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April 1997

1. Penny-Wise and Protease Foolish
2. HIV on Capitol Hill
3. The "X" Factor
4. Is It AIDS?
5. Adults 4, Kids 2
6. Lean Beef
7. The Morning After
8. Glovesick Hearts
9. Keep Your Czar, Give Us Needles
10. TB or not TB

Penny-Wise and Protease-Foolish

Citing high cost, Florida rations protease inhibitors

This month, through its AIDS Drug Assistance Program (ADAP), Florida will begin providing protease inhibitors to its needy PWAs. Unfortunately, the $8.5 million in new federal funding for the program will cover less than half of the people in the state who are eligible, so the drugs will be rationed, going first to people with the most advanced cases of AIDS. As another means of limiting costs, only people who were enrolled in ADAP before February are being considered for the protease inhibitors. State health officials have requested an additional $5 million in state funds to treat people who will not otherwise be covered, but Governor Lawton Childs' proposed budget includes only $3 million for this purpose.

Given the considerable cost of the protease inhibitors, there is growing concern about how individuals without adequate health coverage will be able to afford combination therapies that include a protease inhibitor-and how the country's health system will pay for these drugs for patients on Medicaid. Several studies presented at the 4th Conference on Retroviruses and Opportunistic Infections suggest that government cannot afford not to pay for antiretroviral regimens that include protease inhibitors-because despite their high cost, combination therapies seem to reduce the overall cost of AIDS treatment.

One of these studies, conducted by researchers at Tower Infectious Disease Medical Associates in Los Angeles, found that while total drug costs for AIDS patients at the center increased in 1996, overall health care costs dropped 23%. For each dollar spent on the drugs, two dollars were saved in overall treatment costs, largely as a result of fewer hospitalizations and a decreased need for home health care. If states like Florida-and the federal government itself-balk at paying for these expensive new drugs, they may find themselves saddled with increased costs in the end.

HIV on Capitol Hill

Bill in Congress calls for broader HIV reporting, testing and disclosure

Oklahoma Representative Tom Coburn, a Republican, has introduced a bill in Congress that is misleadingly entitled "The HIV Prevention Act of 1997." Does this bill authorize federal funding for condom distribution and needle exchange, or mandate AIDS education and safer sex seminars for all of the nation's schools? No. Instead it resurrects calls for broader HIV reporting, testing, and disclosure.

While all 50 states currently report HIV cases and AIDS deaths to the Centers for Disease Control and Prevention, only 28 states track HIV infections. Coburn's bill would require that every state track HIV infections and contact all of the sexual partners of all people with HIV, to warn them of their possible exposure. It also would require HIV tests for anyone indicted on sexual assault charges.

Proponents of the bill say that with new HIV treatments yielding good results, the benefits of early detection of HIV infection are increasing, making it imperative to step up testing and disclosure. Opponents, including many AIDS advocates who have fought mandatory reporting and contact tracing since the beginning of the pandemic, say that besides violating the rights of people with HIV, the law would discourage people at risk from seeking testing or treatment.

The "X" Factor

The illegal drug "Ecstasy" can be dangerous for Norvir users

The release of the first protease inhibitors last year sparked many questions about the daily use of these drugs. These questions deal with such practical issues as how to avoid or minimize side effects, how best to integrate the drugs into a meal schedule or existing drug regimen, and how to predict or recognize interactions with other medications. Judging from postings on the Internet, one nagging question for some people taking protease inhibitors is how these new drugs may interact with so-called recreational drugs.

A report from England raises serious concerns about possibly fatal interactions between ritonavir (Norvir®) and MDMA, the street drug commonly known as "Ecstasy." AIDS Treatment News reports that Phillip Kay, a British PWA who was taking ritonavir, recently died of an overdose of Ecstasy. An autopsy revealed that the amount of Ecstasy in Kay's blood was ten times the amount that causes serious toxicities, and Kay's friends feel certain that he would not have intentionally taken such a high dose.

In light of this case Abbott Laboratories, the maker of ritonavir, has cautioned that combining of the two drugs may be dangerous. The company plans no studies of interactions between ritonavir and Ecstasy (or any other illegal substances), but Abbott has announced that its researchers believe that when Ecstasy is taken with ritonavir, blood levels of Ecstasy may double or even triple. In 3% to 10% of the population, these researchers speculate, the increase in Ecstasy levels could be as much as ten times the level attained when Ecstasy is taken alone.


Italian study suggests Hodgkin's disease may be an AIDS-defining illness

HIV has a strong affinity for the body's lymph nodes -- which is why swollen lymph glands are a widely recognized early indication of HIV infection. Even when viral levels in the blood are low, HIV may be very active in other parts of the body, particularly the lymph glands. In the last issue of AIDS Care we reported Dr. David Ho's hypothesis that early treatment with antiretroviral combinations may be able to eradicate HIV from the body (see Vol. 1, No. 1, page 11). Dr. Ho acknowledges that one problem with this approach is that even after several years of treatment -- when HIV has been completely eliminated from the blood stream -- it may still be active in the lymph glands.

All that viral activity apparently takes its toll. Research conducted in the U.S. has already shown that people with HIV have a higher incidence of non-Hodgkin's lymphoma than people without HIV. Now an Italian study suggests that Hodgkin's disease is also much more common in people with HIV. In fact, the study showed cases of this lymph cancer to be 38 times more frequent in people with HIV. The Italian researchers have therefore suggested that Hodgkin's disease be added to the list of AIDS-defining illnesses.

Adults 4, Kids 2

Fourth protease inhibitor is approved for adults and two are OK'd for children

Last month the F.D.A. approved a fourth protease inhibitor to fight HIV. Pre-approval studies of Agouron Pharmaceuticals' nelfinavir mesylate (Viracept®) have shown that it causes fewer side effects than the three previously approved protease inhibitors. More importantly, perhaps, nelfinavir exhibits no cross-resistance with those drugs. This means that if HIV does develop resistance to nelfinavir, the virus remains susceptible to any or all of the other protease inhibitors. This is a boon to PWAs, because cross-resistance among the three older drugs has been a problem.

Nelfinavir was simultaneously approved for use in children and adults (see "A fourth protease inhibitor, Viracept®, awaits F.D.A. approval for adults and children," Vol. 1, No. 1, page 4). Previously, protease inhibitors were available to children as part of a few clinical trials or on a compassionate use basis for the very ill, but none was actually approved for pediatric use.

The makers of these drugs -- which have been available to adults for most of last year and have been widely celebrated in the media for revolutionizing the treatment of AIDS -- had been criticized for being slow to test the protease inhibitors in children. They are now catching up ... and when it rains it pours: on the same day nelfinavir was approved by the F.D.A., Abbott Laboratories' ritonavir was also approved for use in children. People with AIDS and their advocates had been pushing Abbott to seek this approval because ritonavir is available in a liquid formulation, which makes it especially easy for children and infants to take.

Lean Beef

Oral anabolic steroid reverses wasting; amino acid enhances effect

Wasting -- the steady loss of lean body mass (that is, muscle) -- is all too common in people with advanced HIV disease, and it can have a marked impact on survival. Now, two studies presented at the 4th Conference on Retroviruses and Opportunistic Infections suggest that the anabolic steroid oxandrolone can be effective in reversing wasting in PWAs. In one study, participants who had lost 5% or more of their body weight were given oxandrolone for 120 days. This regimen led to significant, steady increases in body fat, cell mass, and total body weight -- with no adverse effects. The patients in this small study regained roughly equal amounts of muscle and fat.

A second study combined the oxandrolone treatment with regular doses of L-glutamine, an amino acid. Amino acids are the building blocks of muscle, and glutamine is the most abundant amino acid in the body. Loss of glutamine has long been considered a contributing factor in AIDS wasting. Researchers hoped that adding glutamine to a regimen of oxandrolone would help their patients regain lost muscle mass rather than fat. Results of the month-long study were encouraging: while all sixteen participants gained weight (an average of 2.9 kg) and body cell mass (1.2 kg on average), only 12 of the 16 gained body fat, and those who did gain fat added only insignificant amounts.

Unlike many anabolic steroids, oxandrolone can be taken orally and does not need to be injected. And unlike oral formulations of other anabolic steroids, oxandrolone -- which is made by Bio-Technology General under the name Oxandrin -- is not dangerously toxic to the liver.

The Morning After

Immediate antiviral treatment for sexual exposures to HIV moves into the prevention spotlight

When healthcare workers are exposed to HIV on the job, it is now standard procedure to treat them with antiretroviral drugs. Studies have shown that taking these drugs dramatically reduces the risk of infection, and the C.D.C. currently recommends immediate treatment with a combination of AZT (Retrovir®) and 3TC (Epivir®) for all healthcare workers who are inadvertently exposed to HIV through needlesticks or other accidents.

For some time the C.D.C. and its AIDS hotline have been fielding calls from people wondering about follow-up treatment after possible sexual exposure. These calls have come from rape crisis centers as well as from individuals who think they may have been exposed through unsafe sex. Much less frequently, they come from someone who has had a condom break during sex (a rare event, as we report in "Where the Rubber Meets the Road,"). As a result, the C.D.C. is currently developing recommendations for preventive treatment after sexual exposure to HIV. These guidelines should be announced later this year.

Meanwhile, San Francisco General Hospital is recruiting participants for a study of how effective prompt treatment is in preventing HIV infection after sexual exposure. People who believe that they may have been exposed to HIV through an isolated incident -- rather than through habitual high-risk sex -- will be given a 30-day supply of AZT and 3TC in the study. They will subsequently be tested for HIV, to determine how effective such early treatment is in preventing infection.

Even if such early intervention proves successful, it will not be an unclouded victory for prevention efforts, however. HIV prevention experts worry that if this "morning after" antiretroviral treatment is effective at thwarting infection after sexual exposure, fear of exposure to HIV may diminish -- and "safer sex" practices may fall by the wayside, leading to an increase in infections.

Glovesick Hearts

Latex allergies skyrocket in the age of AIDS

The costs and complications of the AIDS epidemic extend far beyond the lives of those directly affected, underscoring the wisdom of the observation "We are all living with AIDS." Take, for example, a recent New York Times report on an unusual byproduct of the health crisis: Allergies to latex are on the rise, particularly among members of professions where AIDS awareness has led to routine use of latex gloves.

Food handlers, toll collectors, and police officers are among those affected, but healthcare workers have been the hardest hit. Since 1980, the number of people in the general population with latex allergies has risen from 1% to 8%. During the same period, the incidence of latex allergies among dental workers has risen from 7% to 40%, and among other healthcare workers it has gone from 3% to 20%.

Powderless gloves, while more difficult to put on and take off, are now being used at many locations because they are less likely to promote allergic reactions. Vinyl gloves are an option for those who have already become sensitized, and more relief is on the way. The U.S. Department of Agriculture has developed and patented a process for producing hypoallergenic latex from a plant. Yulex, a Philadelphia company, has been licensed to use the new process, but the first products, gloves and catheters, will probably not be available for about four years.

Keep Your Czar; Give Us Needles

This Administration could use an injection of courage on the subject of needle exchange

Numerous studies done around the world, including ones by the C.D.C. and the National Academy of Sciences, have led to the same conclusions: Needle exchange programs dramatically decrease the spread of HIV among injection drug users and their sex partners, and they do not promote drug use. These findings have been duplicated so often in so many situations that the scientific community simply accepts them as fact. On the face of it, then, the conditions imposed by Congress for lifting a ban on federal funding for needle exchange programs have been met.

Nevertheless, President Clinton and his Health and Human Services Secretary, Donna Shalala -- who are apparently fearful of seeming to be "soft on drugs" -- have ignored the pleas of AIDS prevention experts (and editorial boards across the country) and refused to lift the ban. Instead, they have named a new Acting Director of the Office of National AIDS Policy, the President's third AIDS czar in the last four years. Can you name his predecessors?

Meanwhile, Hillary Rodham Clinton has taken to the Washington Post's op-ed page to celebrate the courage of her friend the pediatric AIDS crusader Elizabeth Glaser, who died of AIDS in 1994. The First Lady's encomium is entitled "A Brave Spirit Survives, Helping AIDS Victims." If only an equally brave spirit survived in the White House.

TB or Not TB

Aggressive treatment programs defuse a global crisis

During the late '80s and early '90s, tuberculosis cases increased at a steady rate around the world, largely due to the high susceptibility of a new population: people with HIV. But now the tide appears to have turned again. The C.D.C. recently reported that the number of cases in the U.S. has declined for the fourth year in a row-this time by 7%, to 21,327. At the same time, the World Health Organization announced that the global TB pandemic -- which kills one third of all people with HIV worldwide -- has finally leveled off.

This welcome trend is believed to be a direct result of rigorous new programs to treat people with active cases of TB. The strategy known as Directly Observed Treatment Short-Course, or DOTS, provides close monitoring of people with TB, to make sure they complete a six- to eight-month course of treatment. WHO notes that the program has been very effective everywhere it has been used, from Tanzania to New York. And Dr. Helene Gayle of the C.D.C. calls the New York City Health Department's implementation of DOTS, which cut TB cases in the city by 16% in 1996, a model for the world.

The effectiveness of DOTS is perhaps most sharply highlighted by the dismal results of TB control programs that do not use the strategy. In Washington, D.C., for example, the city's continuing financial difficulties have led to a reduction in the number of public health workers and in the number of cars that can be used to deliver medication to people who may not otherwise take it. Unable to implement DOTS, Washington saw a 36% increase in TB cases in 1996, even as New York City's case load was falling 16%.

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This article was provided by San Francisco General Hospital. It is a part of the publication AIDS Care.