CDC Releases Draft of Guidelines for HIV Testing in Pregnanc

WASHINGTON--Since the first case of AIDS appeared in the United States in 1981, 60,000 women have been diagnosed with the disease, 14,000 of them (25% of the total number of women) in 1994 alone. HIV in women is increasing at the rate of 17% a year, and one in four new cases in 1994 occurred in women under the age of 20.

At a well-attended 3-day conference on HIV infection in women, Martha Rogers, MD, chief of the epidemiology branch in the Centers for Disease Control's HIV/AIDS Prevention Division, announced the agency's new draft guidelines about HIV testing and treatment in pregnant women.

The guidelines (see table ) stem from a study done by the National Institute of Allergy and Infectious Diseases (NIAID) AIDS Clinical Trials Group that showed a clear advantage to women who had received AZT (zidovudine, Retrovir) during their pregnancy, as well as to neonates who received the drug for the first 6 weeks of life.

The controlled double-blind study, completed in early 1994, showed that the women who received AZT had an 8% vertical transmission rate, compared with 25% for the control group. Now that AZT has been shown to be beneficial during pregnancy, the FDA has changed the drug's labeling to allow its use during gestation and labor.

The meeting was not without controversy, as AIDS activists also were heard. Maxine Wolfe, from ACT-UP in New York, described the federal delays in recognizing the incidence and prevalence of HIV infection in women as "criminal behavior."

Kathy Anastos, MD, director of Ambulatory Services at Bronx-Lebanon Hospital in New York, noted that women were not generally used as clinical research subjects when she entered medicine in the 1980s. "Early in the epidemic, there was almost no research on AIDS in women, and what there is treats them as vectors for the disease in men--not as victims themselves," she said.

Patricia Fleming, director of the Health and Human Services (HHS) Office of National AIDS Policy, said that women's HIV symptoms traditionally have been ignored "because everyone thought they didn't get AIDS." She added that women had been given short shrift in clinical research until the NIH instituted a regulation that requires women and minority representation in all clinical trials.

"NIH now has a task force on women's issues," Ms. Fleming said, and it is sponsoring an interagency study on the natural history of HIV infection in women. Moreover, "NIH is committed to the development of female control barriers such as a vaginal microbicide."

HHS encourages all pregnant women to submit to voluntary HIV testing (about 90% accept), a policy endorsed by the American College of Physicians, the American College of Obstetricians and Gynecologists, and other medical groups. The federal government, Ms. Fleming said, does not recommend mandatory testing of pregnant women because it believes that such a policy might cause women to avoid testing by eschewing all prenatal care.

About 4 million women become pregnant each year in the United States; therefore, the $25 per HIV test represents a major health-care investment. Approximately 7,000 HIV-positive women give birth each year, according to the CDC, and about 2,000 babies are born HIV positive. However, the CDC maintains that the cost of HIV testing will pay for itself if the number of HIV-infected babies can be significantly reduced.

Recommendations (Draft) From the United States Public Health Service for HIV Counseling and Testing for Pregnant Women

All American health-care providers should routinely counsel pregnant women about HIV testing and encourage them to be tested as early in their pregnancy as possible.

Such testing should be voluntary and preceded by informed consent.

Uninfected women, especially those at high risk, should be retested in the third trimester of their pregnancy.

Women who have not had prenatal care should be rapidly assessed for HIV infection and considered for intrapartum and postpartum administration of AZT (zidovudine, Retrovir).

If a woman refuses to be tested, she should be encouraged to have her newborn tested, particularly if it is to be placed in foster care.

HIV-infected women should be evaluated to assess their need for antiviral treatment, such as AZT, during pregnancy and labor.