Long-term outcomes for HIV-infected infants less than 6 months of age at initiation of lopinavir/ritonavir combination antiretroviral therapy

Ellen G. Chadwick, Ram Yogev, Carmelita G. Alvero, Michael D. Hughes, Rohan Hazra, Jorge A. Pinto, Brian L. Robbins, Barbara E. Heckman, Paul E. Palumbo, Edmund V. Capparelli

Research output: Contribution to journalArticlepeer-review

24 Scopus citations

Abstract

Objective: To investigate the longitudinal pharmacokinetics, safety and efficacy of lopinavir/ritonavir (LPV/r) in HIV-infected infants initiating combination antiretroviral therapy (cART) between 2 weeks and 6 months of age. Method: A prospective, open-label, multicenter Phase I/II study of LPV/r-based cART at a dose of 300/75 mg/m/dose LPV/r twice daily. Intensive pharmacokinetic sampling at 12 months of age and quarterly predose LPV concentrations were collected and safety, virologic and immunologic responses were monitored every 4-12 weeks up to 252 weeks. Results: Thirty-one HIV-infected infants enrolled into two age cohorts, 14 days to <6 weeks and 6 weeks to <6 months; 29 completed ≥48 weeks of follow-up (median = 123 weeks, range 4-252). At 12 months of age, median LPV area under the curve was comparable for both age cohorts and similar to older children and adults. At week 48, 22 of 31 patients (71%) had HIV-1 RNA <400 copies/ml and 11 of 15 (73%) had <50 copies/ml; 29 of 31 achieved HIV-1 RNA <400 copies/ml on study treatment and 19 (66%) remained durably suppressed until the end of study; viral suppression correlated with a higher percentage of predose time points exceeding the LPV target of 1 μg/ml (92 vs. 71%, P = 0.002). Conclusion: LPV/r at 300/75 mg/m/dose as part of a cART regimen resulted in viral suppression through 96 weeks of treatment in >65% of young infants. Due to initially low LPV exposure in infants <6 weeks of age, frequent dose adjustment for weight gain is advisable and consideration should be given to studying a higher dose for very young infants.

Original languageEnglish (US)
Pages (from-to)643-649
Number of pages7
JournalAIDS
Volume25
Issue number5
DOIs
StatePublished - Mar 13 2011

Keywords

  • AIDS
  • HIV-1
  • initiation of antiretroviral therapy in young infants
  • lopinavir/ritonavir
  • pharmacokinetics of antiretrovirals

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Infectious Diseases

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