Appendix VII: Antiretroviral Therapy: Hepatic Impairment Dosing

Updated April 2010

Antiretroviral Therapy: Hepatic Impairment Dosing

Table 1: ARV Hepatic Impairment Dosing

Agent	Hepatic Impairment Dosing
*NRTI*
Abacavir (ABC)	Child-Pugh Score 5-6: 200 mg (10 mL of oral solution) twice daily. Limited clinical data. Child-Pugh Score 7-12: Not recommended by manufacturer
Didanosine (ddI)	No adjustment. Use with close monitoring
Emtricitabine (FTC)	No adjustment
Lamivudine (3TC)	No adjustment
Stavudine (d4T)	No adjustment. Use with close monitoring
Tenofovir (TDF)	No adjustment
Zidovudine (AZT, ZDV)	Use with close monitoring
*NNRTI*
Delavirdine (DLV)	Use with caution in patients with hepatic impairment
Efavirenz (EFV)	Monitor serum liver enzymes before and during treatment in patients with underlying hepatic disease, including hepatitis B or C co-infection, marked transaminase elevations, or who are taking medications associated with liver toxicity
Etravirine (ETR)	Use with caution in patients with severe hepatic impairment (Child-Pugh class C); pharmacokinetics of etravirine have not been studied in these patients
Nevirapine (NVP)	Should not be administered in patients with moderate to severe hepatic impairment; patients with hepatic fibrosis or cirrhosis may be at risk for drug accumulation
PI
Amprenavir (APV)	Child-Pugh Score 5-8: 450 mg twice daily (capsules); Consider using FPV Child-Pugh Score 9-12: 300 mg twice daily (capsules); Consider using FPV
Atazanavir (ATV)	Child-Pugh Score 7-9: 300 mg qd Child-Pugh Score >9: do not use Note: Do not use ATV with RTV in patients with hepatic impairment
Darunavir (DRV)	No dose adjustment necessary for patients with either mild or moderate hepatic impairment. No data available for patients with severe hepatic impairment – not recommended for use in patients with severe hepatic impairment
Fosamprenavir (FPV)	Child-Pugh Score 5-6: 700 mg twice daily without RTV (therapy-naïve) or FPV 700 twice daily + RTV 100 mg once daily (therapy-experienced or therapy naive) Child-Pugh Score 7-9: 700 mg twice daily without RTV (therapy-naïve) or FPV 450 mg twice daily + RTV 100 mg once daily (therapy-experienced or therapy-naive) Child-Pugh Score 10-15: Use with caution due to limited clinical data. Consider FPV 350 mg twice daily (therapy-naïve) or FPV 300 mg twice daily + RTV 100 mg once daily (therapy-naïve or PI-experienced) No data with FPV/r in patients with severe hepatic impairment
Indinavir (IDV)	Mild to moderate hepatic impairment due to cirrhosis: 600 mg q8h
Lopinavir/ritonavir (LPV/RTV)	Use with caution in patients with hepatic impairment
Nelfinavir (NFV)	Should not be used or used with caution in patients with moderate to severe hepatic impairment
Ritonavir (RTV)	No dose adjustment for mild hepatic impairment; use with caution for moderate to severe hepatic impairment
Saquinavir (SQV)	Use with caution in patients with hepatic impairment
Tipranavir (TPV)	Should not be administered in patients with moderate to severe hepatic impairment (Child-Pugh Class B and C). Discontinue TPV/RTV in patients who: develop asymptomatic elevations in AST/ALT >10 x ULN or show elevations in AST/ALT between 5-10 x ULN + increases in total bilirubin >2.5 x ULN
FI
Enfuvirtide (T-20)	No adjustment
*CCR5 Co-receptor Antagonist*
Maraviroc (MVC)	Dose adjustment necessary with severe hepatic impairment; no dose adjustment likely with mild to moderate hepatic impairment. Use with caution in patients receiving a concomitant/potent CYP3A4 inhibitor
*Integrase Inhibitor*
Raltegravir (RAL)	No dose adjustment is necessary for patients with mild to moderate hepatic impairment. The effect of severe hepatic impairment on the pharmacokinetics of raltegravir has not been studied. Use with caution in patients with severe hepatic impairment