AZT, d4T OK’d for infants

At the same time a blue-ribbon panel found that the benefits of zidovudine (AZT) therapy for HIV-positive pregnant women and their babies outweigh the risk, an oral solution of stavudine (d4T) became available for infected infants and children.

In response to a study showing increased incidence of liver and lung tumors in mice exposed to high doses of AZT, the panel reaffirmed the importance to preventing HIV transmission with the drug. The study outcome was balanced by a second trial by the drug’s maker, Research Triangle Park, NC-based Glaxo Wellcome, finding no elevation in the incidence of tumors. However, both studies found an increased incidence in vaginal tumors in mice, consistent with earlier studies.

Scientists are unsure how well the mice studies predict "transplacental carcinogenicity," says Lynn Smiley, MD, Glaxo Wellcome’s director of antiviral research.

Meanwhile, the availability of d4T for infants and children provides a significant addition to the limited therapeutic options for treating this population, says the drug’s manufacturer, Bristol-Myers Squibb of Princeton, NJ.

In a recent government trial comparing AZT with d4T in infected children, those receiving d4T experienced better weight gain and better maintenance of CD4 counts, researchers report.