Safety and Efficacy of Starting Antiretroviral Therapy in the First Week of Life

Author:

Maswabi Kenneth1ORCID,Ajibola Gbolahan1,Bennett Kara2,Capparelli Edmund V3,Jean-Philippe Patrick4,Moyo Sikhulile15,Mohammed Terence1,Batlang Oganne1,Sakoi Maureen1,Lockman Shahin156,Makhema Joseph15,Lichterfeld Mathias6,Kuritzkes Daniel R6,Hughes Michael D5,Shapiro Roger L15

Affiliation:

1. Botswana-Harvard AIDS Institute Partnership, LLC, Gaborone, Botswana

2. Bennett Statistical Consulting, Inc, Ballston Lake, New York, USA

3. University of California, San Diego, La Jolla, California, USA

4. National Institutes of Health, Bethesda, Maryland, USA

5. Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA

6. Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts, USA

Abstract

Abstract Background Early antiretroviral therapy (ART) is recommended for infants with human immunodeficiency virus (HIV) infection. However, few antiretroviral options are available for neonates. Methods The Early Infant Treatment Study in Botswana tested HIV-exposed infants within 96 hours of birth, and HIV-infected infants started nevirapine (NVP) 6 mg/kg twice daily, zidovudine (ZDV), and lamivudine (3TC) at age < 7 days. NVP trough concentrations were tested at 1 and 2 weeks. NVP was switched to ritonavir-boosted lopinavir (LPV/r) at week 2, 3, 4, or 5 according to delivery gestational age. Results Forty HIV-infected infants started ART at median age 2 days (range, 1–5 days). NVP trough concentrations were highly variable and below therapeutic target (3000 ng/mL) for 50% of 2-week measurements; concentrations did not correlate with viral decline at weeks 2, 4, or 12. Two deaths unrelated to ART occurred through 24 weeks. Only 1 unscheduled treatment modification was required. Within 4 weeks of transition to LPV/r, 9 (22.5%) had transient HIV RNA increases, likely due to poor LPV/r palatability. At 12 weeks, 22 (55%) of 40 were <40 copies/mL (93% <400 copies/mL); by 24 weeks, 27 of 38 (71%) were < 40 copies/mL (84% < 400 copies/mL). HIV-1 RNA response at 12 and 24 weeks did not differ by baseline HIV RNA or other factors. Conclusions NVP/ZDV/3TC started in the first week of life was safe and effective, even when trough NVP levels were below target. Transient viral increases occurred following transition to LPV/r, but by 12 and 24 weeks most children achieved and maintained viral suppression. Clinical Trials Registration NCT02369406.

Funder

National Institute of Allergy and Infectious Diseases

National Institutes of Health

Publisher

Oxford University Press (OUP)

Subject

Infectious Diseases,Microbiology (medical)

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