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 Associated Press, Philadelphia Inquirer, USA Today, NIAID News, Nature, Science, New England Journal of Medicine, Washington Post
Clinton plans major cuts in Medicare home care benefits
Protease drugs work more rapidly than thought
State tells TPAC to change board
Mississippi PWAs to lose drug access
Discount drug pricing challenged in Senate
Viral load "baselines" found for kids with HIV
Minorities hard hit by infectious diseases
Many MDs ignorant of cryptosporidiosis
Change would affect Medicare coverage
The proposed rule changes would dramatically change how the term "homebound" is used to determine eligibility for Medicare home health benefits. Under the current regulations, a person who is unable to leave their home without "considerable and taxing effort" qualifies for the benefit, as long as any non-medical trips outside the home are "infrequent or of relatively short duration."
Under the proposed rules, Medicare home care recipients would not be allowed to leave home more than five times per month, and no trip would be allowed to exceed three hours. Recipients would lose their eligibility for benefits if the total of all their absences from home exceeded sixteen hours, on average, per month.
The rules would be enforced by the home health agency providing the service, according to Tom Hoyer, a Medicare official interviewed by the Philadelphia Inquirer.
The Inquirer article quoted Hoyer as saying that the rules are not aimed at limiting eligibility for home care services, but are an attempt to make more explicit "what our current subjective policy requires."
Over fifty organizations, mostly representing elderly disabled people, have petitioned President Clinton to reconsider the new rules. "How are they going to police it?", asked Howard Bedlin of the National Council on Aging in an Inquirer interview. "Are they going to put a little monitor on your hip to determine whether you go to church?"
Others criticized the new policies as forcing elderly and disabled people into isolation from friends and relatives, and preventing disabled people from attending social and support programs specifically designed to help them. Some said that the new rules will lead to increased admissions to nursing homes, which will increase government costs far beyond the cost increases being experienced in home care services.
The new program will directly impact on local people with AIDS, who are already experiencing significant cutbacks in accessing home care benefits under the state's new HealthChoices program for Medicaid recipients. Disabled PWAs have traditionally looked for relief from the strict Medicaid limitations when they eventually qualify for the more flexible Medicare coverage, which usually occurs after two years of ongoing disability.
Home care services funded under the Ryan White CARE Act traditionally are only available to uninsured people with AIDS, according to federal rules. If the Clinton plan goes into effect, uninsured people may be able to access a better home care benefit than those covered by Medicaid and Medicare.
While federal officials said that the new plan was not related to saving money in the Medicare budget, cost savings in home care are a major priority of the new budget deal recently announced between the White House and Congress. Medicare says that home care costs now comprise nearly 10% of the entire Medicare budget, with the annual average number of visits rising from 25 in 1985 to 70 in 1995. Home care advocates have said that the increase in home care services directly results from limits on hospitalizations related to the advent of managed care plans, and that the shift to home care is a less costly and often more effective method of keeping people healthy.
Protease drugs work more rapidly than thought
by David Brown
Washington Post
The powerful new treatments for HIV infection appear to deplete the body's vast storehouse of virus much more rapidly than previously believed. Even relatively protected havens for the virus appear vulnerable. In theory at least, three years of treatment may be enough to eradicate HIV from the bodies of infected patients.
Those are among the conclusions of three scientific papers released this month that sketch on a cellular level the dramatic effects "triple therapy" is having in the lives of many people with AIDS.
Whether the new drug combinations are actually -- rather than just theoretically -- potent enough to eliminate every last one of the billions of viruses an infected person harbors is a question not yet answered. "It would be wrong to believe that we are close to a cure for AIDS," mathematician Alan S. Perelson and biologist David D. Ho wrote at the conclusion their paper, published in the journal Nature.
"However, the recent advances in treatment . . . do warrant a close examination of the feasibility of eradicating [the virus] from an infected person." For about two years, AIDS researchers have known that treatment with three antiviral drugs (one of them usually one of the protease inhibitors) can dramatically reduce the amount of HIV circulating in a patient's bloodstream.
In innumerable cases, a month of treatment will drive down the amount of HIV from 100,000 viruses per milliliter of blood (about one-fifth of a teaspoon) to fewer than 200 viruses per milliliter. The actual count may be lower, but most tests are incapable of detecting virus when there are fewer than 200 in a volume that size.
In an infected person, however, most HIV is not in the bloodstream. More than 90 percent of it is in lymph nodes, tonsils and other organs of the immune system where microbial invaders are analyzed and attacks against them are mounted. Until now, a major unanswered question was whether the dramatic die-off of virus seen in the blood also was occurring in this so-called lymphoid tissue.
The answer, in brief, is yes, it is, according to the new research.
To get the answer, Winston Cavert and Ashley T. Haase, of the University of Minnesota Medical School, and their collaborators biopsied the tonsils of 10 HIV patients before and after the start of triple therapy. They counted virus that was either inside immune system cells there, or was outside of cells and stuck to the microscopic struts and buttresses that form that organ. After six months of treatment, more than 99.9 percent of the virus was gone, the team reports in the journal Science.
However, the arithmetic of HIV infection is such that even after such a dramatic response about 100,000 viruses per gram of tonsil tissue remained. Any one of those viruses, in theory, could rekindle a roaring HIV infection were the patient to stop taking the medicine.
In another article in Nature, Tae-Wook Chun and Robert F. Siliciano, of the Johns Hopkins University School of Medicine, studied the immune system cells, called lymphocytes, that remained infected after a period of apparently successful triple therapy.
The researchers found that the virus is damaged, incomplete or otherwise "incompetent" in most of those cells. In about one in a million of them, however, the virus is tucked away in the host's genetic material, hidden from the immune system , and -- under the right conditions -- capable of being awoken and made virulent again.
"The importance of this small reservoir should not be underestimated because [certain categories of these cells] can survive for months and possibly years," the two researchers and their collaborators wrote.
In the other Nature article, Perelson, of the Los Alamos National Laboratory, and Ho, of the Aaron Diamond AIDS Research Center in New York, measured bloodstream virus in eight HIV patients either weekly or every other week after the initiation of treatment.
They noticed the amount of virus declined in two steps. There was a steep initial fall that reflected the death of "activated" lymphocytes infected with the virus. This was followed by a more gently sloping decline that reflected the death of more long-lived, "resting" cells.
Extrapolating the lines into the future, they calculated that after 2.3 to 3.1 years of treatment, the viral count might go to zero. It is possible -- and perhaps even likely -- that cell populations too small to be detected in the graphs will remain infected forever.
The first hint of whether HIV infection is curable in some cases may come from Ho's institution, where a study is underway of 11 patients who have said they may be willing to stop treatment sometime in the future. One patient has been on triple therapy for 22 months, and the others for shorter times, so moments of decision are still relatively far off.
Of the new research, AIDS researcher Anthony Fauci of the National Institutes of Health said: "The good news is that the dramatic decrease of virus that we are seeing in the blood is paralleled in the lymphoid tissue. What we haven't nailed down yet is whether we can, or cannot, totally eliminate the virus from the body."
State tells TPAC to change board
After years of controversy, the Philadelphia AIDS Consortium (TPAC) n required by the state health department to remove from planning and allocations decisions any individual who works for an AIDS provider agency -- who currently comprise at least half of its board of directors.
Since 1991, TPAC's board of directors has acted as the regional "planning coalition" for state AIDS funds and federal Title II Ryan White CARE Act funding awarded for southeastern Pennsylvania. It currently manages close to $5 million in AIDS funding for services in the region.
The provider conflict-of-interest issue was a major factor cited by city officials last year when they removed from TPAC authority over about $10 million in Title I CARE Act funds.
State officials had been asking TPAC to remove the conflicts of interest on its board for at least four years, but each year had granted an exception when the group pledged to address the problem in the future. This year, state officials demanded immediate action, according to Larry Hochendoner, executive director of the group.
TPAC's board had previously agreed to assign decisions about specific agency funding to an independent, objective review board in an attempt to preserve provider participation on the board itself. This action did not go far enough, according to state officials, although it has significantly reduced complaints that TPAC decisions were unfairly influenced by providers on its board.
According to an article in Pride Weekly, Hochendoner and two TPAC board officers met with state health department program officer on May 2nd and agreed to remove providers from the TPAC board and set up a "provider committee" which would have input at TPAC but no voting power. It was unclear whether the new requirements would affect agency board members or other agency volunteers who serve on the TPAC board.
As a private, non-profit corporation, TPAC will need to change its by-laws regarding board membership and decisionmaking for the changes to take effect. Hochendoner told Pride Weekly that the organization plans to have implemented the changes by its September meeting.
Some current TPAC board members told fastfax that they are considering proposing a second alternative to the state, which would separate out the state-mandated "planning coalition" function from TPAC's corporate responsibilities as a non-profit. These board members said that it might be possible for TPAC to have a planning body which meets the state requirements, but also have a corporation board of directors which has no role in planning or policy recommendations with regard to state and federal AIDS funding. This plan would allow TPAC to benefit from provider experience in managing TPAC as a non-profit corporation, they said, and give an incentive to individuals who work for provider agencies to remain active in the organization.
Mississippi PWAs to lose drug access
Next week, 660 Mississippians will receive letters stating that their medications will no longer be funded through the Ryan White Drug Assistance Program because there is not enough money for the number of HIV+ recipients, according to state AIDS activists.
The action will leave less than 200 people with HIV/AIDS in the state still eligible to receive free prescription drugs, according to the AIDS Action Council.
The group says that there will be no other source for the AIDS drugs for the people with HIV affected. Mississippi has one of the poorest state medical programs for low-income people in the nation.
Activists are asking that telephone calls opposing the action be made to Mississippi Governor Kirk Fordice at 601-359-3150.
Discount drug pricing challenged in Senate
Section 323 of the Senate Supplemental Appropriations bill (S. 627) would repeal the federal cooperative purchasing program established under Section 1555 of the Federal Acquisition Streamlining Act of 1994 (FASA).
This program would have allowed public hospitals, state and local health departments and state AIDS Drug Assistance Programs (ADAP) to take advantage of even greater discounts than are now available to federally qualified health centers and some ADAP programs under the PHS 340-B pricing program. This would mean cost savings of between 31% and 62% on major HIV drugs.
The program was subject to GAO and GSA studies before being implemented nationwide. Because neither GAO nor GSA has completed their studies, the Congressional committees with jurisdiction over this program have not yet scheduled hearings or received public comments.
The AIDS Action Council calls the provision "a sneak attack by the pharmaceutical industry and other federal suppliers to kill this program before it has even begun. "This could be particularly disastrous at a time when ADAP programs and other public health suppliers are struggling under the burden of the costs of providing the HIV standard of care.
Viral load "baselines" found for kids with HIV
The amount of HIV in the blood of perinatally infected infants peaks at 1 to 2 months of age and then declines slowly to level off at 24 months at relatively high concentrations compared to those for an adult, according to a study supported by the National Institutes of Health (NIH).
The study was reported in The New England Journal of Medicine.
Peak viral loads at 1 month of age suggested that the majority of the infected infants were exposed around the time of delivery. A small number of infected infants had high blood levels of HIV at birth, indicating that some may have become infected in utero.
"The results are the first to provide a baseline on the natural history of HIV blood levels (viral load) in infants and children, and can provide guidance on how to use viral load information to evaluate treatment options for HIV-infected children," says Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), one of the sponsoring institutes at NIH.
Scientists measured the amount of HIV in the blood of 106 HIV-infected babies from birth up to 5 years of age. The study demonstrated that viral load measurements could be used to predict the severity of disease and suggested that babies with higher viral loads might benefit from antiretroviral treatment.
Children with HIV viral loads greater than a 299,000 (median level) virus particles per milliliter (mL) of blood during the first few months of life had a 44 percent probability of progressing to AIDS or death within the first 24 months of life.
For those children with viral loads less than 299,000 (median level) particles/mL, the rate of progression to AIDS or death was only 15 percent. The authors note that although there was no threshold above which all children were rapid progressors, there was a lower threshold below which they saw no progression to overt disease or death. Those infants in the study with viral loads of less than 70,000 particles/mL within the first few months of life did not progress rapidly to AIDS or death within their first 18 months of life.
"The surprise to the investigators," says William T. Shearer, M.D., Ph.D., study chair and professor of pediatrics, microbiology and immunology at Baylor College of Medicine and at Texas Children's Hospital, "was that the very early HIV blood levels may predict the outcome of progression to AIDS in children. Thus, it may be important to determine HIV RNA levels very early in life."
Minorities hard hit by infectious diseases
Minority populations are at risk for a number of emerging and re-emerging infectious diseases, including Group B streptococcal infection and infection with Helicobacter pylori, scientists at a meeting of the American Society of Microbiology reported recently. The higher rates of these and other diseases in minority groups might be attributed to diet or food preparation, poverty, and inadequate water and sewer systems. Consuelo Beck-Sague of the Centers for Disease Control and Prevention notes that incarceration is another factor, enabling epidemics of pneumonia, tuberculosis, hepatitis, and syphilis to spread rapidly, as prisons become overcrowded and provide insufficient health care.
Many MDs ignorant of crypto
Too many physicians do not know enough about cryptosporidiosis, the parasitic disease that killed 110 in Milwaukee in 1993, according to a study led by Craig A. Morin of the Connecticut Department of Public Health. A random survey of 511 doctors indicated that most knew very little about the disease, with more than 30 percent incorrectly assuming a standard stool culture would uncover the microbe. The researchers found that doctors often did not test for cryptosporidium even when symptoms were plainly evident in patients. According to the study, published in the Archives of Internal Medicine, infectious disease specialists fared better than other specialists in responding to the survey -- most likely because of their experience with AIDS patients, who are more susceptible to the disease.
Gallo doubts AIDS vaccine
Despite an extensive and detailed understanding of AIDS, noted AIDS researcher Robert Gallo said this month that it is possible that medical science will never find a vaccine that protects against infection from the virus.
Drugs have been found that appear to suppress HIV, but researchers still don't know how to make a vaccine that will keep people from getting infected after being exposed to HIV, Gallo, who claims to be the co-discoverer of HIV, said at a vaccine symposium.
Vaccines now protect against polio, measles, small pox and many other diseases, but HIV presents unique problems, he said. "We have to say it is a serious possibility that we will never succeed with a vaccine against HIV. Nobody can say that we will (succeed) for sure," he said.
"That needs to be said. We have to be realistic."
This problem, he said, has led some people in the World Bank to investigate the possibility of controlling AIDS by treating all of the world's HIV patients with new and expensive protease inhibitors, that can suppress HIV to the point that the virus is undetectable.
"I had discussions with people at the World Bank who are seriously contemplating the possibility of taking the drugs and treating everybody," said Gallo. But he said the discussion was only "exploratory" and that there are no firm plans for drug treatments on such a massive scale.
Gallo said that researchers have put out "an enormous effort" to understand HIV and how it reproduces in the body.
"It is safe to say that we know more about this virus and this disease than we know about any," he said. But Gallo said there are several major obstacles, with no known solutions, that may prevent a vaccine from ever being developed.
There is no cheap, short-lived laboratory animal that can be infected with HIV for the testing of vaccines, Gallo said. Some monkeys can get a form of the disease, but they are expensive, rare and develop the disease very slowly.
Also, he said, HIV constantly changes. Often there are a variety of strains within a single patient. To be effective, a vaccine would have to protect against each strain, or clade.
HIV integrates itself into the body, becoming part of the DNA in cells of the immune system, Gallo pointed out. "As soon as you get infected, it starts impairing the immune system. Once infection occurs, you've got it" and the immune system, which usually protects the body, is itself under attack.
To be protective, Gallo continued, a vaccine has to prime the immune system against a microbe. "We don't know if the immune system could be primed to do that" against HIV, he said.
Gallo said that he thinks it will be impossible to produce a vaccine that will kill every single virus in the body, a trick that is not required of other vaccines. He said, for instance, that polio vaccine merely represses the virus and "then it goes away," preventing an infection. It may take more than this to prevent an HIV infection, he said.
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