|
 |
|
|
|
Issue #237: July 9, 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:
Region passes 16,000 AIDS cases; racial disparity continues
Drug, alcohol use affects HAART adherence: study
Viral load a bigger influence on OIs than t-cell count
Unlimited access to AIDS drugs is cost-effective: study
CMV speeds AIDS progression in infants
FDA approval for Preveon sought
Insurers checking up on "disabled" PWAs
Illinois starts HIV reporting with codes
South Africans protest over AIDS drugs
Over 16,000 people have been diagnosed with AIDS since AIDS cases began being reported in 1981, according to the latest AIDS surveillance report issued by the Philadelphia AIDS Activities Coordinating Office (AACO)
About 57% of them have died, according to the report.
Nonetheless, the number of AIDS cases reported annually has continued to decline from a high of 1705 in 1993 (the year the Centers for Disease Control (CDC) broadened the definition of AIDS), to 905 in 1998. AACO projects a slightly higher number of reports for 1999, at 1,036, based on the pace of AIDS case reports in the first three months of this year.
The AACO report also notes that in the past four years, the number of people with AIDS who depend on Medical Assistance and other public programs for their health insurance has increased dramatically, to 68.5% of all living people with AIDS in 1998. In 1994, the percentage of PWAs on public insurance was only 55%.
AACO says that only about 4% of those living with AIDS had no health insurance at all in 1998, about the same proportion as in 1994.
The report says that people of color are more likely to be on public insurance. Among Latinos, 84% of PWAs were covered by public insurance in 1998, as compared to 71.5% in 1994; among African Americans, 74.3% had public insurance, compared to 64.1% in 1994. Among whites, meanwhile, the dependence on public insurance is decreasing slightly, from 51.8% in 1995 to 51.3% in 1998.
The vast majority of people on public insurance live in Philadelphia, according to AACO. "Of the 6,119 cases reported between 1994 and 1998 that either had public insurance or no insurance in the Philadelphia [region]," the AACO report says, "76% were reported in Philadelphia. The remaining 24% were dividing among all the surrounding NJ and Pennsylvania counties."
The Philadelphia region, for AIDS service and planning purposes, includes Bucks, Chester, Delaware, Montgomery and Philadelphia counties in Pennsylvania, and Burlington, Camden, Gloucester and Salem counties in southern New Jersey.
Racial disparity continues to increase
Meanwhile, the concentration of new AIDS cases in communities of color continues, according to the most recent AACO report. A striking 84% of new AIDS cases reported in the twelve months between April, 1998 and March, 1999, were among people of color (African American 71.2%; Latino 12.4; Asian, 0.5%).
AIDS diagnoses arising out of heterosexual sex and injection drug use also continue to rise in proportion to cases involving men who have sex with men (MSM). While about 50% of all AIDS cases since 1981 have been among men who have sex with men and MSM who use intravenous drugs, this percentage decreased to only 25.5% in cases reported over the past twelve months.
The largest proportion of AIDS cases over the last twelve months have been reported among heterosexual intravenous drug users, who represent almost 40% of all new AIDS cases in that period.
New cases have been reported over the period from January to March of 1999 among MSM of color at three times the rates of whites. Over the past twelve months, out of 64 new MSM cases in Philadelphia, 48 (75%) were among men of color, 16 (25%) among whites. The overwhelming majority of MSM cases are among African American men, who account for 64% (41) of all new MSM cases. Latino MSM account for 7 new cases, there were 16 among whites, and no new reported cases among Asian/Pacific Islander MSM, over the first three months of 1999.
Since records began being kept in 1981, 56% of all MSM cases have been African American, 39% among whites, 5% among Latinos, and less than one percent among Asian/Pacific Islanders.
Women of color also predominate among women with HIV, representing almost 88% of all cases among women since 1981. Over 90% of children with AIDS under the age of 13 in the region are African American or Latino, according to AACO.
Neighborhoods in the city with the highest number of new AIDS cases (as reported over the past 12 months) including North Philadelphia (19121, 19132, 19133, 19140 zip codes), which saw 513 of new AIDS case reports in that period (25% of the total), and West and Southwest Philadelphia (19104, 19139, 19143), which saw 324 (16%) of the new cases. Center City Philadelphia (19102, 19103, 19106, 19107, 19146, 19147) had 304 cases.
A long trend toward AIDS diagnoses based on low CD4 counts rather than opportunistic infections, which began in 1993 when the CDC added low CD4 counts to the AIDS definition, has continued, with over 65% of new AIDS cases over the past twelve months based on a CD4 count. Only 16% of people diagnosed over the last twelve months had suffered from pneumocystis carinii pneumonia (PCP), which at what time was the leading AIDS indicator in the region.
In a related report, AACO says that only one person has been diagnosed so far this year with a case of HIV-related cryptosporidiosis. Since January of 1990, 159 people with AIDS have been reported with cryptosporidiosis.
Drug, alcohol use affects HAART adherence: study
Certain patient factors predict the response of HIV+ people to highly active antiretroviral therapy (HAART), according to California-based investigators.
Specifically, they found that patients who reported poor treatment adherence and those who used alcohol and drugs were more likely to be unresponsive to treatment after 6 months.
Dr. Richard H. Haubrich of the University of California at San Diego and members of the California Collaborative Treatment Group conducted a prospective observational study of treatment adherence at 5 university-affiliated HIV clinics.
Of 173 HIV-infected patients who were followed from baseline, 164 completed a treatment adherence questionnaire at 2 months; and 119 patients completed the questionnaire at 6 months. At baseline, the subjects' mean CD4 cell count was 142/µL.
The subjects, who all received individualized and restricted antiretroviral therapy, were classified into 1 of 4 groups according to treatment adherence in the previous 4 weeks.
"Recreational drug or alcohol use was associated with decreased adherence," the investigators report in the June 18th issue of AIDS. No association was found between adherence and "...frequency of HIV RNA monitoring, demographic variables, (age, gender, education, and risk group), and stage of disease."
At 6 months, Dr. Haubrich's group found that greater plasma HIV RNA suppression correlated with extent of treatment adherence. Patients reporting 100% adherence had a decrease in HIV RNA of 1.1 log10 copies/mL and an increase in CD4 T cell count of 72/µL. Conversely, patients reporting less than 80% adherence had an increase in viral load of 0.2 log10 copies/mL and a decrease in CD4 T cell count of 19/µL.
The majority (80%) of the subjects had excellent adherence ratings at each monitoring interval. The investigators were surprised to find, however, that baseline adherence scores were not predictive of outcome. They suggest that this is probably explained by changes in the patients' adherence patterns over the course of the study.
Dr. Haubrich's team believes larger studies that consider a "broader spectrum of adherence are needed to determine the exact threshold where poor adherence negates any therapeutic benefit." (Reuters/AIDS)
Viral load a bigger influence on OIs than t-cell count
With antiretroviral therapy, a drop in HIV load reduces the risk of opportunistic infections, investigators report in the June 18th issue of AIDS.
In fact, "Early decreases in [HIV-1] RNA were generally more predictive of [opportunistic infection] risk than were early increases in CD4 cell counts."
Dr. Paige L. Williams of Harvard School of Public Health and colleagues collected retrospective patient data from four antiretroviral therapy studies that included a total of 842 HIV patients. The investigators assessed the effects of HIV RNA levels and CD4 cell counts before and after antiretroviral therapy on risk of developing Pneumocystis carinii pneumonia (PCP), cytomegalovirus infection (CMV) or Mycobacterium avium complex (MAC).
Dr. Williams and colleagues point out that protease inhibitors were not available at the initiation of some of the trials they analyzed, and that chemoprophylaxis for MAC has improved considerably since the start of the trials under scrutiny.
The researchers report that baseline CD4 cell counts and baseline HIV RNA levels both affected risk of opportunistic infections. Patients with the highest levels of HIV RNA levels were three to six times more likely to acquire an opportunistic infection than those with lower HIV RNA levels. Effective, early reductions in HIV RNA levels with therapy significantly reduced risk of opportunistic infection and were more predictive of lower opportunistic infection risk than were increases in CD4 cell count.
Dr. Williams and colleagues assert that prospective trials of the effects of antiretroviral therapy on opportunistic infection risk are "urgently needed." The outcome of such studies will help in the formulation of guidelines on the need for chemoprophylaxis for opportunistic infections. Research indicates, they say, that "...it may be possible to identify levels of HIV RNA below which the yearly risk is considered acceptable and above which there is a consensus that prophylaxis is desirable."
The investigators add that they also would like to see studies designed to measure what happens to viral load at the time an opportunistic infection is acquired. (Reuters/AIDS)
Unlimited access to AIDS drugs is cost-effective: study
From a societal perspective, providing unlimited access to highly active antiretroviral drugs (HAART) can result in substantial productivity gains, despite the added healthcare costs, according to a multicenter group.
The Swiss healthcare system currently provides unlimited access to HAART for HIV-infected individuals, Dr. Peter P. Sendi of the University of Basel and members of the Swiss HIV Cohort Study explain. Dr. Sendi's team examined the effects of this policy on the healthcare system and on society as a whole.
They conducted a cost-effectiveness analysis using data from participants of the Swiss Cohort Study. The analyses were performed using an "optimistic" scenario, in which patients had a longer life expectancy, and a "pessimistic" scenario, in which patients had a shorter life expectancy. Monetary cost estimates were based on 1997 Swiss francs (CHF).
"In the analysis limited to healthcare costs, on the basis of projected survival in each scenario, the cost-effectiveness ratio was 33,000 CHF (base case), 14,000 CHF (optimistic), and 45,000 CHF (pessimistic) per year of life gained," they report in the June 18th issue of AIDS. "When changes in productivity were included, cost savings occurred in the base-case and optimistic scenarios."
Dr. Sendi and others conclude that when productivity gains are included in the treatment benefits analyses "...society will probably save costs or pay a low price for substantial health benefits." Overall, the findings provide "strong arguments, from a societal perspective, to continue the current policy of providing unrestricted access to HAART in Switzerland."
Dr. Sendi's group also suggests that an unlimited antiretroviral drug access policy could be beneficial in other developed countries and that healthcare decision makers "...should re-evaluate their policy for the benefit of society at large." (Reuters/AIDS)
CMV speeds AIDS progression in infants
HIV-positive infants progress to AIDS faster if they are also infected with cytomegalovirus (CMV) before birth or in the first months of life, a study suggests.
CMV is a herpes-type virus that is relatively harmless in those with healthy immune systems, but can cause potentially-life threatening eye and brain infections in adults with HIV, who usually become infected with CMV before they acquire HIV. In contrast, children usually acquire CMV infection at the same time or after they are infected with HIV.
By age 18 months, about 70% of infants with both HIV and CMV showed disease progression compared with 30% of infants infected with HIV alone. What's more, 36% of infants with both HIV and CMV infection had impaired brain growth or motor deficits compared with only 9% of infants infected with HIV alone, according to the report in the July 8th issue of The New England Journal of Medicine.
"More than half of infants with both infections had an AIDS-defining condition or died by 18 months of age," report Dr. Andrea Kovacs of the University of California in Los Angeles and colleagues.
The study of 440 infants born to HIV-infected mothers included 75 infants who also were infected with HIV. Overall, just over 4% of infants were born with CMV, whether or not they also carried the HIV virus. In the general population, about 0.2% to 2.2% of infants are born infected with CMV.
HIV-infected infants also tended to acquire CMV infection more rapidly after birth. For example, 15% of HIV- infants had CMV by 6 months of age, compared with 40% of HIV-infected infants.
"Our results strongly imply that any attempts to prevent CMV infection in the offspring of HIV-1 infected women will have to target the perinatal period and the first 18 months of life," the authors write.
Early treatment with anti-CMV drugs, vaccination and high doses of anti-CMV antibodies may help prevent infection in vulnerable infants, according to the report.
"Strategies for the prevention of CMV infection in these high-risk infants should be the focus of future research," they conclude. (Reuters/New England Journal of Medicine)
FDA approval for Preveon sought
Gilead Sciences has submitted a new drug application (NDA) for Preveon (adefovir dipivoxil) to the US Food and Drug Administration, according to a company press release.
Preveon is an investigational oral nucleotide reverse transcriptase inhibitor (RTI) that is administered once daily at 60 mg, the company said.
The drug, which has received a "fast track" designation from the FDA, is intended for treatment of HIV-infected patients who experience clinical, immunologic or virologic treatment failure with other RTIs, such as Ziagen (abacavir), AZT, ddI, etc.
Thus far, safety data are available on more than 7,000 patients who have received Preveon, including some who have participated in a Philadelphia-area trial sponsored by Hahnemann University and Philadelphia FIGHT. Efficacy data on Preveon administered in combination with other drugs are available for more than 1,000 patients. The findings suggest that this drug shows antiretroviral activity in previously treated HIV-infected patients who have developed resistance to other antiretroviral drugs.
Drug resistance is one of the biggest challenges that physicians face in treating HIV-infected patients, Dr. John Mellors of the University of Pittsburgh points out. "Given the antiviral activity observed in clinical studies of adefovir dipivoxil in the presence of the most common mutation in treatment-experienced patients -- the lamivudine (3TC)-induced M184V mutation -- this compound may be a new option for the growing number of patients whose viral load is no longer adequately controlled by current therapy."
There are currently 8,300 patients enrolled in the Preveon expanded access program, according to John C. Martin, Gilead CEO.
The NDA submission is an "important milestone" he continued, as "there is evidence that patients are exhausting their therapeutic options and need access to new treatments."
Project Inform has reported that people taking Preveon for more than 20 weeks may be at higher risk for developing kidney toxicity due to accumulation of the drug in their blood, according to preliminary observations.
People taking adefovir are now recommended to either reduce to a lower dose (from 120mg once a day to 60mg once a day) after being on the higher dose for 20 weeks and/or increase monitoring of serum creatinine levels, which are a measure of kidney function, according to the group.
Insurers checking up on "disabled" PWAs
by James Bandler
Boston Globe
At 8:48 a.m. the surveillance camera started rolling. It filmed Robin Lambert as he crossed the street, his dog, Harley, in tow. It recorded him leaving the Cumberland Farms, reading his newspaper as Harley did his business in the snow.
The investigator tailing Lambert in February had been hired by his disability insurer MetLife. The company had shelled out $48,000 a year in disability payments since 1996 when Lambert left his job with AIDS. Now, with his health stabilized by new protease inhibitor drugs, MetLife was preparing to cut him loose.
"They thought I would be dead by now," said Lambert who was notified in March that his insurance had been terminated. "As we live longer, (the insurance companies) are being more aggressive in trying to take away our benefits."
A few years ago AIDS was often an almost certain death sentence. Now, as new medications extend their lives, people with AIDS are increasingly coming in conflict with their disability insurance carriers. These companies, sometimes using surveillance, are scrutizing AIDS claims with the same rigor they apply to sufferers of other chronic ailments.
"It has been the case that we do pay more ongoing attention to people who are out on disability with AIDS" than in the past, said Catherine Harnett, a spokeswoman for UNUM Life Insurance Company of America, a Portland, Maine-based disability provider. "We do so simply because we have discovered that people who are responding favorably to treatment are able to go back to work."
A Metlife spokesman said the company applied the same "case management procedures" to all people with disabilities. He said as a company Metlife is "not taking a harder look per se at people with AIDS who are on disability." He would not comment on the specifics of Lambert's case, but said surveillance was only used after a medical authority stated that a claimant could go back to work.
For people with AIDS, battles with insurers are nothing new. In earlier stages of the epidemic, insurers fought not to cover health or life insurance for those with the disease.
While the success of the drug regimens now raises the prospect of extended periods of insured disability, it also provides insurers with a reason to stop costly disability benefits. But AIDS activists and doctors who treat patients with AIDS accuse the insurance companies of being overzealous. They say stories in the media have given a false impression that the new drug therapies are cure-alls.
While many people on the new protease-inhibitor drugs do live full and productive lives, other recoveries are short-lived. And many experience severe side-effects caused by their medications -diarrhea, chronic fatigue, and nausea.
"We're seeing private disability insurers taking extremely aggressive and unreasonable positions when terminating people with AIDS from benefits," said Benjamin Klein of the Boston based group Gay & Lesbian Advocates & Defenders, who represented Lambert in his case against MetLife.
Lambert argued he still suffers from debilitating fatigue, while the insurer claimed that its investigation showed he could work professionally: the videotape had shown him visiting the Portland restaurant he had bought. Klein said his client rarely spent more than an hour or two at the restaurant and questioned whether he could ever return to his former position in the human-resources department of a corporation.
MetLife eventually restored Lambert's disability payments after negotiations with Klein. But Klein said many people with AIDS in similar straits aren't able to wage a legal fight.
"These insurance companies understand that most people are not going to be able to find a lawyer to challenge them," Klein said. "So they have an economic incentive to be aggressive rather than cautious in terminating benefits."
Dr. Jerome Groopman, an AIDS specialist at Beth Israel Deaconess Hospital, said most of his AIDS patients on disability are eager to re-enter the workforce. But he said they faced the very real possibility that their AIDS might flare up again, leaving them with less of a safety net than they'd previously had. "Most insurance companies are loath to take these kinds of people," Groopman said.
Richard Delozier, an AIDS patient who is covered by Harvard University's total disability plan, was told in May that the university intended to terminate his coverage. He'd been on disability since 1995 when he left his job as director of fiscal services at the Harvard School of Design.
"I'm just losing the whole system of support that I've taken for granted," Delozier, 51, said."Everything was in place for me to live in genteel poverty and die a dignified death. Now, I don't know what will happen.
Delozier's health has fluctuated wildly over the last decade. After numerous exerimental drug therapies failed, he was put on salvage therapy, a medication regimen for patients who have exhausted all other theraputic options. While his viral load count was once as high as 750,000 viral copies per deciliter, it has dropped to a less ominous level of 6,000. But in a March 1999 report, his physician, Dr. Kenneth Gold, stated he would eventually fail his drug regimen, adding that he continued to be plagued with severe diarrhea.
"In fact, though my counts on paper look good, I feel much worse than I did four years ago," Delozier said.
Harvard University would not comment on the specifics of the case, citing Delozier's privacy. In its letter to Delozier, Harvard repeatedly quoted doctors' notes reporting that Delozier was feeling "fine." The letter stated that "mental health ramifications" were a large part of the reason for his disability. Delozier was hospitalized in the 1990s for alcholism.
But Delozier said "fine" was a relative concept.
"When I tell Dr. Gold, I feel fine, I mean I'm fine considering I have AIDS," Delozier said. "I'm taking lots of medicines with evil side-effects."
And Gold said he was confident Harvard would reconsider its decision during the appeal.
"On paper, he looks like one of those people with AIDS who is doing fine," Gold said. "But if you take a look at the whole picture... just take one look at Richard and you can see that he's a pretty sick guy."
Illinois starts HIV reporting with codes
Illinois physicians were ordered to start assigning unique identification codes to anyone testing positive for HIV on July 1st.
The measure, instituted by the state Department of Public Health as a way of monitoring and preventing the epidemic, broadens the existing system of tracking only AIDS cases. Under pressure from AIDS activists, department officials last fall backed off on their original proposal to have names of those diagnosed with HIV reported to local officials.
"One of the things that persuaded us to go a different route and seek a compromise was we didn't want to discourage people from getting tested," said department spokesman Thomas Schafer.
Meanwhile, the current issue of the National Council of State Legislatures' State Health Notes features an overview of various state HIV-reporting laws, writing that Vermont, Illinois and Massachusetts have enacted code-based systems since 1998. They plan to "conduct follow-up activities to fill in gaps in the information received and to ensure completeness of the data, much as Maryland has done since adopting its unique identifier system in 1994."
Several state legislators are concerned that a pending federal privacy bill could potentially pre-empt state law. North Carolina Rep. Dan Blue (D) recently urged Congress to "set a minimum federal (privacy) standard" and let states "enact stronger protections ... in response to innovations in technology and changes in the use of health information." Washington and Texas are seeking to increase maximum penalties for misuse of HIV medical data from $5,000 to $10,000 per violation. Sixteen states have considered bills that would give "health care providers, emergency medical personnel and corrections officials access to patient or prisoner information on AIDS, and in Missouri legislators are considering an amendment to give "law officers and prosecuting attorneys access to information" on HIV status. (Chicago Tribune, Kaiser Daily HIV/AIDS Report)
South Africans protest over AIDS drugs
Hundreds protested at the US consulates in Johannesburg and Cape Town on the 4th of July, accusing Washington of greed in trying to prevent South Africans buying medicines from the cheapest source.
About 250 people paraded outside the consulates, closed for the US Independence Day holiday, with placards reading "Put life before profits," "Blood money" and "US government is a killer."
They handed over a memorandum urging the United States not to block South Africa's Medicine and Related Substances Control Amendment Act, by which government can import drugs from the cheapest sources or licence manufacturers to produce the drugs locally.
"The US government is trying to dissuade our government from using (the act)," said organizer Deena Bosch in Cape Town on public SABC radio.
"We find it very difficult not to believe that the US is doing this solely to protect the interests of pharmeceutical companies which are making huge profits," added Bosch, from the HIV/AIDS Treatment Action Campaign.
The controversial law, enacted in 1997 has not yet been implemented.
The South African Pharmaceutical Manufacturers' Association has challenged it in court, with companies saying it violates the World Trade Organization agreement on trade-related intellectual property (TRIPS).
US drug companies have called for sanctions against South Africa unless it stops threatening patents on medicines and the government has raised its concerns with Pretoria. One of the drugs that would be affected by the law is AZT, said to reduce the risk of contracting HIV, the precursor to the deadly AIDS virus. About 3.6 million people in South Africa are infected with HIV/AIDS, according to a recent study, but government will not provide AZT to pregnant women, citing its cost as one reason.
The protests, in South Africa and the US, appear to be having an impact.
On July 6th, US Deputy Commerce Secretary Robert Mallett promised a group of Africans that the US government would do "everything in its power" to bring cheaper AIDS drugs to the continent -- as long as the efforts do not violate international patent laws. Urging pharmaceutical companies to make their drugs more affordable, Mallett said, "Find a way to put your drugs within reach of the millions for whom they are literally matters of life or death. For the United States' part, we will work to find a way to make these drugs affordable without breaking any of the hard-won intellectual agreements about the rights to a good idea."
Mallett, leading the US delegation at the World Economic Forum's regional economic summit in Durban, South Africa, told the Black Management Forum that controversy over South Africa's compulsory licensing and parallel importing measures has been "one disagreement that's caused some controversy both here and in the United States." He attributed the dispute to the law "allowing South Africa's health minster to bring in less expensive AIDS drugs -- in violation of their patent protections." He reiterated that "the US would defend the rights of companies to protect intellectual property," but added that his country "did not believe that six million South Africans infected with HIV could afford to spend more" than 6000 Rand a month, or about $990 for treatment.
Meanwhile, Vice President Al Gore's attempt to distance himself from this issue is having mixed results. Gore has been harassed by demonstrators organized by ACT UP at a number of campaign stops in recent weeks. The protesters say that Gore has been a leading proponent inside the Clinton Administration in opposing freer access to AIDS drugs in South Africa and elsewhere.
The New York Times reports that a statement by the Gore campaign that the candidate supported efforts to reduce the cost of AIDS drugs for African countries, as long as current "international agreements" are honored, has heightened concern among both activists and the Congressional Black Caucus (CBC), which is becoming increasingly critical of his position on the issue.
James Clyburn (D-SC) said after receiving a letter from Gore, "We thought we generally were on the same page with him on this issue. [But] my suspicions as to what this was all about seem to have been well-placed." Public Citizen's Dr. Peter Lurie argued that if Gore was saying that South African law violates intellectual property rights agreements, "then this letter means absolutely nothing." Gore spokesperson Chris Lehane said, "This is one of those situations where emotions are obscuring what the real information is. The vice president supports efforts to provide South Africa with AIDS drugs at reduced prices. He's working to create a framework to make that happen."
But the issue seems destined to continue to haunt Gore's campaign. ACT UP Philadelphia's Asia Russell said that Gore's "statement is smoke and mirrors. We want action. We plan to continue our work against Gore until he does more than simply issue a statement about this yearlong effort ... to do the dirty work of the pharmaceutical industry." (African National Congress, Agence France-Presse, Associated Press, New York Times)