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Issue #246: September 10, 1999
FASTFAX is available by fax in the 215 and 610 area codes at no cost, by mail anywhere for 20.00 per year, by calling 215-545-6868, and on the fastfax index page. Information in fastfax is drawn mostly from secondary sources; people living with HIV/AIDS should share information of interest to them with their primary care provider before making treatment choices. For more information on HIV medications and treatments, contact Kiyoshi Kuromiya of the Critical Path AIDS Project, 215-545-2212 or by email to The presence of the name or image of any individual in fastfax should not be construed as an indication of their HIV status or sexual preference unless specifically stated. Questions or comments should be directed to Editor, fastfax, 425 S. Broad St., Phila., PA 19147-1126 or by email to
In This Issue:
Hemophiliacs with HIV rally in DC
d4T, ddI get official approval as frontline treatments
Longer lives imposing stress on some PWAs
Outlook improving for AIDS vaccine: Gallo
Few young gays know HIV status
Effectiveness of female condom questioned
NJ law mandates hepatitis C reporting
Consumer Picnic set for Saturday
Town meeting on global AIDS crisis set
Hemophiliacs who contracted HIV from contaminated clotting factor came to Capitol Hill on September 8th to demand funding for payments authorized last year.
The "Ricky Ray Hemophilia Relief Fund Act" called for payments of $100,000 each to the estimated 7,500 patients and families of those who have already died. The payments are to match a settlement provided by makers of the clotting factor. The Institute of Medicine in 1995 concluded that at least part of the blame for failing to maintain blood supply safety belongs to the federal government due to regulatory failures.
While the 1998 law authorized the payments, they must still be appropriated through the regular annual spending bill process. That is a particular problem this year, because House and Senate Appropriations Committees have allocated some $15 billion less to the bill that funds the Department of Health and Human Services than the amount needed to fund existing programs, not including new ones like the Ricky Ray fund. The House subcommittee on Labor, Health and Human Services, and Education was tentatively scheduled to begin work on the bill on September 9th.
Some 100 members of the "Committee of 10,000," a reference to the number of hemophiliacs who contracted HIV from clotting factors, held a rally on the Capitol Steps in advance of that session to prepare for visits to individual members. "It's a law. They have to fund it," said Dana Kuhn, a board member of the organization who contracted HIV and then infected his wife before it was detected in the mid-1980s.
Although members of the Appropriations Committees in both the House and Senate have been pessimistic about their ability to fund the program this year, the families say they will not take 'no' for an answer. "Don't fall into the trap of trying to tell them where to get the money," was one of the talking points distributed to family members to use during visits to individual members of Congress. "We are the injured parties, they are the ones who can figure out how to make the money available."
Advocates for the funds are also hampered by the fact that President Clinton did not include funding for the program in the budget he submitted in February. A letter to the group from the Department of Health and Human Services said that the 1998 bill passed too late for the budget request to be included.
The US Food and Drug Administration (FDA) has approved d4T (stavudine, Zerit) and ddI (didanosine, Videx) for use as a first-line component of combination antiretroviral regimens for HIV-1 infection, according to Bristol-Myers Squibb officials.
The decision makes FDA labeling consistent with what has already become standard care among many physicians who treat HIV-infected patients and conforms with the most recent federal Guidelines for the Use of Antivirals in HIV-Infected Adults and Adolescents.
The FDA announcement is good news for both patients and physicians, according to a statement from the National Association of People with AIDS (NAPWA).
"Getting the right treatment is a challenge for many patients," A. Cornelius Baker, executive director of the Washington, DC-based organization said. "The FDA must do everything possible to ensure that labeling mirrors the standard of care."
NAPWA officials also pointed to the need for the FDA to rapidly review and consider other labeling changes to simplify dosing schedules for HIV-infected patients, which will facilitate patient adherence to complex combination antiretroviral regimens.
Bristol-Myers Squibb is seeking to expand the role of Zerit in the US, which is already one of the most prescribed nucleoside reverse transcriptase inhibitors. The company is investigating the use of Zerit in multiple combination regimens with other nucleoside analogues, non-nucleoside analogues and protease inhibitors. Bristol-Myers Squibb is also evaluating other formulations and improvements to Videx that should eliminate the need for buffers and antacids, and improve upon current Videx dosing. (Reuters/Company Press Release/NAPWA)
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A gel containing the detergent sodium lauryl sulfate (SLS) could be useful in reducing the sexual transmission of HIV, herpes simplex virus and possibly other pathogens, Canadian researchers reported at the National HIV Prevention Conference.
The results of a study performed by Sylvie Roy and co-investigators at the Centre de Recherche en Infectiologie, Universite Laval, Quebec, suggest that the gel formulation by itself acts as a physical barrier and that SLS acts as an additional chemical barrier by disrupting the membranes or envelopes of pathogens.
Roy pointed out that "SLS is a detergent like nonoxynol-9, but SLS is more effective because it can denature proteins and cause them to disassociate. It is more toxic against proteins so that is the advantage."
To evaluate the ability of the gel to block the passage of HIV-1 and prevent infection of susceptible cells, the researchers measured virally encoded luciferase activity in control cells and cells treated with SLS. They found that the cells treated with SLS completely resisted infection with HIV.
SLS also appeared to be effective against HSV-2. Mice were pre-treated intravaginally with the gel formulation containing SLS and 5 minutes after application the mice were inoculated with a strain of herpes simplex virus. "All mice pretreated with the gel containing 5% SLS survived the HSV-2 lethal intravaginal infection and did not show any signs of infection."
The researchers concluded that the sodium lauryl sulfate gel "...acts as an efficient physical barrier to block the passage of HSV-1 and HSV-2, preventing infection of target cells. The group also found that pretreatment of viruses with SLS decreased, in a concentration-dependent manner, their infectivity to susceptible cells.
"The next step will be to measure the efficacy of the gel against HIV in an animal model and also to examine its effects against other pathogens," Roy said. (Reuters)
Longer lives imposing stress on some PWAs
What happens to people who have accepted imminent death -- and then learn that they will live? In a pioneering new study of the psychological impact of revival on people who have HIV and AIDS, researchers find that miracle improvements in health brought about by highly active combination drug therapies "also bring new uncertainties that can become unexpected and significant life stressors."
So says Dale Brashers, a professor of speech communication at the University of Illinois who led a team of researchers in the first study of uncertainty caused by physical revival. The findings appear in the current issue of AIDS Care.
According to Brashers, individuals who are diagnosed with HIV or AIDS often must negotiate any number of life priorities, for example, types of financial support and work status, personal relationships and long-term plans.
The renewed prospect of living requires "renegotiating" many of the realities that they had come to accept. This renegotiation is a source of uncertainty, and often stress, affecting their feelings of:
* Hope and future orientation (not having any information about the long-term effects of medications and the ambiguity of immune restoration);
* Social roles and identities (concern about how to re-renter life as a person living with a chronic illness rather than a person dying from a disease);
* Interpersonal relationships (having to deal long-term with people they thought they never would have to deal with again, and feeling guilt for living longer than friends and loved ones); and
* Changes in quality of life (having to cope with impediments to a normal life that derive from side effects of medications, unforeseen illnesses, living with a chronic disease and the financial drain of taking expensive medications).
The comments of one study participant illustrate the situation:
"... there's a lot more uncertainty now for me, I think. Because I made my peace a long time ago about the dying issue and now it's 'uh-oh' ... It's a good 'uh-oh' but at the same time, when you're financially devastated because of the disease, it's a very scary and uncertain 'uh-oh.' "
For the study, which was funded by the National Institutes of Health, data were collected from six groups of people who share what is called the Lazarus Syndrome.
In the United States, combination therapy with protease inhibitors and other antiretroviral drugs is the "standard of care." Not all experiences associated with revival were stressful for participants in the study, Brashers said.
Several implications result from the findings, including a few in the realm of education and prevention. According to Brashers, "Some people now believe that the improved treatments mean that unsafe sex isn't as big a problem, because if they get infected, they can begin treatment. What they don't realize is that there are significant problems associated with a life on antiretroviral therapy." (Daily University Science News/AIDS Care)
Scientific advances, increased federal money for research, and Third World countries finally waking up to the fact that AIDS has ravaged their populations is creating optimism for a milestone that could save millions: a vaccine for HIV.
Just two years ago, when President Clinton pledged to Morgan State University graduates that scientists would find a vaccine for AIDS within a decade, there was plenty of cynicism. Today, there is much less.
"It is possible that the components for a reasonably successful vaccine are almost there, in our hands, but we don't know it yet," said Dr. Robert C. Gallo, co-discoverer of HIV. "I'm much more positively inclined than a year or two ago."
More than 1,000 physicians, scientists and others from 20 countries discussed progress on the AIDS vaccine at a week long conference held annually in Baltimore, with Gallo and the University of Maryland's Institute of Human Virology, which he directs, as the hosts.
The meeting, which began years ago as an informal gathering of Gallo and his colleagues, has grown into one of the largest AIDS conferences in the world.
No one thinks a vaccine to stop the human immunodeficiency virus is as close as a few years away, and no one wants to raise false expectations about stopping a virus that infects 16,000 people a day worldwide. The subject is fraught with political, ethical and financial issues. And in the lab, scientists are facing one of their most elusive and toughest targets.
Unlike polio or other viruses, no infected person has ever been shown to clear HIV from his body, so scientists have no clues as to what might work. They say they don't even know if a natural protective state against HIV can exist in humans. Also, the virus mutates quickly within individuals and populations -- changing its genetic makeup, which makes it harder to fight. And the major target of HIV is the very thing the body needs to defend itself: the immune system.
"The barriers are almost all scientific constraints," said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.
More than 90 percent of new infections occur in developing countries, where few people have access to the complex and expensive medication regimen that can keep the virus in check. Among those who take the "cocktail" drugs, resistant HIV strains are emerging. More than 33 million people are infected with HIV around the globe. About 13.9 million have died.
Experts say the only long-term answer is a vaccine that prevents HIV.
"It's the silver bullet," said Steven Fisher, a spokesman for AIDS Action, the nation's leading advocacy group.
At the conference, one of the more significant discussions to dealt with Tat, or transactivating protein, which is made by HIV. Over the years, researchers have found that Tat plays a key role in HIV spreading and wreaking damage.
"You can regard it as one of the missiles from HIV infection that leads to the problems in the immune system and facilitates the virus' spread," said Gallo, who has done some of the work. Researchers have shown that vaccinating monkeys against Tat lowers the amount of the virus and lessens the immune system's impairment.
Gallo and his collaborators have tested Tat in humans for safety, both as a preventive vaccine and as a therapeutic one -- meaning it would help control the virus in someone already infected. He said his group's strategy will be to create a sort of vaccine cocktail, by combining an inactivated Tat protein with another vaccine approach.
The difficulties with the AIDS vaccine have led some scientists to conclude that a therapeutic vaccine is more realistic than one that can prevent infection. By keeping HIV from multiplying in the body, the therapeutic vaccine would stop the virus from progressing to the disease stage. Lower levels of HIV in a person's body also make it more difficult to transmit the virus.
"This would be a major achievement," Gallo said. "But my personal belief is we haven't tried hard enough yet to accept that notion completely."
Others involved in the AIDS fight say they are heartened by what is going on outside the labs.
Federal efforts that appeared uncoordinated and bogged down in bureaucracy for a few years now seem to be coming together, Fisher said. For two years, the position of director of the new federal Vaccine Research Center was unfilled before Dr. Gary Nabel of the University of Michigan was hired in April.
"That was like having a Manhattan Project without having a Robert Oppenheimer," Fisher said.
Funding for AIDS vaccine research at the National Institutes of Health has doubled since fiscal year 1995, according to NIH figures. Now, of the $1.8 billion in NIH money for AIDS, 11 percent is devoted to vaccine efforts, according to Fauci.
Many countries in Africa had officially looked the other way as the epidemic took off. There was little public education or prevention efforts. But Gallo says that is changing. He also said there is more active participation from those countries in vaccine efforts, as well as a "breakdown of paranoia, a feeling they're being blamed."
The progress hasn't been limited to the past few years.
Margaret Heckler, President Ronald Reagan's secretary of Health and Human Services, said in the mid-1980s that HIV vaccine studies would begin in two years, and that did happen, said Sam Avrett, executive director of the AIDS Vaccine Advocacy Coalition.
Over the past 10 years, more than 40 preventive AIDS vaccines have been tested worldwide involving about 10,000 volunteers, including more than 500 in the Baltimore area. The studies investigated the vaccines' safety and whether they generated immune responses. Only one AIDS vaccine, made by the California company VaxGen, is headed for the testing stage that will determine if it prevents HIV.
Scientists are trying many approaches. They're modifying a bacterium or virus so it doesn't cause disease, and then using it to carry HIV proteins into the body to stimulate the immune system. They're also experimenting with inserting pieces of the outer surface of HIV, or pieces of the DNA of certain HIV proteins. Some researchers are trying various combinations.
All the vaccines tested have been well-tolerated by the volunteers, generally producing only mild side-effects, researchers said. Most subjects receive some compensation for their time.
One of the subjects, Wendell Brown, 46, volunteered for an AIDS vaccine trial at the Johns Hopkins Center for Immunization Research after seeing many incarcerated AIDS patients suffer in the state prison at Jessup, where he worked.
The East Baltimore man said that once it was all explained to him, he was confident that he wasn't in danger of contracting the virus by participating. And he understood that the vaccine wasn't going to protect him from the virus. Still, when the moment came, it was a little scary.
"I'm thinking, `Oh Lord, what am I doing now? It's in me now. It's in me now,' " said Brown. He is participating in other studies, and, as a black -- a demographic group under represented in medical studies -- believes that more people of color should participate.
"People seem to think AIDS only affects certain segments of the community," Brown said. "But it affects everyone. The fight is still on." (Baltimore Sun)
Few young gays know HIV status
Study results announced at the National HIV Prevention Conference show that among a sample of over 3,000 young gay men in seven urban areas, 7% were infected with HIV but only 18% of them knew it.
Dr. Linda Valleroy and colleagues at the Centers for Disease Control and Prevention also found that as many as 35% of the young men, aged between 15 and 22 years old, had never been tested for HIV infection. Reasons cited for not being tested were a perception that they were not at risk (44%), fear of knowing their status (38%), and fear of needles (18%).
The CDC investigators reported that only 15% of the HIV-positive men were receiving medical care and only 8% were receiving HIV/AIDS drugs.
"HIV testing can provide a critical pathway to both improved HIV prevention and care for those infected. But reaching these young people with testing will require providing services that meet their needs and address their fears," Dr. Valleroy said.
Another study presented at the conference underscored the importance of HIV testing among adolescents and young adults. Dr. Paul Denning and colleagues from the CDC analyzed interview data from 1,446 young people from 12 states who were newly reported with HIV or AIDS. Of the 1,123 sexually active subjects, 60% reported having unprotected intercourse in the preceding year.
Although risky behavior was common among the subjects, Dr. Denning's team found that knowledge of HIV status correlated with significant reductions in high-risk sexual behavior.
"The early identification of HIV-infected young persons, in conjunction with counseling, has the potential to markedly reduce high-risk sexual behavior among this group and to limit the spread of HIV to subsequent generations," Dr. Denning concluded.
Effectiveness of female condom questioned
Use of the female condom is associated with relatively high rates of exposure to semen, according to researchers attending the recent National HIV Prevention Conference, in Atlanta. The finding suggests that the device may not be as protective against HIV and other sexually transmitted diseases as previously thought.
These exposures occurred even in the absence of "user problems" (incorrect usage of the female condom), explained lead researcher Dr. Ann Duerr and colleagues at the Centers for Disease Control and Prevention (CDC) in Atlanta.
The female condom has been promoted as a tool to prevent sexually transmitted disease like AIDS.
In their study, Duerr's team trained 210 US women at low risk for sexually transmitted diseases (STDs) to use the female condom. The women were also supplied with a sampling device to assess vaginal semen exposure, and each completed diaries and questionnaires regarding condom use.
Overall, subjects used the female condom over 2,300 times during the course of the study. Duerr and colleagues found that 25% of uses resulted in at least one reported mechanical or non-mechanical problem.
Mechanical problems -- reported in 17% of uses -- included condom breakage or semen leaking from the condom.
Non-mechanical problems, such as discomfort of either partner, were reported in 5% of uses.
The overall rate of semen exposure associated with female condom use ranged from 7% to 22%. The researchers estimate that user-reported problems accounted for 59% of the instances of semen exposure. This means that 41% of semen exposures occurred during episodes where women reported no obvious problems with usage.
"Unfortunately, studies comparing male and female condoms and semen exposure have not been conducted yet," study co-author Dr. Louise Lawson noted. These types of studies "would answer a lot of questions about condom use, STD exposure and pregnancy rates." (Reuters)
A new state law in New Jersey says doctors and hospitals must report all cases of Hepatitis C, along with the names of those infected, to the state Department of Health and Senior Services. This information will help New Jersey determine the best way to approach new cases, which can take up to 30 years to develop, sponsors of the law said.
New Jersey is also the only state in the Philadelphia region which requires reporting of the names of people with HIV that has not yet progressed to an AIDS diagnosis.
Doctors say people should not believe there is an outbreak of hepatitis C. The new law seeks to identify existing cases, most of which involve baby boomers who were infected 20 to 30 years ago. In fact, there have been fewer new cases of the disease because of better blood-testing methods, health officials said.
"We don't feel it's an epidemic," said David Feit, associate at the new Hepatitis Center at Hackensack University Medical Center.
The law, passed last year, provides guidelines on how to screen patients for the disease. Assemblyman Francis J. Blee (R., Atlantic), who cosponsored the bill, said because there was no law requiring reports of the disease, numbers from federal agencies may not be accurate.
"I would expect 50 to 100 percent more than the current estimate suggests," Feit said.
Previously, only acute cases were reported to the federal Centers for Disease Control and Prevention and state health agencies. But more people are chronically ill with the disease - about 90 percent.
About 450 of the 144,000 people with hepatitis C in New Jersey die each year. Nationally, 2.7 million Americans are infected with the virus and up to 10,000 die each year, according to the Centers for Disease Control.
"This law will allow us to obtain better numbers," said Tom Breslin, spokesman of the New Jersey Department of Health and Senior Services.
Hepatitis C comes from a viral infection of the blood and can lead to cirrhosis and liver cancer. It is spread through intravenous drug use, unprotected sex, tattooing, body piercing, and some blood transfusions before screening began in 1992. Symptoms include extreme fatigue, low fever and loss of appetite. Hepatitis C is the most common blood-borne disease in the nation and results in about 1,000 liver transplants each year, the CDC reported.
Treatment includes interferon and other drug therapy, which has been successful with about 45 percent of patients. No vaccine yet exists.
Other types of hepatitis are A and B. They are reportable diseases and are infectious viral inflammations of the liver. Hepatitis A, not chronic, usually is spread through contaminated food or water. Most people completely recover. Hepatitis B is more serious and is spread through contaminated blood. About 90 percent of people recover; 10 percent may develop liver complications. (Associated Press)
A picnic for members of the HIV community will be held on Saturday, September 11th, from 10 am to 6 pm in Fairmount Park near Memorial Hall. The event is sponsored by the Philadelphia EMA HIV Commission, Philadelphia FIGHT, Project TEACH, and the Minute by Minute project.
The picnic will take place in Areas 1 and 2 behind the building, which is near 42nd Street and Parkside Avenue.
Picnic sponsors promise swimming, games, free food, and the opportunity to "meet and greet other consumers and their families in a relaxed atmosphere."
Over 300 people are expected to attend.
For more information call Hassan Gibbs or Roy Hayes 215-985-4448 ext 164. No transportation will be provided.
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An "AIDS Community Town Meeting on Access to Treatment in the Global AIDS Crisis" will be held on Monday, September 20th from 7 to 9 pm at the Church of St. Luke's and the Epiphany, 330 South 13th Street. The event is sponsored by ActionAIDS and ACT UP Philadelphia and will be moderated by Kevin Conare, ActionAIDS executive director, as well as other speakers from Washington.
SEPTA tokens and refreshments will be provided.
"In Zimbabwe, morgues are now open 24 hours a day to accommodate AIDS-related deaths," said a statement announcing the event. "Learn about the increasing impact of HIV in Africa, Asia and other parts of the world, and how you can contribute to the fight to bring life-saving therapies to millions of people with HIV. Efforts to cut the cost of life-saving AIDS drugs in Thailand and South Africa are being blocked by the Clinton/Gore Administration in the US."
Speakers will discuss:
--Strategies to get drugs to people with HIV worldwide
--Recent victories of the global coalition of people with HIV and activists fighting for changes in public health and trade priorities
--The role of the White House, the US Trade Representative and other branches of the US government in helping or hindering these efforts
--The upcoming protest in Washington DC demanding that the US government stop blocking drug access in poor countries.
For more information, call ACT UP Philadelphia at (215) 731-1844 or jdavids@critpath.org.