Recommendations from the Meeting on Prevention of Mother-to-Infant Transmission of HIV by Use of Antiretrovirals

3. At present, there is no information regarding potential long-term ZDV toxicity to
infected and uninfected infants. Neither do we know the implications of (potentially
repeated) ZDV treatment during pregnancy for the efficacy of later ZDV treatment of
the mothers and children. Attempts should be made to undertake long-term follow-up
of mothers who have received antiretroviral treatment during pregnancy, and of their
infants, to ascertain whether there are long-term adverse effects. The need for such
follow-up should be considered in relation to the duration of exposure of the infant
to such therapy.
4. Since there is currently no safety or efficacy information available for other
antiretrovirals used in pregnancy, their use in attempting to prevent MTI transmission
of HIV should be limited to clinical trials.
5. To increase the applicability of antiretrovirals in the reduction of MTI transmission
of HIV, it is essential to explore simpler and less costly drug regimens in the full
spectrum of HIV-infected pregnant women. Such regimens, including interventions
restricted to the intrapartum period, should be urgently studied in randomized
controlled trials. Initial studies on safety and pharmacokinetics of specific
antiretrovirals may have to be done in populations for which no such data are
available.
6. Placebo-controlled trials offer the best option for a rapid and scientifically valid
assessment of alternative antiretroviral drug regimens to prevent MTI transmission of
HIV.

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