Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection

The information in the brief version is excerpted directly from the full-text guidelines. The brief version is a compilation of the tables and boxed recommendations.

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Management of Medication Toxicity or Intolerance

Hepatic Events

Last Updated: May 22, 2018; Last Reviewed: May 22, 2018


General Reviews

  1. Aurpibul L, Bunupuradah T, Sophan S, et al. Prevalence and incidence of liver dysfunction and assessment of biomarkers of liver disease in HIV-infected Asian children. Pediatr Infect Dis J. 2015;34(6):e153-158. Available at
  2. Huntington S, Thorne C, Newell ML, et al. Pregnancy is associated with elevation of liver enzymes in HIV-positive women on antiretroviral therapy. AIDS. 2015;29(7):801-809. Available at
  3. Kovari H, Sabin CA, Ledergerber B, et al. Antiretroviral drugs and risk of chronic alanine aminotransferase elevation in human immunodeficiency virus (HIV)-monoinfected persons: the data collection on Adverse Events of Anti-HIV Drugs Study. Open Forum Infect Dis. 2016;3(1):ofw009. Available at
  4. Navarro VJ, Khan I, Bjornsson E, Seeff LB, Serrano J, Hoofnagle JH. Liver injury from herbal and dietary supplements. Hepatology. 2017;65(1):363-373. Available at
  5. Sonderup MW, Wainwright HC. Human immunodeficiency virus infection, antiretroviral therapy, and liver pathology. Gastroenterol Clin North Am. 2017;46(2):327-343. Available at
  6. The National Institute of Diabetes and Digestive and Kidney Diseases. Clinical and Research Information on Drug-Induced Liver Injury. 2017. Available at

Hepatic Events and NRTIs

  1. Van Dyke RB, Wang L, Williams PL, Pediatric ACTGCT. Toxicities associated with dual nucleoside reverse-transcriptase inhibitor regimens in HIV-infected children. J Infect Dis. 2008;198(11):1599-1608. Available at
  2. Logan S, Rodger A, Maynard-Smith L, et al. Prevalence of significant liver disease in human immunodeficiency virus-infected patients exposed to Didanosine: A cross sectional study. World J Hepatol. 2016;8(36):1623-1628. Available at

Hepatic Events and NNRTIs

  1. Phillips E, Bartlett JA, Sanne I, et al. Associations between HLA-DRB1*0102, HLA-B*5801, and hepatotoxicity during initiation of nevirapine-containing regimens in South Africa. J Acquir Immune Defic Syndr. 2013;62(2):e55-57. Available at
  2. Sonderup MW, Maughan D, Gogela N, et al. Identification of a novel and severe pattern of efavirenz drug-induced liver injury in South Africa. AIDS. 2016;30(9):1483-1485. Available at

Hepatic Events and NRTIs plus NNRTIs

  1. Wu PY, Cheng CY, Liu CE, et al. Multicenter study of skin rashes and hepatotoxicity in antiretroviral-naive HIV-positive patients receiving non-nucleoside reverse-transcriptase inhibitor plus nucleoside reverse-transcriptase inhibitors in Taiwan. PLoS One. 2017;12(2):e0171596. Available at

Hepatic Events and PIs including Indirect Hyperbilirubinemia

  1. McDonald C, Uy J, Hu W, et al. Clinical significance of hyperbilirubinemia among HIV-1-infected patients treated with atazanavir/ritonavir through 96 weeks in the CASTLE study. AIDS Patient Care STDS. 2012;26(5):259-264. Available at
  2. Strehlau R, Donati AP, Arce PM, et al. PRINCE-1: safety and efficacy of atazanavir powder and ritonavir liquid in HIV-1-infected antiretroviral-naive and -experienced infants and children aged >/=3 months to <6 years. J Int AIDS Soc. 2015;18:19467. Available at
  3. Rutstein RM, Samson P, Fenton T, Fletcher CV, Kiser JJ, Mofenson LM, et al. for the PACTG 1020A Study Team. Long-term safety and efficacy of atazanavir-based therapy in HIV-infected infants, children, and adolescents: The Pediatric AIDS Clinical Trials Group Protocol 1020A. Pediatr Infect Dis J. 2015;34:162-167. Available at
  4. Crutchley RD, Guduru RC, Cheng AM. Evaluating the role of atazanavir/cobicistat and darunavir/cobicistat fixed-dose combinations for the treatment of HIV-1 infection. Hi/Aids. 2016;8:47-65. Available at
  5. The European Pregnancy and Paediatric HIV Cohort Collaboration, (EPPICC) study group in EuroCoord. Safety of zidovudine/lamivudine scored tablets in children with HIV infection in Europe and Thailand. European Journal of Clinical Pharmacology. 2017;73(4):463-468.

HIV and Hepatitis B/C Coinfections

  1. Kovari H, Ledergerber B, Battegay M, et al. Incidence and risk factors for chronic elevation of alanine aminotransferase levels in HIV-infected persons without hepatitis b or c virus co-infection. Clin Infect Dis. 2010;50(4):502-511. Available at
  2. Gowda C, Newcomb CW, Liu Q, et al. Risk of acute liver injury with antiretroviral therapy by viral hepatitis status. Open Forum Infect Dis. 2017;4(2):ofx012. Available at
  3. Phung BC, Sogni P, Launay O. Hepatitis B and human immunodeficiency virus co-infection. World J Gastroenterol. 2014;20(46):17360-17367. Available at

Nodular Regenerative Hyperplasia and Noncirrhotic Portal Hypertension

  1. Cotte L, Benet T, Billioud C, et al. The role of nucleoside and nucleotide analogues in nodular regenerative hyperplasia in HIV-infected patients: a case control study. J Hepatol. 2011;54(3):489-496. Available at
  2. Kovari H, Ledergerber B, Peter U, et al. Association of noncirrhotic portal hypertension in HIV-infected persons and antiretroviral therapy with didanosine: a nested case-control study. Clin Infect Dis. 2009;49(4):626-635. Available at
  3. Schouten JN, Van der Ende ME, Koeter T, et al. Risk factors and outcome of HIV-associated idiopathic noncirrhotic portal hypertension. Aliment Pharmacol Ther. 2012;36(9):875-885. Available at
  4. Vispo E, Morello J, Rodriguez-Novoa S, Soriano V. Noncirrhotic portal hypertension in HIV infection. Curr Opin Infect Dis. 2011;24(1):12-18. Available at
  5. Parikh ND, Martel-Laferriere V, Kushner T, et al. Clinical factors that predict noncirrhotic portal hypertension in HIV-infected patients: a proposed diagnostic algorithm. J Infect Dis. 2014;209(5):734-738. Available at
  6. Scherpbier HJ, Terpstra V, Pajkrt D, et al. Noncirrhotic portal hypertension in perinatally HIV-infected adolescents treated with didanosine-containing antiretroviral regimens in childhood. Pediatr Infect Dis J. 2016. Available at
  7. Sood A, Castrejon M, Saab S. Human immunodeficiency virus and nodular regenerative hyperplasia of liver: A systematic review. World J Hepatol. 2014;6(1):55-63. Available at

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