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Issue #130: June 22, 1997
FASTFAX is available by fax in the 215 and 610 area codes at no cost, or by mail anywhere for $20.00 per year, by calling 215-545-6868, and by E-mail by contacting and type the message SUBSCRIBE in the message section. Sources for some information in this issue include AIDS Action Council, Associated Press, Los Angeles Times, NIAID News, Treatment Action Group.
U.S. formally recommends early combo therapy
Congress set to weaken Medicaid
AACO to set case management standards
TPAC seeks PWAs for interviews
U.S. formally recommends early combo therapy
New treatment guidelines for Americans living with HIV recommend an aggressive three-drug blend as the most effective therapy.The report from a federal task force urged treating patients early with a combination of three anti-viral agents, calling the use of two "less than optimal" and rejecting altogether treatment with only one drug.
"The preferred regimen ... is two nucleoside analogues [a category of AIDS drugs that includes AZT, 3TC and d4T] and one potent protease inhibitor," the guidelines stated.
The Panel on Clinical Practices for Treatment of HIV infection, a three-year partnership between the U.S. Public Health Service and the Henry J. Kaiser Family Foundation, reviewed the current scientific knowledge regarding HIV and treatment of the disease before issuing its guidelines for doctors and patients.
The guidelines were prompted by clinical studies proving that a combination of three drugs offers the best hope of suppressing the virus and helping HIV patients maintain a healthy immune system. But sorting out which of the many drug combinations are best for which type of patients has added complexity and confusion to HIV treatment, the experts said.
"Combination therapy is the most effective ... treatment should be aggressive. Therefore, three-drug therapy is the preferred choice, and any drug regimen that does not achieve maximum viral suppression is not optimal," the panel said.
The triple blend offered "a high chance" of completely suppressing replication of HIV, it added.
However, the panel did not address the cost of fighting HIV with a trio of drugs. Some protease inhibitors can cost more than $6,000 a year just for one drug, while AZT and other nucleoside analogues can run as high annually as $3,000 each.
The clinical practice guidelines, the first since the AIDS epidemic exploded 15 years ago, were developed by public health officials, AIDS doctors and scientists.
Dr. Anthony Fauci, director of Allergy and Infectious Diseases at the National Institutes of Health and a co-chairman of the panel, said decisions about treatment for people with HIV should still be guided by regular monitoring of the amount of HIV in the patient's blood (viral load) and the number of CD4 cells that fight infection.
One exception to the panel's three-drug recommendation was the use of AZT alone to prevent HIV transmission from a pregnant woman to her baby in cases where the mother did not otherwise require anti-viral therapy for her own treatment.
Improper use of the AIDS drugs, the authors warned, can "do more harm than good."
"We have to make sure that practitioners know these are the standards of care," said Dr. John G. Bartlett, a Johns Hopkins University medical professor and co-chairman of a panel that drew up the guidelines. "There have been mistakes made in the past."
The guidelines detail when patients infected with HIV should be started on the demanding and expensive three-drug cocktail that has been successful in suppressing the disease in thousands of patients. It also suggests what doctors and patients should do if a selected drug combination fails to work.
The Guidelines recommend starting treatment with three drugs and changing at least two drugs when there are indications that treatment is failing, such as when HIV levels in the blood increase. Treatment with only two drugs, in general, is considered less than optimal.
However, the 11 drugs now available have slightly different chemical structures and the reaction of patients can vary widely, the panel said.
A key message of the guidelines, the experts said, is that once patients start using the drugs, the treatment must be relentless, aimed at a knockdown blow that suppresses the virus and keeps it down as long as possible.
"There has been confusion over the use of these drugs," said Dr. Eric P. Goosby, director of HIV/AIDS policy for the Health and Human Services Department. "Physicians without expert guidance are at risk of unintentionally doing harm."
"A little bit of treatment won't work," said Bartlett. "Once you've decided to treat, you must be aggressive."
"Considerable uncertainty exists among patients and their physicians" about when and how best to use new HIV drugs, Fauci said.
"One thing you don't want to do is give the wrong dose," said Fauci. "You could do more harm than good."
This is one of the mistakes doctors have made in the past, the panel said. Philadelphians living with HIV disease have strongly criticized the state's new HealthChoices Medicaid managed care program, because it sets no formal standard of HIV care and has refused to measure the experience level or competence of Medicaid doctors approved for treating AIDS.
Starting the drug treatment locks patients into an expensive program with frequent visits to a doctor, the threat of debilitating side effects, and an inflexible life style built around taking the next pill.
The combination of drug treatment calls for two to three drug sessions daily, involving 15 to 20 pills that have a wholesale cost of $10,000 to $12,000 a year.
Some of the drugs or combinations can cause nausea, vomiting, diarrhea, pain in the feet, kidney stones and bone marrow suppression. These side effects sometimes discourage patients from continuing the therapy.
"It is not a trivial matter to put one on multi-drug therapy," said Fauci. "It changes one's lifestyle."
The recommendations also stressed that the decision to begin drug-combination therapy in asymptomatic patients "is complex, and must be made in the setting of careful patient counseling and education."
Health and Human Services Secretary Donna Shalala praised the panel for its efforts.
"We are providing much-needed guidance to patients and medical practitioners ... at the same time, we recognize that these new medical guidelines raise important public policy issues and we're working rapidly to address them," she said.
AIDS activists welcomed the guidelines -- which are not binding on health practitioners -- but were concerned that the cost would make the recommended standard of care inaccessible to many people.
"For these guidelines to truly make a difference there must be a commitment from both the public and private sector to find the resources to allow all people the ability to access the best treatment available," the National Association of People with AIDS said in a written statement.
Officials of the AIDS Action Council, an AIDS lobbying organization, applauded the guidelines but said they are meaningless unless the government assures that all patients can get the expensive drugs and other treatment they require.
"The federal government and society at large needs to assure that the hope of this therapy is available to all people with HIV," said Jose Zuniga, of AIDS Action.
He noted that the guidelines call for aggressive treatment with the expensive drugs early in the disease, but that federal funds are not available to many patients until they actually develop AIDS.
AIDS Action and other AIDS activists have called for the expansion of Medicaid eligibility to people in early, asymptomatic stages of infection, and for additional funds for the Ryan White Care Act, which supports numerous AIDS treatment programs.
The coverage gap "directly threatens thousands of people with AIDS across the country," said Daniel Zingale, AIDS Action executive director. "At a moment's notice, these individuals may be unable to access the treatments they require to remain alive and healthy."
Members of the Treatment Action Group (TAG), a non-profit AIDS research and treatment advocacy group in New York City, offered strong praise for the new guidelines on AIDS therapy.
According to TAG's President Barbara Hughes, "In the last two years, AIDS treatment has undergone a revolutionary transformation. People living with HIV can expect much longer, healthier lives than was the case even a short while ago. These guidelines will strengthen our struggle to ensure that HIV-infected individuals have access to the best current standard of care."
Spencer Cox, Director of TAG's Antiviral Project, and TAG Policy Director Mark Harrington served as members of the PHS task force which developed the guidelines.
According to Harrington, "the new PHS guidelines serve a threefold purpose: first, to provide guidance to physicians and people with HIV in making the best available treatment decisions, second, to strengthen the basis for third-party payment for combination antiretroviral therapy and viral load monitoring, and third, to lay out the research agenda to fill the gaps in our current knowledge about when to start antiretroviral therapy and how to manage patients who are no longer benefitting from current drugs."
Cox added, "Past approaches to HIV treatment used inadequate therapy by giving patients just one or two drugs, which weren't strong enough to maximally suppress HIV. As a result, most patients rapidly developed resistance to the treatments and their immune system damage continued to progress. Under the new model, potent triple combination therapies are applied to reduce HIV levels beneath the limit of detection of current viral load tests, slowing down or stopping immune system damage and delaying or preventing the emergence of drug resistance. The new guidelines also recognize that treatment must be tailored to one's individual readiness to start therapy and stick with it, one=s viral load, immune status, and symptoms, and one's treatment history."
Gregg Gonsalves, TAG's Director of Legislative Affairs, also noted that the new treatment guidelines would support efforts to increase government and private-sector funding for AIDS treatment. "These guidelines make clear the new consensus that HIV treatment needs to occur earlier in the course of disease and more aggressively than has previously been the case, and should include multiple antiretroviral drugs and regular laboratory monitoring. As publicly funded health care programs struggle to decide what should be covered, these guidelines will define the minimally acceptable standard of treatment."
But Harrington cautioned that "unequal access to health care hinders our ability to ensure that all HIV-infected people receive state-of-the-art AIDS treatment. AIDS deaths dropped last year by 12%, but we could do much better. Women, African-Americans, Latinos and Latinas, children and adolescents, and prisoners, among others, continue to be denied access to the best treatment for their HIV disease. AIDS advocates will struggle in the coming years to ensure that all HIV-infected Americans can access the HIV treatment they need to survive."
The new guidelines, announced in the Federal Register June 19, are available for a 30-day comment period. The draft documents are available from the National AIDS Clearinghouse (1-800-458-5231) and on their Web site (http://www.cdcnac.org) and from the HIV/AIDS Treatment Information Service (1-800-448-0440) and on their Web site (http://www.hivatis.org).
Written comments should be submitted to the HIV/AIDS Treatment Information Service, P.O. Box 6363, Rockville, Maryland, 20849-6303. Only written responses will be accepted. They are due by July 21, 1997.
Additional information and commentary from New York's Treatment Action Group about the new HIV treatment guidelines can be accessed at the group's world wide web site at http://www.aidsnyc.org/tag/.
After consideration of comments, both documents will be published in the Centers for Disease Control and Prevention (CDC) Morbidity and Mortality Weekly Report.
Congress set to weaken Medicaid
Congressional proposals to shift control over the Medicaid program to the states, and thus allow states to push millions of Medicaid beneficiaries into mandatory managed care, threatens the health care safety-net for over 37.5 million Americans, according to AIDS Action, the AIDS lobbying group.AIDS Action's Jose Zuniga said Congress is opening a "Pandora's Box" that may exacerbate the access to care crisis already faced by thousands of people with AIDS by undermining the health care that Medicaid beneficiaries with AIDS now receive.
Philadelphia area residents living with HIV/AIDS have already been forced into a mandatory Medicaid managed care program, called HealthChoices. The state implemented the new plan without a system to guarantee access to qualified, experienced physicians or a common standard of clinical care. Under the current implementation schedule, all low-income people living with HIV/AIDS -- over 70% of those infected in the region -- will become part of HealthChoices by late August.
"Medicaid represents the only link to state-of-the-art care for over half of adults and 90 percent of children living with AIDS," said Christine Lubinski, AIDS Action's deputy executive director. "These sweeping changes - born out of blind faith in the managed care industry - jeopardize their health care by weakening consumer protections, quality standards, and the guarantee of due process. Congress is treading in dangerous waters."
In its mark-up of the House of Representatives' version of the Budget Reconciliation Bill, the House Commerce Committee has moved to allow states to push Medicaid beneficiaries into managed care by eliminating the need for states to obtain a waiver of federal rules, or a Section 1915 B waiver, from the Secretary of Health and Human Services. Under current law, the Health Care Financing Administration (HCFA) reviews waiver requests, including the effect of the proposal on recipient access to services and the quality of services.
The waiver process has allowed consumers, including people with AIDS, and their advocates to participate in the process and ensure that the health care needs of Medicaid beneficiaries are met under the new system. In New York and Pennsylvania, for example, the collaborative process has yielded significant improvements in program design.
Pennsylvania's HealthChoices program is subject to various requirements which seek to force the state to respond to the needs of people living with HIV/AIDS which were established as a result of testimony submitted to HCFA under the waiver rules. The elimination of the waiver requirement would make it harder for PWAs in other states to influence how Medicaid managed care programs are organized.
In lieu of the high level of consumer involvement to date in the waiver process, the bill would require only that states have public notice and comment procedures.
Lubinski explained that Medicaid disabled populations, including people with AIDS, are especially vulnerable. She fears that under the current proposal, these populations are placed at greater risk, especially since most managed care plans have little experience with addressing the health care needs of disabled populations. Lubinski added that the federal government more than once has rejected state-initiated Medicaid managed care proposals because they did not demonstrate the ability and capacity to adequately treat disabled populations.
AIDS Action said it was pleased with the consumer protections which were added to the House Budget Reconciliation Bill - protections for consumers in enrollment and marketing, the "prudent lay-person standard" for the payment of emergency care claims, and the exemption of special needs children from mandatory enrollment in managed care. Lubinski said, however, that much more must be done. She expressed significant concern about the lack of consumer protections for disabled populations.
"What are people living with disabilities, including people with AIDS, to do if inadequate consumer protections allow a state to move them into a managed care plan that lacks the level of medical expertise needed to address complex diseases such as HIV? According to this bill, very little," Lubinski said.
Lubinski said the Senate has a unique opportunity to serve as an advocate for vulnerable Medicaid beneficiaries with special health care needs, including people with AIDS. She urged Senate adoption of the exemption of special needs children from mandatory enrollment in managed care and its expansion to include adults with special needs. Lubinski explained that much like special needs children, adults with HIV/AIDS require the same protections from a managed care system with little experience serving their needs.
Lubinski also called on the Senate to ensure that disabled beneficiaries in managed care plans get the health care they need by adopting a provision which would allow disease specialists to serve as primary care providers, or "gatekeepers."
In a related matter, Lubinski said the final budget reconciliation bill must also reflect the bipartisan budget agreement which calls for the restoration of SSI and Medicaid benefits to legal immigrants in the country by August 22, 1996, who were then disabled or who might become disabled some time in the future. The House bill breaks the agreement by denying cash assistance and Medicaid benefits for any legal immigrant who experiences a disabling disease, including HIV disease, some time in the future.
AACO to set case management standards
The AIDS Case Management Coordination project of the Philadelphia AIDS Activities Coordinating Office (AACO) has established an ad-hoc advisory committee to "begin to look at developing AIDS case management "standards of care" which would be applied to publicly-funded case management services in the Philadelphia region.Most AIDS case management services are funded through a combination of city, state and federal funding awarded through the Ryan White CARE Act. PWA advocates have been calling for formal standards to evaluate the quality of case management services for many years.
The case management coordination project was developed by ActionAIDS and We The People in 1993. It became a formal part of AACO in 1994.
The Philadelphia HIV Commission and the Philadelphia AIDS Consortium, the two major sources of AIDS case management funding in the region, agreed earlier this year with federal officials to establish "benchmarks" for quality AIDS case management services as part of a national AIDS service evaluation effort. Primary medical care and nutrition services are also included in the evaluation effort.
People living with HIV/AIDS in the region who are interested in being a part of AACO's ad hoc committee should call or write Erica Taxin-Bleznak, M.S.W., AIDS Activities Coordinating Office, 500 South Broad Street, 2nd floor, Philadelphia, PA 19146, (215) 685-6808.
TPAC seeks PWAs for interviews
The Philadelphia AIDS Consortium (TPAC) is seeking people living with HIV/AIDS in the Philadelphia region to participate in intensive, hour-long interviews as part of its AIDS services planning process.TPAC is responsible for managing close to $5 million in state and federal HIV care and prevention funding awarded by the state of Pennsylvania and through Title II of the federal Ryan White CARE Act. Most of the funding will be re-allocated next year through the first comprehensive competitive bidding process held since early funding decisions were made over five years ago.
TPAC policy allows people living with HIV/AIDS to set the primary priorities for where the AIDS funding should be concentrated.
"The face of HIV/AIDS in the Philadelphia EMA has changed; over the 16 years' expansion of the epidemic, the description of who becomes infected has shifted dramatically," the group said in a statement.
"Once a disease that primarily affected gay white men, HIV/AIDS now cuts across cultures, races, religions, genders, ages, and sexual orientations. The Philadelphia region is witnessing HIV/AIDS' threatening spread through three major populations: minority communities, women and children, and poor people. There has been increasing recognition that this EMA must ensure that the resources that come into this region follow the path of the virus as it changes and develops. However, if we truly want to shift our resources according to the demographics and geography of the epidemic, as they have been identified, we need to understand the specific needs of the different communities that are being affected."
TPAC says it will conduct individual PWA interviews "order to provide better and more appropriate care for the women, children, and minority communities that are increasingly threatened by the virus." It is especially asking for the help and participation of individuals who have HIV/AIDS and who are African-American, Latino/a, Asian and Pacific Islander, adolescent, female, and/or live in the suburban counties of the Philadelphia EMA.
"To understand and meet the needs of these different communities, we are conducting hour-long interviews with individuals who are willing to share their time and knowledge with us. In these interviews, we will be asking questions about living with HIV/AIDS, about the services that people use or those that they need, about the concerns and needs that they have, which may or may not be being met," the group said.
TPAC says that the information collected from the interviews will be confidential, and the identities of those participating will never be revealed.
Participants should contact Nastia Snider or Tim Williams at (215)-985-6200. As compensation for their time and help, interviewees will be paid $15 dollars. The interviews will be conducted at the time and place chosen by the PWA.
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