Pharmacokinetics of Efavirenz in HIV-1 Infected Subjects With Hepatic Impairment

Pharmacokinetics of Efavirenz During Treatment of HIV-1 Infected Subjects With Hepatic Impairment.

The purpose of the study was to assess the steady-state pharmacokinetics (PK) of efavirenz (EFV) in human immunodeficiency virus type 1 (HIV-1) infected subjects on stable antiretroviral regimens containing EFV, and having selected degrees of hepatic impairment or normal hepatic function.

Inclusion Criteria:

• HIV-1 infection with or without Hepatitis B or C infection
• Stable antiretroviral regimen containing efavirenz and nucleoside/nucleotide reverse transcriptase inhibitors (NRTI) for at least 1 month
• Mild, moderate or severe hepatic impairment with hepatic cirrhosis

Exclusion Criteria:

• Acute flare of hepatitis
• Positive pregnancy test for a female
• Significant acute medical illness in past 2 months
• Use of agents known to significantly affect liver metabolism
• Change in medications to treat a chronic disease in the past 2 months