Being Alive - December, 1999
Walt Senterfitt
Victory! Congress Passes the Work Incentives Act of 1999.
The Senate passed a major item on the lobbying agenda of the national AIDS organizations in the early hours of November 20. The House of Representatives had previously overwhelmingly passed it. This bill was important not only to those living with HIV/AIDS but also to all Americans with disabilities. It lays the groundwork for allowing one to keep Medicare and Medicaid (MediCal) health benefits if one returns to work after being out of the workforce with a disability. Many of its provisions must be determined at the state level, however, so work remains before these new possibilities become a reality. The new law will permit states to offer Medicaid coverage, or to permit individuals to buy into it at low rates, without the previous income limit of 250% of the federal poverty level. States can now set upper income, unearned income and resource limits. The bill provides money as incentives to the states to establish infrastructure for operating this program. It also provides $250 million over five years to states for demonstration projects to assess the health and financial benefits of providing Medicaid coverage to those whose conditions have not yet deteriorated enough to create disability, thus allowing them to remain in the workforce. It is hoped that this will permit coverage of anti-HIV drugs for many people who are still able and wishing to work. The bill also extends Medicare coverage (for those who have it as a result of two years or more of disability) for up to nine years after returning to work, and at a much smaller premium than was available before ($45.50 per month vs. almost $350). This assistance will be available nationwide, even in those states which do not take the Medicaid options.
Another Victory! Increases in AIDS Funding
Congress also completed action on the federal budget on November 20, and the Health and Human Services appropriation was in the last appropriations bill. Several provisions are successes for persons living with HIV or AIDS, though nearly all of them really need to be larger. The Ryan White CARE Act got a $183 million increase and AIDS-related research at the National Institutes of Health (NIH) will rise $300 million. There will be $73 million more for prevention and $80 million in additional funding for the Minority AIDS Initiative among African Americans and Latinos. People with hemophilia who were infected with HIV from contaminated blood products will each get a one-time payment of $100,000 as part of a $75 million appropriation to the Ricky Ray Hemophilia Relief Fund. Finally there will be $20 million (200% increase) for funding health education, prevention and treatment services to address disparities in HIV health outcomes in minority as compared to white/Anglo populations, and $100 million to fight AIDS internationally.
The Food and Drug Administration (FDA) on November 2 approved Bristol-Myers Squibb's application to permit the change in indication for ddI (Videx) to once a day. It is the first nucleoside reverse transcriptase inhibitor (NRTI) that needs to be taken just once a day. Bristol's spokespersons said that the new 200 mg Videx, dosed two tablets once a day, would be available in pharmacies in December. The company stressed that "patients must take at least two of the appropriate strength tablets, to provide adequate buffering to prevent gastric breakdown of Videx." This drug has always been somewhat controversial because of its side effects and toxicities, but has held up amazingly well as a part of combination therapy regimens, in part because resistance to it happens less frequently and less quickly than to several other NRTIs.
Bristol-Myers Squibb has strengthened the warning on its drug Videx (ddI) after four patients who were on both ddI and d4T (Zerit) died recently of pancreatitis. Pancreatitis has been long known as one risk of taking ddI alone, and it may be that taking ddI together with d4T may increase that risk for some people. Bristol-Myers said that none of the deaths could be directly linked to the use of its drugs, and that three of the patients had other risk factors for pancreatitis. This potentially life-threatening condition does not always give advance notice of its coming, but most times it can be prevented by careful monitoring of one's laboratory test values.
The FDA's Antiviral Drugs Advisory Committee voted 13 to 1 on November 1 against accelerated approval of the first nucleotide reverse transcriptase inhibitor adefovir (Preveon) as a second-line therapy for those who have not responded to HAART. The drug was touted to have modest activity against 3TC-and AZT-resistant HIV. However, the panel judged that this effect has not been conclusively demonstrated, certainly not with enough force to justify accelerated approval. There is also considerable concern about the kidney toxicity experienced by a number of people who have been taking the drug. Gilead Sciences has the option of continuing its trials of this drug in order to amass more evidence for its effectiveness and long-term safety.
Liver Disease Increasingly Threatening to PWAs "HIV-infected patients who also have hepatitis-C are at increased risk for accelerated progression from chronic, active hepatitis to cirrhosis.
End-stage liver disease is now the leading cause of death among HIV+ patients at our institution." These remarks by Dr. Barbara McGovern of the Tufts University School of Medicine and the Lemuel Shattuck Hospital in Boston described her presentation at the annual meeting of the Infectious Diseases Society of America on November 19 in Philadelphia. She went on to note, "HIV patients taking HAART are at particular risk because of the drugs' potential toxicity to the liver. One third of our HIV patients with underlying liver disease have had to stop taking HAART because of liver toxicity alone."
McGovern and her colleagues conducted a retrospective chart review of all HIV+ patients who died from May 1998 through April 1999 and compared it with those HIV patients who died at the hospital in 1991. Of the 22 deaths in the 1998-1999 time period, half were due directly to end-stage liver disease while two others suffered liver damage as a significant secondary cause of death. By contrast, only four (15%) of the 27 patients who died in 1991 had end-stage liver disease.
Dr. Rainer Weber of the University Hospital in Zurich, Switzerland conducted a pilot study of 30 HIV+ persons showing that a standardized preparation of 35 Chinese herbs decreased symptoms and improved quality of life. To further explore this potential benefit, Dr. Weber then randomized 68 HIV-infected adults who were on either stable or no antiretroviral therapy, to receive either placebo or the same herb preparation. The two groups had similar baseline CD4 counts, viral loads and antiretroviral treatment histories. Follow up data were available on 53 of the participants who continued in the trial for six months.
At the completion of the six months, "no significant differences were found regarding plasma viral loads, CD4 counts, symptoms and psychometric parameters," the research team reports in the September 1 issue of the Journal of Acquired Immune Deficiency Syndromes. The incidence of side effects was greater in the group that got the herbs as compared to the group receiving placebo, entirely due to gastrointestinal symptoms.
Dr. Weber concludes that his data do not support claims that the standardized Chinese herbal formula is helpful for HIV+ individuals. However, he notes, "the Chinese herbs were administered in a Western medicine setting and [the current lack of difference in outcomes] do not necessarily address their efficacy when used in the setting where they were developed."
991201
BA991202
ÆGIS is made possible through unrestricted grants from Roxane Laboratories, the National Library of Medicine, and donations from users like you. Always watch for outdated information. This article first appeared in 1999. This material is designed to support, not replace, the relationship that exists between you and your doctor.
Copyright © 1999 - Being Alive. Permission granted for noncommercial reproduction, provided that our address and phone number are included if more than short quotations are used. Subscription lists are kept confidential. Being Alive, 621 N. San Vicente Blvd., West Hollywood, CA 90069 TEL: 310.289.2551; FAX: 310.289.9866; Email: BeiAlive@aol.com http://www.beingalivela.org/
This information is designed to support, not replace, the relationship that exists between you and your doctor.