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News & Notes

August 1997

Diabetes | Vaccine Race | Cocktail Guidelines |
Mouth Ulcer Medicine | Women Use Condoms | Medicaid & Treatment |

Protease Inhibitors and Diabetes

On June 11, the Food and Drug Administration issued a health advisory to physicians around the country warning that protease inhibitors may contribute to increases in blood sugar and even diabetes in people with HIV, recommending the close monitoring of patients' glucose levels. In a letter to doctors, the FDA said it received 83 reported cases of new or exacerbated diabetes mellitus and hyperglycemia (increased blood sugar levels) in HIV-positive patients taking any one of the new class of AIDS drugs. Of the 83 people, 27 required hospitalization; six cases were life-threatening. Five cases resulted in ketoacidosis, a serious diabetes-related condition characterized by a fruity mouth odor, nausea and vomiting, dehydration, weight loss, confusion, and, when left untreated, coma or death.

Although diabetes is certainly serious, the FDA believes that its infrequent occurrence does not warrant the cessation of protease therapy. Many of the patients who developed diabetes while on protease inhibitors were able to control it through insulin or other treatments. All four FDA-approved protease inhibitors -- saquinavir, indinavir, ritonavir, and nelfinavir -- will soon carry revised labeling that lists the potential side effects. People with HIV who take protease inhibitors should know the warning signs of hyperglycemia and diabetes: increased thirst and hunger; unexplained weight loss; increased urination; fatigue; and dry, itchy skin. In the cases reported to the FDA, these symptoms appeared an average of 76 days from the start of protease inhibitor therapy.


Government Guidelines on Protease Inhibitors Imminent

Now that we've gotten your attention, here's a little more on protease inhibitors: A group of AIDS experts convened by the Department of Health and Human Services is currently putting the finishing touches on the first federal guidelines on how to use protease inhibitors. According to The Wall Street Journal on June 5, the guidelines sound that now familiar refrain,"hit hard, hit early," but the document is expected to clarify when exactly to start patients on protease inhibitors, what combinations to use, how to monitor the effects, and what to do if the drugs fail.

Principles the new guidelines cite are: treat aggressively to suppress HIV to below the level of detection; use a combination of two nucleoside analogs and one protease inhibitor; inform the patient of the drawbacks of the treatment, including toxicity and the possibility of developing resistance that limits future options (and now, presumably, the somewhat remote risk of diabetes); perform regular tests to measure the level of virus in the patient. Not recommended: the use of one or two nucleoside analogs without a protease inhibitor.

The draft guidelines come at a time when there is growing concern -- and mounting evidence -- that physicians aren't up to speed on the latest developments in AIDS treatments; indeed, there are examples of doctors who still prescribe AZT monotherapy. "I'm more worried than I've ever been about the level of care being provided to AIDS patients," said Dr. Eric P. Goosby of the Health and Human Services Department and the White House Office of AIDS Policy. David Barr, Director of the Forum for Collaborative HIV Research, cautions bluntly, "Some doctors just don't get it." The confusion about treatment regimens is understandable: It was only a year ago that the drugs became available and were hailed as the most potent weapon to be added to the anti-HIV arsenal. The federal guidelines are the work of two panels convened by the HHS's National Institutes of Health and the Public Health Service.

Thalidomide Gets Rid of HIV-Related Mouth Ulcers, Fed Study Says

A study supported by the National Institute of Allergy and Infectious Disease and reported in the May 22 issue of The New England Journal of Medicine found the drug thalidomide effectively heals mouth and throat ulcers experienced by people with HIV. "Thalidomide appears to have great potential as therapy for HIV-infected patients who have severe oral apthous ulcers," says Lawrence Fox, M.D., Ph.D., one of the study's authors, "but only when administered by a physician who is vigilant for the possible serious side effects, including irreversible, painful peripheral nerve damage, rash and birth defects." The ulcers healed completely in 55 percent of patients after four weeks of thalidomide treatment, compared with 7 percent healing in patients who received placebo. Almost all -- 90 percent -- of those receiving thalidomide had at least partial healing. A total of 57 volunteers took part in the study, 29 of whom received thalidomide.

Use of Condoms Among Women Doubles Since 1982

Women are using condoms more than any time over the past 15 years, according to a survey issued by the federal Centers for Disease Control and Prevention in Atlanta. Condom use among women has more than doubled since 1982, with 7.9 million saying they had their partner wear one during sex in 1995 -- up from 3.6 million in 1982. The CDC survey, which involved 10,847 women ages 15 to 44, also found that more than half of the women who had sex for the first time between 1990 and 1995 made their partner use a condom, up from 18 percent in the 1970s. These statistics are the first to be released from the 1995 National Survey of Family Growth. Women living with HIV is a group that is often underrepresented in HIV-related studies. This study is a step in the right direction.

Monkey Business Pays Off in AIDS Vaccine Research

A National Cancer Institute research team led by Marjorie Guroff reported that chimpanzees inoculated with an experimental AIDS vaccine have successfully fought off HIV infection despite repeated exposure to the virus. The team's study, published in the June issue of the journal Nature Medicine, found that vaccinated chimps remained alive, healthy -- and uninfected -- through the year-long study, while unvaccinated animals became infected within a month of exposure. The vaccine was made from adenovirus -- a type of virus that causes colds in humans -- that was genetically engineered to contain an extra gene, gp160, normally found only in HIV. The vaccine was administered through a series of nasal sprays followed a few weeks later by a booster shot in the arm. When sprayed into the nasal passages of chimps the virus settled in to animals' upper respiratory tract. The virus replicated and the chimps' immune systems responded by producing antibodies and white blood cells programmed to attack HIV.

Eleven months after the booster, chimps were subjected to intravenous infusions of HIV. Although scientists have often cautioned that other vaccines have looked similarly effective in chimpanzees only to fail in humans, researchers said they were encouraged by the strong immune response triggered by this vaccine. The findings are the latest in a number of promising data being gathered in the search for an AIDS vaccine.

Will New HIV Drugs be Covered by Medicaid?

Following a feasibility study request made by Vice Presidnet Al Gore in April, White House and federal officials now say they will soon propose expanding Medicaid to cover treatments for low income people who are HIV-infected but have no symptoms. Such a move will pave the way for government picking up the tab for costly antiviral cocktails as people begin treatment sooner. Under current federal policy, people with AIDS who are disabled qualify for Medicaid, the federal health insurance plan for the poor. Because the new AIDS drugs prevent disability, people with HIV currently can't qualify for the program until they become very ill.

The Clinton administration says it will expand Medicaid coverage by using its authority to conduct and approve state demonstration projects rather than go to Congress to change the Medicaid law. "Our view is that getting these drugs to people earlier won't cost more in the long run," said Vice President Gore. "It may even save money. It will certainly save lives." The initiative has been drafted by the Department of Health and Human Services, which will assess whether eligibility for Medicaid in the earlier stages of HIV infection is cost effective in reducing Mediciad care costs.

Victor Zonana, a spokesperson for HHS, said, "We believe that a person who has been treated is less infectious, and therefore less likely to transmit the virus, than a person who is not being treated. The Medicaid expansion was suggested by AIDS Action Council.

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