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Issue #201: October 30, 1998
fastfax is available by fax in the 215 and 610 area codes at no cost, or by mail anywhere for $20.00 per year, by calling 215-545-6868, and by E-mail by contacting and type the message SUBSCRIBE in the message section. Sources for some articles in this issue include Boston Herald, Journal of the American Medical Association, New England Journal of Medicine, Philadelphia Inquirer, Pittsburgh Post-Gazette, Reuters, San Francisco Chronicle.
HAART linked to premature births in studies
Simpler drug regimens unsuccessful
State charges misuse of charitable funds at Allegheny
Studies conflict on name v. code reporting
Massachusetts chooses code reporting
Fighting wasting with exercise
HAART linked to premature births in studies
Pregnant women using the three-drug cocktail to fight HIV may bear an increased risk of premature delivery, the CDC has announced.
A few small studies have shown "higher than expected rates of premature births" in some HIV-infected women on combination drug therapy, according to a CDC statement.
The CDC said that officials were troubled by a relatively high incidence of early labor in two of three clinical trials sponsored by the National Institutes of Health. Known as the Pediatric AIDS Clinical Trials Group, the trials are early-stage investigations of different combinations of AIDS drugs.
In a Swiss study, 10 of 30 newborns were delivered before reaching full term, although the protease-inhibitor drugs did not appear to be the culprit. But other studies have found no evidence of danger.
Officials said they need to conduct a full- scale review of all the studies before drawing any conclusions. Meanwhile, the CDC emphasized the clear evidence that the antivirals work as intended, benefitting both the mother and child.
The CDC recommended no changes in current medical practice and said all women should continue their drug regimens as recommended by their health care providers.
The AIDS drug cocktails typically include a protease inhibitor and two or three other antivirals such as AZT or 3TC. Little is known yet as to the pregnancy-related side effects of the protease drugs, which have entered into widespread use only during the past two years.
Dr. Karen Beckerman, director of the Perinatal AIDS Center at San Francisco General Hospital, said state-of-the-art therapy during pregnancy has virtually eliminated newborn infections, even in women with advanced cases of full-blown AIDS.
She said there has been no sign of any more pre-term births because of the drugs. She noted that many of the HIV-positive women taking the drugs also have other risk factors for early labor, including young age, drug use and multiple sexually transmitted diseases.
"We see lower-than-expected prematurity rates considering the high-risk nature of the population," Beckerman said.
From 1992 to 1996, perinatally acquired AIDS cases dropped 43 percent in the United States, the CDC said. Counseling, testing and drug treatments for pregnant women have saved at least 1,500 babies a year from HIV infection, assuming a 25 percent perinatal transmission rate without the intervention.
"Studies continue to show that perinatal HIV prevention is making a difference, both in terms of lives and resources saved," health officials said.
Simpler drug regimens unsuccessful
Continuing intensive HIV drug treatment regimens that include at least three drugs is often a more effective strategy than switching patients from such therapy to "maintenance" regimens that include only one or two drugs once the virus has been suppressed, according to two large studies published in The New England Journal of Medicine.
The findings suggest that switching patients from three-drug to two- or one-drug regimens may not suppress the virus as well as continuing the three-drug regimen.
After doctors backed off from intense treatment, HIV reappeared in 23 to 46 percent of patients who earlier had no detectable virus in their bloodstream, according to two studies of nearly 600 patients. A third study of 354 patients, published recently, had the same result.
For now, the three-drug combination therapy most PWAs are currently using ''must be seen as a lifelong undertaking, since the immune system is not able to clear residual disease,'' Dr. David A. Cooper and Sean Emery of the University of New South Wales in Australia commented in an editorial that accompanies the reports.
The idea of starting with intense drug therapy and then stepping down to a less aggressive long-term regimen is borrowed from cancer treatment.
While AIDS researchers said they were disappointed the approach did not work with HIV infection, they added that the results should not discourage further efforts to devise less demanding, less costly, and less toxic combination therapy to keep HIV at bay.
For one thing, the studies showed that in half to three-quarters of patients, a simpler drug regimen did control the virus, at least for the duration of the 12-to 18-month studies. This suggests that a simpler regimen might be possible for some patients if researchers could determine in advance which individuals could benefit.
The new studies, done in the United States, France, and the Netherlands, contained some clues. Those whose virus rose with less-intense treatment were more likely to start out with higher blood levels of HIV. They were also more likely to have developed resistance to AZT.
And paradoxically, patients who had the best immune-system response to intense therapy -- as measured by large increases in CD4 counts -- were also more likely to fail on the stepped-down treatment.
Researchers hypothesize that greater numbers of CD4s gave whatever virus was still lurking more opportunity to spread and reproduce.
Both teams of researchers, one from the US and the other from France, evaluated HIV-positive subjects who had responded to combination treatment with AZT, Crixivan, and 3TC.
In one study, Dr. Diane V. Havlir of the University of California in San Diego and members of the AIDS Clinical Trials Group Study 343 randomly assigned 376 patients to maintenance therapy with Crixivan alone, AZT plus 3TC, or to continue on the triple therapy. All of the subjects had CD4 counts greater than 200 cells per microliter and less than 200 copies of HIV RNA per milliliter of plasma following triple therapy. Loss of viral suppression was used as the study end-point.
Dr. Havlir's group found that only 4% of the subjects who continued on triple therapy experienced an increase in viral load. However, 23% of the subjects receiving either of the two maintenance regimens had a loss of viral suppression.
In the second report, Dr. Gilles Pialoux of Hopital Rothschild in Paris and associates followed 378 HIV-positive subjects who received triple combination therapy. After 3 months, 279 subjects who achieved plasma load suppression of less than 500 copies HIV RNA per milliliter where switched to AZT plus 3TC, AZT plus Crixivan, or continued on the triple combination regimen.
The findings of Dr. Pialoux's group were similar to those reported by Havlir. "The proportion of patients who reached the primary end point [loss of viral suppression] was significantly higher among patients receiving zidovudine (AZT) plus lamivudine (3TC) (29 of 93 patients) or zidovudine plus indinavir (Crixivan) (21 of 94) than among patients receiving continued triple-drug therapy (8 of 92)."
Dr. Anthony S. Fauci, Director of the National Institute of Allergy and Infectious Diseases (NIAID), said that while the results of the studies were disappointing, researchers should continue to look for answers. Fauci said that the study data do not completely rule out maintenance therapy as a successful strategy for some patients. However, for now, he believes that "...patients who have responded well to intensive antiretroviral therapy, as evidenced by prolonged suppression of HIV viral load, should continue with their current treatment regimen."
The French researchers also believe that the search for an effective antiretroviral maintenance regimen should continue, noting the side effects and problems of compliance associated with HAART. The findings do not mean that a "...different maintenance regimen, or a longer induction period with the same maintenance regimen, is unlikely to be effective," they said.
In the editorial by Cooper and Emery, the assert that "it would be premature to stop investigating the efficacy of induction therapy followed by maintenance therapy for HIV-infection." This is particularly true "...in the light of new data showing that duration of remission is related to the length of induction therapy and the potency of the therapeutic regimen."
One question that needs to be answered is "...why patients with small increases in the CD4 cell count during induction therapy had higher rates of sustained remission than those with larger increases in the CD4 cell count," they point out.
The Australian researchers also believe these new findings should motivate researchers to explore treatment approaches to HIV infection other than antiretroviral therapy.
State charges misuse of charitable funds at Allegheny
Pennsylvania Attorney General Mike Fisher has charged that the managers who brought the nine-hospital Allegheny health system into bankruptcy - threatening the care of hundreds of PWAs and thousands of other Philadelphians - may have used at least $8.5 million from charitable funds to help pay their creditors.
The use of the funds, associated with 23 restricted "endowment" funds, would be a violation of state law, according to Fisher. Fisher said his office believes that Allegheny officials have taken the money endowment funds which were set aside for Graduate Hospital.
"We think it went into operating funds," Fisher said in an interview published in the Philadelphia Inquirer. "That doesn't sound like good news to me. It's just the tip of the iceberg," Fisher said.
Many people with HIV/AIDS receive their primary medical care through the Allegheny system. Allegheny also has operated the Partnership Comprehensive Care practice, which is supported by federal funds to provide care to low-income and uninsured people.
The Inquirer report said that Fisher has identified at least 550 restricted funds connected with Allegheny hospitals and professional schools that filed for bankruptcy this summer. Despite a serious staffing shortage, Fisher's office is trying to review each of the restricted funds to see if Allegheny used the funds in ways not permitted under the funds' rules.
Fisher's statements confirm the charges of AIDS advocates and others that Allegheny failed to manage its charitable funding legally and endangered the future of the nine hospitals by using the money to help fend off its creditors. The Inquirer has reported that Allegheny officials systematically removed money from restricted accounts in an apparent bid to avoid bankruptcy. Allegheny's internal accountants have identified at least $17 million in interest income alone that was taken, according to the Inquirer.
Members of We The People, the Philadelphia Unemployment Project and other advocacy groups testified before the bankruptcy court several weeks ago demanding that the judge protect Allegheny's charitable funds, and that he appoint an official to protect the public interest as the Allegheny situation develops. McCullough denied the request, saying "the Indian's weren't paid fairly, either."
Rob Capone, We The People's interim executive director, told McCollough at the hearing that "the lives of poor people living in Philadelphia are being placed in jeopardy for nothing more than greed. This court says that we have no say in this matter despite the fact that our tax dollars, charitable assets and sweat equity have built these institutions. This is wrong! We are creditors too."
Meanwhile, an attempt by Fisher to appoint a trustee to oversee the endowment funds while the bankruptcy and sale of the Allegheny system are negotiated has been turned back by U.S. Bankruptcy Court Judge M. Bruce McCullough. The judge has issued a temporary restraining order to prevent the attorney general from asking Allegheny County Orphans Court to name a trustee.
"Bankruptcy Court hasn't been very kind to us," Fisher said. Still, Fisher said he has been working with Sen. Arlen Specter (R., Pa.) to get the federal bankruptcy code amended so that Bankruptcy Court cannot remove the attorney general's right to oversee charitable funds.
The judge's order said that the bankruptcy court, by virtue of Allegheny's Chapter 11 case, has jurisdiction over the issues. Fisher had filed his petition for a trustee in Orphan's Court.
Despite McCullough's ruling, Fisher has also tried to delay approval of Drexel University's plan to take over management of Allegheny University, the chain's medical school. He McCullough that his office wants the transfer of $168 million of Allegheny's charitable assets to go through Orphans Court for approval. Approximately two-thirds of the millions in endowments and grants were made to the university and one-third to the hospitals.
Deputy Attorney General Mark Pacella said that the bankruptcy court process initiated by Allegheny "seems an end run around Orphans Court." He said that under Pennsylvania law, charitable institutions and funds fall under the jurisdiction of Orphans Court.
An Orphans Court review of Allegheny's charitable funds could delay for several weeks any action on approving Drexel's takeover of Allegheny's university. And without Drexel's involvement, the university would be in grave danger of closing, and the purchase of the hospitals by Tenet Healthcare, a national chain of for-profit hospitals, would be in jeopardy.
McCullough has not said when he will formally respond to Fisher's petition.
Tenet attorney Michael Rosenthal has raised questions about how Allegheny has used research grants.
"Allegheny may have been paid tens of millions of dollars to perform research that was not performed," Rosenthal said. Some of those grants may have involved HIV/AIDS research, he said, but he could not be sure until Tenet's review was completed.
Tenet is currently reviewing the Allegheny financial records, Rosenthal said. When asked whether the missing funds are from federal grants, he said, "It may be federal funds...We are worried about it." Allegheny also receives federal AIDS funding under the Ryan White CARE Act for the Partnership AIDS clinic.
Pacella, the deputy attorney general, said his office wants Orphans Court to assure that Allegheny's charitable assets would not be used to benefit Tenet, which is a for-profit company. In addition, a federal Bankruptcy Court cannot assign charitable assets to pay off creditors, he said.
Studies conflict on name v. code reporting
Should testing for HIV be completely anonymous or merely kept confidential? Two studies just released differ sharply on which method works best.
Various states now require hospitals and clinics to report new cases of HIV infection to state health officials as a way of tracking the epidemic's progress. Pennsylvania's health department is currently considering enforcing an HIV reporting policy in the state, and official say they have not yet made up their mind on whether the reports should be by name (confidential reports) or by code, which keeps the individual's identity unknown to the state.
Now, a University of California, San Francisco, study found that people whose results were kept anonymous by replacing their names with a number were tested earlier and got connected to medical care more quickly and for longer periods than those whose records had been kept confidential but under their own names.
The difference between the two methods is that confidential testing retains the person's name with his or her test results, while anonymous testing replaces the patient's name with a unique identifier, such as a number, and test results are never put in a record that has the patient's name.
Many AIDS advocates have lobbied for absolute secrecy in testing, arguing that the consequences of unauthorized or accidental release of the information were too great and that fewer people would get an HIV test if it were not anonymous.
''To achieve the public health goal of providing early access to HIV testing and HIV-related medical care, public health departments should maintain and in some instances enhance the broad availability of anonymous testing options,'' Andrew Bindman, author of the study, wrote in the Journal of the American Medical Association.
But a second study, from the Centers for Disease Control and Prevention (CDC) in Atlanta, examined data from six states where publicly funded testing sites changed their policy to HIV name reporting, and came to a different conclusion.
In four of the six states, the number of people getting tested at the sites increased markedly, while the number tested declined only slightly in the other two states, according to the CDC.
The study's author, Allyn Nakashima, wrote that monitoring of infection rates was needed to allocate resources to battle the disease.
''These data indicate that the impact of surveillance on those seeking HIV testing will be small and should not hinder HIV prevention efforts,'' she wrote.
Nakashima claimed that most people who get tested for HIV are probably not aware of the reporting requirements within their state. Based on her results, she said she suspects that state HIV testing policies do not really "enter into the equation" and are generally not going to keep people from getting tested.
Bindman's study compared the use of anonymous HIV testing and confidential HIV testing, and whether or not the timing of testing and subsequent treatment varied by type of testing system used.
Bindman's group evaluated a group of 835 newly diagnosed AIDS patients; which included 643 who underwent confidential HIV testing and 192 who underwent anonymous HIV testing. The subjects were tested in one of the following seven states: Arizona, Colorado, Missouri, New Mexico, North Carolina, Oregon and Texas.
The investigators also looked at the subjects' initial CD4+ cell counts (an indication of disease progression), the time elapsed between a positive HIV test result and commencement of treatment, and time to progression to AIDS.
Overall, Bindman's team found that individuals who were "tested anonymously sought testing and medical care earlier in the course of HIV disease than did persons tested confidentially."
"The availability of anonymous testing seems to be important for a substantial number of people at risk for HIV in terms of their decision to go ahead and get tested," Bindman said.
In most states where HIV name reporting has been adopted, anonymous testing has remained an available option, he pointed out. Anonymous testing is an important "safety valve" for those who really fear that any type of testing could result in their name being reported, he continued.
Bindman added that people who are tested early usually do not delay for a long time before coming for medical care. Therefore, offering the option of anonymous HIV testing "seems to be something of a win-win situation."
The study said that people being tested anonymously tended to be in an earlier stage of HIV disease and to be diagnosed with AIDS about a year and a half later from the time of diagnosis than the confidential group. The anonymous group received 918 days of medical care between testing positive and being diagnosed with AIDS, compared to only 531 days for the confidential patients. The anonymous group also had higher CD4 counts than those testing confidentially.
The researchers also found those opting for anonymous testing were younger, white, better educated and more likely to be homosexual than those seeking confidential testing, said co-researcher J. Stan Lehman of the CDC.
While Bindman's group addressed the type of HIV testing option available, the CDC report addressed the impact of new HIV reporting laws in some states, and whether these laws have altered the overall patterns of HIV testing.
The CDC study evaluated the trends in HIV testing for six states in which a confidential HIV reporting by name system has been implemented. The states were Louisiana, Michigan, Nebraska, Nevada, New Jersey and Tennessee. Four of the states continued to offer anonymous HIV testing.
"One of the key concerns about HIV reporting is that it might deter people at risk for being tested or seeking care," they admitted. The results of the study, however, indicate that this is not the case, they said.
"No significant declines in the total number of HIV tests provided at counseling and testing sites in the months immediately after implementation of HIV reporting occurred in any state, other than those expected from trends present before HIV reporting," Nakashima's team reported.
Increased HIV testing rates were noted in four of the six states, and among at-risk heterosexuals in all six states.
While one concern of those opposed to name-based HIV reporting is that some groups - including injection-drug users and gay and bisexual men - will avoid testing due to privacy concerns, no clear pattern emerged when the researchers broke down the numbers by risk groups. Among men who have sex with men, testing dropped in two states but rose in the remaining four. And half the states posted a rise in testing among injection-drug users while the other half saw a drop, the study showed.
In a statement, CDC officials said that the study should "help allay these concerns [that people will avoid getting tested], as these data show no significant declines in testing following the implementation of HIV reporting."
The CDC recommends that states continue to make anonymous testing available, even if they move to HIV name reporting.
"Maintaining anonymous test sites is important for prevention efforts and may help ensure that more individuals learn their status and receive the maximum benefit from HIV treatment," according to agency officials.
On the surface, the two reports may appear to bolster opposing sides of the HIV-reporting debate, but this is not necessarily the case, according to one public-health expert.
Reporting HIV cases by names ``is the only way we are going to crack this epidemic,'' said Dr. Mohammad Akhter, the executive director of the American Public Health Association in Washington, D.C. But for those who are fearful of having their privacy violated, anonymous testing should be available, he said. However, Akhter predicted that the percentage of people who make use of anonymous testing will decline as people realize that breaches of confidentiality are rare.
Daniel Zingale, the executive director of the D.C.-based advocacy group AIDS Action, hoped that the findings of the first study will spur the CDC to increase pressure on states to provide anonymous testing.
"The CDC could take a very forceful approach," he said, noting that the federal agency provides financial support to state health departments. Currently, the CDC requires that states make anonymous testing available, unless state law prohibits the practice. All but 11 states have anonymous testing, according to the CDC.
Zingale agreed on the need for an HIV-reporting system, although AIDS Action favors a plan that uses unique identifiers rather than names.
He also agreed with Akhter on the need for voluntary testing. "There's never been a better time to get tested for HIV," he said, noting the development of effective treatments and the legal protection against discrimination.
Massachusetts chooses code reporting
The Massachusetts' Department of Public Health has approved an anonymous HIV reporting system that requires doctors to report all HIV cases to state health officials beginning in January of next year.
The reporting plan received a "last-minute amendment" to continue anonymous testing, inserted by department staffers in response to the studies reported above.
Jean Maguire, director of the state's AIDS bureau, "said 60% of those who are tested at state sites choose anonymous testing," and that for "tracking purposes, those who are tested anonymously will be picked up by the system later, most likely when they enter treatment."
Public Health Commissioner Dr. Howard Koh said, "We'll be one of the few states tracking HIV on a non-name basis. We'll be making public health history." Maryland and Hawaii are the only other states with coded HIV reporting systems.
The state will review its policy again after two years.
Fighting wasting with exercise
MANNA will sponsor a free breakfast for people living with HIV, their caregivers, and AIDS service professionals on Friday, December 4, 1998, from 8:30-10:00 a.m. at their headquarters at 12 S. 23rd Street in central Philadelphia (entrance on Ranstead Street).
The event features an exercise training with Mary Lou Galantino, a physical therapist and researcher and author on issues related to exercise and HIV. She will discuss the use of "Thera-Bands," a system of progressive resistance exercises, and participants will get a free set of Thera-Bands to use at home.
Reservations are necessary. Call 215-496-2662 for information.
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