Three Postpartum Antiretroviral Regimens to Prevent Intrapartum HIV Infection

Abstract

Background The safety and efficacy of adding antiretroviral drugs to standard zidovudine prophylaxis in infants of mothers with human immunodeficiency virus (HIV) infection who did not receive antenatal antiretroviral therapy (ART) because of late identification are unclear. We evaluated three ART regimens in such infants. Methods Within 48 hours after their birth, we randomly assigned formula-fed infants born to women with a peripartum diagnosis of HIV type 1 (HIV-1) infection to one of three regimens: zidovudine for 6 weeks (zidovudine-alone group), zidovudine for 6 weeks plus three doses of nevirapine during the first 8 days of life (two-drug group), or zidovudine for 6 weeks plus nelfinavir and lamivudine for 2 weeks (three-drug group). The primary outcome was HIV-1 infection at 3 months in infants uninfected at birth. Results A total of 1684 infants were enrolled in the Americas and South Africa (566 in the zidovudine-alone group, 562 in the two-drug group, and 556 in the three-drug group). The overall rate of in utero transmission of HIV-1 on the basis of Kaplan–Meier estimates was 5.7% (93 infants), with no significant differences among the groups. Intra-partum transmission occurred in 24 infants in the zidovudine-alone group (4.8%; 95% confidence interval [CI], 3.2 to 7.1), as compared with 11 infants in the two-drug group (2.2%; 95% CI, 1.2 to 3.9; P = 0.046) and 12 in the three-drug group (2.4%; 95% CI, 1.4 to 4.3; P = 0.046). The overall transmission rate was 8.5% (140 infants), with an increased rate in the zidovudine-alone group (P = 0.03 for the comparisons with the two- and three-drug groups). On multivariate analysis, zidovudine monotherapy, a higher maternal viral load, and maternal use of illegal substances were significantly associated with transmission. The rate of neutropenia was significantly increased in the three-drug group (P<0.001 for both comparisons with the other groups). Conclusions In neonates whose mothers did not receive ART during pregnancy, prophylaxis with a two- or three-drug ART regimen is superior to zidovudine alone for the prevention of intrapartum HIV transmission; the two-drug regimen has less toxicity than the three-drug regimen. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development [NICHD] and others; ClinicalTrials.gov number, NCT00099359.)

Laboratory information system data demonstrate successful implementation of the prevention of mother-to-child transmission programme in South Africa

“…[14][15][16] NHLS CDW data cannot measure the number of infants who receive their HIV PCR results or are initiated on ART timeously until a unique identifier for each patient is introduced so that longitudinal data such as regular viral load and CD4 + monitoring can be linked to the HIV PCR test. HIV transmission rates at later time points, viz.…”

Factors That Affect Mother-to-Child Hiv Transmission at a University Hospital in Southern Brazil

“…All newborns (100.0%, n = 299) received either ZDV orally (81.9%, n = 245) or ZDV and nevirapine (18.1%, n = 54) orally starting within the first 4 hours of life and lasting for four weeks 13 . Only one uninfected newborn was breastfed, although all mothers were instructed not to breastfeed, and all newborns received infant milk formula until they completed six months.…”

Outcomes of Infants Born to HIV-Infected Women Identified by Rapid HIV Testing Late in Pregnancy or at Delivery: The MIRIAD Study

“…Even when administered only to the exposed infant following delivery, ARVs can reduce the rate of MTCT [10]. A study conducted in Brazil and South Africa (HPTN 040) demonstrated that among infants born to HIV-infected mothers who did not receive ARV, postpartum combination ARV is significantly more effective than ZDV alone in preventing intrapartum transmission [11]. Thus, rapid testing of women of unknown HIV status during labor affords a final opportunity to reduce the risk of MTCT.…”