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Issue #147: October 19, 1997
FASTFAX is available by fax in the 215 and 610 area codes at no cost, or by mail anywhere for $20.00 per year, by calling 215-545-6868, and by E-mail by contacting and type the message SUBSCRIBE in the message section. Sources for some information in this issue include AIDS, New England Journal of Medicine, Proceedings of the National Academy of Sciences, Reuters, The San Francisco Examiner.
In this issue:
California Gov. vetoes AIDS Medicaid bill
Glaxo says AZT key to combat AIDS in brain
Merck says Sustiva reduces viral load
Rapid PI resistance seen in "advanced" patients
Groups sponsor forum on microbicides
NAPWA supports HIV reporting, without names
Support the AIDS Walk this Sunday!
California Gov. vetoes AIDS Medicaid bill
by Robert SalladayThe San Francisco Examiner
California Gov. Pete Wilson has vetoed a popular measure - supported by right-wing conservatives and liberal Democrats alike - that would have allowed low-income people with AIDS to return to work without losing their Medi-Cal benefits. Medi-Cal is California's version of the Medicaid program.
The veto angered AIDS activists and lawmakers, who viewed the bill as a good-government measure that might have saved the state money and kept patients working - and paying taxes - longer.
"It's a tragedy for our clients," said Paul Causey, executive director of AIDS Benefits Counselors in San Francisco, which has a caseload of about 2,500 people, 400 of whom he said might have been helped by the measure.
The bill, written by Assemblywoman Carole Migden, D-San Francisco, sought to avoid a Catch-22 situation common with people with AIDS on Medi-Cal.
As many patients take advantage of new protease-inhibitor drugs, their health improves and they often want to return to work. But returning to work means losing Medi-Cal, the state-federal health insurance for the poor.
The Migden measure would have exempted up to $2,500 a month in income for disabled people, including those with HIV and AIDS, from the Medi-Cal income requirements. This six-month extension would have allowed patients to continue working while Medi-Cal helped pay for the expensive "AIDS cocktail" drugs, which can run up to $1,800 a month.
"Don't forget," Causey said. "when someone goes back to work, they are paying taxes, they are eating out, they are participating in the economy rather than getting paid out by the system."
Migden's bill passed the Assembly unanimously, garnering votes even from the most conservative Republicans. It had eight "no" votes in the Senate.
Migden said the bill would have helped move patients out of an endless disability system and given them self-esteem. "We are bitterly disappointed," she said. "This was a humane and appropriate measure to address a unique social and medical problem."
In his three-paragraph veto message, Wilson said the measure was not authorized by federal law and contains "significant ambiguities that would make it difficult to implement and subject to litigation."
And, the Republican governor said, "This bill would create a new entitlement program supported only by the state general fund." One Senate analysis said the changes could potentially cost the state $19 million a year; an Assembly analysis put the cost at $7.4 million.
Migden said she would return next session with another bill that addresses the governor's concerns. She said any problems with meeting federal Medicaid regulations could be worked out between bureaucrats in Washington and Sacramento.
"It takes a little bureaucratic maneuvering to make this thing work," Migden said. "We had heard a little bit about the governor's reservations. We regard them as subterfuge because these minor differences in terminology and regulatory scope could have been resolved."
Glaxo says AZT key to combat AIDS in brain
AZT should continue to be included in combination therapy for AIDS and HIV as the only marketed drug proven to show effect against the virus in the brain, Britain's Glaxo Wellcome claims.In a statement, the company cited evidence presented to the sixth European Conference on Clinical Aspects of Treatment and HIV Infection in Hamburg by Peter Portegies, an expert on HIV and the brain at the Academic Medical Centre in Amsterdam.
"We need new drugs which will get into the brain and suppress the virus there," Portegies said.
"Until we do, AZT should be part of all combination therapies wherever possible, to ensure that maximum suppression of the virus in the brain, as well as the rest of the body, is achieved."
Portegies said although combination of drugs had been shown to suppress HIV in the blood to almost undetectable levels, the virus was known to persist in sanctuary sites.
"The brain is probably the most important sanctuary for HIV because the majority of drugs are unable to enter this part of the body," he said.
In order to penetrate the brain, drugs have to cross the blood-brain barrier, membranes between the blood supply and the cells of the brain.
Portegies said data from animal studies to be presented in Hamburg would show AZT, also known as Retrovir, penetrated the blood, the fluid surrounding the spine and the brain tissue.
He said the data showed a similar class of drug to AZT, Zerit (stavudine), was present in the blood and spinal fluid "but only in minimal amounts in the brain tissue."
Merck says Sustiva reduces viral load
DuPont Merck Pharmaceutical Co. Says that Sustiva, its once-daily investigational anti-HIV medicine, has shown significant viral load reduction.The company said this viral load reduction is in patients receiving combination therapy not involving a protease inhibitor.
Most triple combination therapy to date involves protease inhibitors, the company said.
The company said Sustiva is being studied in combination with Retrovir and Epivir to treat HIV and AIDS.
In a 137-patient Phase III study of three Sustiva doses in combination with AZT and 3TC, significant reductions in plasma HIV-RNA were observed, it said.
The company said these findings were presented as part of the current Sixth European Conference on Clinical Aspects and Treatment of HIV Infection in Hamburg, Germany.
Gene said to kill HIV+ cells
A California biotech company has said that it has found a way to genetically alter immune cells so that they sought out and killed other cells infected with HIV.The company, Cell Genesys, Inc., said its findings offered hope of a new treatment that would not just suppress HIV, but eradicate it altogether.
Trials have so far been completed only in cells in a laboratory setting, so there is no indication that the treatment will work as effectively in practice. But Cell Genesys has studies under way in humans, and said it expects to report results of a Phase II clinical trial some time next year.
The company collaborated on the study with the Partners AIDS Research Center at Massachusetts General Hospital and Harvard Medical School. Results of the trial are published in the Oct. 14 issue of the Proceedings of the National Academy of Sciences.
While drug combinations currently being given to people with AIDS have been successful in driving down viral load to undetectable levels, they have not been able to attack pockets of the virus that remain in the cells.
As a result, when patients go off the drugs, their viral loads often shoot back up. "This suggests that there are reservoirs of the virus remaining in the body just waiting to replicate," said Margo Roberts, principal scientist at Cell Genesys.
Cell Genesys' gene therapy is based on altering human immune cells so they can work as well as they could before they were depleted by HIV.
"We're basically giving the patients what they are missing -- their own immune response against the virus," Roberts explained.
She said the genetically modified cells attack the two main reservoirs for HIV: T cells and another kind of immune cell known as macrophages. Other antiviral drugs currently in use have not been able to attack the HIV resting in the macrophages.
In practice, the treatment would be administered by collecting a patient's T cells through a process similar to a blood test, and modifying those cells outside the body. The altered cells would be replicated until there were enough of them to pose a potent attack, and then put back into the body.
Cell Genesys, which is based in Foster City, California, has also developed other gene therapies it is testing in cancer.
Rapid PI resistance seen in "advanced" patients
In patients with advanced HIV infection treated with Ritonavir and Saquinavir, good compliance and optimal plasma drug levels are not always enough to prevent the emergence of protease mutations, according to members of the Swiss HIV Cohort.In the October issue of AIDS, Dr. Bernard Hirschel of the Hopital Cantonal Universitaire in Geneva and colleagues report the results of a pilot trial of a combination of the two protease inhibitors administered to 18 patients with a median CD4 count of 12/microliter and HIV viremia of 5.25 log10 copies/mL. The subjects, who were protease inhibitor naive, had previously been treated with reverse transcriptase inhibitors, which were no longer an option.
Following 5 weeks of treatment, 11 patients had responded to the combination protease regimen. However, by week 13 of treatment, only 6 patients were categorized as treatment responders, and only 2 of these patients had undetectable levels of viremia. In general, responders had higher plasma levels of both Saquinavir and Ritonavir compared with the non-responders.
Treatment side effects was the major reason that subjects dropped out of the study--other reasons included patient choice, protocol violation and death.
HIV protease gene sequencing at baseline showed that some of the subjects had pre-existing protease mutations. "In two compliant non-responders, new mutations emerged within 5 weeks of combination therapy," the investigators report. "The rapid appearance of multiple mutations was unexpected and...suggests that data obtained in moderately advanced HIV disease may not apply to very advance HIV infection."
Overall, Dr. Hirschel's team concluded that "...response to Ritonavir plus Saquinavir in advance HIV infection is unpredictable." Only a minority of the subjects in the current pilot study had suppression of HIV viremia. They found that "the cumulative emergence of protease mutations conferring resistance to the treatment could not always be predicted by good compliance and relatively high plasma levels."
Groups sponsor forum on microbicides
Philadelphia FIGHT, ACT UP and the National Abortion Rights Action League are sponsoring a forum aimed at encouraging advocacy for more research on microbicides, a cheap, non-hormonal contraceptive agent that could prevent pregnancy as well as sexually transmitted diseases.The World Health Organization has said that the development of safe, effective microbicides is crucial to improving women's health and stopping the spread of HIV/AIDS. But the lack of coordination and research support is slowing progress towards comprehensive microbicides.
The three groups are sponsoring a panel discussion on Wednesday, October 22nd, to hear about the range of potential new microbicides ready for wider research, and to learn how to effectively advocate for their development.
The event will be held in the Mayor's Reception Room, Room 202, City Hall, Broad and Market Sts. in Philadelphia. It begins with a reception at 5:00 p.m. and a panel discussion from 5:30 to 7:30 p.m. Participants should use the northeast entrance to City Hall.
The panel will be moderated by Frances Page, RN, MPH, Senior Public Health Advisor, US Public Health Service Office on Women's Health, and will feature presentations by River Huston, International Community of Women Living with HIV/AIDS; Michelle Lopez, Community Family Planning Council, New York City; and Zena Rosenberg, ScD, Division of AIDS, National Institutes of Health.
To register, call Jose DeMarco at Philadelphia FIGHT: 215-985-4448.
NAPWA supports HIV reporting, without names
The National Association of People with AIDS (NAPWA) has issued a "Policy Position Paper on Monitoring of the HIV Epidemic" which calls for "a comprehensive approach to both our nation's surveillance system and our nation's HIV counseling and testing system, as well as federal public policy and civil rights concerns."Under no circumstance does NAPWA support HIV named reporting, the CDC's promotion of a national standard in support of HIV named reporting or the creation of a federal name-based registry of people living with HIV/AIDS," the group said. "The CDC should in no way encourage or require states to do HIV named reporting."
However, NAPWA said it "guardedly supports the expansion of our national HIV/AIDS
surveillance system to include HIV infection case reporting; however, only using unique or coded identifiers that insure privacy and confidentiality of the individual."
NAPWA also called on the CDC to "aggressively promote, expand and improve anonymous HIV testing in the United States. The availability of readily accessible anonymous testing is a necessary condition/prerequisite for any maintenance and/or expansion of HIV surveillance in the United States. CDC must mandate readily accessible anonymous testing in all HIV Prevention Cooperative Agreement jurisdictions as a condition of establishing HIV surveillance tools nationally."
CDC-funded research has shown that certain individuals and/or communities will only use anonymous testing sites, the group said. "Therefore, access to primary care after testing positive is predicated upon the availability of anonymous testing."
NAPWA said that decisions regarding what type of HIV/AIDS surveillance to implement in a given jurisdiction are best made by each jurisdiction based on resources, community acceptance, confidentiality/privacy protections, the severity of the epidemic, and other local considerations. Meanwhile, an editorial in The New England Journal of Medicine says that the United States needs a national system of HIV case reporting.
Up to now, the AIDS surveillance system has "...formed the cornerstone of the nation's efforts to monitor and characterize the epidemic of [HIV] infection," Laurence O. Gostin of Georgetown University Law Center in Washington, DC and colleagues wrote. Because this system reports advanced cases of HIV infection, it only "...provides a snapshot of a decade-old epidemic." The authors believe that "the compelling need for accurate monitoring of HIV infection and for effective medical and public health interventions mandates a fundamental reevaluation of AIDS surveillance."
They argue that there is now a "new era" of more sophisticated treatments for HIV infection. "Recent research suggests that a treatment regimen of HIV reverse-transcriptase inhibitors and protease inhibitors reduces mortality and delays progression of disease."
Dr. Gostin and colleagues believe we have reached a "defining moment in the epidemic" and "unless we revise our surveillance system, health authorities will not have reliable information about the prevalence, incidence, and future directions of HIV infection." They say a collaboration between public health, advocacy, and academia can produce an HIV-reporting system "...that is both scientifically sound and protective of personal privacy."
TPAC elects new board
After several years of controversy, and an ultimatum from state officials, the Philadelphia AIDS Consortium (TPAC) has elected a new board of directors which it calls "completely free of conflict of interest."TPAC, which allocates and monitors almost $6 million in state education funds and federal AIDS funding made available through Title II of the Ryan White CARE Act, has struggled over the conflict of interest issue since its founding in 1990. The group lost its authority over $13.2 million in Title I CARE Act funds in 1996, largely because of charges of favoritism and conflicts of interest among its leadership body.
Twenty-three individuals, none of whom are said to be connected as board or staff to organizations which receive TPAC funds, were elected to the new board on October 14th. Three seats remain vacant, pending an additional election next month.
The new board represents the second major reorganization TPAC has undergone since losing its Title I authority in 1996. The last reorganization replaced the original 83-member board of directors, but still maintained too many representatives from provider agencies funded by TPAC to meet the standard of state health officials. They demanded earlier this year that TPAC finally eradicate any provider influence on its board.
About half of the current board members are people living with HIV disease, and five are "caregivers" or parents of people living with HIV. Seventy percent of the board members are people of color (57% African American, 13% Latino, and 9% Asian or Pacific Islander. Four percent of the board members are transgendered, and two are youth.
Two of the three vacant seats are those representing Montgomery County. No applications for TPAC board members were received from the county, according to a TPAC statement. The remaining vacant board seat is being held for an African American candidate from Philadelphia.
At its first meeting, the board re-elected Blair Durant, AIDS service manager at Community Behavioral Health, Inc. (CBH), as its president. Charlene Moore was elected as Vice-President, Dennis Murphy, director of the Delaware County AIDS Network, as Treasurer, and Tyrone McCray as Secretary.
Support the AIDS Walk this Sunday!
The annual Philadelphia AIDS Walk takes place this Sunday, October 19, 1997 and is a great opportunity for everyone to raise money to support and fund AIDS services in the Philadelphia region.We The People Living with AIDS/HIV of the Delaware Valley would love it if you would join our team, whether you're a member of We The People, a friend of people living with HIV/AIDS, or just someone who'd like to help.
The AIDS Fund, which sponsors Philadelphia's annual AIDS Walk, last year raised $35,000 for We The People's LifeSavers Fund, which provides emergency assistance to people living with HIV/AIDS, and another $55,000 for our ongoing support services for low-income and homeless people with HIV disease. Over a million dollars was raised for over sixty other critically-needed AIDS services in the Philadelphia region as well.
Won't you help? We're Team #33, and you can register NOW at We The People's Life Center, 425 South Broad Street, or on the web at http://www.CritPath.Org/aidsfund/indreg.html.
And if you can't walk, please make a donation anyway. Checks can be written to the "AIDS Fund" and sent directly to the AIDS Fund office at 1227 Locust Street, Philadelphia, PA 19107. Please remember to mention We The People or Team #33 on your check.
If you do want to walk, the event starts (rain or shine) at the Eakins Oval on the Ben Franklin Parkway in Philadelphia. Sign-in and Opening Ceremonies begin at 9 AM; the Walk starts promptly at 11 AM.
Register NOW to walk and raise money to fight AIDS and support people with HIV or AIDS! For more information, call 215-545-6868 or email aidsfund@critpath.org or wtp@critpath.org.
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