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Issue #170: March 29, 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 information in this issue include Journal of AIDS and Human Retrovirology, Journal of the American Medical Association, The Journal of Infectious Diseases, New England Journal of Medicine, Reuters, The Lancet.
Study confirms "dramatic" jump in health of PWAs
Nevirapine study shows HIV suppression
Study highlights increase in AIDS drug cost
Income, not race, seen as reason for high black death rates
Syphilis stimulates HIV replication
TEACH offers women's self-defense workshop
Study confirms "dramatic" jump in health of PWAs
A "dramatic" decline in sickness and death among people living with advanced HIV infection has occurred since highly active antiretroviral treatment (HAART) has become routinely available, according to HIV Outpatient Study investigators. They therefore recommend "...that an intensive combination drug-therapy regimen that includes a protease inhibitor should be considered the standard of care for patients with advanced HIV infection."Dr. Frank J. Palella, Jr. of Northwestern University Medical School in Chicago, Illinois and colleagues reviewed data from patients treated at nine HIV clinics in different US cities between January 1994 and June 1997. They analyzed the mortality and incidence of opportunistic infections in 1,255 AIDS patients who had at least one CD4+ cell count below 100 cells per microliter. Many of the subjects had received extensive antiretroviral treatment.
The results indicate that decreased morbidity and mortality "...were clearly linked to the increasing use of combination therapy, with the most dramatic reductions coinciding with increases in the use of protease inhibitors."
After adjustments were made severity of immune deficiency, "...the reductions in morbidity and mortality were seen regardless of sex, race or ethnic group, and risk factor for transmission of HIV." Specifically, Dr. Palella's group found that in 1995, mortality was 29.4 per 100 person-years, which declined to 8.8 per 100 person-years by the second quarter of 1997.
The incidence of Pneumocystis carinii pneumonia (PCP), Mycobacterium avium complex (MAC) disease and cytomegalovirus retinitis (CMV), three major opportunistic infections, also declined during this period.
They also found that compared with patients on Medicare or Medicaid, patients with private insurance were prescribed protease inhibitors more often and also had lower mortality rates.
The issue of whether poor people are able to take advantage of progress in AIDS treatments is particularly important in the Philadelphia area, which has seen a reduction in funding for clinical care services for the uninsured and new obstacles to care for Medicaid recipients under the state HealthChoices managed care program.
Palella et al. present evidence of a "massive decrease" in morbidity and mortality in a mixed population of HIV-positive patients, Drs. Bernard Hirschel of the 12th World AIDS Conference in Geneva and Patrick Francioli of University Hospital in Lausanne point out. The findings also support "...a growing body of evidence that the number of inpatients with AIDS has decreased while the number of outpatients has increased."
Although the findings reflect a "major achievement" in HIV treatment, they also raise new questions, the physicians continue. For example, " Should we hit HIV early and hard?" The fact remains that the clinical benefits of highly active antiretroviral treatments have been documented only in severely immunosuppressed patients.
Another issue is the burden of this type of therapy on the quality of life of patients. "We need simpler treatments," they point out. Other problems include what to do when treatment fails to control viremia, the question of long-term compliance with treatment, and the high costs of treatment.
In addition, HIV-positive patients in many developing countries simply do not have access to highly active antiretroviral therapy. "Nothing is likely to bridge the gap between the rich and the poor countries," they add. "Only prevention and perhaps someday a vaccine are likely to make a real difference."
Nevirapine study shows HIV suppression
Triple-drug combination treatment with the two nucleoside analogues, zidovudine (AZT) and didanosine (ddI), plus nevirapine, a nonnucleoside reverse transcriptase inhibitor, effectively suppresses HIV replication.
The finding is critically important for those who are unable to tolerate protease inhibitors or who cannot afford the expensive drugs.
Dr. Julio Montaner of the University of British Columbia in Vancouver, Canada and members of the INCAS trial, which included HIV-positive people in Italy, the Netherlands, Canada and Australia (INCAS), evaluated the effects of different combinations of nevirapine, ddI and AZT. The 151 treatment-naive HIV-positive subjects were treated with two drugs, AZT plus nevirapine or AZT plus ddI, or all three antiretrovirals.
The group's findings appear in the March 25th issue of the Journal of the American Medical Association. "Zidovudine, didanosine, and nevirapine led to a substantially greater and sustained decrease in plasma viral load than the 2-drug regimens studied." Over half (51%) of patients in the triple therapy group had sustained HIV RNA levels below 20 copies/mL after 1 year of treatment, compared with 21% among those treated with AZT plus ddI and 0% among those on AZT plus nevirapine.
Other findings from the study "...also suggest that suppression of viral replication, as demonstrated by a decrease in the plasma HIV-1 RNA load below the level of quantitation of the most sensitive test available, may at least forestall the development of resistance."
Current treatment guidelines for people with AIDS or advanced HIV infection recommend combination regimens that contain a protease inhibitor, Dr. Roy Gulick of New York Hospital-Cornell Medical Center comments in an accompanying editorial. "For patients with earlier stages of HIV disease,
the choice among currently available regimens should be carefully considered, with easier-to-take regimens kept in mind," he continues.
"While formal guidelines are important and useful," Dr. Gulick also points out that "...the clinician ultimately must interpret and apply the recommendations in choosing a specific regimen for an individual patient. In such cases, one size does not fit all, and multiple factors relating to the patient, the proposed regimen, and characteristics of the viral strain must be considered."
Dr. Gulick believes that "the philosophy of 'treat early, treat hard" in early HIV infection must now yield to a philosophy of 'treat smart' for all stages of HIV infection."
Study highlights increase in AIDS drug cost
Between 1995 and 1996 the overall cost of drug therapy for HIV infected patients increased significantly, especially cost of antiretroviral drugs, according to a Maryland-based team of researchers. These cost increases "...appear to be the result of increasing complexity of drug regimens, particularly antiretroviral therapy in combinations," they concluded.
Beulah E. Perdue of The Johns Hopkins University School of Public Health in Baltimore and colleagues evaluated the drug costs for 79 HIV-positive patients receiving ambulatory treatment at a university clinic. They examined the data for four periods between June 1995 and September 1996 that reflected "landmark" changes in drug therapy. Their findings appear in the April 1st issue of the Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology.
The mean monthly drug costs rose from $447 in the beginning of the study, to $1,048 at the end of the study period. Costs were particularly high for people with CD4+ counts of less than 200 cells per microliter.
"The proportion of costs attributable to antiretroviral therapy increased from 34% in period 1 to 53% in period 4." This may be explained by the fact that the use of combination therapy increased by more the 10-fold over the study period, from 8% to 94%. The use of protease inhibitors also increased from 4% to 53%.
The cost factor and the increasing complexity of combination regimens "...raises the question of patient adherence," the researchers point out. "With ever-growing knowledge about the treatment and prophylaxis for current and emerging infections associated with HIV infection, we must remember the challenge to patients to adhere to therapy to derive the maximum benefit from these drugs."
Income, not race, seen as reason for high black death rates
Adult black men faced an almost 50% higher risk of death compared with white men of the same age over the course of a recent 16-year study. However, the study authors believe this heightened risk is primarily due to differences in income rather than race.
"Socioeconomic position is the major contributor to differences in death rates between black and white men," conclude investigators from the University of Bristol in Bristol, England, the University of Minnesota, Minneapolis, and Northwestern University Medical School, in Chicago. Their report appears in the March 28th issue of The Lancet.
The researchers focused on health and socioeconomic data drawn from the 1980 US Census, as well as information on 361,662 men (20,224 of them African-American) collected during the 1973-1975 Multiple Risk Factor Intervention Trial. The researchers followed the rates (and causes) of death of their study group until December of 1990.
They discovered that adult black men in the study had a 47% higher rate of death from all causes compared with white men of similar age.
The study found that black men also had a 47% higher risk of dying from cancer than white men, and a 36% higher risk of dying from cardiovascular disease.
Black males were also more than 2.5 times more likely to die from infectious disease. including AIDS, compared with whites.
More than six times as many black men were victims of homicide during the study period, compared with white men.
But the study also showed that black men had 30% lower risk of suicide than whites.
The researchers point out that income -- not race -- may be the underlying cause for the differences in death rates. "Adjustment for age and income gave a much lower relative risk of all-cause mortality," they say, causing the overall risk of death for black men to fall to 19% above that of whites. And they say the overall excess death risk of black males from either cardiovascular disease or cancer fell to 9% and 25%, respectively, compared to that of whites, after factoring in differences in income.
Finally, the authors point out that "for (all) men residing in zip codes with median family incomes of $25,000 or more, the adjusted black-white mortality difference was small and non-significant."
The study authors believe lowered income is the primary impetus behind a myriad of negative lifestyle factors tied to poor health, the most important of which may be residence in neighborhoods with high rates of stress, violence, pollution and unemployment. They contend that "at a given level on any indicator the material conditions for existence may be less favorable for black than white people."
Pervasive societal racism may also push up stress levels among black males, further impacting on health. The authors call racism "the 'missing variable' in research on black-white differences in health."
Overall, they conclude that the major causes of differences in mortality between blacks and whites are socioenvironmental, "and efforts to decrease differences should be focused at this level."
Syphilis stimulates HIV replication
The presence of Treponema pallidum infection induces HIV replication, and treponemal lipoproteins appear to be key mediators in this process, according to Dallas-based researchers. The findings provide a basis for the association of syphilis with enhanced HIV transmission, they say.
"Syphilis...is a chronic, systemic illness in which the bacteria migrate rather freely throughout the body causing inflammation at numerous sites," senior investigator Dr. Michael Norgard explained in a press release. "By extrapolation of what likely occurs in the genital ulcers caused by syphilis, systemic levels of bacteria from that disease actually may activate immune cells throughout the body.'
Previous reports have documented high rates of syphilis in individuals with HIV infection, and "...syphilitic chancres have been implicated in facilitating HIV transmission," Dr. Norgard and colleagues at the University of Texas Southwestern Medical Center write in the April issue of The Journal of Infectious Diseases.
In the current study, the investigators used an in vitro model, which included U937 human promonocytic cells infected with HIV-1, to study the role of syphilis in HIV infection. Overall, Dr. Norgard's team found that T. pallidum and its membrane lipoproteins induced HIV replication in vitro. "These stimuli also induced HIV gene expression from a wild type HIV LTR [long terminal repeat]."
The researchers believe that spirochetes, even during latent syphilis, may produce persistent antigenic stimulation, increase systemic HIV levels, and accelerate the course of HIV infection.
NMAC offers TA on adherence
Given the new treatment options for people living with HIV and the challenge of adherence to these therapies, the National Minority AIDS Council has announced a new program, On-Site Treatment Education Adherence Technical Assistance Program. The purpose of this new national initiative is to develop or strengthen AIDS treatment education and adherence programs in minority community based organizations (CBOs) by supplying on-site technical assistance. NMAC says it developed this program because it was "concerned that our communities and their clients were not getting equivalent access to treatment information that could save their lives or the lives of people they love."
Since most CBOs do not have treatment education programs, an NMAC announcement said, this initiative will develop programs on-site to educate the agency's clients about their treatment options. It will also work with them to set-up adherence support systems. The model for this program is NMAC's current technical assistance initiative in which it provides technical assistance on management infrastructure challenges within CBOs.
NMAC said it will select 20 agencies from 10 different cities/states/territories (2 agencies at each site) to receive individualized on-site technical assistance to develop or strengthen their treatment education program. The selection process will be through a competitive, but simple application. Once the agencies are selected, they will go through an extensive analysis, including an on-site visit, to work with the agency to set-up a treatment education program. In addition, 6 and 12 month follow-up support will be provided. Start-up funds ($1,500) to initiate new programs may be provided when appropriate. These funds can be used for a variety of needs, such as, to hook up to the Internet for the latest treatment information or to print brochures to be distributed to clients.
In addition, regional trainings on treatment education and adherence will be held in these 10 sites so that the entire community can benefit from this program. The regional trainings will be supported by NMAC in collaboration with the selected agencies as well as other local partners. Rather then have one cookie cutter training, NMAC said it will work collaboratively with the local partners to develop a training that meets the needs specific to the site. The regional trainings will target case managers and PWAs.
The 10 sites include: Brooklyn/Bronx, New York, Denver, Colorado, Detroit, Michigan, East/South Central Los Angeles, California, El Paso/Rio Grande Valley, Texas, Hartford/New Haven, Connecticut, Hawaii, Mississippi, Puerto Rico, and St. Louis, Missouri. NMAC did not indicate how the initial sites for the project were selected.TEACH offers women's self-defense workshop
A free self-defense workshop for women living with HIV disease has been announced by the Women's TEA Time (Treatment Education and Advocacy) Group of Project TEACH, the local HIV treatment education program of Philadelphia FIGHT.
The workshop will be held on Friday, April 3, from 10am - 1pm (including lunch), and will be led by Marie Bloom of AWARE. Bloom is an experienced self defense instructor who has worked with thousands of women, according to the group. She is particularly sensitive to issues of women who have been the victims of violence or abuse. She is currently teaching a self defense course for women in the Philadelphia prison system.
The workshop will include discussion, roleplays and physical practice. All physical work will be tailored to meet each woman's physical capacities or concerns.
Space is limited, so pre-registration is necessary. To register, or for more information, call Agnes Harley of Project TEACH at 215-985-4448 or jdavids@critpath.org.
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