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Issue #249: October 1, 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:
CDC reduces local HIV prevalence projections
Congress increases 2000 CARE Act funding
US remains hostile to South Africa drugs act
DC demonstration on AIDS drugs set for October 6th
Scientists hear progress on resistance drugs
Physicians urged to lower threshold for HIV testing
Molecule blocks HIV in lab tests
Isolation, drug use influence hospital readmissions of PWAs
US AIDS treatment averages $17,600/year
eBay rejects auction of PWA's corpse
The U.S. Centers for Disease Control now projects that there were slightly over 16,000 people living with HIV or AIDS in the Philadelphia area in 1998 - about 5,000 last than the year before.
Of those, the CDC says that about 47% have been diagnosed with AIDS. The overwhelming majority are people of color, with African Americans comprising 64% being African American, 10% Latino, and less than 1% Asian or Pacific Islander. Twenty-five percent of those living today with HIV are white.
The proportion of people of color among those living with HIV but not AIDS is higher than among those who have actually been diagnosed with AIDS in the Philadelphia metropolitan area, according to the CDC. The agency projects that while almost 77% of those with HIV alone are people of color, that proportion among people who have been diagnosed is 73%.
The reduction in the number of people with HIV and AIDS prevalence in the Philadelphia area results from changes in the way the CDC makes these calculations. While in the past, the CDC formulas relied most heavily on statistical projections from the number of AIDS cases reported in a region, the agency now includes other data based on the number of HIV case reports. Since Pennsylvania does not require HIV reporting, the formula applied to the Philadelphia region, in effect, penalizes the metropolitan area because of the lack of reliable HIV data.
The CDC has been pressuring states to require HIV reporting because, among other reasons, it believes that improving treatments mean that people with HIV will progress to AIDS more slowly. It says that this makes data on AIDS diagnosis alone less reliable as a predictor of the total number of people with HIV disease in the region that it used to. Most advocates also agree that HIV reporting is necessary, although there remain angry disputes on whether the reporting should be done by name or by some kind of unique code that protects the anonymity of those infected.
In other projections, the CDC says that 1 in 4 of those living with HIV in the region are women, and that about 8 in 10 are between the ages of 20 and 44. Overall, the CDC says, most of those with HIV disease contracted the disease through injection drug use (37%), closely followed by men who have sex with men (36%). An additional 5% are gay men who also inject drugs. About 20% of those living with HIV or AIDS are heterosexuals, the CDC says.
Congress increases 2000 CARE Act funding
The House and Senate Labor HHS appropriations subcommittees each passed versions of the FY2000 federal AIDS budget during the last week that maintain critical funding for care and treatment but neglect support for efforts to slow epidemic crisis spots, particularly rising HIV infections, according to AIDS Action, the Washington lobbying group.
For the Ryan White CARE Act, the House subcommittee on September 23 passed a $108 million increase over FY99 for a total of $1.519 billion. On September 27, Senate appropriators passed an approximately $199 million increase for Ryan White. That figure is about $100 million more than requested by the President. For comprehensive research at the National Institutes of Health, the House passed a 9% increase and the Senate passed a $2 billion increase.
For prevention funding at the CDC and substance abuse treatment, the two areas in most need of additional investment, only the Senate provided any hope. While the House flat-funded prevention and funding for the Substance Abuse and Mental Health Services Administration (SAMHSA), the Senate increased prevention funding by only $5 million and SAMHSA by $131 million. These programs are critical to the fight against HIV in some of the hardest hit communities.
In reference to a Congressional Black Caucus meeting last week, AIDS Action's Daniel Zingale said that "the starkest example of where we're failing to address the HIV epidemic among African Americans is the fact that national HIV prevention funding has been flat for four years, while the rate of infection has increased among communities of color."
"The void of national HIV prevention efforts is at the epicenter of today's AIDS crisis, particularly among communities of color. Neglecting prevention and substance abuse treatment fails to meet the needs of communities at greatest risk for HIV/AIDS...We need to make the same commitment to stopping HIV in the first place as we have to ensuring care for those already infected."
While the House failed to fund the Administration's recently announced $100 million global AIDS initiative, Senate appropriators fully funded the program.
Global efforts aimed at preventing HIV infection must be intensified, as effective treatment becomes a less and less feasible option for controlling this disease on a worldwide scale, according to Dr. Anthony S. Fauci, the director of National Institutes of Allergy and Infectious Diseases (NIAID) in Bethesda, Maryland.
"What began as a handful of recognized cases among homosexual men in the United States has become a global pandemic of such proportions that it clearly ranks as one of the most destructive microbial scourges in history," Fauci said in an article in the New England Journal of Medicine. "Unless methods of prevention, with or without a vaccine, are successful, the worst of the global pandemic will occur in the 21st century."
Dr. Fauci discusses in the article the state of the worldwide HIV pandemic and the need for an international response to this disease.
In the United States, the number of new HIV cases each year has leveled off at 40,000 people, half of them under 25.
However, the number of new cases elsewhere is growing at an alarming rate.
"Sub-Saharan Africa (is) currently bearing the greatest burden of the epidemic worldwide," Fauci said. The infection rate in the former Soviet Union "has escalated sharply over the past few years" and the virus threatened to invade the Indian subcontinent and Southeast Asia.
"An estimated 5.8 million new HIV infections occurred worldwide during 1998 -- approximately 16,000 each day. More than 95 percent of these new infections occurred in developing countries," he said.
Some 2.3 million people worldwide died last year from contracting the human immunodeficiency virus which leads to acquired immune deficiency syndrome.
"If the current trend continues, more than 40 million people will be infected with HIV as we enter the new millennium," Fauci said.
"Prevention is really the answer," Dr. Fauci told Reuters Health. Approximately 90% of HIV-infected individuals worldwide live in areas where effective treatment for the disease either isn't available or isn't affordable, he noted.
Also, "the hopes of eradicating the virus in people who can actually afford therapy," are becoming less realistic, and the complex, life-long regimens required to control HIV infection are difficult for most patients to adhere to.
In order to succeed in any efforts to control HIV worldwide, Dr. Fauci believes that researchers, physicians and public health workers in the US need to form partnerships with each other and with their counterparts in other countries, "as well as a stronger political will among the nations of the world." In addition, physicians in the US must "continue to heighten their awareness of HIV," he recommends, "particularly when you're dealing with a population...where you know the incidence of HIV is spreading quite rapidly." (Reuters)
US remains hostile to South Africa drugs act
The US government has not officially signed off on SA using parallel imports or compulsory licensing to obtain drugs at lower prices than those offered by patent holders, or shifted from its hostility to such practices, according to a report in the journal Business Day in Johannesburg.
The journal said that in an interview with South African Trade and Industry Minister Alec Erwin, Erwin shed fresh light on the agreement he reached with US trade representative Charlene Barshefsky a week earlier to defuse the long-running row over Section 15c of South Africa's as-yet-unimplemented Medicines Act.
"What we sought to reach agreement on was the policy objectives of the two governments. We succeeded. Our policy objective of affordable health care is recognized and our policy statement that we are not seeking to undermine the intellectual property right is accepted.
"But under what conditions, and when we could do parallel importation (buying drugs from channels not authorized by a patent holder), was not part of the agreement."
South African sought no agreement, Erwin said, on patent right exhaustion, the point in the marketing chain at which a patent holder loses control over further sale of his products.
This is a key issue because while the World Trade Organization (WTO) agreement on intellectual property (called TRIPS) prohibits parallel importing, it does not resolve the exhaustion question, leaving countries to use their own discretion, which may not be challenged.
Erwin said if the US did not like South Africa's interpretation of patent exhaustion - to be determined in regulations that still have to be crafted -- it would have to take the matter up at "TRIPS-level, WTO-level," or in other words seek the reopening of the treaty itself. TRIPS permits compulsory licensing - that is, countries may license local firms to manufacture goods using another company's patented formulae - for the public good, so long as the patent owner is compensated and the government's action is subject to judicial review.
The US government has nonetheless opposed compulsory licensing on principle and reserved the right to pressure countries not to use it. Asked whether the administration had shifted from this stance, Erwin replied: "Ours was a carefully formulated proposition.... I would not draw the inference that they necessarily accept compulsory licensing."
The agreement did not preclude companies from exercising their legal right to challenge government's actions, Erwin said. "If they wish, they can still take this matter up. They could still, through the legislation of the US or anywhere else, attempt to have this matter addressed through the WTO.... we never sought to prevent the exercise of legal rights."
As for whether South Africa would now be taken off the trade representative's "watch list," Erwin made clear the issue was moot. He did not accept the validity of section 301 of US trade law which establishes the "watch list" mechanism, which requires the US trade representative to go after countries where US companies feel their intellectual property is under threat, even if the countries are complying fully with TRIPS.
"We believe that the unilateral use of pressure is a fundamental attack on the rules-based (international trading) system. The fact that the US is a very powerful economy makes the attack even more fundamental, because the purpose of the system is to get fair rules for all regardless of size. Therefore, we will not, and have not, negotiated any of our status under 301."
Issues that may keep South Africa on the list, including allegations that government is ignoring the use of pirate software, are being dealt with under the trade and investment framework agreement reached between the two countries earlier this year. (Johannesburg Business Day)
DC demonstration on AIDS drugs set for October 6th
In an effort to dramatize the demand that AIDS drugs be made available to every nation, ACT UP and other groups are sponsoring a major demonstration in Washington, DC, on Wednesday, October 6, beginning at noon at Farragut Square, 17th Street and Connecticut Avenue.
The location is near the office of US Trade Representative Charlene Barshevsky, who has led U.S. efforts to threaten less wealthy countries with economic sanctions if they try to use AIDS drugs manufactured by U.S. companies in ways which the companies believe threatens their profits.
In Philadelphia, buses will leave at 8 am from Broad and Walnut Streets. Lunch will be provided. Transportation is also available from New York and other locations.
"90% of people with HIV worldwide have no access to lifesaving drugs," a statement announcing the demonstration said. "Poor nations seek to manufacture affordable generic versions of expensive drugs, and also shop around the globe for the best price. These legal and common trade practices are used by the United States and many other whiter, wealthier nations without fear of punishment. Rather than supporting these efforts, the US Government threatens developing nations with sanctions and demands changes in the laws of sovereign countries.:
The statement continues, "As the top trade official of the United States, Charlene Barshevsky plays big stick for the drug companies -- the world's most profitable industry and top contributor to politicians. For poor nations populated mostly with people of color, the racist trade policies of the US are a death sentence."
For more information, call ACT UP Philadelphia at 215-731-1844.
Scientists hear progress on resistance drugs
An experimental AIDS drug from Gilead Sciences Inc., tenofovir, had a significant antiviral effect without toxicity in a trial of patients who had become resistant to some of the most common AIDS therapies.
Resistance is one of the toughest problems doctors treating people with AIDS face.
In some people who have had long experience with older AIDS drugs, the virus can mutate swiftly, circumventing powerful drugs in a matter of months and causing debilitating symptoms to recur. As a result, new drugs with more long-lasting effectiveness are considered critical as the battle against the disease unfolds.
At a recent science meeting, several drug makers and AIDS researchers presented studies of new drugs and new combinations of existing drugs designed to deal with the troubling rise in resistance among some long-treated patients. DuPont Co., Glaxo Wellcome PLC, Abbott Laboratories and others showcased dozens of studies for the more than 16,000 scientists, doctors and other health-care workers at the conference.
Gilead's study generated interest because its drug works differently than existing medicines. In essence, it is chemically preactivated, making it more effective in a wider range of cells than existing drugs, which undergo more chemical changes inside a cell.
In the study, the company said, 189 patients for whom other therapies had failed showed no resistance to tenofovir after six months. Moreover, patients suffered no serious side effects even as the drug at the highest dose eliminated more than 80% of the virus from their bloodstreams. In larger studies to begin shortly, the company hopes to show the drug's activity against resistant viruses is sustained.
"This represents an impressive and durable effect," said Robert Schooley, a University of Colorado AIDS expert and chief investigator in Gilead's Phase II trial. "As a doctor, there are a lot of positive features that warrant enthusiasm." One big benefit is that unlike most AIDS drugs, tenofovir need only be taken once daily.
Analysts said the results, reported at the Interscience Conference on Antimicrobial Agents and Chemotherapy, clear up the nagging question of tenofovir's safety. Safety data are closely watched because a similar AIDS drug developed by Gilead known as adefovir triggers kidney problems in some patients. That toxicity has delayed adefovir in the clinic, but Gilead could win regulatory approval to begin selling it by the end of the year.
Other drug makers are racing to develop drugs that fight resistant strains of the virus. And because people with AIDS currently face a lifetime of drug therapy, tenofovir potency may not be long lasting enough.
John Martin, Gilead's president and chief executive, said, "There are bound to be patients somewhere sometime who develop resistance to tenofovir. But we think resistance will be slow to emerge."
In another small study, researchers showed that an experimental drug called T-20 may also be useful in treating patients who have developed resistance. The drug, developed by Trimeris Inc., a small Durham, N.C., company, also works differently from existing medicines; it blocks viruses from entering into cells. In a 16-week test of 55 previously treated patients whose virus appeared to develop resistance to existing drugs, T-20 reduced the levels of virus in the bloodstream of 20 patients to below where it could be detected by the most sensitive tests.
But T-20 will need to be injected by patients twice daily, and producing the drug is expected to be very expensive. Roche, however, recently licensed T-20 and plans to aggressively expand human trials, especially among patients with resistant virus, and to seek less expensive ways to make the drug.
Meanwhile, results of clinical trials on a new Abbott Laboratories AIDS drug show that the medication, called ABT-378, has the effect after 36 weeks of treatment of lowering virus levels, both in patients who haven't previously been treated and in those whose previous drug regimens had failed them.
The results of two separate Phase II clinical trials on ABT-378 show that the new Abbott protease inhibitor, used in combination with Abbott's existing protease drug, Norvir, is both potent and well tolerated in both groups of patients, Abbott officials and outside investigators said. (Norvir generically is called ritonavir.)
"ABT-378 with ritonavir demonstrated activity against HIV and a promising tolerability profile in both studies," said Joseph Eron, director of the infectious diseases department at the University of North Carolina in Chapel Hill. After 36 weeks of treatment, 89% of the previously untreated patients with HIV virus had their viral loads reduced below the level of detection after taking the 378-ritonavir combination. This doesn't necessarily mean the virus has been eradicated, but merely that it isn't detectable. In fact, many scientists believe the virus has become dormant with some of the existing protease drugs, only to mutate and grow again. In a separate Phase II study, 78% of patients who had failed on other AIDS drugs saw their viral loads fall to below detectable levels with the ABT-378/ritonavir combination. In this study, patients took the ABT-378/ritonavir combination for two weeks and then kept taking it in combination with other standard therapy, nevirapine and two nucleoside reverse-transcriptase inhibitors.
Abbott officials said two of 170 patients discontinued the studies because of adverse events related to the ABT-378/ritonavir combination. The most common adverse events in the trials were diarrhea, nausea, lack of strength (asthenia) and headache. (Wall Street Journal)
Physicians urged to lower threshold for HIV testing
Although the incidence of HIV appears to have reached a plateau among high-risk groups in the US, rates of the infection continue to rise in lower-risk groups, indicating a need for "reappraisal" of screening practices in this country.
Dr. Jeffrey H. Samet, of Boston University, in Massachusetts, and colleague Dr. Kenneth A. Freedberg discuss the need for expanding HIV screening recommendations in the US in a review article in the September 27th issue of Archives of Internal Medicine.
"How high does the risk have to be for the doctor to test that person for HIV?" Dr. Samet wondered in an interview with Reuters Health. From a cost-effectiveness perspective, this threshold is as low as 1%, he said, which is not much higher than the 0.3% risk in the US population as a whole.
The arguments in favor of lowering the threshold for testing are threefold, Dr. Samet said. First, most HIV-infected patients are "diagnosed and treated very late in the course of." the disease. "People literally come in years, on average, after they become infected with HIV." The prognosis is substantially improved for HIV-infected patients when they are identified and treated early in the course of the disease.
Second, "it's quite clear now that when [individuals are] aware of their HIV infection, their behaviors become safer" and they are less likely to transmit the infection.
Finally, Dr. Samet said, "physicians, especially front-line physicians, see these patients and some of them have obvious risk factors." Although most physicians routinely recommend HIV testing for the highest-risk patients, they are not as likely to recognize "more subtle" risk factors as indications for screening.
These less-recognized "red flags" include trichomoniasis infection, a single episode of herpes zoster infection, and even bacterial pneumonia in patients younger than 50 or 60 years of age. In addition, patients treated for alcohol addiction are at increased risk of HIV, as are those undergoing a diagnostic work-up for sudden weight loss, according to Dr. Samet.
Of course, testing for HIV is not as simple as testing for some other conditions, he commented, since pretest counseling must be provided by the physician or other healthcare worker. This means that expanded HIV testing "may require some reorganization of resources."
The physician also noted that some lower-risk patients may be "surprised" at the recommendation that they be tested for HIV, in most cases because the possibility of infection had not previously occurred to them.
However, the patient response to this recommendation is also a function of the context in which it is presented, Dr. Samet said. "Generally, [patients] will follow advice if it's given in a caring, nonjudgmental way."
The bottom line, Drs. Samet and Freedberg say in their report, is that HIV testing should no longer be "primarily diagnostic." In other words, "the era of embracing a screening paradigm for HIV testing has arrived." (Reuters)
Molecule blocks HIV in lab tests
Scientists have identified a molecule that can prevent HIV from infecting cells -- at least in the laboratory.
Though the approach is still in the early stages of development, it may one day prove effective at treating people infected with HIV, researchers report.
Current medications combat HIV by preventing it from reproducing once it has entered a cell. While many people experience dramatic improvements once they start taking a combination of these drugs, the medications do not eliminate the virus from the body. Besides the cost of such treatment, which can be as high as $15,000 a year, another drawback of current medications is that HIV can become resistant to their effects.
But in a study published in the October issue of the journal Nature Structural Biology, researchers led by Dr. Stephen C. Harrison, of Harvard University, Cambridge, Massachusetts, report on a molecule that stops HIV from entering cells in the first place.
When HIV infects a cell, the virus's membrane becomes joined, or fused, to the membrane of the cell. In laboratory tests, however, Harrison's team identified a molecule that can prevent HIV from taking over a cell by targeting a protein called gp41, which is involved in the fusion process.
The molecule prevents the protein from undergoing the changes necessary for fusion to occur, the investigators report.
The study is "a very modest step forward," Harrison told Reuters Health in an interview. It verifies the validity of targeting gp41 to prevent HIV from entering cells, he said.
Although Harrison's team did not test the molecule in people, Drs. Oleksandr V. Buzko and Kevan M. Shokat, both of the University of California, San Francisco, also agree that targeting gp41 is a good idea.
Due to the structure of gp41, it is unlikely that HIV will develop resistance to drugs that try to interrupt the fusion process, they write in an article accompanying the study.
"This new strategy represents a promising step towards finding new drugs that target HIV entry," the journal editors note in another editorial.
However, the article points out that even though a medication based on a similar approach was effective at reducing HIV levels in people, it had to be given twice a day by injection. This made the therapy impractical for most patients except those who do not benefit from current medications, the authors note. (Reuters)
Isolation, drug use influence hospital readmissions of PWAs
Factors associated with early readmission following hospital discharge of people with AIDS and pneumonia include the lack of a companion at discharge and crack cocaine use.
These findings are reported by Dr. Richard W. Grant of Massachusetts General Hospital in Boston and colleagues, who conducted a case-control analysis of 177 AIDS patients hospitalized for Pneumocystis carinii pneumonia (PCP) or bacterial pneumonia.
Of these patients, who were seen at a municipal teaching hospital between January 1992 and March 1995, ninety subjects were readmitted with 2 weeks. These individuals were compared with the 87 controls who were not readmitted.
"Patients were at significantly increased risk of early readmission if they left the hospital unaccompanied by family or friend," the investigators report in the September issue of the Journal of General Internal Medicine.
Crack use, one or more AIDS-related diagnoses and hospital admission within the past 6 months were also associated with increase risk of early readmission.
"Demographic characteristics, alcoholism, intravenous drug use, illness severity on admission, and length of hospitalization did not predict early readmission," they write.
Although highly active antiretroviral therapy has reduced AIDS-related morbidity and mortality, the "problems associated with social isolation, illicit drug use, and nonadherent with therapy still remain."
Overall, Dr. Grant's group concludes that reducing the rate of early readmission in AIDS patients will require a "better understanding of the social milieu that defines indigent AIDS patients."
US AIDS treatment averages $17,600/year
The cost to treat a person with highly active antiretroviral therapy costs about $17,600 per year per person, according to a study by Caro Research, an independent consulting firm in Massachusetts,
Judith O'Brien and her colleagues monitored 13,000 people with HIV and 49,000 with AIDS, and found that providing HAART reduced the annual cost of caring for an HIV patient by 30%, as compared to the cost of care for those patients who developed AIDS. While the costs of HAART ranged from $10,500 to $22,300, depending on the type of drugs in the combination, the researchers found that it cost an average of $24,900 annually to treat people with AIDS.
"The average cost of one hospitalization for a person with AIDS is approximately $11,300," O'Brien said, adding that the PWAs were hospitalized on average twice each year.
"Even though the cost of managing a patient in the pre-AIDS state with HAART is costly, a substantial annual savings in costs could be achieved" by using HAART to help people keep AIDS at bay, she said.
eBay rejects auction of PWA's corpse
A Canadian person with AIDS who tried to auction the rights to his corpse on the Internet after he dies has been prevented from doing so.
The man, who lives in British Columbia, put his corpse on the block through U.S. Internet auction house, eBay, with the heading "For Sale: A Dying Human Body For Life."
But eBay pulled the item within 24 hours because it violated a company policy against offering bodies or body parts for auction.
eBay spokesman Kevin Pursglove said British Columbia resident Richard Hollingsworth planned the move as a publicity stunt to raise awareness of the fight against AIDS.
"Our sympathy goes out to him and anyone with a terminal illness," Pursglove said. "We wish him every bit of success, but you just can't sell body parts under federal law."
The company has been plagued by a string of hoax items in September. Bids for a human kidney climbed as high as $7 million, while the starting price for an unborn baby was $155,000. (Reuters)