Antiretroviral Regimens to Prevent Intrapartum HIV Infection

Jenson, Hal B.
August 2012
Infectious Disease Alert;8/1/2012, p127
A total of 1745 infants from 17 sites in Brazil (70.1%), South Africa (27.4%), Argentina (1.6%) and the United States (0.8%) born to women with a peripartum diagnosis of HIV type I infection were randomized within 48 hours of birth to receive one of three six-week postpartum antiretroviral regimens. The mothers had not received antiretroviral therapy during pregnancy, and all infants were formula fed. Ten infants did not receive study drugs, and 51 mothers were HIV-negative on than 40 confirmatory tests. There were a total of 1684 infants enrolled, including 566 infants receiving zidovudine alone for six weeks, 562 infants receiving zidovudine for six weeks plus three doses of nevirapine during the first eight days of life (first dose within 48 hours of birth, second dose 48 hours after the first dose, and third dose 96 hours after the second dose), and 556 infants receiving zidovudine for six weeks plus nelfinavir and lamivudine for two weeks. Fixed dosing was used based on weight categories (birth weight <=2.0 kg, or >2.0 kg). The overall transmission rate at three months of life was 8.3% (140 infants), with an increased transmission rate in the zidovudine-alone group (P=0.03) compared to the other two groups. The overall rate of in utero transmission of HIV was 5.7%, ranging from 5.1% to 6.8% across the three groups. The rate in the zidovudinealone group did not differ significantly from the other two groups (P=0.24 for both comparisons). Intrapartum transmission occurred in 24 infants in the zidovudine alone group (4.8%; 95% CI, 3.2-7.1%), compared to 11 infants in the two-drug group (2.2%; 95% CI, 1.2-3.9%) and 12 infants in the three-drug group (2.4%; 95% CI, 1.4-4.3%). Multivariate analysis showed that zidovudine monotherapy, higher maternal viral load, and maternal use of illegal substances were significantly associated with HIV transmission. Complete blood count and hepatic aminotransferase levels were measured at birth, 4-7 days, 10-14 days, 4-6 weeks, and 3 months of age. The rate of neutropenia was significantly increased in the three-drug group (P<0.001). Elevated aminotransferase levels were uncommon and occurred in only 2.5% of all infants, which did not differ significantly among the groups. Mutations conferring resistance to nonnucleoside reverse-transcriptase inhibitors (NNRTIs) were present in 12 infants: three in the zidovudine-alone group, six in the two-drug group, and three in the three-drug group (P=0.15 for multiple comparisons). Mutations conferring resistance to nucleoside analogue reverse-transcriptase inhibitors (NRTIs) were found in two infants in the three-drug group and one infant in the two-drug group, and mutations conferring resistance to protease inhibitors were present in two infants in the three-drug group. No significant differences in the distribution of resistance mutations were found among the groups.


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