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August 1999 Chronicles
From the CDC National AIDS Clearinghouse

Compiled by Ernie Evangelista

August 1999

FDA Approves AIDS Drug | Genotyping Trial | Genotyping Previously Treated Patients?
New Drug May Fight Resistant Strains | AIDS Vaccine Breakthrough | Vaccine Candidates | Lack of Education Barrier to Therapy | Online Treatment Data Project | Including Female Condoms | Gay Men Using Safer Sex | Growing Global Threat Warning | Old Diseases Re-Emerging | Life, Love and HIV | Teens Unaware of Risk | Confidential Counseling and Testing | Anonymous Testing and Medical Care | Home HIV Tests Warning | Senate Approves Health Care for Disabled | Variations in the Care of Adults in U.S. | Protesters to Follow Gore


FDA Approves Abbott AIDS Drug. Nearly a year after Abbott had to halt the sale of the capsule form of Norvir because of production-related problems, the company said on Wednesday, June 30, that it won Food and Drug Administration permission to sell a soft-gelatin capsule form of the AIDS drug. Since last July, Norvir has been available only in liquid form, but Abbott said the newly-approved version would be available for consumer use as early as the week of July 4. The capsules can be kept at room temperature for thirty days, but Abbott is encouraging patients to keep the product refrigerated.

Drug-Resistance Genotyping in HIV-1 Therapy: The VIRADAPT Randomised Controlled Trial. French researchers examined the efficacy of genotypic resistance-analysis when creating medication therapy for patients with drug-resistant HIV-1. Patients were similar in risk factors, age, sex, previous treatment, CD4-cell count and HIV-1 viral load. Forty-three of the patients received treatment according to standard guidelines, while 65 received treatment according to genotyping. In month three, the mean change in HIV-1 RNA was -1.04 log in the genotyping group, compared to -0.46 log in the standard treatment group. By month six, the changes were -1.05 log copies/mL in the genotypic group, compared to -0.67 log copies/mL in the control group. Investigators noted that by month three, 29 percent of patients in the control group had undetectable levels of HIV-1 RNA, compared to 14 percent in the standard treatment group. After six months of treatment, 32 percent of the genotyping group had undetectable levels of HIV-1 RNA, as compared to 14 percent for the control group. The researchers conclude that genotypic resistance profiling can be beneficial when choosing therapeutic alternatives for drug-resistant HIV. Further study of genotypic resistance testing for clinical decision-making is suggested.

Time to Genotype for Selection of Antiretroviral Regimens in Previously Treated Patients? In a commentary, Judith Falloon, of the National Institute for Allergy and Infectious Diseases, reviews the use of genotyping in creating effective antiretroviral regimens for HIV-infected patients. Falloon cites the VIRADAPT trial, which showed that a treatment regimen designed by genotyping resulted in much more progress for patients with drug-resistant forms of HIV. However, Falloon questions whether the success can be attributed solely to the genotyping. She suggests that it cannot be assumed that regimens designed from genotyping are primarily responsible for recent successes, because "not all sites of resistance are known, and the effects of interactions between mutations at different codons are poorly understood." Falloon says that genotyping looks like a promising technique for designing antiretroviral regimens, but that more research is needed.

New Drug From Pharmacia May Fight Resistant AIDS Strains. Researchers from Pharmacia & Upjohn and the Belgian biotechnology firm Virco report that a protease inhibitor being developed by Pharmacia is active against many strains of HIV, including some that are resistant to other anti-HIV drugs. The drug, tripranavir, has performed beyond all expectations in laboratory tests, and researchers hope to begin trials in patients resistant to existing drugs later this year. The researchers, who presented their findings at the Third International Workshop on HIV Resistance and Treatment Strategies, found that only three of 107 mutated HIV strains tested were completely resistant to tripranavir, and eight were mildly resistant. According to Virco's Dr. Brendan Larder, tripranavir seems more flexible than other protease inhibitors -- which include Merck & Co.'s Crixivan and Agouron's Viracept -- allowing it to fit into active sites regardless of whether they change shape.

Breakthrough Offers New Hope for AIDS Vaccine. An international team of researchers has found a link between HIV and key proteins the virus uses to attack cells, and they have developed a vaccine based on their discovery. HIV requires receptors, including the CD4 receptor and CCR5 proteins, for access into cells. Tests revealed a very close link between CCR5 and CD4 but not between other proteins and receptors involved in HIV's infection process. The study, published in the Proceedings of the National Academy of Sciences, notes that previous research suggests that those with naturally defective CCR5 genes can resist HIV infection.

The Field of Vaccine Candidates. There are about 40 experimental HIV vaccines in clinical trials worldwide, although AIDSvax has progressed the farthest. For fiscal year 1999, the National Institutes of Health is spending $194 million in an effort to find a viable vaccine. The most common approach to a vaccine involves putting HIV genes into canarypox, where it replicates HIV protein, giving the host immunity. A more controversial method involves using a whole killed or live-attenuated virus for vaccination. Most vaccines successful against viruses have use either whole killed or live-attenuated vaccines; however, HIV enters cell genes and remains there permanently, complicating matters. Other possible HIV vaccines are using salmonella or the cowpox virus to induce immunity.

Lack of Education May Be Barrier to HIV Protease Inhibitor Therapy. Investigators from the Charles R. Drew University of Medicine and Science say that HIV-infected people with a college education and perception of overall improved health are more likely to receive protease inhibitor therapy. The study followed 1,034 HIV-infected patients at a large HIV/AIDS community service organization. Those who knew the least about protease inhibitor therapy were non-white, earned less than $9,600 a year, and were not college educated. Furthermore, African-Americans, non-English speakers, uninsured people and those who earned less than $9,600 a year were less likely to receive drugs. While the authors note some limitations of their research -- including the fact that the data was obtained in 1996, as protease inhibitors came on the scene -- they note the findings highlight the need for increased education efforts among disadvantaged groups that are not as likely to receive protease inhibitors.

AIDS Patients to Share Treatment Data On Line. The Treatment Data Project launched on Monday, June 21, what could develop into the largest private database of private medical records online. The program aims to have AIDS patients share their experiences in the ever-changing treatment arena so benefits and problems with any therapies could possibly be identified without waiting for results of clinical trials, says the coalition of AIDS activists, computer experts, and health insurers that is organizing the effort. Activist Larry Kramer, who came up with the concept, explains that "this [approach] could work for any illness where people take different medications and there isn't a standard of therapy that you know works." Under the program, which will start at two test sites in New York and one in California, volunteers will fill out a questionnaire on subjects ranging from blood test results to how they are feeling; and if all goes well, the data will go online next year on WebMD, an Internet health information provider. An outline of that data would be available to patients, researchers, and doctors, according to plans now being finalized with WebMD.

Global HIV Prevention Efforts Should Include Female Condoms. UNAIDS officials are urging donors, non-governmental organizations, and the international community to push for more widespread distribution of the female condom. To that end, the organization is working with manufacturer The Female Health Co.; and thus far six million female condoms have been supplied at a reduced cost in 16 developing nations. In addition, the UNAIDS Data Safety and Monitoring Board is convening the week of June 20 to assess the status of a low-dose nonoxynol-9 gel trial now being conducted in Benin, Côte d'Ivoire, South Africa and Thailand. UNAIDS statistics show that whereas women made up one-quarter of all HIV infections in 1992, that figure has since increased to 43 percent.

New York Study Finds Gay Men Using Safer Sex. A survey conducted by New York City officials and the Gay Men's Health Crisis last year indicates that homosexual men in New York City are significantly cutting back on risky sexual behavior. The study involved 7,650 gay and bisexual men between the ages of 12 and 88 in New York City. About one in seven participants were HIV-positive, compared to studies showing one infection in three in 1985. In addition, about nine out of ten participants reported having been tested for HIV, with eight in ten saying that they had been tested at some time during the three years preceding the study. The study found that men over 60 and under 24 were less likely to have been tested for HIV. Also, according to Dr. Tracy J. Mayne, the director of epidemiology for the New York City Health Department's AIDS prevention planning group, use condoms for first anal intercourse increased to about 78 percent compared to 34 percent in 1985. While investigators say the study indicates that prevention is working, they also note that more efforts must be made to extend the message to non-white gay men. African-American and Hispanic homosexual men were found less likely to engage in risk reduction behaviors. As a result of the study, GMHC officials are more aggressively targeting minorities with prevention efforts during Gay Pride month.

Annan Warns of Growing Global Threat From AIDS. United Nations Secretary-General Kofi Annan issued the West a warning on June 25 regarding the continuing threat posed by AIDS. In a lecture dedicated to the memory of Diana, Princess of Wales, Annan reminded the audience that AIDS is Africa's biggest killer, taking 5,000 lives a day. AIDS has also significantly lowered the life expectancy in some African countries, and the death toll is being felt economically as well. According to Annan, spending on HIV/AIDS in African nations would need a six-fold increase to be minimally effective.

Report Says Old Diseases Re-Emerging In Africa. "The World Disaster Report 1999," released Thursday, June 24, by the International Federation of Red Cross and Red Crescent Societies, warns that older diseases are re-emerging and spreading in Africa. Diseases like cholera, tuberculosis, malaria, meningitis and measles are coming to the fore because of a weak public health infrastructure, the development of antibiotic-resistant bacteria and viruses, mass movements of people and reservoirs of diseases in crowded areas. Scientists say that global warming will also change disease patterns, causing the emergence of some diseases in places they have never been seen in before.

Facing Delicate Issues of Life, Love and HIV. The number of female AIDS patients in the United States has increased significantly in recent years, from seven percent of all AIDS cases in 1985 to 22 percent in 1997, show CDC statistics. Within that group, African-American women accounted for the majority (60 percent) of the AIDS cases among women in 1997, and sex is now the primary source of HIV exposure for women. Furthermore, CDC data show that women in 25 states accounted for 17 percent of overall AIDS cases but 28 percent of HIV infections in the period between January 1994 and June 1997. Powerful new AIDS drugs have helped to reduce AIDS-related mortality; however, AIDS is still the primary cause of death for African-American men and women. As patients learn to deal with their infections, other issues -- such as sexual intimacy and falling in love -- must also be confronted.

Many U.S. Teens Unaware of HIV Risk. A new report released by the Henry J. Kaiser Family Foundation indicates that American teenagers are well aware of HIV prevention, but some still engage in risky behavior. The study was a product of focus groups and interviews with teens at risk in Miami, Houston, New York and Newark, N.J. The report also noted that if teenagers are in a youth-friendly, respectful situation, and a confidential HIV testing option is offered, the majority would accept. The Kaiser Foundation is teaming up with MTV and Black Entertainment Television to educate viewers on sexual health issues, including HIV and other sexually transmitted diseases.

CDC Recommends Anonymous or Confidential HIV Counseling and Voluntary Testing. To make HIV testing as accessible as possible, the CDC strongly supports the availability of both anonymous and confidential testing options. This analysis of data on over seven million HIV tests performed between 1995 and 1997 finds a high prevalence of HIV in both anonymous counseling and testing sites (two percent) and confidential medical and other settings (1.5 percent in STD clinics, 2.1 percent in community health centers, 2.4 percent in drug treatment centers, and 3.5 percent in prisons), with each type of testing reaching unique populations at risk. For example, Asian Pacific Islander and white men who have sex with men (MSM) were much more likely to choose anonymous testing than any other risk groups (71.6 percent and 61.9 percent respectively). By contrast, black MSM were much more likely to be tested in confidential settings (67.5 percent). Making both options available is critical to ensure that all populations at risk have access to testing and early treatment and prevention services.

Anonymous HIV Testing and Medical Care. One key issue that may be obscured in the debate over anonymous versus confidential HIV testing is why patients are learning of their infection so late in disease progression, asserts George Washington University's Jeffrey Levi in a letter to the editor of the Journal of the American Medical Association. A recent article by Bindman et al. discussed the need to maintain the option of anonymous testing. However, Levi notes that the delay of learning one's status delays or eliminates other critical factors, such as opportunities for early treatment and targeted prevention interventions for HIV-infected individuals. Bindman's findings, Levi contends, "should compel public health officials, clinicians, and the AIDS advocacy community to rethink their approaches to HIV testing and care to learn how to successfully encourage earlier testing." In response, Bindman and colleagues write that the CDC's draft guidelines in favor of HIV reporting appear to stem from the hope that such surveillance will provide more useful data on the epidemic and thus help with planning services. In a separate letter, CDC's J. Stan Lehman agrees with Levi's assertions, but he notes that anonymous testing alone cannot lower the individual and societal cost of delayed testing and care. Common reasons individuals at risk for infection cite for delaying or postponing testing include fear of learning they are infected and lack of knowledge about their personal risk for the virus; HIV reporting fears are cited much less frequently. According to Lehman, two primary public health goals should be to encourage individuals to recognize their own risk behaviors, seek counseling and testing, and change their risky behaviors; and to offer HIV counseling and testing to at-risk individuals whenever they are seen in medical care or public health settings.

FTC Warns Against Home HIV Tests. The U.S. Federal Trade Commission has issued a warning about some home HIV tests sold over the Internet. In a consumer alert, the agency cautioned, "Using one of these kits could give a person who might be infected with HIV the false impression that he or she is not infected." FTC tests showed that, when a known HIV-infected sample was used, the tests indicated that the sample was not infected. While Internet advertisements have falsely stated or suggested that the kits were cleared by various well-known health groups, the U.S. Food and Drug Administration has approved only Home Access Health's Home Access Express home HIV test kit and the World Health Organization does not approve or license HIV tests, the FTC said.

Senate Approves Health Care for Disabled. The Senate passed the Work Incentives Improvement Act in a vote of 99 to 0 on Wednesday, June 16. The bill, which garnered bipartisan support, discourages discrimination against people with disabilities in the workplace and gives America's eight million disabled individuals incentive to take higher paying jobs. Provisions in the bill include allowing people who return to work to keep their Medicare coverage; enabling people with disabilities to buy Medicare coverage if their income would have previously disqualified them; allowing people who would have lost Medicare coverage due to improved health to pay to maintain coverage; and letting states provide Medicaid coverage to people with physical or mental conditions that are "reasonably expected" to become severe if no health care is available, such as people with HIV who have not yet developed symptoms. Indeed, AIDS Action's Daniel Zingale lauded the measure as "a huge victor for people with HIV."

Variations in the Care of HIV-Infected Adults in the United States. A study conducted by the HIV Cost and Services Utilization Consortium has found that access to care for those with HIV has improved since 1996, but it remains sub-optimal. The cohort study followed 2,864 respondents between 1996 and 1998. Specifically, inferior patterns of care were observed for African Americans and Hispanics compared to whites, the uninsured and Medicaid-insured compared to those who have private insurance, women compared with men, and other risk and/or exposure groups versus men who had sex with men. The study measured outcomes through service utilization, ambulatory visits, at least one emergency department visit (not resulting in hospitalization), at least one hospitalization, and receipt of antiretroviral therapy. The researchers recommend careful review of HIV treatment policies, so that neglected groups receive better care.

AIDS Protesters Vow to Follow Gore Campaign Trail.Unless Vice President Al Gore pledges to support a South African law intended to provide patients with less expensive drugs, AIDS activists say they will continue to draw attention to the issue throughout his campaign for president. The activists claims that Gore is working on behalf of U.S. drug firms to keep South Africa from using trade powers that could supply less expensive drugs to poor AIDS patients. Under the South African Medicines Act, officials can order cheaper, generic versions of drugs -- even if they are still under patent -- by giving "compulsory licenses to local drug makers; the law would also allow the country to import cheaper drugs from a third party. However, a spokesman for Gore rejected the charges and said the vice president would back steps that did not infringe upon international patent protection regulations.




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