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Issue #251: October 15, 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:
Local company suspends study after PWA dies
Costs of AIDS drugs increase dramatically
Pharmacies resume filling Keystone prescriptions
Most in US unaware of racial health gaps
Study to investigate sex differences in AIDS care
New AIDS care database available for doctors
VaxGen completes US enrollment in vaccine trial
CA governor acts on several AIDS bills
Maryland code system shows promise
Case managers offered help with holiday planning
U.S. Bioscience, of West Conshohocken, has announced that it has suspended a study of the company's AIDS drug lodenosine after one patient died and several showed signs of possible liver and kidney damage in a Phase II trial.
A separate Phase I study of the drug involving about 60 patients being conducted by the National Cancer Institute has also been suspended pending review of all trial data, U.S. Bioscience spokesman Robert Kriebel told Reuters Health Information Service.
The U.S. Bioscience placebo-control trial was meant to study three different dosages of lodenosine, a member of the class of drugs known as nucleoside reverse transcriptase inhibitors, in combination with two additional AIDS drugs for treatment of HIV-infected adults, the company said.
It involved about 176 patients on lodenosine at 27 clinical centers in three countries.
"Effective immediately, all patients are being discontinued from lodenosine and are being monitored closely," the Pennsylvania-based company said in a prepared release. The company said it had suggested to the U.S. Food and Drug Administration that the study be suspended pending review of scientific information.
U.S. Bioscience said the company is working closely with the FDA to review and assess the data.
At a San Francisco conference on September 28, U.S. Bioscience presented positive lodenosine data involving 66 patients in the same Phase II trial of the drug taken with other anti-HIV medicines in a three-drug cocktail.
It said 55 percent of patients receiving lodenosine in triple combination therapy showed a reduction of HIV virus levels to below detectable limits after 12 weeks, compared with 50 percent of patients who took the popular reverse transcriptase inhibitor 3TC instead of lodenosine.
"Several significant adverse events were reported after the San Francisco conference. There was one death and there were a few patients showing elevated enzyme levels that are markers for possible liver and renal problems," Kriebel said.
Asked if lodenosine caused the patient's death, Kriebel replied, "We can't say for certain but there were enough signs that it could have been linked that we decided to suspend the trial."
"It was surprising to us," Kriebel said, referring to the negative developments.
He said the Phase II trial was the only study of lodenosine being conducted by U.S. Bioscience. (Reuters)
Costs of AIDS drugs increase dramatically
While use of new antiretroviral drug treatments has resulted in dramatic improvements in AIDS-related deaths, along with a shift from inpatient to outpatient care, the costs of AIDS treatment have escalated, according to the results of a study by researchers at the US Department of Veterans Affairs (VA).
Between 1992 and 1998, the number of prescriptions for antiretroviral drugs filled by the VA system increased by 546%, VA epidemiologist Dr. Abid Rahman told participants at the Third International Conference on Healthcare Resource Allocation for HIV/AIDS and Other Life-Threatening Illnesses in Vienna, Austria.
During the study period, Dr. Rahman and members of the AIDS/HIV Drug Utilization study also found that quantities of antiretroviral drugs prescribed increased by 502%, and the costs increased by 434%.
Antiretroviral drugs accounted for 47% of total pharmacy costs of HIV-infected patients in 1992. By 1998, this rose 78%.
Overall, "antiretroviral drug use has dramatically increased in the country's largest integrated healthcare system," Dr. Rahman commented in a VA Department statement.
"Patients with HIV gain clear survival benefits from [antiretroviral therapy]," he continued. But "we don't yet know the extent by which higher drug and clinical expenses are offset by reduced hospital care."
Dr. Rahman' group concludes that the long-term benefits associated with antiretroviral therapy, which include decreases inpatient care utilization and increases in survival, will need to be considered along with the increased quantity and costs of antiretroviral drugs. (Reuters)
Pharmacies resume filling Keystone prescriptions
As of September 1, 1999, CVS and Eckerd pharmacies have resumed filling prescriptions for people on HealthChoices who have selected Keystone Mercy Health Plan as their HMO.
Since about half of all Medicaid recipients in the Delaware Valley are enrolled in Keystone Mercy, this change substantially expands pharmacy access for thousands of people with HIV/AIDS in our region.
The CVS and Eckerd chains stopped accepting prescriptions issued by three of the four HealthChoices HMOs in 1998 because the payment rates they received from the HMOs were too low to cover the cost of the medications dispensed. Only Oaktree HMO (formerly Oxford/Oaktree) members have had uninterrupted access to prescription coverage through these pharmacies. This situation left most HealthChoices participants with a substantially restricted network of pharmacies at which to have their prescriptions filled.
The situation forced many people with HIV/AIDS to rely on local Rite Aid pharmacies, which have had a controversial relationship with AIDS advocates because of charges of poor service to PWAs, and on smaller chain pharmacies such as Walgreens and the ever decreasing number of independent pharmacies in the region.
Since September 1, this restricted network has expanded for Keystone HMO members who can now resume using CVS and Eckerd to fill their prescriptions. Members of Health Partners and HMA, the other two HealthChoices HMOs, are still stuck with limited pharmacy access.
Neither the pharmacies nor Keystone Mercy will release details as to how this agreement to resume services was reached.
The local HIV/AIDS specialty pharmacies -- including StatScript Pharmacy, CVS ProCare and APP Specialty Pharmacy -- continue to accept all HealthChoices prescription plans.
Most in US unaware of racial health gaps
Most Americans are unaware that African Americans fare worse on a number of key health measures compared with whites, and perceptions of care differ by race and ethnicity, according to a survey released by the Kaiser Family Foundation.
A majority of white Americans (54%) are not aware that infant mortality is higher for black infants than for white infants, and 58% of African Americans share the same misperception. According to the Kaiser Family Foundation, in 1997, the black infant mortality rate was 14.2 per 1,000 infants compared with 6 per 1,000 white infants.
In addition, 57% of whites are unaware that life expectancy is shorter for black Americans, while 53% of African Americans are unaware that their life expectancy is shorter. According to 1996 data, blacks in America lived 6.6 years less than whites.
While a majority of African Americans (51%) believe that there are differences in access to healthcare, 67% of whites surveyed said that African Americans are "just as well or better off than the average white person when it comes to getting routine medical care when they need it."
Fifty-six percent of African Americans surveyed believe that blacks with heart disease are less likely than whites to receive specialized medical procedures and undergo surgery compared with 33% of whites who believe the same. Similarly, 64% of African Americans believe that they are less likely candidates than whites to receive the newest treatments for HIV-AIDS compared with 43% of whites who share the same perception.
Forty percent of African Americans say that race or ethnic background is a major problem in getting care, while 45% of African Americans cite the problem of a sufficient number of physicians or health providers in their demographic area as a problem with getting care. A majority of African Americans (71%) say that the cost of insurance is a major problem access to medical care.
According to the survey, which was released at Kaiser's forum on Race, Ethnicity and Medical Care in Washington, DC, minority groups are concerned that the quality of care they receive is lower than the care provided to whites. Sixty-four percent of African Americans and 56% of Latinos say that they believe that the care they receive is of lower quality than the care received by whites.
Only 1% of whites say that they feel that they have been judged unfairly or treated with disrespect because of their race or ethnic background compared with 12% of African Americans and 15% of Latinos. In addition, 14% of Latinos say that they have been poorly treated due to a language barrier with the healthcare provider.
Dr. Marsha Lillie-Blanton, vice president of the Kaiser Family Foundation, observed that the "survey shows that neither efforts to improve financing or efforts to prevent racial discrimination alone will improve health access for minority groups. Both race and money matter." (Reuters)
Study to investigate sex differences in AIDS care
Details on a new clinical trial to determine differences between the sexes in the treatment of HIV were released on October 11th at a National Conference on Women and HIV/AIDS.
"Scientists and doctors don't know if women and men should be taking the same prescribed dosages. We hope this study will help us to find out," Nancy MacNeil, executive director of advocacy group Women Alive, said in a statement.
The new trial, sponsored by Bristol-Meyers Squibb Co. and Merck & Co., will compare a group of 100 women and 100 men for whom current drug regimens have failed.
"There is not a lot of information and education from a clinical standpoint on women with AIDS," said Mark Short, a spokesman for Bristol-Meyers.
A gender gap in survival rates between men and women with AIDS still exists. In Los Angeles County, women are 18 percent less likely to survive than men, even with the advent of new medications, according to Women Alive.
Short noted that trial participants will be paired with "peer advocates" in an effort eliminate distractions, ranging from transportation to child care, that could interfere with adherence to the trial parameters.
"We don't want a single person -- woman or man -- to have to drop out of this study due to the demands of day-to-day life. We feel that adherence is so important that our peer advocates will be asked to wear pagers in order to be available at all hours to provide support to patients," said DeAnna Bowens, Women Alive's peer advocate coordinator.
The 48-week trial will compare sex differences for viral load suppression, diabetes, abnormal distribution of body fat and elevated cholesterol levels patients expected to be enrolled at 10 sites around the United States.
The study will assess the regimen of two nucleoside reverse transcriptor inhibitors with two protease inhibitors. (Reuters)
New AIDS care database available for doctors
A new HIV/AIDS database being developed at UC San Francisco is designed to serve as a centralized location for real-world treatment outcomes and as a resource for the international medical community in treating HIV disease.
The system is named HIVWatch. The UCSF Positive Health Program based at San Francisco General Hospital Medical Center is acting as the initial test and development site for the database, in cooperation with the San Francisco Department of Public Health.
From the pilot project, the UCSF team has determined the rate of increase in CD4 cells and the reduction in viral load among its patients.
James O. Kahn, MD, associate director of the UCSF Positive Health Program, presented these and other findings at the recent Interscience Conference on Antimicrobial Agents and Chemotherapy that took place in San Francisco.
"Preliminary data demonstrate that overall our patients at San Francisco General are experiencing increases in their CD4 cells over the levels of a few years ago. We also are seeing an increase in CD4 cells among patients at their first clinic meeting," Kahn said.
"This may indicate that people are coming into care early when medications are particularly helpful. The viral load is stable in our patients. Further analysis will help determine why we are not seeing a reduction in viral load to match the increase in CD4 cells," he said.
Data taken from the population of UCSF Positive Health patients at San Francisco General shows:
-- Between July 1995 and November 1998, more than 12,000 new patients were seen.
-- Prior to introduction in 1996 of highly active antiretroviral therapy (HAART), patients had an average CD4 cell count of 296. With HAART, the CD4 cell count increased to an average of 383.
"Information like this is valuable for tracking trends related to HIV disease and improving treatment strategies. There has long been a need for a definitive clinical database like HIVWatch. As a resource, it is expected to provide community-based physicians with improved insight into the advantages and disadvantages of particular treatment options available to their patients," said Kahn, who also serves as director of the pilot project.
At present, the database has information provided by UCSF. All data is presented in aggregate form, and no individual patient information is provided in order to protect patient confidentiality. Ultimately AIDS treatment centers from around the world are expected to contribute patient, pharmacy, laboratory, clinical, and treatment-outcome data into the system.
The system will be funded on a long-term basis by an unrestricted educational grant from Bristol-Myers Squibb, a pharmaceutical company involved in developing AIDS therapies.
UCSF data being provided to HIVWatch as part of the pilot project will be available soon on the Internet through HIV InSite at http://hivinsite.ucsf.edu. HIV Insite is a project of the UCSF Positive Health Program and the UCSF Center for AIDS Prevention Studies, both of which are programs of the UCSF AIDS Research Institute.
VaxGen completes US enrollment in vaccine trial
VaxGen, Inc.has announced that it has inoculated more than 5,000 volunteers, completing enrollment in the United States portion of the North American trial of AIDSVax, a vaccine designed to prevent infection by HIV.
Additionally, the company announced it has completed a private placement of common stock resulting in proceeds of $25 million to the company, enabling the company to expand its vaccine research to develop HIV vaccines for worldwide eradication of AIDS.
The inoculation of more than 5,000 volunteers in the study, the first-ever Phase III clinical trial of a preventive HIV vaccine, took place at 56 clinics in the U.S. and at one clinic each in Puerto Rico and the Netherlands. [Philadelphia FIGHT is the local AIDSVax trial site.] Enrollment of volunteers at three Canadian clinics will continue through October, resulting in a total of 5,400 volunteers. The company is also conducting a Phase III trial in Thailand of a separate formulation of AIDSVAX. The Thai trial is being conducted at 17 clinics and will involve 2,500 volunteers.
The additional financing will enable VaxGen to embark on a comprehensive program to develop AIDSVax into formulation which prevent infection by all major strains of HIV, including those found in China, India, Africa and South America. The company will then develop a single vaccine formulation for general use.
"We are making this investment to jumpstart the development of a worldwide vaccine for HIV," said Ruth B. Kunath, director of Vulcan Ventures Biotechnology Portfolio, Paul Allen's investment group. "Only a vaccine can bring an end to this epidemic, and that is possible only when companies have the determination and resolve to move from research into human clinical trials, as VaxGen has."
To date, no vaccine to prevent HIV infection, other than AIDSVax, has received FDA approval for testing in Phase III clinical trials. (VaxGen)
CA governor acts on several AIDS bills
California's Gov. Gray Davis (D) has vetoed a bill requiring the use of unique identifiers in tracking new cases of HIV infection, but signed another which allows people with AIDS and other disabilities to continue to receive Medicaid benefits after they return to work. He also signed a compromise measure allowing the establishment of needle exchange programs under certain conditions, while vetoing yet another bill that would have required special reimbursement rates for Medicaid managed care plans.
The first Medicaid bill will allow disabled individuals, including those with AIDS, to return to work and maintain their health care benefits through the Medi-Cal program, California's version of Medical Assistance. The new law "will ensure that individuals living with AIDS can enter or reenter the workplace without compromising the access to care and treatment needed to maintain stable health and sustain their quality of life," said Thompson.
The needle exchange bill will give local governments the option of setting up syringe exchange programs without fear of criminal prosecution. "When implemented, as a part of a comprehensive prevention program for injection drug users, needle exchange is one of our most effective HIV prevention options," said Thompson.
While Davis vetoed the unique identifier bill, California currently is pursuing a CDC grant to fund such a system and the governor said he "will take steps to immediately implement such a system," if the state receives funding.
Maryland code system shows promise
Meanwhile, Maryland's unique identifier HIV surveillance system has yielded figures that correspond with CDC estimates of the number of HIV cases in the state, contradicting earlier CDC concerns that confidential reporting may cause errors, according to the Washington Times.
While the state uses names-based reporting to track the number of AIDS cases statewide, a confidential, unique-identifier system, which uses a number derived from a combination of a patient's social security number, date of birth, race and gender, tracks the state's HIV cases.
The CDC has long recommended the names-based reporting system, in part because a 1994-1996 analysis of several non-names based reporting systems found incomplete records and duplicates.
However, according to statistics released by the CDC last August, as of December 1998 there were 10,714 HIV-positive Maryland residents. The state's estimates, also released in August, indicated that there were 10,749 HIV cases.
Dr. Lois Eldred, assistant director of the Health and Mental Hygiene AIDS Administration, said, "The system is controversial, but it has worked very well in our state. We've been able to evaluate our system, and we feel good about that."
At the same time, Eldred said, the system works to "encourage people who may be at risk not to feel threatened" or deterred by a names-based reporting system. However, CDC Spokesperson Kitty Bina said, "It's not a formal evaluation of Maryland's system. I'm not sure if it's OK to compare our estimate with their findings." The CDC uses a modeling system that determines the HIV infection rate based on the number of full-blown AIDS cases. (AIDS Project Los Angeles, Washington Times)
Case managers offered help with holiday planning
As part of its Frontline Information Series, Philadelphia FIGHT will focus next month on "Holiday Help: Getting Stuff for your Clients."
"Sometimes its tough for your clients and their families to make the holidays special. Come and find out what resources there are in the area to make Thanksgiving, Christmas and other winter holidays more festive," a FIGHT statement said.
The discussion, labeled a "neighborhood advisory roundtable," will be held on Wednesday, November 10, 1999, from 3:00-5:00 p.m. at St. Luke and the Epiphany Church, 330 S. 13th Street, Philadelphia. Admission is free; refreshments will be served.
The event counts as two (2) hours toward the Case Management Coordination Project continuing education requirements for Ryan White Year 09. Please contact the Project at 215-685-5665 or 215-985-6200 for further details.
For more information, call (215) 985-4448. Sign language and Spanish Language interpretation can be provided if requested at least two weeks in advance.