AIDS-Related Illnesses, Pregnant Women and Children

by Food and Drug Administration (FDA)

(Page 2 of 3)

AIDS treatments may interact with many commonly prescribed drugs. For example, Pfizer Inc. plans to label its impotence drug Viagra to warn of possible interactions with certain protease inhibitors, which appear to raise levels of Viagra in the blood.

AIDS drugs also may prompt onset of diabetes or a worsening of existing diabetes and hyperglycemia (high blood sugar), along with increased bleeding in people with hemophilia types A or B.

Some patients on triple therapy have experienced a type of weight redistribution where face and limbs become thin while breasts, stomach or neck enlarges. Some have nicknamed the appearance of fat deposits at the back of the shoulders "buffalo hump." Fat deposits in the midsection are sometimes called "Crix belly," after the drug Crixivan, "although it has been seen in people taking all approved protease inhibitors," says Klein.

Research is currently under way to determine if protease inhibitors cause a permanent change in fat metabolism. "There is considerable concern over the long-term effects for patients," says Klein, including the possibility that the cholesterol increases in some patients who experience fat redistribution could increase the risk for cardiovascular complications such as strokes or heart attacks. FDA has asked each of the makers of protease inhibitors to study these abnormalities.

AIDS-Related Illnesses

Because AIDS patients have suppressed immune systems, they can fall prey to certain illnesses that people with healthy immune responses don't get, or get only very rarely. One common such illness is Pneumocystis carinii pneumonia (PCP), which can be life-threatening. Treatments to prevent PCP are NebuPent (aerosolized pentamidine), a fine mist inhaler, and drugs such as Bactrim and Septra that contain both trimethoprim and sulfa. Mepron (atovaquone) is approved for treating mild-to-moderate PCP in pregnant women and patients who cannot tolerate standard treatment. Neutrexin (trimexetrate glucoronate) also is approved for pregnant women and for moderate-to-severe PCP when given with Leucovorin (folinic acid).

Cytomegalovirus retinitis is a potentially severe AIDS-related eye infection that can lead to blindness. Approved treatments include ganciclovir, marketed as Cytovene in oral dosage and as Vitrosert as an implant, Foscavir (foscarnet), and Vistide (cidovir).

For mycobacterium avium, an infection that before AIDS was almost always confined to patients with severe chronic lung diseases such as emphysema, FDA has approved Biaxin (clarithromycin), Mycobutin (rifabutin), and Zithromax (azithromycin).

Kaposi's sarcoma (KS) is a type of AIDS-related cancer that causes characteristic purple or pink skin tumors that are flat or slightly raised. Intron A (human interferon-alpha), doxorubicin liposome injection, or daunorubicin citrate liposome injection can be used to treat KS. Panretin, a topical gel, also is approved for treating certain types of KS lesions.

AIDS wasting syndrome involves major weight loss, chronic diarrhea or weakness, and constant or intermittent fever for at least 30 days. Approved treatments include Marinol (dronabinol), Megace (megestrol), and Serostim (somatropin rDNA for injection).

Pregnant Women and Children

In 1998 recommendations, the Public Health Service Task Force stated that the decision to take anti-HIV drugs during pregnancy should be made by the pregnant woman after her health care-provider has explained benefits and risks. There are some compelling reasons to take the drugs. For example, an HIV-positive pregnant woman who takes AZT after the first trimester decreases the chance of the baby being born with HIV. Studies show that AZT taken according to a strict regimen decreases by nearly 66 percent the odds of infecting the newborn.

The task force says women should consider delaying therapy until after the 10th to 12th week of pregnancy, after the fetus's organs have gone through their most rapid development. This delay may minimize any adverse effects of AZT on fetal development, but it needs to be balanced with the health of the mother and possible transmission of HIV to the fetus.

Most children with HIV became infected from their mothers near the time of birth. This means that for many babies, treatment can be started soon after birth. Federal guidelines recommend that all HIV-infected children younger than 1 year and all HIV-infected children of any age with symptoms of HIV infection or evidence of immune suppression be treated with anti-HIV drugs. For HIV-infected children with no symptoms, therapy can be deferred if risk of disease is considered low based on viral load and immune status.

Triple combination therapy can be used for all HIV-infected infants, children and adolescents treated with HIV drugs. Infants during the first six weeks of life who have been exposed to HIV but whose HIV status is unknown can be treated with AZT as sole therapy. Infants diagnosed with HIV while receiving AZT alone should be switched to combination therapy.

About the Author

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