Methods to Prevent and Treat AIDS: Drugs, Nutrition

by Food and Drug Administration (FDA)

(Page 3 of 3)

Drugs

In December 1995, a new class of drugs called protease inhibitors was added to the earlier approved class of nucleoside analogs, which included Retrovir (zidovudine, also known as AZT), Videx (didanosine, or ddI), Hivid (zalcitabine, or ddC), Zerit (stavudine, or d4t), and Epivir (lamivudine, or 3TC).

In September 1997, FDA approved Combivir, an AZT-and-3TC combination medicine for AIDS and HIV infection. Because AZT and 3TC are frequently prescribed with one another, the combination of the two drugs into one tablet may help decrease from as many as eight to only two the number of these pills that people take daily.

The protease inhibitors — Invirase and Fortovase (saquinavir), Norvir (ritonavir), Crixivan (indinavir), and Viracept (nelfinavir) — inhibit replication of HIV in a similar way as nucleoside analogs, but are active at different points in the replication process. Tested alone or in combination with the nucleoside analogs, the three protease inhibitors markedly reduced the viral load and increased the number of CD4 cells, which sharply declines in HIV infection and AIDS.

However, in June 1997, FDA warned that protease inhibitors may contribute to increases in blood sugar and even diabetes in HIV patients and advised doctors to closely monitor the blood glucose levels of patients on these drugs. In a letter to doctors, FDA noted that it had received 83 reported cases of new or exacerbated diabetes mellitus and hyperglycemia (high blood sugar levels) in HIV patients using protease inhibitors. Although there appears to be a link, FDA said that the data do not "definitively" demonstrate that the drugs cause diabetes and hyperglycemia.

In 1996, FDA approved Viramune (nevirapine), the first in a new class of drugs called non-nucleoside reverse transcriptase inhibitors. A second drug in this class, Rescriptor (delavirdine), was approved in April 1997. Viramune was approved for use in combination with nucleoside analogs to treat adults with HIV infection who have experienced clinical and/or immunological deterioration. Rescriptor was approved for use in combination with appropriate anti-HIV medicines for patients with HIV infection when treatment is warranted.

FDA also has approved at least 22 drugs for HIV- and AIDS-related conditions. Among them are NebuPent (aerosolized pentamidine isethionate) to prevent Pneumocystis carinii pneumonia, the most common life-threatening infection of people with AIDS, and Roferon-A (interferon alfa-2a) and Intron-A (interferon alfa-2b) for Kaposi's sarcoma, an aggressive cancer that affects primarily male homosexuals with AIDS.

Nutrition

Some patients with HIV have wasting syndrome, with symptoms that include major weight loss, chronic diarrhea or weakness, and constant or intermittent fever for at least 30 days. The syndrome is classified as an AIDS-defining illness.

Loss of appetite (anorexia) can be treated with three FDA-approved prescription medicines for HIV and AIDS patients. Marinol (dronabinol), a synthetic extract of marijuana, is indicated for anorexia associated with weight loss. Megace (megestrol acetate) can be used for anorexia, cachexia (emaciation), or any unexplained significant weight loss. And Serostim (recombinant human growth hormone) is approved for AIDS-related cachexia.

All people with HIV should carefully follow food safety practices, because their weakened immunity leaves them particularly vulnerable to food-borne illness. Diarrhea caused by such illness can lead to or worsen wasting syndrome.

To prevent food-borne illnesses, people with HIV should avoid nonpasteurized dairy products, wash hands and utensils with soap and hot water when preparing meals, and cook food thoroughly to kill harmful bacteria. Raw eggs and raw seafood such as oysters, clams, sushi, and sashimi should not be eaten. Additional information about food safety and HIV can be obtained from FDA.

Unapproved Therapies

Recognizing the special needs of people with HIV infection and AIDS, FDA uses its discretion to allow them to import for their personal use unapproved but promising drugs for HIV and HIV-related life-threatening diseases. At the same time, the agency vigorously campaigns against AIDS health scams that have bilked their victims of as much as $ 10 billion a year.

As a result of FDA investigations, federal and state authorities have taken legal actions against individuals involved in hundreds of fraudulent cures for AIDS such as "energized" water, "ozone therapy," and hydrogen peroxide "treatment."

Because most of the scams are local enterprises, FDA initiated in 1989 an AIDS Health Fraud Task Force Network to monitor and counter the promotion of suspected fraudulent AIDS products. The task forces, so far established in 10 states, have built broadly based coalitions of federal, state and local authorities with the medical community and AIDS activists. They cooperate in explaining to individuals and organizations how to identify fraudulent health products and distribute general information about HIV infection.

About the Author

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FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.