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Newsline

September 2002

The Newsline section recalls the pioneering HIV/AIDS publication of the same name produced by the People With AIDS Coalition of New York (PWAC-NY).


Novel Nucleoside Analog Active Against Drug-Resistant Strains

Researchers in the United States may have found a way to augment antiretroviral therapy's effectiveness against drug-resistant HIV strains. "Highly active antiretroviral therapy (HAART) is the standard treatment for infection with the human immunodeficiency virus (HIV)," explained Dr. Raymond F. Schinazi and colleagues working with Tucker, Georgia-based Pharmasset Inc., Emory University and the Veterans Affairs Medical Center in Atlanta, the University of Pittsburgh and the Veterans Affairs Medical Center in Pittsburgh, and the DuPont Pharmaceuticals Company in Wilmington, Del.

The cytidine nucleoside analog DPC 817 remains effective against viruses with resistance mutations countering reverse transcriptase inhibitors, a crucial element of HAART, according to Schinazi and coauthors. Many HAART regimens utilize the nucleoside reverse transcriptase inhibitors (NRTIs) zidovudine and/or lamivudine, the researchers said. Viruses with mutations conferring protection from these agents remained vulnerable to DPC 817, which demonstrated powerful activity against wild-type viruses as well as resistant mutants.

DPC 817 had attractive qualities beyond its ability to target drug-resistant viral strains. The agent was quickly converted to its active metabolite, which remains in plasma for extended periods of time, study data showed. In fact, experiments with nonhuman primates suggested that the plasma half-life of DPC 817 was longer than that of several commonly used reverse transcriptase inhibitors ("DPC 817: A Cytidine Nucleoside Analog with Activity Against Zidovudine- and Lamivudine-Resistant Viral Variants," Antimicrobial Agents and Chemotherapy, May 2002; 46(5):1394-1401).

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"Together, these properties suggest that DPC 817 may be useful as a component of HAART regimens in individuals with resistance to older NRTI agents," Schinazi and colleagues concluded. (AIDS Weekly, 05.27.02, Michael Greer)


HIV Patients Try to Remedy Gaunt Appearance

Like many people taking drugs to combat HIV, Steven Hodges, a former hairdresser in San Francisco, noticed a few years ago that he was becoming gaunt and hollow-cheeked even though he still felt healthy. So, Hodges, who has since retired to Palm Springs, did what thousands of other people with HIV have been doing lately: he began exploring cosmetic and reconstructive options for reversing the disfiguring loss of fat tissue in the face.

First, Hodges' dermatologist injected collagen, made from bovine tissue, into his cheeks. The procedure filled out his face, but his body metabolized the substance quickly and he had to repeat the treatment to sustain the effect. Then the doctor tried Fascian, a filler material synthesized from cadaver tissue and used in plastic surgery. Again, the improvement was temporary, leaving Hodges discouraged. "To be 50 and look in the mirror and see a 60-year-old is very disconcerting," he said. Even as people with HIV are living longer than ever, a significant number look deathly ill because of lipodystrophy -- a disruption in the body's methods of processing and distributing fat. Many say their emaciated appearance frightens family members, friends and co-workers and severely undermines their self-confidence.

"Cheek-wasting has become the modern day scarlet letter," said Dr. David Teplica, a Chicago plastic surgeon with many HIV patients. Many plastic surgeons, like Dr. Jeffery Brande in New York, say the best strategy is to harvest a person's own fat from elsewhere in the body and transfer it to the cheeks. "If you're missing fat on your face, the logical therapy is to replace it with more body fat," he said. The problem, he added, is that many people with facial wasting have no extra body fat. Plastic surgeons and dermatologists who perform the procedures acknowledge that none of them is problem-free. (New York Times, 05.21.02, David Tuller)


Guidelines for Using Antiretroviral Agents

The availability of an increasing number of antiretroviral agents and the rapid evolution of new information has introduced substantial complexity into treatment regimens for persons infected with human immunodeficiency virus (HIV). In 1996, the Department of Health and Human Services and the Henry J. Kaiser Family Foundation convened the Panel on Clinical Practices for the Treatment of HIV to develop guidelines for clinical management of HIV-infected adults and adolescents.

This report, which updates the 1998 guidelines, addresses 1) using testing for plasma HIV ribonucleic acid levels (i.e., viral load) and CD4+ T cell count; 2) using testing for antiretroviral drug resistance; 3) considerations for when to initiate therapy; 4) adherence to antiretroviral therapy; 5) considerations for therapy among patients with advanced disease; 6) therapy-related adverse events; 7) interruption of therapy; 8) considerations for changing therapy and available therapeutic options; 9) treatment for acute HIV infection; 10) considerations for antiretroviral therapy among adolescents; 11) considerations for antiretroviral therapy among pregnant women; and 12) concerns related to transmission of HIV to others.

Antiretroviral regimens are complex, have serious side effects, pose difficulty with adherence, and carry serious potential consequences from the development of viral resistance because of nonadherence to the drug regimen or suboptimal levels of antiretroviral agents. Patient education and involvement in therapeutic decisions is critical. Treatment should usually be offered to all patients with symptoms ascribed to HIV infection. Recommendations for offering antiretroviral therapy among asymptomatic patients require analysis of real and potential risks and benefits.

Treatment should be offered to persons who have less than 350 CD4+ T cells/mm or plasma HIV ribonucleic acid (RNA) levels of greater than 55,000 copies/mL (by b-deoxyribonucleic acid [bDNA] or reverse transcriptase-polymerase chain reaction [RT-PCR] assays). The recommendation to treat asymptomatic patients should be based on the willingness and readiness of the person to begin therapy; the degree of existing immunodeficiency as determined by the CD4+ T cell count; the risk for disease progression as determined by the CD4+ T cell count and level of plasma HIV RNA; the potential benefits and risks of initiating therapy in an asymptomatic person; and the likelihood, after counseling and education, of adherence to the prescribed treatment regimen. Treatment goals should be maximal and durable suppression of viral load, restoration and preservation of immunologic function, improvement of quality of life, and reduction of HIV-related morbidity and mortality. Results of therapy are evaluated through plasma HIV RNA levels, which are expected to indicate a 1.0 log10 decrease at 2-8 weeks and no detectable virus (less than 50 copies/mL) at 4-6 months after treatment initiation.

Failure of therapy at 4-6 months might be ascribed to nonadherence, inadequate potency of drugs or suboptimal levels of antiretroviral agents, viral resistance, and other factors that are poorly understood. Patients whose therapy fails in spite of a high level of adherence to the regimen should have their regimen changed; this change should be guided by a thorough drug treatment history and the results of drug-resistance testing. Because of limitations in the available alternative antiretroviral regimens that have documented efficacy, optimal changes in therapy might be difficult to achieve for patients in whom the preferred regimen has failed. These decisions are further confounded by problems with adherence, toxicity, and resistance. For certain patients, participating in a clinical trial with or without access to new drugs or using a regimen that might not achieve complete suppression of viral replication might be preferable. Because concepts regarding HIV management are evolving rapidly, readers should check regularly for additional information and updates at the HIV/AIDS Treatment Information Service website (www.hivatis.org). Note: Data regarding use of hydroxyurea in combination with antiretroviral agents are limited; therefore, this report does not include recommendations regarding its use in treating persons infected with HIV. (Morbidity and Mortality Weekly Report, Recommendations and Reports, 05.17.02, Vol. 51; No. RR-7)


HIV Therapy Works for Older People, Too

Despite concerns that older people do not respond as well as younger people to HIV medications, the results of a new study published in the April Journal of the American Geriatrics Society (2002;50:605-7) suggest that the drugs provide similar benefits to people ages 50 and older as younger patients. In fact, older patients in the study were more likely to have their HIV levels under control, perhaps because they did a better job of taking the medication as prescribed, the report indicates.

"Older HIV-infected patients respond just as well as younger HIV patients," said Dr. Kenneth E. Schmader, of Duke University Medical Center and lead author of the report. As therapies for HIV have improved, more and more older people are living with the virus. Some studies have shown that older patients do not fare as well after being diagnosed with HIV, but this research was conducted before drug combination therapy became available in the mid-1990s. To see whether the benefits of these therapies extend to older patients, Schmader and his colleagues reviewed the records of 101 patients ages 50 and older and 2002 patients ages 18 to 39 who were treated from 1993 through 1999.

The researchers detected no signs that HIV therapy was any less effective in older patients. Both groups experienced similar rises in levels of CD4 T cells, and older patients were actually more likely to have extremely low blood levels of HIV. Viral load was undetectable in 47 percent of patients ages 50 and older but only in 34 percent of younger patients. That was "a little surprising," said Schmader. "I don't think that's because they have better immune systems," he said. Though older and younger patients had similar treatment histories, older patients were less likely to have stopped taking their medications. Schmader speculated that older individuals might be more likely to adhere to the often complex cocktail regimens. He and his colleagues note that more research is needed to confirm the findings and to determine the long-term outcomes of older patients on HIV therapy. They concluded that combination therapy, "should be offered to older patients when clinically indicated, and the failure of an older patient to respond to this regimen should not be attributed to age alone." (Reuters, 05.09.02, Merritt McKinney )


Findings: Hepatitis C

Sharing drug paraphernalia other than syringes might also increase the risk of hepatitis C infection, concluded a study among 702 injection drug users in Chicago, published in the American Journal of Epidemiology (02.01.02; 155: 645-653). The cohort of IDUs 18-30 years old was tested for HCV at the outset of the study, which ran from 1997 to 1999.

Those who were found to be seronegative were tested at the six- and 12-month marks. While 27 percent of the study participants initially tested positive, 4 percent, or 29 patients, seroconverted by the study's end. After controlling for demographics and drug-use covariates, and adjusting for syringe-sharing, the researchers concluded that the sharing of drug "cookers," the devices used to heat and dissolve drugs like cocaine and heroin, resulted in a four-fold increase in the risk of contracting HCV. Sharing cotton filters, used to purify the drug, gave a 2.5-fold risk increase. The investigators said prevention messages should address the issue of all equipment-sharing practices among IDUs. As many as 90 percent of IDUs contract HCV after five years of injecting, according to the Centers for Disease Control and Prevention, which also said that "injecting drug use is the primary risk factor for acquiring HCV infection." (AIDS Policy & Law, 04.26.02)


Annual HIV Tests Urged for Gay Men

Sexually active gay and bisexual men should get tested at least once a year for HIV, the government said in a new recommendation aimed at heading off a feared surge of infections. The new guidelines, released Thursday by the CDC, marked the first time the government has made such a recommendation.

Previous guidelines from federal health officials have been less specific, urging doctors to recommend HIV tests for patients whose behavior might put them at risk for infection. But recent studies have shown that gay and bisexual men, possibly lulled into complacency by medical breakthroughs that have helped AIDS patients live longer, are having more unprotected sex. Rates of syphilis and gonorrhea are up among gay and bisexual men in many US cities, and health officials worry that those diseases signal a coming spike in HIV/AIDS rates.

The new guidelines recommend annual screening for HIV, chlamydia, syphilis and gonorrhea for gay and bisexual men, plus vaccination against hepatitis A and B. Some men in high-risk groups may need to be screened more often, the CDC said. "There has been an increase in awareness of the level of risk behavior of men who have sex with men," said the CDC's Dr. Stuart Berman. "There really haven't been recommendations before." The guidelines also urge doctors to ask their male patients about the gender of their sex partners -- a question CDC experts say doctors are sometimes hesitant to ask.

"It's important for them to provide educational messages about what's important in terms of safe sex behavior," said lead author Dr. Kimberly Workowski. "A lot of times providers have reticence in asking their patients these questions." The CDC updates its STD guidelines every four years. They were first published in 1982, and the last update was issued in 1998. (Associated Press, 05.10.02, Erin McClam)


AIDS Vaccine May Offer Compromise, Researcher Says

A vaccine that does not prevent HIV infection but helps the body control the AIDS virus shows promise in monkeys and will soon be tested in humans, a researcher said on Wednesday. It is one of the first vaccines designed with a compromise in mind: As none of the 30 or so vaccines being tested looks like it can prevent infection, scientists are now aiming at a vaccine that can at least dull the most lethal effects of HIV. Virologist Harriet Robinson of the Yerkes Regional Primate Research Center at Atlanta's Emory University said a vaccine she is working on did not prevent infection in monkeys, but did stop them from getting sick.

"All the vaccinated animals became infected, but in contrast to non-vaccinated [animals], the vaccinated animals controlled their infections to levels seen in humans who are long-term non-progressors and non-transmitters," Robinson said. "I think we are going to be able to control HIV infection." Robinson helped develop a vaccine that she said works as well as highly active antiretroviral therapy [HAART], at least in monkeys. The researchers first vaccinated the monkeys with an experimental vaccine using DNA from the virus -- three genes called gag, pol and env-boosted with a vaccine made from a pox virus. Seven months later, the monkeys were infected with simian HIV rectally, which simulates real-life sexual transmission of HIV in people. She said 19 of the 20 animals that got the vaccine were still controlling the virus to just barely detectable levels nearly two years later which, in humans, translates into having no symptoms.

"This could be as effective, if not more effective, than HAART," said Robinson, who presented her findings in Baltimore to the National Foundation for Infectious Diseases. Robinson said her team is moving under the auspices of the US National Institutes of Health to start human trials later this year. The first tests will probably use healthy people at low risk of HIV infection to see if the vaccine is safe. (Reuters; 05.08.02; Maggie Fox)


HIV-Positive Man Not Disabled Under IRS Statute, Court Finds

An HIV-positive man was not disabled under Internal Revenue Service requirements when he withdrew funds from an individual retirement account (IRA). A tax court recently said the $38,855 withdrawal made by Gregory Scott West was not exempt from a 10 percent tax. West had taken the money from his IRA in 1997, two years after quitting his job due to declining health. West said he knew HIV was the cause for his poor health, but he did not get tested until 1998, a year later. West told the court this was in part because he wanted to avoid creating drug resistance.

"The longer you can wait to start medication the better," he said. He also said he didn't seek medical attention from 1996 through 1998 because he was looking for a job that provided health insurance with no annual limit. He found such a job in mid-1998 at American Express. West reported the amount on his income tax but did not add the 10 percent charge normally computed on such withdrawals. The Internal Revenue Code specifies that someone is disabled "if he is unable to engage in any substantial gainful activity by reason of any medically determinable physical or mental impairment which can be expected to result in death or to be of long-continued and indefinite duration."

West contended that he was disabled due to his HIV status and should not be liable for taxes on his IRA withdrawal. However, since he was not treated for HIV until 1999, he had no medical records to support his claim. West testified that he contacted the IRS, and that an agency representative informed him he was not liable for taxes on the IRA withdrawal. The court said, "the authoritative sources of federal tax law are statutes, regulations, and judicial case law, and not informal IRS sources." Therefore, the court said the advice West received did "not have the force and effect of law."

The court also found that West failed to prove his disability. West testified that had he been able to find a company with no annual caps on medical insurance sooner than he did, he would have gone back to work. Accordingly, the court found that West was capable of gainful activity during the period he was unemployed and therefore not disabled. (West v. Commissioner of Internal Revenue, No. 2784-00S. US Tax Ct., 04/01/02) (AIDS Policy & Law, 04.26.02)


Back to the July/August 2002 issue of Body Positive magazine.



  
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This article was provided by Body Positive. It is a part of the publication Body Positive.
 

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