Recommendations of the U.S. Public Health Service Task Force on the Use of Zidovudine to Reduce Perinatal Transmission of Human Immuno deficiency Virus

Vol. 43 / No. RR-11

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system functions, neuropsychologic testing, and quality of life. Information about the
potential long-term effects of the complete or partial ACTG Protocol 076 ZDV regimen
on women and children receiving the regimen outside a clinical trial protocol also may
be provided from evaluation of federally funded and other prospective studies of HIVinfected women and their infants.
Recommendation:
Additional efforts are required to characterize the long-term effects of the ACTG
Protocol 076 ZDV regimen on women and children. The specific issues of viral resistance and disease progression should be addressed among women who receive ZDV
during pregnancy solely to reduce perinatal HIV transmission. Monitoring for these
HIV-infected women should include Pap smears and gynecologic examinations as recommended in previously published guidelines (56), as well as an assessment of the
patient's future needs for family planning consultation and services.
Long-term follow-up of both uninfected and infected infants born to mothers
receiving ZDV during pregnancy is important. Assessment of organ system toxicities,
neurodevelopment, pubertal development, reproductive capacity, and development
of neoplasms should be emphasized. Special studies will need to be developed to
address these specific concerns, and innovative methods and support systems should
be designed to assist in follow-up of these women and their children.
CONCLUSION
The decision by an HIV-infected pregnant woman to use ZDV to reduce the risk for
perinatal transmission requires a complex balance of individual benefits and risks that
is best accomplished through discussions with her health-care provider. Such discussions should be noncoercive, linguistically and culturally appropriate, and tailored to
the patient's educational level.
The recommendations in this report have been developed for use in the United
States. Although perinatal transmission of HIV infection is an international problem,
alternative strategies may be appropriate in other countries (57). The policy and practice in other countries may differ from these recommendations and depend on local
considerations, such as availability of ZDV, access to facilities for intravenous infusion
during labor, and alternative interventions that may be under evaluation.
These recommendations have been developed in response to the urgent need to
provide guidance to women and health-care providers in the United States about the
use of ZDV to reduce the risk for perinatal HIV transmission and about the possible
adverse outcomes of such ZDV treatment. They have been formulated on the basis of
the available data from ACTG Protocol 076 and current information regarding factors
associated with transmission. The information on which these recommendations are
based is incomplete, and additional information is needed to optimize use of ZDV for
this purpose.
The decision to use the ACTG Protocol 076 regimen for preventing perinatal transmission of HIV requires weighing the benefits and potential risks to the HIV-infected
woman and her child despite numerous uncertainties. Further research is a high priority and should include a) clarification of long-term risks of the ZDV regimen to the
woman and/or her child, b) elucidation of the reasons for transmission despite use of