Date: Mon, 17 Apr 1995 13:44:15 +0500 From: ghmcleaf{CONTRACTOR/ASPEN/ghmcleaf}%NAC-GATEWAY.ASPEN@ace.aspensys.com Subject: CDC Nat. AIDS Hotline Training Bul. #133 CENTERS FOR DISEASE CONTROL AND PREVENTION HIV/AIDS PREVENTION CDC NATIONAL AIDS HOTLINE TRAINING BULLETIN ................................................................. March 24, 1995 #133 These are answers from the Centers for Disease Control and Prevention (CDC) to questions submitted by the CDC National AIDS Hotline concerning the United States Public Health Service recommendations for HIV counseling and testing for pregnant women. 1. As a result of the draft recommendations, will we be expected to encourage pregnant women to get tested? We won't make any official changes until the final guidelines are published. Once the final guidelines are published, we will tell callers that the U.S. Public Health Service (USPHS), including the CDC, recommends that all pregnant women be tested for HIV. So, while it would be premature to speak of a CDC testing recommendation for all pregnant women, we want to be careful not to discourage pregnant women from getting a test. Therefore, we should continue encouraging pregnant women to discuss HIV concerns with a health care provider because of the important implications for their own health and transmission to their infants if they are infected. We should explain the benefits and risks of testing, and inform callers that CDC recommends that anyone concerned about their HIV status be tested. When addressing the benefits and risks of testing, it is important to discuss the use of Zidovudine (AZT or ZDV) as a way to reduce the risk of transmission of HIV to the infant. For a further discussion of the study involving the use of AZT to reduce perinatal transmission of HIV, refer to the "Pediatric" section of the information manual. Benefits and risks of testing for pregnant women are covered more thoroughly in the answer to question 2. 2. Why is USPHS coming out with these recommendations? How are we expected to discuss these recommendations during the 45- day public comment period and before the final recommendations are released? Explain to callers that USPHS has proposed guidelines which state that health care providers should conduct routine HIV counseling and recommend voluntary HIV testing to all pregnant women. Guidelines issued in 1985 targeted pregnant women known to be at risk for HIV infection (e.g., injecting drug users, women whose sex partners were HIV-infected or at risk for infection). Studies have shown, however, that a targeted strategy fails to identify and offer services to many HIV-infected women. Therefore, the goal of the newly proposed guidelines is to make HIV counseling and a recommendation for voluntary testing routine aspects of prenatal care for all pregnant women. Final guidelines are subject to change and won't be official until feedback from a 45 day period for public comment is taken into account. Explain the rationale behind the proposed recommendation: if a woman is infected with HIV, there is now medical therapy (AZT) available which can lower the chance of passing HIV to the infant before, during, or after birth. In addition, HIV testing would make it possible for infected women to begin taking steps to care for their own health, including CD4+ monitoring, antiviral therapy, and prophylaxis for opportunistic infections. HIV counseling would assist uninfected pregnant women in reducing their risk for acquiring HIV infection. It is important to continue to acknowledge that there may be risks associated with testing as well, such as discrimination, insurance issues, and psychological consequences. Encourage callers for whom this is an issue to discuss benefits and potential risks of HIV testing with their health care provider as well. If a woman is infected with HIV, she and her health care provider should also discuss the benefits, potential risks, and unknown long term effects of AZT therapy. A more thorough discussion of the rationale for the proposed recommendations can be found in the draft document. 3. The draft of the recommendations states that "an increasing proportion of perinatal AIDS cases have been reported through heterosexual contact with an infected partner whose risk was not known or recognized by the mother." It would help us to know how much the "increasing proportion of perinatal AIDS cases" has been. Between July 1992 and June 1993, 102 of the total 822 perinatal AIDS cases reported, or 12.4%, were assigned to the mother's heterosexual contact with an infected partner whose risk was not know or recognized by the mother. Between July 1993 and June 1994, the number of cases and proportion reported increased to 131 out of 992, or 13.2%. (A note for the detail aware: The category from the HIV/AIDS Surveillance Report from which these numbers are taken is labeled ". . .risk not specified" rather than ". . .risk not known or recognized by the mother." A check with CDC's Technical Information Activities section verified that they refer to the same data.) 4. Our written information doesn't adequately explain how HIV transmits in utero. Our callers have always wanted more detail on this subject. No one knows for sure. Accumulating data do suggest that at least half of perinatal transmissions may occur close to or during the time of birth. Several maternal factors have been associated with an increased risk of transmission including low CD4 counts, high maternal viral titer (amount of virus), advanced HIV disease, the presence of p24 antigen in maternal serum, placental membrane inflammation, intrapartum events resulting in increased exposure of the fetus to maternal blood, breastfeeding, premature rupture of membranes, and premature delivery. 5. Is the USPHS recommending a C-section for HIV infected women? No. While some studies indicate possible benefits in preventing the transmission of HIV, others show no difference. More research is being conducted to see if there is a protective effect. 6. What do the following mean: intrapartum, parous, antimicrobial prophylaxis, and teratogenic effects? intrapartum: occurring during childbirth parous: having borne one or more viable offspring antimicrobial prophylaxis: disease prevention through the use of an agent that kills microorganisms teratogenic effects: marked deviations from normal formation or development (e.g., of the fetus). 7. What were the clinical conditions required of the women and infants in the clinical trial? How long were the mothers given AZT? the infants? How long were they monitored post- trial? Eligible participants in the trial were HIV-infected pregnant women at 14-34 weeks of gestation who: a. had received no antiretroviral therapy during their current pregnancy, b. had no clinical indications which would suggest receiving antiretroviral therapy for her own health benefit (because of the possibility of being in the placebo group) and c. had CD4+ counts of > 200 at the time of entry into the study (again, because of the possibility of being in the placebo group.) Mothers were given AZT orally throughout pregnancy and intravenously during labor until delivery. Oral administration of AZT was given to the newborn for the first 6 weeks of life, beginning 8-12 hours after birth. Follow- up of patients enrolled in the study is ongoing. (Information taken from August 5,1994 MMWR , Vol 43/No. RR- 11) 8. How will health care providers make individualized recommendations for their HIV-infected pregnant clients based on the trial? The August 5, 1994 MMWR, Vol. 43/No. RR-11 provides health- care providers with recommendations for noncoercive discussions with the pregnant woman about her decision regarding the use of AZT as a treatment option. It includes treatment considerations under various circumstances. These circumstances include low CD4+ counts, prior use of antiretrovirals, and other clinical situations. The recommendations also encourage discussion and consideration of potential benefits, unknown long-term effects, and gaps in knowledge about the woman's clinical situation. 9. The wording on page 8 of our copy states that "the recommendations for ZDV therapy extend to HIV-infected pregnant women with clinical conditions different from those of the women in the clinical trial... ." Is this an update from the August, 1994 ZDV guidelines? No. The August 1994 MMWR guidelines make recommendations for pregnant women who have a variety of clinical conditions, including conditions which differ from those of women who were part of the clinical trial. In other words, "extending" the recommendations to clinical conditions different from those of the women in the clinical trial is already covered in the original August 1994 guidelines. The word "extend" does not imply a later revision or addition to the discussions and recommendations set forth in that document. 10. Does the recommendation for prophylactic therapy for PCP at two months apply to all newborns of an infected mother (pg 9), given that infants might not be known to have HIV until their 18 month? Yes. New guidelines for PCP prophylactic therapy recommend that Bactrim be given to all infants born to HIV infected mothers. The benefits of prophylaxis are said to outweigh any risks. Therapy should begin at 4-6 weeks of age and continue until the HIV status of the child is established. At that point, infants not infected with HIV would be taken off therapy, while those infected would continue indefinitely.