Safety and pharmacokinetics of lopinavir in HIV/HCV coinfected patients with advanced liver disease.


Journal Article

PURPOSE: There are few data about the safety and pharmacokinetics of lopinavir in HIV/HCV coinfected patients with very advanced liver disease. METHOD: Prospective study of 60 HIV/HCV coinfected patients who underwent a liver biopsy and received a lopinavir-based regimen. The rate of hepatotoxiciy and plasma trough levels were determined in absence/presence of cirrhosis (25 cases), especially in 11 patients with Child-Pugh stage B-C. RESULTS: Overall, geometric mean level of lopi-navir was 7,109 ng/mL (interquartile range [IQR], 5,163-9,029), without differences according to cirrhosis (7,662; IQR, 5,165-10,442) or not (6,708; IQR, 5,524-8,526; P = .6). In 11 patients with Child-Pugh stage B-C, trough level was 9,640 ng/mL (IQR, 1,620-11,622 ng/mL), but there was a 99% interpatient variability (72 to 13,331 ng/mL). During a follow-up of 195.2 patient-years, there were 7 cases of hepatotox-icity, with an incidence of 3.39 episodes/100 patient-years (2.2 to 7.9). This incidence was higher in patients with Child-Pugh stage B-C (5.43 episodes/100 patient-years). There were no differences in lopinavir trough levels between patients with or without liver toxicity (7,100 vs 7,119 ng/mL; P = .9). CONCLUSION: The risk of lopinavir-associated hepatotoxicity in patients with very advanced liver disease is low. However, lopinavir plasma trough levels are increased, and there is a high interpatient variability.

Full Text

Cited Authors

  • Casado, JL; Del Palacio, M; Moya, J; Rodriguez, JM; Moreno, A; Perez-Elías, MJ; Belso, A; Dronda, F; Moreno, S

Published Date

  • September 2011

Published In

Volume / Issue

  • 12 / 5

Start / End Page

  • 235 - 243

PubMed ID

  • 22180521

Pubmed Central ID

  • 22180521

Electronic International Standard Serial Number (EISSN)

  • 1945-5771

International Standard Serial Number (ISSN)

  • 1528-4336

Digital Object Identifier (DOI)

  • 10.1310/hct1205-235


  • eng