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March 1999 Treatment Chronicles

March 1999

Good News, Bad News for Patients With AIDS. The availability of potent anti-HIV drugs is allowing many AIDS patients to live longer, but with that change also comes several new problems. Statistics show that between 1996 and 1997, the number of AIDS-related deaths fell 47 percent. Furthermore, between 1995 and 1998, AIDS-related deaths among homosexual men dropped by 81 percent, and by 60 percent among heterosexuals, Johns Hopkins University researchers report. Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, notes that with the new drugs, "there is less suppression of the immune response, or the immune system is able to rebound to fight the virus." However, Fauci notes that the drugs do not completely suppress HIV and that the AIDS cocktails require patients to follow a complex regimen and special diets. Some individuals have also been lulled into a sense of complacency because of the drugs, especially sexually active youths. New cases of HIV infection are on the rise, with half of the 40,000 new cases each year reported among individuals under age 25.

What You Need to Know About AIDS in Minority Groups. President Clinton recently unveiled a $156 million initiative focusing on HIV/AIDS among minorities. The campaign, intended to develop HIV-prevention programs and increase access to drug treatment programs, among other things, was established because AIDS is "hitting hardest in areas where knowledge about the disease is scarce and poverty is high," Clinton said. The Centers for Disease Control and Prevention (CDC) currently provides $253 million in funding to state and local health departments for HIV prevention programs. The agency, which also directly funds various organizations that have HIV prevention programs geared to high-risk individuals in specific minority groups, has been allotted an extra $4 million this year for community-based HIV-prevention organizations focusing on African-Americans and Hispanics. While minorities only made up about one-quarter of the total U.S. population in 1997, over half of all AIDS cases were among racial and ethnic minorities that year. Nearly 50 percent of all new AIDS cases in the United States were among African-Americans in 1997, while Hispanics now account for almost one-quarter -- 22 percent -- of new AIDS cases. The rise of HIV among young Hispanics is especially worrisome. The National Institute of Allergy and Infectious Diseases noted in a report that minorities "bear a disproportionate burden of sickness and disease," including tuberculosis.

Roche's HIV Drug Invirase Gets Prix Galien 1998 Award. The International Prix Galien 1998 Award, which is awarded every two years to an innovative pharmaceutical product that has made an important contribution to modern therapy, has been jointly awarded to three HIV drugs: Roche's Invirase, Merck's Crixivan, and Abbott Laboratories' Norvir. Roche characterized the award as the Nobel prize for medicines and said this year's decision reflects the important role protease inhibitors play in the battle against HIV and AIDS.

Drug-Resistant HIV Becomes More Widespread. Researchers involved in a number of different studies presented data on February 4, that suggests drug-resistant forms of HIV are now more prevalent in the United States, a trend that will complicate and even threaten the successful use of new anti-AIDS medicines. The studies, conducted with two new sensitive diagnostic tests, indicated that roughly 20 percent to 30 percent of people newly infected with HIV have a form of the virus that is now resistant to one of the 13 medicines used in drug cocktails. Investigators from one study presented evidence that about ten percent of newly infected people are contracting a form of the virus that can withstand at least two drugs. In separate news, DuPont Co. said its Sustiva, which works through a different mechanism than rival protease inhibitors, is as effective as new protease inhibitors when it is used in drug cocktails. The findings were presented at the Sixth Conference on Retroviruses and Opportunistic Infections in Chicago.

Risk of New AIDS Diseases in People on Triple Therapy. German researchers report on the degree to which triple therapy-associated increases in CD4 cell counts are related to the reduction of new AIDS disease risks. In a study of HIV-positive people who started triple-drug therapy, patients who had CD4 cell counts of less than 20 per microliter had a greater mortality rate and increased number of AIDS events compared to patients who had cell counts of above 100 per microliter at a mean follow-up of 1.4 years. According to the authors, the findings indicate that CD4 cell count increases in the peripheral blood in response to treatment are indicative of substantially reduced risks for new AIDS diseases.

The Price of Success. Researchers from the University of California at San Francisco have developed a mathematical model showing that drug resistance in some HIV-infected individuals to highly active antiretroviral therapy (HAART) could lead to large increases in HIV incidence in the future. Sally Blower and others found that if the incidence in San Francisco of drug resistance in HIV among homosexual men is equal to levels seen in clinical trials, then the HIV incidence in the city will decrease by 20 percent in the next 10 years. Additionally, if risky sexual activity among homosexual men in the city falls by half, then the HIV incidence will decrease by 50 percent. However, if 90 percent of homosexual men in San Francisco take HAART and adherence is worse than seen in clinical trials, the HIV rate will increase 15 percent over the next 10 years, according to Blower's model. Blower notes that one way to avoid this scenario is to expand the strict policy of monitoring patients used in clinical trials to all HIV-positive patients. Drug companies are also trying to increase adherence by simplifying regimens.

How Compliant Are Patients on HAART? In a recent study of HAART in HIV-infected individuals, frequent use of stimulant nonrecreational drugs was most strongly associated with noncompliance. Led by Dr. J.C. Walsh of the Imperial College in London, researchers analyzed data from 179 patients on triple- or quadruple-drug therapy. Just over half the patients were taking the medication twice daily, with 49 percent taking medication three times per day. Patients took an average of 18.4 pills a day. While mean adherence rates were 95 percent according to self-reported data, 21 percent of patients took 80 percent of their medications or less. Fifty-two percent of patients reported full adherence in the prior month, and about one-third said they had never missed a dose. A total of 83 percent of respondents reported taking most of their medications on time.

Women's Advances Slowed, Forum Told. At a United Nations population conference on Monday, February 8, AIDS prevention was made a top priority. The Hague Forum, which includes delegates from 180 nations worldwide, is the first key follow-up to the 1994 Cairo conference, in which it was declared that empowering women and contributing to their reproductive health could help stem population growth. On Monday, February 8, UNAIDS head Peter Piot noted that the AIDS epidemic is obstructing progress in increasing women's health care. Piot explained that with 16,000 new HIV infections each day -- a figure two times that reported in 1994 -- AIDS could possibly eliminate any gains made since the Cairo conference.

US to Give HIV Drug Fast-Track Review. Trimeris Inc. has received fast-track status from the Food and Drug Administration for its new fusion inhibitor, T-20. The drug is designed to inhibit the entry of HIV into the cell, while protease inhibitors and reverse transcriptase inhibitors target HIV after it has entered the cells. Trimeris, which will present a preliminary report of Phase II trials of 78 patients at the Sixth Conference of Retroviruses and Opportunistic Infections in Chicago, noted that earlier research has shown the drug to be effective against HIV.

New Drugs May Lessen HIV Rate of Infection. A number of researchers believe that anti-HIV drugs may reduce viral transmission by cutting viral levels in blood, semen and vaginal secretions, thereby decreasing the number of new infections. However, the number of new infections has not yet significantly changed, with about 40,000 people in the United States contracting the virus annually. Speaking at the Sixth Conference on Retroviruses and Opportunistic Infections in Chicago on February 3, the CDC's Jonathan Kaplan said that while the drugs likely reduce infectiousness, "we're probably not seeing a significant impact yet." He added that only about half of the HIV-infected people in the United States receive drug treatment and that they may have higher risk factors for the transmission of HIV, including needle sharing or risky sex. Additionally, some data indicate that treated individuals are increasingly undertaking high-risk behavior, such as ignoring safe sex measures and engaging in sex with many partners. These factors could offset any benefit in transmission reduction that would normally be seen from the drug therapy. Kaplan reminds that there is no guarantee that low viral levels guarantee reduced transmission risk.

Ligand Drug Receives Approval. Ligand Pharmaceuticals said February 4, it received Food and Drug Administration approval to begin marketing its Panretin gel, a treatment for skin lesions in AIDS patients with Kaposi's sarcoma. The company expects annual sales of the drug, its first approved product, to top $35 million in the United States and $70 million in western Europe.

New Treatment Seems to Eliminate HIV Signs. Researchers report that two patients who received the immune booster interleukin-2 in addition to standard AIDS treatment with protease inhibitors now show no signs of HIV in their blood or in lymph node samples. Tae-Wook Chun, of the National Institute of Allergy and Infectious Diseases, said that it is too early to conclude that HIV was eradicated in the patients. The two patients were removed from HIV treatment three weeks ago to determine if their infection was eradicated; neither has shown signs of the virus in the blood. The study was presented at the Sixth Conference on Retroviruses and Opportunistic Infections in Chicago.

New HIV Cases Point the Way to Prevention. New research indicates that the majority of new HIV infections in the United States among first-time blood donors were in the Southeast. Furthermore, most of the infected individuals had little education and were Hispanic or African-American. The CDC's Harold Jaffe noted that the study "confirms where the problem is." On average, one in 10,000 donors were found to be infected with HIV, confirming that few donors carry the virus. The data show where the new infections are occurring, providing information on areas that need to be targeted for HIV prevention. The study was reported at the Sixth Conference on Retroviruses and Opportunistic Infections in Chicago.

HIV Study Finds Virus Use in Vaccine May Cause AIDS. A study reported in the February issue of Nature Medicine indicates that using a weakened HIV vaccine may cause disease. The study, conducted by Dr. Ruth Reprecht of the Dana-Farber Cancer Institute and others, involved 16 macaques that were inoculated with a genetically crippled version of SIV as adults and eight that were inoculated as infants. During the study, one of the adult macaques and six of the macaques vaccinated when young developed AIDS, while some of the others developed immune-system abnormalities. Although some weakened HIV vaccine studies have been encouraging, the new finding casts doubts on the viability of the use of such a system in humans.

Public Health Targets Teens' Private Acts. Scientists presented findings on risky behavior by adolescents at the annual meeting of the American Public Health Association late last year. Dr. Bradley Boekeloo, of George Washington University, and associates surveyed over 200 boys aged 12 to 15 years who received general physical examinations. The examining physicians talked with the boys about sex, including condom use and abstinence. The researchers found that discussions can increase condom use, but they were unsure of the effect on abstinence. At three-months follow-up, 8 percent of the surveyed boys said that they felt the physicians thought it was okay for them to engage in intercourse. In another study, Dr. John B. Jemmott III of Princeton University and others analyzed data on peer-led and adult-led risk reduction interventions among 659 African-American teens. Jemmott's group conducted three intervention groups: one on abstinence, one on safe sex and one on unrelated health issues. They found that teens in the abstinence intervention group were less likely than the others to engage in sex at three-months follow-up, but not at six-months or 12-months time. Safe sex intervention resulted in less unprotected intercourse at three-months, six-months, and 12-months time. Other presentations at the meeting showed that the use of alcohol and drugs results in increased risky behavior. One study found an association between watching violent and sexual television shows and HIV risk-related sexual behavior and teen pregnancy.

Tuberculosis in Patients With Human Immunodeficiency Virus Infection. HIV-positive individuals are at an increased risk for primary or reactivation of tuberculosis and for second episodes of TB from exogenous reinfection. Research indicates that HIV-infected patients produce less interferon-gamma when exposed to Mycobacterium tuberculosis compared to HIV-negative patients with TB, suggesting that reduced T1 lymphocyte response, which produce the interferon, contributes to the susceptibility to tuberculosis. Tuberculosis also appears to increase HIV progression, with the risk of death in HIV-infected patients with TB reported to be twice that of HIV-positive patients without TB, independent of CD4 cell count. The high death rate among TB patients is apparently because of progressive HIV disease, versus TB itself. All patients with tuberculosis are suggested to undergo testing for HIV coinfection because of the possible benefits of early detection. Selective testing of HIV in these patients is not recommended due to the common failure to identify risk factors related to heterosexual transmission by health care providers. Acid-fast staining, mycobacterial cultures, and drug susceptibility testing are suggested. Restriction length fragment polymorphism allows for the identification of specific M. tuberculosis strains, enabling the documentation of disease transmission. The Centers for Disease Control and Prevention suggests a minimum of six months treatment for TB, with longer treatment for slow clinical or bacteriologic response. Rifampin and rifabutin treatment can have effects on and be affected by anti-HIV treatment. Chemoprophylaxis for tuberculosis is recommended for at-risk HIV-infected individuals.

After Living With HIV, Living Without Medication. Researchers at the National Institutes of Health are trying to determine if HIV-infected patients on protease inhibitor therapy who have responded to treatment can successfully fight off the virus after discontinuing their drug regimen. Richard Davey, the head of the study, said they have targeted 50 patients, expecting that only about 20 percent will fail to relapse, although there is no concrete data. Many people who use the drugs complain of the rigorous schedule involved in taking the medications and of their adverse effects. A few reports suggest that some people on therapy become non-progressors. As Davey explains, "We think that in some cases, the body's immune system may be able to control virus at low levels without [the drugs], and if so, we'd like to characterize those patients." All of the participants must have undetectable viral levels and have been on combination therapy for a year to be eligible. In the event of HIV resurgence, participants will be urged to resume therapy. A similar study at Massachusetts General Hospital removed 20 people who had been on therapy from treatment. While their infections have been suppressed since then, one of the researchers involved reports that the first patient to stop the drug treatment recently showed reemergence of HIV infection and resumed treatment.

Health Tips: AIDS Drugs Found Effective. Research by Dr. Robert Shafer and colleagues at Stanford University shows that protease inhibitors are active against a prevalent HIV subtype. The drugs were originally tested against subtype B in the United States, but the new research indicates that the drugs also work against subtype C. HIV subtype C is highly prevalent in Africa in India, and it is believed to be the cause of 90 percent of all HIV infections worldwide.

1999: Treatments, Issues to Watch. The future of AIDS research is uncertain, but there are a number of issues that appear will be prominent in 1999. New classes of drugs based on recently discovered targets appear promising, although there will probably be a lengthy period of time before new treatments are ready for testing in humans. The antiviral T-20, which is known to be highly active against HIV-1 in patients, will continue to be analyzed as a possible HIV treatment. It uses a different mechanism of action than current treatments and would likely have no cross-resistance with other drugs. Research in the upcoming year will examine how the body loses its natural ability to control HIV and investigate HIV-specific CD4 helper response. A new measuring technique using CD4 cells tagged with deuterium will help in the study of the natural production and life span of immune cells in the body. Body-shape changes and abnormal fat metabolism that sometimes accompanies HIV treatment will continue to be studied in 1999. Tests for viral resistance to drugs and to determine if opportunistic infection prophylaxis is still necessary will be analyzed and implemented. Scientists should also carry through investigations of alternative or complimentary treatments. Other key issues include drug pricing, international access to treatment, managed care reimbursement for HIV care, and needle-exchange programs.

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This article was provided by AIDS Survival Project. It is a part of the publication Survival News.
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