Appendix B. Antiretroviral Dosing Recommendations in Adults With Renal or Hepatic Insufficiency

Updated Reviewed

 

These tables include antiretroviral (ARV) products that are not approved by the U.S. Food and Drug Administration (FDA) for use in adolescents with HIV. For information regarding the use of ARV medications in adolescents with HIV, including weight limitations and additional dosage forms, please consult FDA product labeling or Appendix A in the Pediatric Antiretroviral Guidelines.

Renal dosing information for fixed-dose combination products, as well as coformulated and copackaged antiretroviral regimens, is included in the tables below. The older antiretroviral drugs fosamprenavir (FPV), lopinavir/ritonavir (LPV/r), nelfinavir (NFV), nevirapine (NVP), tipranavir (TPV), and zidovudine (ZDV) have been removed from this table. Please refer to the FDA product labels for these drugs for recommendations on dosing in adults and adolescents with renal or hepatic insufficiency.

Please refer to the National Institute of Diabetes and Digestive and Kidney Diseases Determining Drug Dosing in Adults With Chronic Kidney Disease webpage for a discussion on using estimated creatinine clearance (CrCl) versus estimated glomerular filtration rate (eGFR) in determining renal function. eGFR based on the 2021 Chronic Kidney Disease Epidemiology Collaboration (or CKD-EPI) equation can be determined using this eGFR calculator. In FDA prescribing information, renal dosing recommendations for most ARVs are based on CrCl using the Cockroft-Gault formula.

See the section at the end of this table for criteria for Child-Pugh Classifications.

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Appendix B. Antiretroviral Dosing Recommendations in Adults With Renal or Hepatic Insufficiency
  
  
  
  

References

  1. Bohjanen P, Johnson M, Szczech L, et al. Steady-state pharmacokinetics of lamivudine in human immunodeficiency virus-infected patients with end-stage renal disease receiving chronic dialysis. Antimicrob Agents Chemother. 2002;46(8):2387-2392. Available at: https://pubmed.ncbi.nlm.nih.gov/12121909.
  2. Fischetti B, Shah K, Taft D, Berkowitz L, Bakshi A, Cha A. Real-world experience with higher-than-recommended doses of lamivudine in patients with varying degrees of renal impairment. Open Forum Infect Di 2018;5(10):ofy225. Available at: https://pubmed.ncbi.nlm.nih.gov/30302352.
  3. Michienzi S, Schriever C, Badowski M. Abacavir/lamivudine/dolutegravir single tablet regimen in patients with human immunodeficiency virus and end-stage renal disease on hemodialysis. Int J STD AIDS. 2019;30(2):181-187. Available at: https://pubmed.ncbi.nlm.nih.gov/30381029.
  4. Wood B, Pozniak A. Dosing lamivudine or emtricitabine in renal impairment: new data confirm it's time for updated guidance! AID 2021;35(8):1305-1307. Available at: https://pubmed.ncbi.nlm.nih.gov/34076616.
  5. Lucas G, Ross M, Stock P, et al. Clinical practice guideline for the management of chronic kidney disease in patients infected with HIV: 2014 update by the HIV Medicine Association of the Infectious Diseases Society of America. Clin Infect Dis. 2014;59(9):e96-e138. Available at: https://academic.oup.com/cid/article/59/9/e96/422813.

 

These tables include antiretroviral (ARV) products that are not approved by the U.S. Food and Drug Administration (FDA) for use in adolescents with HIV. For information regarding the use of ARV medications in adolescents with HIV, including weight limitations and additional dosage forms, please consult FDA product labeling or Appendix A in the Pediatric Antiretroviral Guidelines.

Renal dosing information for fixed-dose combination products, as well as coformulated and copackaged antiretroviral regimens, is included in the tables below. The older antiretroviral drugs fosamprenavir (FPV), lopinavir/ritonavir (LPV/r), nelfinavir (NFV), nevirapine (NVP), tipranavir (TPV), and zidovudine (ZDV) have been removed from this table. Please refer to the FDA product labels for these drugs for recommendations on dosing in adults and adolescents with renal or hepatic insufficiency.

Please refer to the National Institute of Diabetes and Digestive and Kidney Diseases Determining Drug Dosing in Adults With Chronic Kidney Disease webpage for a discussion on using estimated creatinine clearance (CrCl) versus estimated glomerular filtration rate (eGFR) in determining renal function. eGFR based on the 2021 Chronic Kidney Disease Epidemiology Collaboration (or CKD-EPI) equation can be determined using this eGFR calculator. In FDA prescribing information, renal dosing recommendations for most ARVs are based on CrCl using the Cockroft-Gault formula.

See the section at the end of this table for criteria for Child-Pugh Classifications.

View full version of Appendix B
Appendix B. Antiretroviral Dosing Recommendations in Adults With Renal or Hepatic Insufficiency
  
  
  
  

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