  
Lamivudine plus zidovudine decreases vertical HIV transmission, but at a cost
Last Updated: 2001-04-24 16:10:04 EDT (Reuters Health)
WESTPORT, CT (Reuters Health) - The addition of lamivudine to zidovudine therapy late in pregnancy appears to reduce maternal-infant transmission of HIV-1 significantly, but there can be complications in the infants, according to the results of a French study.
Dr. Laurent Mandelbrot, of Hopital Cochin in Paris, and colleagues compared outcomes of 445 women treated with zidovudine plus lamivudine with those of a historical control group, 899 pregnant HIV-infected women who received zidovudine monotherapy. Lamivudine was administered beginning at 32 weeks' gestation at 150 mg b.i.d. until delivery, and then to children at 2 mg/kg b.i.d. for 6 weeks.
HIV transmission was 1.6% among women given dual therapy versus 6.8% in the control group. According to the investigators, the transmission rate in the dual therapy group is the lowest reported from a large prospective study. They partially attribute this success to the finding that dual therapy decreased maternal plasma HIV-1 RNA levels by more than 1 log-10 copies/mL compared with monotherapy.
The researchers report in The Journal of the American Medical Association for April 25 that they detected lamivudine resistance in more than a third of the mothers at 6 weeks after delivery. Two infants were infected with lamivudine-resistant variants.
Among the infants who received lamivudine, there were 151 moderate to severe hematologic adverse events. Nine required blood transfusion. Two children diagnosed with mitochondrial dysfunction died at age 1 year. Treatment was discontinued early in 40 infants because of adverse effects, including hematologic disorders, biochemical abnormalities, and vomiting.
The mean hemoglobin level at birth was significantly lower in the dual therapy group than in the control group, although the proportions later requiring transfusion or exhibiting moderate to severe anemia or neutropenia did not differ significantly between groups.
"The precise relationship between incremental benefit and incremental risk [associated with the addition of lamivudine] remain to be determined, and compared with those of alternative prevention strategies," concludes Dr. Mandelbrot's group.
In an editorial, Dr. Nathan Shaffer of the Centers for Disease Control and Prevention in Atlanta writes, "The safety and toxicity data emphasize the need for close monitoring during the administration of the combination therapy, particularly for hematologic and hepatic toxicity."
JAMA 2001;285:2083-2093,2129-2131.
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