Safety and Tolerability of Raltegravir in a Premature Neonate: A Case Report

To the Editors: Triple antiretroviral prophylaxis with zidovudine, lamivudine and either nevirapine or raltegravir is recommended for infants at high risk of perinatal HIV transmission.1 Raltegravir is recommended for neonatal prophylaxis because of its potent antiviral activity and favorable resistance profile. However, current approval is limited to use in term neonates with a birth weight of at least 2 kg and a gestational age of 37 weeks or greater.1 Data regarding the safety and dosing of raltegravir in premature infants remain scarce. We report the use of raltegravir-containing triple antiretroviral prophylaxis in a premature neonate at high risk of perinatal HIV transmission. The infant was born via normal spontaneous vaginal delivery to a 23-year-old woman living with HIV-1 infection who had not received regular antenatal care or antiretroviral therapy during pregnancy. Gestational age was estimated as 32 weeks based on Ballard scoring, and birth weight was 1800 g. She was referred to our hospital within 24 hours after birth, and oral zidovudine prophylaxis was initiated within the first 6 hours of life at the referring hospital. Oral lamivudine was added at 24 hours of age following transfer. As nevirapine was not available in our country, raltegravir was selected as the third antiretroviral agent. Raltegravir was initiated at a dose of 4 mg once daily (2.2 mg/kg/dose). Unconjugated bilirubin levels peaked on postnatal day 5 and subsequently declined without evidence of cholestasis or elevation in aminotransferase levels (Table 1). TABLE 1. - Laboratory Parameters of the Patient Day of Life Hemoglobin (g/L) Neutrophils (× 109/L) Bilirubin Unconjugated (µmol/L) Bilirubin Conjugated (µmol/L) ALT (U/L) AST (U/L) 2 127 6.5 82.8 6.8