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Issue #185: July 12, 1998
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 articles in this issue include AIDS, American Journal of Medicine, Journal of Experimental Medicine, PR Newswire, Reuters.Study: Homeless PWAs going without care
Spontaneous abortions higher in HIV+ women
Homeless youth: sex, drugs, death
Managed care can work for PWAs: study
Virus rebounds once HAART stops: study
Study: Homeless PWAs going without care
Nearly three quarters of San Francisco's HIV-positive poor and homeless do not receive any AIDS treatment, and only 8% receive antiretroviral drugs, outreach workers reported last month at the 12th World AIDS Conference in Geneva.The report was the first known research on a point which advocates for poor people with HIV/AIDS have made locally for many years -- that still, seventeen years into the epidemic, AIDS services are not routinely available to those whose poverty and homelessness keeps them from seeking help from mainstream agencies. It also comes shortly after city officials have reduced funding for programs aimed at linking homeless and uninsured PWAs to HIV-experienced physicians, including We The People's medical consultation program and Philadelphia FIGHT's Lax Treatment Center.
The study results were also published just as the Philadelphia HIV Commission has decided to ask the city's AIDS Activities Coordinating Office (AACO) to take over $600,000 away from organizations serving the region's poorest PWAs and re-allocate it to suburban areas. AACO is responsible for allocating all federal funding for southeastern Pennsylvania and southern New Jersey under Title I of the Ryan White CARE Act.
Opponents of the Commission decision have complained that there are more poor and homeless people with HIV/AIDS in Philadelphia than in the suburban areas, and that in any case many suburban PWAs come to the city for their care and services. Suburban advocates have countered that suburban PWAs are forced to come to the city for services because their organizations are starving for funds and have historically been forced to take a back seat to the Philadelphia perspective which dominates the regional AIDS planning process.
In the Geneva report, investigators at the University of California San Francisco (UCSF) said that they followed up 151 of the original 153 persons enrolled in the Research in Access to Care in the Homeless (REACH) study one year previously. The study team, led by Dr. David Bangsberg, found that:
-- Only about 28% of the urban poor receive any antiretroviral therapy, compared with nearly 90% of middle-class persons infected with HIV.
-- Only 8% of the poor are on protease inhibitors. The UCSF team that is spearheading the REACH study believe that the poor and homeless are not being prescribed protease inhibitors because of a belief that this population will not adhere properly to the drug regimen.
An informal survey of over 1000 people with HIV/AIDS in the Philadelphia area last year showed that almost 40% of all PWAs who responded were not taking protease inhibitors, although Basile-Ryan, the company which conducted the survey, did not break down those numbers to show on the basis of income status.
The San Francisco study also reported that the average adherence to therapy among homeless patients receiving a protease inhibitor-containing regimen was 92% by patient report, and 88% judging by drug levels in the patients blood, a much higher level of adherence than most medical reports have indicate. Adherence to drug therapy correlated highly with viral load -- missing only 10% of drug therapy resulted in treatment failure.
In a statement issued by UCSF, Bangsberg added that, "the priorities for this population remain housing, prevention of tuberculosis and other opportunistic infections, and treating drug dependency and mental illness."
"Most people think studies can't be done with the homeless because they are hard to keep track of," said Bangsberg. "We found that to be untrue."
The San Francisco study was announced at the same time as another study indicated that providing early access to AIDS treatment for the poor and uninsured would be cost-effective.
This study challenges underlying assumptions supporting current Medicaid requirements that withhold treatment from HIV-infected patients until they exhibit the symptoms of full-blown AIDS. Medicaid is the largest payer of HIV-related medical services in the United States.
Some advocates hope that a recent U.S. Supreme Court decision extending protection of the Americans with Disabilities Act to people with HIV might encourage Medicaid programs to extend Medicaid coverage to them as well.
Current Medicaid eligibility rules extend health care coverage to HIV-infected patients only after they have suffered an AIDS defining illness or after their CD4 count has declined to below 200. People living with HIV but without the symptoms of full-blown AIDS are ineligible and, if unable to gain access to AIDS drugs through other means, must delay treatment until they experience the symptoms of AIDS.
Although federally funded state-administered AIDS Drug Assistance Programs (ADAPs) generally cover the drug costs for patients ineligible for Medicaid, many state programs have experienced financial shortfalls due to rapidly increasing enrollments and per patient costs and, as a result, have responded by restricting access to their programs.
AIDS activists characterized the new study as a solid first step in the development of a critical policy basis for the expansion of life-saving AIDS drug therapies to the uninsured and underinsured. The research, which was conducted by a consortium of academic researchers, professional pharmacoeconomists, AIDS organizations and research-based pharmaceutical interests called the Treatment Access Expansion Project (TAEP), used established pharmacoeconomic simulation techniques and data from existing clinical trials (Roche clinical trials NV15182 and NV15355) to draw two conclusions:
-- early initiation of treatment with AIDS drug cocktails delays the progression of AIDS, and
-- providing early treatment (i.e., when the patient has a CD4 count between 200 and 500 and has never experienced an AIDS defining event) would result in prolonged survival and would be cost-effective, when compared to delayed treatment (when the patient has a CD4 count of less than 200 or has experienced an AIDS defining event).
"At the most basic level, our research shows that patients receiving early, aggressive treatment experience increased lifespan," said Gary Rose, T.II.C.A.N.N. (Ryan White CARE Act Title II Community AIDS National Network) public policy director and community liaison with the Treatment Access Expansion Project and a chief researcher on the project. "Moreover, the overall cost of providing patients with this survival benefit is negligible."
In April 1997, Vice President Al Gore directed federal health officials to determine the feasibility of expanding Medicaid coverage to make new AIDS drugs available to the uninsured for early HIV treatment. In December, the Clinton Administration announced that an expansion in Medicaid along these lines would be too costly.
"Ability to pay should not have to be a barrier to early intervention for people with HIV," said Daniel Zingale, Executive Director of the AIDS Action Council.
The new study shows that early HIV treatment would increase life expectancy of currently infected asymptomatic patients (patients with a CD4 count between 200-500 and never having experienced an AIDS defining event) by 0.43 years (unadjusted for quality of life). The researchers determined that these gains in life expectancy would result in longer treatment with protease inhibitors and an expected increase in lifetime costs per patient of 2.2%. Ultimately, however, early AIDS treatment is projected to delay progression of AIDS-defining events and prolong survival, at a cost well within the range of generally accepted cost-effective medical interventions.
"This pharmacoeconomic study provides an important addition to any discussion on early treatment," said Dr. John Hornberger, Director of Health Economics in Roche Global Pharmacoeconomic Research. "By delaying the onset of the symptoms of AIDS, early treatment only slightly increases medical-care costs over the first 5 years by $241 per patient per year."
Spontaneous abortions higher in HIV+ women
HIV-positive women have a 67% higher rate of spontaneous abortion than their HIV-negative counterparts, according to a report by Italian researchers in the June 18th issue of AIDS.Dr. Carla D'Ubaldo and colleagues at Lazzaro Spallanzani Hospital in Rome obtained reproductive histories from 272 women who were either infected with HIV or were HIV-negative but had similar HIV risk factors. The women were patients in "...16 infectious disease units in 12 Italian cities," the authors write.
A total of 480 pregnancies were reported: 217 in HIV-positive women, 132 in uninfected women and 131 in women whose HIV status was undefined at the time of the pregnancy. There were a total of 60 miscarriages: 23 occurred in HIV-infected women, 22 occurred in uninfected women and 15 occurred in the group whose HIV status was undefined.
Dr. D'Ubaldo explains that women classified as "undefined status" were HIV-positive at the time of the interview; their HIV status at the time of their reported pregnancies was unknown.
The researchers did not find a statistically significant association "...between HIV-1 infection and spontaneous infection, although the estimated adjusted odds ratio of 1.67 suggests a 67% increase in risk among HIV-1 infected women compared with HIV-1-negative participants....[which] is consistent with other studies suggesting a role of HIV-1 on fetal demise...," they say.
The possibility that HIV-1 might be fetotoxic is something that should be considered when counseling HIV-positive women who are of reproductive age, the researchers note.
Homeless youth: sex, drugs, death
A research team in Montreal, Canada, has shown that homeless young people have a much higher likelihood of death than those who are not homeless, according to a brief report in The Lancet.The researchers questioned 517 youths aged 14 to 25 years who had been without a place to sleep more than once in the previous year or who had frequently used Montreal street youth agencies. At baseline, 99.6 percent were sexually active, with 21.9 percent engaging in prostitution and 17.4 percent engaging in homosexual sex. Additionally, 54.7 percent reported using drugs more than twice a week and 39.1 percent reported injecting drugs at least once in their lifetime.
The HIV-1 infection rate among the subjects at baseline was 1.36 percent.
The researchers gave follow-up questionnaires at six month intervals; 479 subjects completed at least one follow-up questionnaire. Ten subjects died: four by suicide, three by drug overdose, one from fulminant hepatitis A, one from a car accident, and one from undisclosed causes. Eight of the subjects who died were injection drug users and two were infected with HIV-1. The street youth had a mortality rate of 11.67, adjusted for age and sex, as compared to the general youth population of Quebec.
The researchers note that "The striking mortality ratio we observed highlights mental health and substance abuse as major issues that must be addressed by health professionals involved in the care of street youth."
Managed care can work for PWAs: study
Managed care systems that emphasize continuity of care, link complex medical and social services, and provide coordination of various providers, will optimally serve patients with HIV infection and other chronic illnesses.This observation, and other key features of caring for HIV-infected patients in a managed care environment, are discussed by a Seattle-based group in the June issue of The American Journal of Medicine.
The areas which the group highlighted are usually precisely those services which AIDS advocates claim are not available from most HMO programs, especially those organized to service people with Medicaid as their health insurance.
"Essential components of the continuum of HIV care include primary and subspecialty services delivered by experienced HIV providers," Dr. Mari M. Kitahata of the University of Washington School of Medicine and colleagues said.
Other important features include "...coordinated medical, social, and ancillary services provided in the clinic, hospital, community, home and extended care facility." Education and support for patients and caregivers, access to antiretroviral drugs and experimental protocols, and financial counseling assistance are also needed.
"Managed care plans encourage use of primary care services to forestall the need for more expensive care and have achieved lower medical costs by reducing hospital admission," they point out. "Savings from reductions in hospital care for HIV-infected patients have already been realized." But they believe that more savings may be possible by better integration of home-based and ambulatory care, along with consolidation of administrative services.
Dr. Kitahata's group points out that managed care systems can also "...negatively impact outcomes for persons with HIV disease if plans seek to limit or regulate medical decision making and collaboration among providers in the team." However, patients who require complex services may potentially benefit the most from well-integrated healthcare delivery systems.
Finally, the authors stress the importance of "meaningful assessments" of HIV care in managed care settings.
Virus rebounds once HAART stops: study
When an HIV-infected patient discontinues highly-active antiretroviral therapy (HAART), the virus almost invariably rebounds to substantial levels, even if virus had become undetectable by standard tests because of therapy.New findings from the National Institute of Allergy and Infectious Diseases (NIAID), reported in the Journal of Experimental Medicine, provide an explanation.
"Latently-infected, resting CD4+ cells, although relatively few in number, may be the embers that re-ignite active HIV infection if a patient stops taking combination therapy, or if the drugs become ineffective," said the paper's lead author, Tae-Wook Chun, Ph.D., of the NIAID Laboratory of Immunoregulation (LIR). "Our new data suggest that the virus rapidly rebounds because of factors present in the normal environment of the lymph nodes, particularly cytokines, which stimulate these cells to produce virus."
HAART (potent combinations of HIV drugs, generally including a protease inhibitor) can reduce the amount of virus in a person's plasma to levels that are not detectable by the most sophisticated laboratory tests. Despite the powerful effects of these drugs, however, HIV is not completely eliminated from the bodies of persons taking them. Rather, the virus persists in safe havens where the immune system cannot detect it.
These hiding places include non-dividing, resting CD4+ T cells in the blood and lymph nodes, which can harbor HIV DNA for prolonged periods while remaining invisible to the immune system. In an HIV-infected person's body, one to 10 of every million resting CD4+ T cells contain HIV that is capable of replicating.
Many scientists think that these viral sanctuaries pose the greatest challenge to the long-term control of HIV infection in patients receiving anti-HIV therapy.
The new data from the LIR buttress this view. In a series of in vitro experiments, Dr. Chun and his colleagues found that resting, latently-infected CD4+ cells readily produced virus when bathed in stimulatory molecules found in the normal environment of the lymph node. If the drugs that comprise HAART were added to the cells, no virus was produced.
"Without HAART, we found that interleukin-6, tumor necrosis factor-alpha and interleukin-2, signaling molecules which are normally found in copious amounts in a person's lymph nodes, readily induced HIV replication in latently infected, resting CD4+ T cells," Dr. Chun said.
"Our in vitro findings help explain the well-documented phenomenon of viral rebound seen in virtually all patients with no easily detectable virus in their blood as a result of HAART who discontinue therapy."
The researchers found that the cytokine combination activated purified resting CD4+ T cells from both HIV-infected patients receiving HAART and from HIV-infected patients who had never taken HAART. Previous studies had shown that the three cytokines could independently induce HIV replication in cell lines, and in certain cells from the bloodstream. Before this study, however, the effects of the cytokines on latently infected, resting CD4+ T cells were unclear.
The new data suggest possible approaches to purging the body of cells latently infected with HIV.
"We now know that it is possible to drive latently-infected CD4+ cells, at least in vitro, to a state of productive infection by using combinations of cytokines and/or antibodies to the CD3 molecule on the cell surface," said Anthony Fauci, M.D., NIAID director, LIR chief, and senior author on the paper. "Thus, one approach to purging these cells might be to stimulate them to spit out virus under the cover of HAART. Two assumptions are built into this scenario: cells activated to produce virus will die and HAART will prevent the spread of released virus."
"Our group and others are pursuing further laboratory studies as well as clinical trials with HIV-infected patients to determine if such an approach is feasible."
ACT UP sets Rite Aid demo
ACT UP Philadelphia will sponsor a demonstration to demand that Rite Aid Corporation, which operates most of the chain drugstores in the Philadelphia area, stock a sufficient quantity of AIDS drugs at all of its branches to assure that people living with HIV/AIDS can get them on a timely basis.Rite Aids throughout the Philadelphia area have been severely criticized in recent months by people with HIV/AIDS who claim that they are either unable to get AIDS prescriptions filled, or are forced to wait days before they are able to obtain the medication. A Rite Aid subsidiary, which runs the prescription drug plan for Keystone Mercy Health Plan, has also reduced reimbursement levels for pharmacists on all prescriptions, and AIDS advocates say this further restricts their options as pharmacies pull out of the Keystone plan because it makes them lose money.
Rite Aid representatives have on several occasions over the past several months issued guarantees that the difficulties in getting AIDS prescriptions filled would be overcome, but PWAs and AIDS case managers say that the problems continue.
"The Rite Aid corporation is the largest pharmacy chain in the United States," according to a statement issued by ACT UP. But "Rite Aid cares more about making giant campaign contributions to Governor Ridge than stocking the drugs that people with HIV need to stay alive.
"Demand that every Rite Aid stock all AIDS drugs all the time."
The demonstration is scheduled for Thursday, July 23rd, and will leave from the northeast corner of Broad Street and Cecil B. Moore Avenue in North Philadelphia, at noon. Free transportation to the demonstration is available by calling ACT UP at 215-731-1844.
ACT UP Philadelphia meets every Monday at 6pm in St Luke's Church on 13th Street between Pine and Spruce Streets.
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