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Drug combo helps rebuild immune system
Viracept shows promise on resistance
Conference hears call for experienced MDs
Medical journal backs marijuana
Committee chair resigns in Commission controversy
ASIAC says API's excluded in evaluation project
Drug combo helps rebuild immune system
The aggressive new AIDS treatments now used more frequently by people with AIDS can partly repair the damaged immune systems of patients, according to sophisticated new analysis of immune cells, researchers said this week.
Since the new combination therapies have become available, researchers have known that the drugs can suppress HIV. But less is known about whether the immune system, which protects the body from everything from the common cold to cancer, can recover.
Based on early, short-term research, the answer appears to be that it can partly recover, according to one major study presented at the 4th Conference on Retroviruses, an annual AIDS meeting.
Dr. Michael Lederman, an AIDS researcher at the University Hospitals of Cleveland and Case Western Reserve University, said his study found some types of immune cells were rebounding, including so-called "naive" cells that are part of the body's basic armament against disease.
But other parts, including something called V-Beta receptors that can help predict how AIDS progresses in an individual, did not return to more normal healthy patterns, he said. "You do see a recovery of naive cells and that was really, really good news," Dr. Lawrence Fox, who worked on this project at the National Institute of Allergy and Infectious Diseases, said. "But there hasn't been an improvement in the (V-beta) part of the immune system."
Lederman said this research re-enforces the emerging consensus among doctors that it is important to treat people soon after they become infected, before the virus wreaks havoc on the immune system.
The research reflected results after 12 weeks of treatment of patients with moderately advanced AIDS, and will continue for at least several more months. It uses more sophisticated analysis of immune system components than previous immune cell studies under newly available resources the National Institute of Allergy and Infectious Diseases (NIAID).
Viracept shows promise on resistance
A new AIDS drug awaiting approval by the Food and Drug Administration offers hope to people who have failed to respond to other therapies, according to data disclosed by Agouron Pharmaceuticals, manufacturer of Viracept, a new protease inhibitor.
Agouran said Viracept produced a response in 61 percent of patients tested who had developed a resistance to other protease inhibitors.
Agouron expects FDA approval of Viracept sometime during the first half of 1997. The company is also the first AIDS drug maker to develop a powder formulation for children who have difficulty swallowing pills.
Protease inhibitors used as part of a three-drug combination, have dramatically improved the health of many people with AIDS, in some cases driving down the viral load to nondetectable levels. But the drug combination has not been universally successful, since HIV frequently mutates into strains that are resistant to some drugs.
A particularly strong cross resistance has been shown between the protease inhibitors made by Merck and Abbott Laboratories. The other protease inhibitor on the market is made by Hoffman-La Roche.
Agouron's trials also showed that HIV could mutate to resist Viracept. But the means by which it did so was different than with the other drugs.
"The big issue regarding resistance is that there have been some patients who become resistant to one drug, only to find they couldn't find another one they respond to," said Agouron's Johnson. "What we have seen so far with Viracept is a different situation. When we have gone back to patients who have become resistant to other drugs, we found they generally remained sensitive to Viracept."
Agouron said it tested 23 patients who were resistant to other protease inhibitors and 14 of them were sensitive to Viracept.
Conference hears call for experienced MDs
Advances in treating AIDS are keeping patients alive longer but more specialized doctors are needed to cope with powerful new drugs and the dangers of resistance to the drugs, health experts said this week at the 4th Conference on Retroviruses, a major annual research meeting in Washington.
"Marcus Welby can't do AIDS anymore," said New York University AIDS expert Dr. Douglas Dieterich, referring to the fictional family doctor popular on television in the 1970s.
"This is not a field for the casual caregiver," said Dr. Douglas Richman, chairman of the Conference. Richman and other doctors said in big cities it was fairly easy to find experienced AIDS doctors but in smaller communities it was more of a challenge. Managed care plans may also channel patients to general practitioners although some programs have begun to make arrangements for AIDS care.
Conference delegates said state-of-the-art AIDS treatment required a special level of expertise and experience, but did not call for the creation of a formal new specialty, like cardiology or dermatology. Scientists know that some strains of HIV resist one or more of the drugs but they do not yet have a sense of how vast a problem resistance is.
AIDS would become an even greater public health problem and harder to treat in the future if many drug-resistant strains emerged because of wrong treatment decisions or patients who do not take the medication correctly. For instance, there are now three protease inhibitors on the market, with a promising fourth one in the wings and newer variants under development. Each of those drugs is used in a "cocktail" with two, sometimes three, other anti-viral medications.
Every patient has a unique profile of possible side effects and drug interactions that could cause the therapy to fail or lead to intolerable or dangerous side effects. Doctors have to make different choices, for instance, for an AIDS patient who has had kidney stones than for one who has experienced liver problems, physicians said.
Further complicating the choices is the patient's history of past AIDS drugs, and possible resistance to earlier medications. Also, clinical guidelines for practitioners have not kept up with
the rapidly changing research and drug development.
"You've got to take into account resistance, a complex treatment history, and side effects," said prominent AIDS researcher Julio Montanar of the Canadian HIV Trials Network in Vancouver, British Columbia.
"But remember, very major progress has been made -- beyond our expectations," added Montanar, some of whose patients have had the virus suppressed to undetectable levels for nearly two years.
Scientists do not know how much of the resistance stems from the virus's innate ability to mutate to evade drugs, and how much is a result of patients' failure to precisely follow complicated regimens, involving dozens of pills a day.
New drugs are expected to become available in the next few years that may offer further options against resistance.
"We don't know the extent of the resistance problem," said National Cancer Institute AIDS researcher Dr. Robert Yarchoan. "The question is what new drugs are we going to have in three years. If we can continue to have new therapies, we will continue" to make progress against AIDS.
AIDS deaths drop 30% in NY
The death rate for AIDS in New York City dropped by a striking 30 percent last year in what public health officials called a likely harbinger of a national trend.
But that encouraging news was tempered by more evidence that the epidemic is raging in some segments of the population including young blacks and Hispanics.
"There are two messages here," said Dr. Harold Jaffe, top AIDS prevention official at the Centers for Disease Control and Prevention. "Through improved care people are living longer and better lives. But new infections are continuing to occur in populations that are often marginalized."
CDC officials say New York is the only place in the nation that has death figures available for 1996. After leveling off in 1995 at about 7,000 AIDS deaths, the number there dropped to 4,944 last year. New York has about 16 percent of the nation's AIDS cases.
Since the national rate also stabilized in 1995, federal officials hope they will see a similar drop when the 1996 death figures are tallied.
"I think the data from New York City could well reflect what we see in 1996 mortality (nationally)," Dr. John Ward, an AIDS surveillance expert at the CDC, told reporters at the 4th Conference on Retroviruses here, where the data was presented.
Even more gains are likely as much-vaunted new protease inhibitor drugs enter widespread use. But those medicines are too new to have been the key factor in New York's decline last year, said Dr. Mary Ann Chiasson, a New York Department of Health official who presented the studies.
She said better survival rates probably reflected more access to treatment, improved anti-viral drugs and gains in preventing and controlling other illnesses and opportunistic infections like pneumonia that often kill AIDS patients.
"It really is an unprecedented drop," she said, adding that the decline showed up in all age, ethnic and racial groups and in both men and women.
But keeping AIDS patients alive is only part of the battle. Also critical is keeping people from becoming infected in the first place and in this area, although the national rate of infection has leveled off, Dr. Paul Denning and CDC colleagues found that AIDS cases among people age 13 to 25 rose by almost 20 percent from 1990-95.
Among minority teen-agers and young women the rise was even more pronounced. The rate among young white gay and bisexual men declined 30 percent but among young black gay and bisexual men it increased 26 percent, while the rate for young, black, heterosexual women increased by a whopping 160 percent, Denning found.
"Unless public health programs address the prevention needs of adolescents and young adults, the HIV epidemic will continue to spread to subsequent generations," Denning said. The studies were part of a series of presentations on prevention, which showed progress, but not across the board.
Several showed that doctors were having success in using the drug AZT to cut the number of babies born with HIV infection because their mothers were infected with the virus. Data is just beginning to come in about whether combination therapies, mixing AZT with newer drugs, will prevent perinatal transmission and also be more useful in prolonging the mothers' lives.
Medical journal backs marijuana
The New England Journal of Medicine has come out in favor of allowing doctors to prescribe marijuana for medical purposes, calling the threat of government sanctions "misguided, heavy-handed and inhumane."
"Whatever their reasons, federal officials are out of step with the public," Dr. Jerome P. Kassirer, the journal's editor, wrote in an editorial. The journal is one of the world's most prestigious medical publications.
After voters in Arizona and California passed propositions letting doctors prescribe pot for medical uses, Attorney General Janet Reno said doctors who do this could lose their prescription-writing privileges, be excluded from Medicare and Medicaid and even be prosecuted. Some doctors believe marijuana can relieve internal eye pressure in glaucoma, control nausea in cancer patients on chemotherapy and combat the severe weight loss seen in AIDS patients. However, administration officials note that such uses of marijuana have not been proved.
Kassirer said marijuana is safer than some drugs used legally for some of the same conditions, such as morphine.
Furthermore, he said experiments to prove marijuana's value would be hard to do because of the difficulty of measuring nausea and other such sensations.
"What really counts for a therapy with this kind of safety margin is whether a seriously ill patient feels relief as a result of the intervention, not whether a controlled trial `proves' its
efficacy," Kassirer wrote.
In a written response, retired Army Gen. Barry McCaffrey, director of the Office of National Drug Policy, said marijuana might someday be approved for specific medical purposes.
"But up to this point, smoke is not a medicine," McCaffrey said. "Other treatments have been deemed safer and more effective than a psychoactive burning carcinogen self-induced through one's throat."
Committee chair resigns in Commission controversy
Citing what she called the "increasingly unrepresentative" leadership of the Philadelphia HIV Commission, Julie Davids, co-chair of the Commission's CARE Committee, announced her resignation from her post on January 23rd.
In a letter to Commission members and others, Davids said "I feel that it is inappropriate for me to continue in this capacity while the Commission and CARE Committee leadership is increasingly unrepresentative of the racial composition of the epidemic in our EMA." She said "it is my sincere hope that I will be succeeded by an African American consumer as CARE committee co-chair," and noted that she intended to remain a committee member.
Almost 70% of people living with HIV/AIDS are people of color, according to city statistics, but no African Americans serve in a leadership capacity in the HIV Commission with the exception of Jesse Milan, who directs the health department's AIDS office. Two weeks ago, the full HIV Commission elected two white co-chairs, defeating by one vote the election of James Roberts, executive director of the Minority AIDS Project of Philadelphia to one of the posts; whites also chair other Commission committees.
ASIAC seeks API input in evaluation project
Richard Liu, executive director of AIDS Services in Asian Communities, has criticized the new program evaluation system being implemented by the AIDS Activities Coordinating Office and The Philadelphia AIDS Consortium, saying that it excludes "non-English speaking Asians and Pacific Islanders living with AIDS" by making it hard for them to participate and refusing to let their advocates speak on their behalf.
According to the Philadelphia Health Department's AIDS surveillance report, only 22 people who have been formally diagnosed with AIDS are Asian or Pacific Islander. However, the U.S. Centers for Disease Control and other public health agencies are convinced that AIDS cases are more severely under-reported among APIs than any other population, because of cultural and linguistic issues.
The Comprehensive Quality Improvement and Outcome Assessment Project is the first plan adopted by local AIDS funders which relies significantly on the input of recipients of services in the evaluation process. In January, specific provisions for consumer participation in setting service standards were spelled out.
The committee adopted the following model for consumer participation: Quality improvement measures for each service category will be set by individual subcommittees whose members will include front-line service providers or their direct supervisors and consumers. The subcommittees, which will meet in the coming months, will draft the quality improvement measures. These measures and an explanation for why they were recommended will then be reviewed by a committee comprised exclusively of consumers. Project TEACH, the city's only HIV treatment peer education training program, which is a joint project of We The People and Philadelphia FIGHT, has agreed to assist the ETC in conducting consumer training and ensuring quality facilitation of consumer sessions. Only after consumers have given their input independently from providers will the standards be presented to the evaluation committee for approval.
Liu believes that API consumers will not participate in the evaluation process for a variety of reasons, and proposed that "their few trusted advocates and providers" should be permitted to represent them in the process. In January, the committee rejected his request, noting that providers will have other mechanisms for asserting their viewpoints in the process.
Last week, Liu appealed the decision of the committee to AACO, saying he is concerned that API consumers may not be heard unless "advocates" are allowed to speak for them.
"Most non-English speaking Asians & Pacific Islanders are immigrants, refugees, and/or undocumented," Liu wrote. "They strongly fear bias, harassment, and discrimination because they are non-U.S. citizens. Additionally, they fear bias, harassment, discrimination, and loss of public benefits for themselves and their families for disclosure of citizenship status and serostatus. Further, they fear deportation of themselves or their family members because of current immigration laws including a policy that allows INS to deport individuals who have 'a communicable disease of public health significance' which by their definition includes those with HIV/AIDS. As a result they are extremely reluctant to be identified except by their few trusted advocates and providers."
Liu said that it is "unfeasible" for non-English speaking APIs to participate in the evaluation process because of translation and interpretation issues and "a number of reasons related to time, sensitivity issues, confidentiality, trust, and project staff/committee membership inability to accommodate."
"In my experience, the perpetuating disempowerment of non-English speaking Asians and Pacific Islanders in evaluation processes has been going on for years. The committee's actions further reinforces the perceived and actual institutionalized racism directed against Asian & Pacific Islander communities in the Philadelphia EMA. As you may be aware, Asian and Pacific Islander consumers and their advocates/representatives have resented past efforts for inclusion which has often been poorly constructed, tokenistic, patronizing, last-minute, and time demanding. The continuing disenfranchisement of these consumers and advocates will further strain efforts to involve them in HIV-related service activity, planning, prioritization, and evaluation processes."
While supporting Liu's advocacy for inclusion of API concerns in the evaluation process, most consumers on the evaluation committee said that they are concerned that the inclusion of providers in the consumer portion of the evaluation process violates the entire purpose of the consumer component, and that some other mechanism for addressing Liu's concerns needs to be found.
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