status. They can exclude coverage for preexisting conditions, for a maximum of 12 months -- where "preexisting conditions" are only those diagnosed, treated, etc. in the last six months. (This appears to prevent insurance companies from excluding HIV infection or AIDS from coverage, if the new employee had been diagnosed over six months ago, and had received no medical attention in the last six months.) While the employer cannot ask job applicants about health status, due to the Americans With Disabilities Act, the employer's insurance company may ask about medical history -- and may exclude coverage for preexisting conditions, as described above. But many group health plans do not exclude preexisting conditions; employees should check this when they choose a plan. Also, a small employer seeking health insurance coverage usually cannot be turned down by any insurance company that sells health insurance to other small employers in that state. (This should greatly reduce insurance discrimination against small businesses believed likely to have gay employees). If a new employee does have one or more preexisting conditions (diagnosed or treated in the last six months), the time that the person was previously insured (in former jobs, but apparently not before the bill was signed) counts toward the 12-month exclusion for those conditions. However, if there was a gap in coverage longer than 63 days, insurance before that gap does not count. When an employee leaves their old job, they should be given documentation showing when they were covered by health insurance, so that they can use that time to credit against the 12-month exclusion of preexisting conditions. Dependents insured on the old job can also get this credit. An employee who turns down health insurance when they get a new job because they already have previous coverage, and then loses their previous coverage, can sometimes enroll as a "late enrollee" -- but only under certain conditions (for example, they must have stated in writing that they were turning down the new coverage because they already had coverage -- and they must request the new coverage within 30 days of the loss of the old). And with late enrollees, the exclusion for preexisting conditions can be 18 months instead of 12 months. The limitations on exclusion for preexisting conditions will often not start exactly on July 1, because they become effective for the "plan year" beginning after July 1 (sometimes even later if the plan is under a collective bargaining agreement). "The Legislation Helps Individuals Leaving or Losing Their Jobs to Maintain Health Coverage. The bill guarantees the availability of individual health coverage to `eligible individuals' who have had employment-based health coverage for at least 18 months, who are ineligible for or have exhausted their COBRA coverage, and who are ineligible for coverage under any other employment-based health plan." Note: The Federal law encourages states to pass their own laws to meet this goal. If states do not, then insurers must respond in one of several ways to offer individuals reasonable access to the insurance they sell in that state. Insurers must start selling these policies on July 1, 1997, although this can be delayed to January 1, 1998 if a state requests (or July 1, 1998 for states whose legislatures do not meet in 1997). Other provisions of the legislation (effective July 1 or earlier) include: Not taxing viatical sale of life-insurance policies, or accelerated death benefits from life insurance, if the recipient is terminally or critically ill. Allowing someone who becomes disabled within 60 days of losing their job to qualify for the 11-month OBRA extension of the 18-month COBRA coverage. Before the new law, they had to be officially disabled at the time of becoming eligible for COBRA (on the day they were fired, for example), in order to qualify for OBRA. (COBRA allows anyone, disabled or not, to continue their health plan for up to 18 months after losing their job, by paying the premiums themselves, provided that the group plan itself remains in effect. OBRA allows disabled persons to extend this for 11 months -- totaling 29 months after the beginning of their disability, at which they become eligible for Medicare. However, they must have been disabled within 60 days of the beginning of the 18-month COBRA period -- long before the OBRA coverage starts). Allowing tax-free withdrawal from IRA accounts for health care if (a) the individual has received unemployment for at least 12 weeks, in the year of the withdrawal or the previous one, or (b) for other medical expenses that exceed 7.5% of adjusted gross income. On July 1 THE WASHINGTON POST published an article by Marilyn Moon, looking at the new health insurance law and its limitations (page Z15). [AIDS Treatment News thanks Betsy Johnsen, benefits attorney with AIDS Legal Referral Panel in San Francisco, for assistance with this article.]

Pediatric Trial of 141W94, Vertex Protease Inhibitor

A new trial of the protease inhibitor 141W94 (formerly called VX-478) is seeking 210 children and adolescents between six months and 18 years old. They must have a viral load of at least 10,000 copies, and must not have taken protease inhibitors before. They will be randomly assigned to receive either the drug or a placebo, in addition to nucleoside analog treatment. This trial will look primarily for the size of the antiviral effect at 16 weeks, and its durability at 48 weeks. It will take place at medical centers in the U.S., Canada, and Europe. Another phase III study in adults started in February 1997. 141W94 is taken twice a day, without regard to food. This phase III study should not be confused with an earlier Phase I single-dose study of the same drug, in 20 HIV-infected children. For more information about trials in the U.S., physicians and parents will be able to call the AIDS Clinical Trials Information Service, 800/TRIALS-A.

Pediatric 1592 Compassionate Use Program Begins

On July 9 Glaxo Wellcome announced that its experimental antiretroviral 1592 (1592U89) will now be available "free of charge to certain pediatric patients with AIDS who are at high risk of disease progression or death despite treatment with current therapies." This program is for children six months to 14 years old who meet certain conditions regarding failure of approved treatments. To have their child considered for this program, parents should have their physician call the 1592U89 Open Label Coordinating Center at 800/501-4672, 8:30 a.m. to 5:30 p.m. Eastern time.

World Wide Web AIDS Medical Information by Tadd T. Tobias and John S. James

During the last several years, current, top-quality medical information has become much more accessible due to widespread use of computer communication. As in other fields, it takes time for people to work out the best ways to use the new tools. This article looks at AIDS World Wide Web sites which are intended primarily for medical professionals, but also are available to anyone. The most important information online includes: Rapid reports from professional conferences. In the past, presenters' abstracts were often printed for participants, but usually the only way someone who did not attend the conference could get a copy was to borrow one from a colleague who did. Now abstracts from many AIDS conferences are available through the World Wide Web, often from the day the conference begins; they can be read or printed from an office or home computer anywhere in the world, usually without charge, any time 24 hours a day. (Conferences would be more productive if the abstracts were made available *before* the meeting, so that those who attended could be better prepared to use their scarce conference time effectively. But this is still the exception, due to proprietary or competitive habits.) Another important advance is the detailed summaries from AIDS conferences, often by teams which combine leading research physicians with medical writers. Usually these reports are online within days or weeks of the meeting; some are even written overnight and then available throughout the world the next day. Very current standards of care from leading medical centers. For example, the standard of care for HIV disease at Johns Hopkins -- a top research institution which also has extensive practical experience treating thousands of HIV patients in Baltimore -- is now updated monthly online (the printed version, which has long been available, is updated annually). Medical professionals and patients alike can compare the care they are receiving with what Johns Hopkins and other major institutions are doing. Research databases, like MEDLINE and AIDSLINE.These have long been available by computer, usually by a dial-up connection -- after an account had been set up, and software obtained and installed. Now these databases and some others can be searched free by anyone, anywhere in the world, who can access the World Wide Web. There is no need to install special software, or to make arrangements in advance -- greatly facilitating access from developing countries, and also allowing near-complete anonymity for anyone who may be concerned about the confidentiality of their inquiries. [Note: We will focus on research databases in a future article.] Full text journals. Some are now online, providing searchable content, reliable access even to current issues which are often hard to find in libraries, and usually an extensive archive. But due to proprietary and marketing concerns, most journals are not online at this time, or are restricted. Some sites provide selected important medical articles, with permission. Continuing medical education (CME) courses. Medical professionals can take them for credit, but anyone can use them for their own information and education. The online format usually has the advantages of being freely available to anyone, regardless of status or geography, being available at the most convenient time for each user, and including a test which provides immediate results. Clinical trials information, many reference books, directories of services provided by different medical centers, and many other kinds of information, are also available through the World Wide Web. Often the same material can be found in print, or through telephone hotlines (which usually means that an information specialist is using the same database, so that the caller does not need to have research skills nor computer access). Compared to print publications, the online versions are usually more current, and they can be used from anywhere, whether or not a specialized library is nearby. This article will briefly review some of the major AIDS medical sites on the World Wide Web. There are hundreds of other credible sites we could have included; fortunately, most if not all of them can be reached through one or more links from the sites we have reviewed. If you know of sites not listed below which would be of interest to our readers, let us know; this article is part of a series about online AIDS treatment information, so we can add others later. AIDS Medical Sites Many of the sites listed below include links to the new treatment guidelines (which we reported in AIDS TREATMENT NEWS #274), and to the research databases of the U.S. National Library of Medicine (which we will describe in a future issue). To avoid repetition, we have often not mentioned these links in discussing the sites below. We listed links to information about major conferences in a separate section, below. Note: If you need to type in the World Wide Web addresses (URLs), note that capitalization *does* matter. Also, note that a few addresses do not include the usual 'www'. And the 'html' which appears in some addresses is using the letter 'l', not the number '1'. The Johns Hopkins University AIDS Service Web Site http://www.hopkins- aids.edu The new Johns Hopkins AIDS site is one of the best organized of the AIDS Web sites, and is likely to be one of the most useful for medical professionals. It includes: MEDICAL MANAGEMENT OF HIV INFECTION, 1997 EDITION, by John G. Bartlett, M.D. This document, 300 pages when printed in book form, is the AIDS standard of care at Johns Hopkins. It is divided into seven sections (Natural History; Laboratory Tests; Disease Prevention; Antiretroviral Therapy; Opportunistic Infections; Guide to Drugs; and Systems Review), each on a separate Web page for convenient viewing or printing. This online document is updated monthly. Case Rounds. Two cases are now discussed online, more will be added. Outcomes Research. Currently there are seven articles in this section, from cost effectiveness of antiretroviral therapy, to adherence, to managed care. AIDS Epidemiology. HIV Women's Issues. Information about the Johns Hopkins AIDS Services -- and its ongoing clinical trials. 7th Annual Clinical Care of the Patient with HIV Infection Conference. Unfortunately only two lectures are available as this issue goes to press -- and they can only be heard with special software from Microsoft, which can be downloaded but at this time runs only on Windows 95. Otherwise, all you can do is see the slides. A calendar of events and conferences. Links to other sites, including government guidelines, other U.S. government AIDS-related sites, major journals, newspapers and wire services, HIV/AIDS hotlines, and other HIV/AIDS sites. When you first get to this site, you will see a column of buttons on the left of the screen, which are links to major areas of this site, including most of those listed above. If you do not immediately see what you want, use the "Table of Contents" button to get to the site index, which provides more complete information about exactly what is available -- with links to individual articles, cases, listings, programs, or other subcategories. HIV InSite (University of California AIDS Web site) http://hivinsite.ucsf.edu (do not type www in this address) This University of California site covers various aspects of AIDS, not only treatment related. Its medical sections include: The AIDS Knowledge Base, a 1600-page textbook, with the latest updates on the site; A searchable database of AIDS clinical trials throughout the U.S., designed to search for trials for a particular patient; Treatment guidelines, medical and scientific articles, U.S. and international statistics, etc. We described this site in more detail in AIDS Treatment News #267. AIDS Program at San Francisco General Hospital http://sfghaids.ucsf.edu Information about the HIV/AIDS programs and services at the University of California/San Francisco General Hospital medical center, including treatment, research, and education. It includes a directory of the medical staff, listed by name and by specialty. JAMA (Journal of the American Medical Association) HIV/AIDS Information Center http://www.ama- assn.org/special/hiv The JAMA site, run by the American Medical Association, provides various practical information to physicians. The HIV/AIDS Information Center on this site is divided into sections including: Journal Scan, consists of certain articles about HIV disease which have been published in medical journals, selected as particularly important for educating physicians who may not be HIV specialists. Full text is available, including graphics. Free access to four databases of the National Library of Medicine: AIDSLINE, AIDSTRIALS, AIDSDRUGS, and BIOETHICSLINE. (We will describe the National Library of Medicine databases later in a separate article.) The site is developing a service to allow medical professionals to email HIV treatment questions to a panel of experts; the answers will then be published on the site as a "FAQ" ("frequently asked questions," a document listing common questions and their answers). This format has proven widely useful on the Internet as a cost-effective way of providing expert answers to peoples' questions -- for once the FAQ has been developed, most new inquiries will have already been answered and will not need more of the experts' time. Hopefully the FAQ will be available to the general public, even if the chance to ask questions is still reserved for professionals. (There is no issue of confidentiality, since identifying information would be removed from the questions before they are published.) A Global Link section has links to AIDS-related Web sites in over 20 countries. Also there are links to U.S. government sites, and academic institutions. Healthcare Communications Group http://www.healthcg.com Healthcare Communications Group enlists leading HIV experts and medical writers to write detailed summaries of major HIV conference presentations. Often these appear as a one-hour or two-hour CME (continuing medical education) training module for each day of the conference; they are made available on the Web so that anyone can use them. Credit for medical professionals is available for six months, and the conference summaries remain online for at least a year. In addition, Healthcare Communications Group organizes an annual meeting for 400 front-line HIV physicians, and publishes an online and print journal. HCG can publish online more rapidly than medical journals. For some conferences, overnight summaries are available worldwide the next morning, written by experts who work late into the night and review each other's work; for other meetings, summaries are published within weeks. This material is made available free to anyone through the Web -- and sometimes is the only readily accessible information about a major talk or panel discussion. The work is supported largely by unrestricted educational grants from pharmaceutical companies. Some of the currently available conference summaries report on the recent resistance meeting (the International Workshop on HIV Drug Resistance, Treatment Strategies, and Eradication, St. Petersburg, Florida, June 25-28 1997), the 1st National AIDS Malignancy Conference (U.S. National Cancer Institute, April 1997), the 4th Conference on Retroviruses and Opportunistic Infections (Washington D.C., January 1997), the XI International Conference on AIDS (Vancouver, July 1996), and Healthcare Communications Group's 7th Annual Symposium, a three-day meeting for front-line HIV physicians (May 1997). Other information available includes: Nutrition and Wasting in HIV, a new online CME course authored by Donald P. Kotler, M.D., June 1997. Seropositive Patient -- Initial Encounter, updated in May 1997. The new government documents on the principles of HIV therapy, and antiretroviral treatment guidelines, converted by Healthcare Communications Group so that they can be read directly on the World Wide Web, without a special download step. Healthcare Communications Group has also started an online journal, HIV JOURNAL, on its site. Medical professionals can obtain a print version of the journal by calling Medical Education Collaborative, 800/442-6632. International Association of Physicians in AIDS Care http://www.iapac.org This site includes articles from the JOURNAL OF THE INTERNATIONAL ASSOCIATION OF PHYSICIANS IN AIDS CARE, and much additional AIDS information directed both to professionals and to the public. It includes: Highlights from many conferences, both as journal articles and as additional online reports; A section on women's health issues; A section on pediatrics; A nutrition page; Information in Spanish, Portuguese, and Italian. National Library of Medicine http://www.nlm.nih.gov Free access to AIDSLINE and MEDLINE databases, as well as to other information services and publications offered by the world's largest medical library. Adult AIDS Clinical Trials Group http://aactg.s-3.com Information about the Adult ACTG, its key people, meetings, and structure and operations. It includes links to Web sites run by the various medical centers of the ACTG. Pediatric AIDS Clinical Trials Group http://pactg.s-3.com Information about the Pediatric ACTG, similar to the adult listing above. CPCRA (Community Programs For Clinical Research on AIDS) http://www.cpcra.org Materials include background information and an overview of programs including clinical trials; CPCRA papers, reports and presentations; and how to locate and contact CPCRA sites. National Institute of Allergy and Infectious Diseases http://www.niaid.nih.gov Note the link to AIDS, under Research Activities. National AIDS Treatment Advocacy Project http://www.aidsnyc.org/natap In-depth reports focusing on protease inhibitors and other antiretrovirals. Note the July 1997 edition of PROTEASE INHIBITOR USER'S GUIDE, a 38-page book for patients on adherence, side effects, food, hydration, drug interactions, etc. (not on site as we go to press); medical centers can order bulk copies without charge by calling NATAP at 212/219- 0106. Protease Inhibitor Response Project; http://www.netcom.com/~protease This site, for both physicians and patients, was set up "to gather information from patients who are taking combinations of anti-HIV drugs, especially combinations involving protease inhibitors... We are collecting stories from people who have failed protease inhibitors, or who have had unusual responses to the drugs." Examples of unusual responses: viral load did not drop rapidly after starting combination therapy; viral load rebounded after dropping; or viral load remained high but T-cell counts increased anyway. This project, started by Rick Loftus, a research associate at Gladstone Institute of Virology and Immunology, includes separate questionnaires for patients using protease inhibitors and for prescribers of the drugs, and also a section on how the information will be used. The Access Project http://www.aidsnyc.org/network/access Information on programs to help pay for HIV/AIDS drugs -- a drug by drug list of pharmaceutical company patient assistance programs, state by state information on ADAP programs and Medicaid, and descriptions of expanded access and compassionate use programs. Journals and other AIDS-related publications available online http://www.cdcnac.org/ heatlink.html http://www.aegis.com/ links.html#jrnl These lists lead to Web sites of medical journals and other AIDS-relevant publications which are available on the World Wide Web. Vanderbilt University Medical Center HIV AIDS Online Help http://www.mc.vanderbilt.edu/adl/aids_project/help.html This specialized service allows persons to ask about how to research particular questions about AIDS. Information specialists answer the questions by email. Pharmaceutical Company Sites http://www. aegis.com/links.html#Pharmaceutical Links to corporate Web sites of over 15 companies involved in AIDS. The Merck Manual http://www.merck.com The Merck corporate site includes a link to a searchable online version of this well-known medical reference. ScienceXchange http://www.sciencexchange.co m Immunology conferences' searchable abstracts, links, other information. Most immunology conferences have little focus on HIV or AIDS, where research has been dominated by virology. The AIDS community needs to work toward overcoming this separation. Conference Abstracts, Reports, and Summaries on the Web Here are Web addresses for abstracts and reports from recent AIDS conferences and meetings. International Workshop on HIV Drug Resistance, Treatment Strategies and Eradication June 25-28, 1997, St. Petersburg, Florida Report by William A. O'Brien, M.D.; http://www.healthcg.com Report by Steven G. Deeks, M.D.; http://hivinsite.ucsf.edu Others are being prepared. We have not seen the abstracts of this resistance workshop online, as of July 12, but above detailed reports are available. The one by O'Brien is somewhat less technical and may be best to read first. 7th Annual Clinical Care Options for HIV Symposium May 29-June 1, 1997, Laguna Niguel, California http://www.healthcg.com Summaries of major talks given at the meeting. National Conference on Women and HIV May 4-7, 1997, Los Angeles http://www.womenhivconf.org Program and daily highlights. The conference abstracts can be browsed or searched on: http://www.iapac.org/women/ncwh/index.shtml 1st National AIDS Malignancy Conference April 28-30, 1997, Bethesda, Maryland http://www.healthcg.com Program; searchable abstracts; daily summaries. Up to six hours of CME credit is available. Second International Conference on Nutrition and HIV Infection April 23-25, 1997, Cannes http://www.planetindustrie.com/HIVNUTRITION/Index.htm Program, abstracts, and index to abstracts. 4th Conference on Retroviruses and Opportunistic Infections January 22-26, 1997, Washington, D.C. http://www.retroconference.org Searchable abstracts; Selected lectures (voice and slides) -- special software. Unofficial summaries and reports prepared at the time of this conference are available at: http://www.healthcg.com/cme.html http://www.iapac.org, under "Conference Reports." XI International Conference on AIDS July 7-12, 1996, Vancouver http://sis.nlm.nih.gov/aidsabs.htm Abstracts, searchable by keyword, title, and/or author. Oxidative Stress and Redox Regulation May 21-24, 1996, Institut Pasteur, Paris http://notes.immunet.org/redoxabs Program and searchable abstracts. Upcoming Conferences and Meetings Here are Web sites for information about future conferences. Infectious Diseases Society of America annual meeting, September 12-16, 1997, San Francisco http://www.idsociety.org This site includes a preliminary program and general information for the IDSA annual meeting in San Francisco, apparently not including registration information. Several sessions are HIV-related. There is also a guide for abstract submission (late breaker abstracts must be received on forms provided by August 15). 37th ICAAC (Interscience Conference on Antimicrobial Agents and Chemotherapy) September 28 - October 1, 1997, Toronto http://www.asmusa.org Complete program, meeting arrangements, registration information. The keynote talk and a number of the slide and poster sessions concern AIDS. (Our experience has been that ICAAC has more valuable AIDS-related information in odd-numbered years, when the international AIDS conference is not scheduled. Abstracts may be submitted through the site, or by email, or on paper (late breaker deadline, September 5). First International Conference on Healthcare Resource Allocation for HIV/AIDS and Other Life-Threatening Illnesses November 10-11, 1997, Marriott Hotel, Washington, D.C. http://www.iapac.org Sponsored by the International Association of Physicians in AIDS Care, cosponsored by AIDS Action Council and Harvard AIDS Institute. 12th World AIDS Conference June 28-July 3, 1998, Geneva http://www.aids98.ch No program is available yet, as the program will be built around the abstracts submitted, and the deadline for abstracts is February 2, 1998. Copyright 1997 by John S. James. Permission granted for noncommercial reproduction, provided that our address and phone number are included if more than short quotations are used.