General Principles Regarding the Use of Antiretrovirals in Pregnancy

Medical care of the HIV-1-infected pregnant woman requires coordination and communication between the HIV-specialist caring for the woman when she is not pregnant and her obstetrician. Decisions regarding the use of antiretroviral drugs during pregnancy should be made by the woman after discussion with her health-care provider about the known and unknown benefits and risks of therapy. Initial evaluation of an infected pregnant woman should include an assessment of HIV-1 disease status and recommendations regarding antiretroviral treatment or alteration of her current antiretroviral regimen. This assessment should include a) evaluation of the degree of existing immunodeficiency determined by CD4+ count, b) risk for disease progression as determined by the level of plasma RNA, c) history of prior or current antiretroviral therapy, d) gestational age, and e) supportive care needs.

Decisions regarding initiation of therapy should be the same for women who are not currently receiving antiretroviral therapy and for women who are not pregnant, with the additional consideration of the potential impact of such therapy on the fetus and infant (14). Similarly, for women currently receiving antiretrovirals, decisions regarding alterations in therapy should involve the same parameters as those used for women who are not pregnant. Additionally, use of the three-part ZDV chemoprophylaxis regimen, alone or in combination with other antiretrovirals, should be discussed with and offered to all infected pregnant women to reduce the risk for perinatal HIV transmission.

Decisions regarding the use and choice of antiretroviral drugs during pregnancy are complex. Several competing factors influencing risk and benefit must be weighed. Discussion regarding the use of antiretroviral drugs during pregnancy should include a) what is known and not known about the effects of such drugs on the fetus and newborn, including lack of long-term outcome data on the use of any of the available antiretroviral drugs during pregnancy; b) what is recommended in terms of treatment for the health of the HIV-1-infected woman; and c) the efficacy of ZDV for reduction of perinatal HIV transmission. Results from preclinical and animal studies and available clinical information about the use of the various antiretroviral agents during pregnancy also should be discussed. The hypothetical risks of these drugs during pregnancy should be placed in perspective to the proven benefit of antiretroviral therapy for the health of the infected woman and the benefit of ZDV chemoprophylaxis for reducing the risk for HIV-1 transmission to her infant.

Discussion of treatment options should be noncoercive, and the final decision regarding the use of antiretroviral drugs is the responsibility of the woman. Decisions regarding use and choice of antiretroviral drugs in persons who are not pregnant are becoming increasingly complicated, as the standard of care moves toward simultaneous use of multiple antiretroviral drugs to suppress viral replication below detectable limits. These decisions are further complicated in pregnancy, because the long-term consequences for the infant who has been exposed to antiretroviral drugs in utero are unknown. A decision to refuse treatment with ZDV or other drugs should not result in punitive action or denial of care. Further, use of ZDV alone should not be denied to a woman who wishes to minimize exposure of the fetus to other antiretroviral drugs and who therefore, following counseling, chooses to receive only ZDV during pregnancy to reduce the risk for perinatal transmission.

A long-term treatment plan should be developed after discussion between the patient and the health-care provider. Such discussions should emphasize the importance of adherence to any prescribed antiretroviral regimen. Depending on individual circumstances, provision of support services, mental health services, and drug abuse treatment may be required. Coordination of services among prenatal care providers, primary care and HIV specialty care providers, mental health and drug abuse treatment services, and public assistance programs is essential to assist the infected woman in ensuring adherence to antiretroviral treatment regimens.

General counseling should include information regarding what is known about risk factors for perinatal transmission. Cigarette smoking, illicit drug use, and unprotected sexual intercourse with multiple partners during pregnancy have been associated with risk for perinatal HIV-1 transmission (85-89), and discontinuing these practices may provide nonpharmacologic interventions that might reduce this risk. In addition, PHS recommends that infected women in the United States refrain from breastfeeding to avoid postnatal transmission of HIV-1 to their infants through breast milk (3,90); these recommendations also should be followed by women receiving antiretroviral therapy. Passage of antiretroviral drugs into breast milk has been evaluated for only a few antiretroviral drugs. ZDV, 3TC, and nevirapine can be detected in the breast milk of women, and ddI, d4T, abacavir, delavirdine, indinavir, ritonavir, saquinavir and amprenavir can be detected in the breast milk of lactating rats. Both the efficacy of antiretroviral therapy for the prevention of postnatal transmission of HIV-1 through breast milk and the toxicity of chronic antiretroviral exposure of the infant via breast milk are unknown.

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