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

MMWR

informed that the long-term risks of ZDV therapy to themselves and their children are
unknown. A woman's decision to use ZDV to reduce the risk for HIV transmission to
her infant should be based on a balance of the benefits and potential risks of the regimen to herself and to her child.
Discussion of treatment options should be noncoercive, and the final decision to
accept or reject ZDV treatment recommended for herself and her child is the right and
responsibility of the woman. A decision not to accept treatment should not result in
punitive action or denial of care, nor should ZDV be denied to a woman who decides
to receive the regimen.
Various circumstances that commonly occur in clinical practice are described and
the factors influencing treatment considerations are highlighted in the following discussion (Box 3). All potential clinical situations cannot be enumerated, and, in many
cases, definitive evidence upon which to base a recommendation is not currently
available. Therefore, each pregnant woman and her health-care provider must consider the potential benefits, unknown long-term effects, and gaps in knowledge
relating to her clinical situation. Furthermore, health-caregivers and institutions
should provide culturally, linguistically, and educationally appropriate information
and counseling to the HIV-infected woman so that she can make informed decisions.
CLINICAL SITUATIONS AND RECOMMENDATIONS FOR USE
OF ZDV TO REDUCE PERINATAL TRANSMISSION
Clinical Situation Meeting the Entry Criteria for ACTG Protocol 076
I. Pregnant HIV-infected women with CD4+ T-lymphocyte counts 200/tL who
are at 14-34 weeks of gestation and who have no clinical indications for ZDV
and no history of extensive (>6 months) prior antiretroviral therapy.
Discussion:
The results of ACTG Protocol 076 are directly applicable only to women who
meet the entry criteria for the study (Table 1). The data from that study indicate
that the complete ACTG Protocol 076 ZDV regimen will likely reduce the risk for
perinatal transmission by about two-thirds.
Because this study was randomized and placebo controlled, entry was
restricted to women who had no clinical indications for ZDV use for their own
health and who had CD4+ T-lymphocyte counts 200/L. Prior ZDV use during
the current pregnancy resulted in exclusion from the study. Few women (4%)
had received ZDV before the current pregnancy, and most of that therapy was of
limited duration.
Women were not enrolled either before the 14th week or after the 34th week
of gestation. The rationale for exclusion before 14 weeks of gestation was to
preclude ZDV exposure during fetal organogenesis. The 34-week limit allowed
most women to receive several weeks of ZDV before delivery to allow time for a
decrease in maternal viral load (a presumed important determinant of transmission risk).
Although ZDV was successful in reducing perinatal transmission, the study
regimen did not completely prevent it. The possible reasons for transmission to