Second study shows virologic failure higher in infants treated with nevirapine versus lopinavir
WEDNESDAY, June 20 (HealthDay News) -- For infants of mothers with HIV who did not receive antenatal antiretroviral therapy (ART), treatment with two or three drugs reduces transmission compared with zidovudine alone; and more infants treated with nevirapine together with zidovudine and lamivudine have virologic failure by six months, according to two studies published in the June 21 issue of the New England Journal of Medicine.
Karin Nielsen-Saines, M.D., from the University of California Los Angeles, and colleagues assessed three ART regimens in infants of mothers with HIV infection who did not receive antenatal ART. Within 48 hours of birth, formula-fed infants were randomly assigned to receive zidovudine alone (566 infants), zidovudine plus nevirapine (562 infants), or zidovudine, nelfinavir, and lamivudine (556 infants). The researchers found that intrapartum transmission occurred in significantly more infants in the zidovudine-alone groups versus the two- or three-drug groups (4.8 versus 2.2 and 2.4 percent, respectively).
To compare the initiation of HIV treatment with zidovudine, lamivudine, and either nevirapine or ritonavir-boosted lopinavir, Avy Violari, M.D., from the University of Witwatersrand in Johannesburg, and colleagues conducted a randomized trial involving 288 HIV-infected children aged 2 to 36 months without prior exposure to nevirapine. Virologic failure or discontinuation of treatment by study week 24 was seen in 40.8 percent of the nevirapine group compared with 19.3 percent of the lopinavir group (P < 0.001). More than half of the nevirapine-treated children with virologic failure and data available had resistance at the time of virologic failure.
"Policymakers are left to weigh the costs and benefits of these two different first-line regimens as they develop national and regional pediatric treatment guidelines," Violari and colleagues write.
Boehringer Ingelheim Pharmaceuticals and GlaxoSmithKline donated drugs for the first study. Several authors from the second study disclosed financial ties to the pharmaceutical industry.
Abstract - Nielsen-Saines
Abstract - Violari