Recommendations for Use of Antiretroviral Drugs in Pregnant Women Infected with HIV-1 for Maternal Health and for Reducing Perinatal HIV-1 Transmission in the U.S., U.S. Public Health Service Task Force Perinatal Guidelines Working Group (2008)

Statutes, Regulations, and Agency Guidelines

The July 2008 version of the guidelines includes language that reaffirms an HIV-positive pregnant woman’s right to retain control over treatment decisions that affect her and her fetus. The Nov. 2007 version had inexplicably omitted language about a woman’s right to refuse ARV therapy without penalty—language that had been included in the Oct. 2006 version. That language has been reinstated, and is accompanied by other language in the document that makes explicit a woman’s right to be counseled in a way that will enable her to make informed decisions about her care.

The recommendations review the special considerations regarding use of antiretroviral drugs for pregnant women, provide new information regarding the use of Viracept, update the results of PACTG 076 and related clinical trials and epidemiologic studies, discuss the use of HIV-1 RNA and antiretroviral drug resistance assays during pregnancy, provide updated recommendations on antiretroviral chemoprophylaxis for reducing perinatal transmission, and provide recommendations related to use of elective cesarean delivery to reduce transmission risk. The guidelines address issues such as evidence of toxicities connected with certain antiretroviral drugs, the importance of information and counseling to pregnant women, various clinical scenarios and appropriate clinical responses, the significance and prevalence of drug resistance, different transmission risks associated with different modes of delivery, recommendations for perinatal and long-term follow-up of HIV-positive women and their infants, and the need for clinical research on factors such as drug safety, drug resistance, stopping antiretroviral therapy, and the use of rapid testing at delivery.

The following sets out the noteworthy changes contained in the July 8, 2008 guidelines in more detail:
1. The introduction eliminates any mention of monotherapy to prevent perinatal transmission. It also adds this language: "After counseling and discussion, a pregnant woman's informed choice on whether to take antiretroviral drugs either for her treatment or for prevention of mother-to-child transmission or to follow other medical recommendations intended to reduce perinatal HIV transmission should be respected. Coercive and punitive policies are potentially counterproductive in that they may undermine provider-patient trust and could discourage women from seeking prenatal care and adopting health care behaviors that optimize fetal and neonatal well-being."
2. In the sections on antepartum care and infant prophylaxis, the guidelines provide updated information about Viracept, the use of which had not been recommended because of "a process-related impurity." As of 3/31/08, the drug was deemed safe for use in all populations, including pregnant women and children.
3. The section on postpartum follow-up care now acknowledges not only the physical changes women go through after delivery, but also the psychological changes.
4. Also in the section on postpartum follow-up, the recommendation on continuation of ARV therapy after delivery has been changed. The recommendation now is to make this decision in consultation with the woman's HIV provider, taking into account several factors. The recommendation used to be continuation of therapy without mention of consultation or consideration of other factors.
5. The section on sterilization as a possible method of contraception now includes the following sentence: "Advance counseling and discussion about sterilization is strongly encouraged in order to enable the woman to make a well informed choice."