While several international trials are testing strategies of early antiretroviral therapy (ART) for infants with HIV, little is known about the outcomes of perinatally infected infants in clinical (non-research) settings, in which neonatal ART options are limited. The Treating Infants Early Study (TIES) is an observational cohort study that aims to describe the management, safety, efficacy of ART initiated at < 6 weeks of life in communities throughout the USA.
Informed consent was obtained by phone or in person, with paper or electronic documentation. Eligibility criteria were HIV diagnosis, age < 2 years, and ART start at < 6 weeks of life. Maternal, birth and ART history, and clinical outcomes were abstracted from medical records, collected periodically during follow up. Descriptive statistics were used for this analysis.
Among 38 infants screened from Dec. 2015 to Sept. 2018, 15 enrolled, providing median (range) follow-up of 19(1-32) months; one was excluded from analysis due to prior research participation. Infants were born at 37(28-40) weeks gestation weighing 2.7 (1.1-3.9) kg to mothers 24 (15-36) years old, 6(43%) of whom were diagnosed with HIV in labor. Infants received zidovudine (ZDV)(n=2), ZDV + 3 doses nevirapine(NVP) with(n=7) or without(n=2) lamivudine (3TC), or ZDV/3TC+NVP twice daily at treatment doses(n=2) prior to HIV diagnosis. ART as treatment was initiated at 8.5 (0-36) days of life: ZDV/3TC + NVP(n=12) or lopinavir/ritonavir(n=2). First CD4 count was 2,390(231-4,190) cells/µl, CD4% was 46(10-66) and HIV RNA was 3.7(1.9-5.0) log10 copies/ml. While 8(53%) and 5(33%) were diagnosed with anemia and neutropenia respectively, ART was never interrupted, and regimens were later changed for anticipated efficacy and tolerance, but not toxicity. With heterogeneity in baseline plasma HIV RNA level and initial response (figure), suppression (RNA 200 c/ml, at 295 days), but many had early and prolonged suppression (e.g. 66 through 958 days of life).
Most infants with HIV in this cohort had initiated ART before 9 days old, underscoring the need for potent and safe ART options in the neonatal period. With rapid and durable virologic suppression, some perinatally infected infants treated in community settings are likely to have low reservoir levels and be good candidates for future studies of remission strategies