Date: Fri, 7 Jul 1995 15:55:37 +0500 From: ghmcleaf{CONTRACTOR/ASPEN/ghmcleaf}%NAC-GATEWAY.ASPEN@ace.aspensys.com Subject: 076 Fact Sheet F A C T S H E E T *************************************************** PUBLIC HEALTH SERVICE Centers for Disease Control and Prevention July 1995 PHS Guidelines for HIV Counseling and Voluntary Testing for Pregnant Women The Centers for Disease Control and Prevention (CDC) has published guidelines that call upon medical professionals to provide HIV counseling and voluntary testing for all pregnant women. In 1993 (the most recent year for which complete data are available), an estimated 7,000 HIV-infected women gave birth in the United States. The prevalence of HIV infection in women giving birth was about 1.6 per 1,000, or about 1 in every 625. Assuming an HIV transmission rate from mother to infant of about 15%-30%, about 1,000-2,000 HIV-infected infants were born in the United States in 1993. For HIV-infected women and their infants to benefit optimally from AZT and other medical treatment, it is important for women to know if they are HIV-infected before or early in pregnancy. CDC guidelines promote early HIV counseling and voluntary testing to help women learn if they are infected. This will enable women to seek and receive the care they need for themselves and for reducing the chances of transmitting HIV to their infants. If women do not receive prenatal care, or if for any reason their HIV status is unknown, the guidelines recommend that HIV testing be offered to the mothers or their babies at or shortly after labor and delivery. Research Showed AZT Significantly Reduces Mother-to-Infant Transmission In February 1994, the results of the National Institutes of Health (NIH) AIDS Clinical Trials Group Protocol were announced, indicating that zidovudine (ZDV, or AZT) could reduce perinatal HIV transmission by as much as two-thirds in some infected women and their babies. The results were reported in the New England Journal of Medicine in November 1994. In August, the Food and Drug Administration approved AZT use for pregnant women and the U.S. Public Health Service issued guidelines on using AZT during pregnancy (MMWR 1994;43[RR-11]). The finding of a 67.5% reduction in HIV transmission is promising, and there were no serious short-term side effects observed in the study. But several questions remain unanswered. The trial included a select group of women in the early stages of disease, who had not previously taken AZT long-term, and who had access to prenatal care. The therapy may differ in effectiveness in women who differ from these characteristics. Since researchers do not know exactly how the therapy prevented transmission, they also don't know the effect of any therapy variations -- such as using AZT only during labor or later in the pregnancy, or using it for a shorter time during pregnancy. Moreover, scientists don't know about the long-term effects of AZT on both mothers and infants. Researchers continue to seek answers to these questions. NIH is continuing to monitor the mothers and babies in the trial. Counseling for All Pregnant Women and Voluntary Testing Work The combined strategy of HIV counseling for all pregnant women and voluntary HIV testing is already proving effective in several communities. Voluntary testing means that after a woman receives appropriate counseling from her health care provider, she is able to make an informed decision about having a test for HIV. Studies show that when her health care provider talks with a pregnant woman about the test and what it means for her and her baby, most women choose to be tested and then to be treated as their doctor recommends. For example, in one inner-city hospital in Atlanta, Georgia, 96% of women chose to be tested after being provided HIV counseling and offered voluntary HIV testing as part of prenatal care. Offering all women voluntary testing in the context of HIV counseling establishes the trusting relationship between a woman and her health care provider that is essential for discussions about care and treatment options. Although AZT therapy is not 100% effective and the long-term risks to both the mother and her child are not yet known, the dramatic reduction in HIV transmission in the trial dictates that every HIV-infected pregnant woman should certainly be offered AZT therapy to reduce the risk of transmitting the virus to her baby. Because of the uncertainties, a woman should make a personal decision about taking AZT only after she discusses the benefits and potential risks for herself and her child with her health care provider. For More Information The guidelines, were published on July 7, 1995, in the Morbidity and Mortality Weekly Reports (MMWR). CDC developed the guidelines in conjunction with federal, state, and local health agencies, health and medical organizations, and members of the affected community. They were released in draft form in February and refined in response to input received during a 45-day public comment period. Printed copies of the "U.S. Public Health Service Recommendations for HIV Counseling and Voluntary Testing for Pregnant Women" and "Recommendations of the U.S. Public Health Service Task Force on the Use of Zidovudine to Reduce Perinatal Transmission of Human Immunodeficiency Virus" (MMWR 1994;43[RR-11]) which has more information about AZT treatment during pregnancy are available from the CDC National AIDS Clearinghouse (CDC NAC). Printed copies may be ordered by calling the CDC National AIDS Hotline (1-800-342-AIDS). The Hotline can also provide information about any AIDS-related issue. The guidelines are also available electronically through the CDC NAC On-line bulletin board as well as through other HIV/AIDS bulletin boards, including the Internet. For specific information regarding the 076 Clinical Trial or any other HIV/AIDS clinical trial, call the AIDS Clinical Trial Information Service (ACTIS) at 1-800-TRIALS A. For information regarding treatment and care of HIV infection and AIDS, including use of AZT in pregnant women, call the HIV/AIDS Treatment Information Service (ATIS) at 1-800-448-0440.