Raltegravir pharmacokinetics in HIV/HCV-coinfected patients with advanced liver cirrhosis (Child-Pugh C).

Published

Journal Article

OBJECTIVES: To describe raltegravir pharmacokinetics at steady-state in HIV/hepatitis C virus (HCV)-coinfected patients under antiretroviral (ARV) treatment with (nā€Š=ā€Š5) and without (nā€Š=ā€Š5) advanced liver cirrhosis (Child-Pugh C). METHODS: This was a non-randomized, Phase I, parallel-assignment, open-label pharmacokinetic study in HIV/HCV-coinfected patients with Child-Pugh grade C hepatic cirrhosis. We recruited clinically stable HIV/HCV-coinfected adult patients with controlled HIV viraemia (<50 copies/mL) for at least 6 months. Raltegravir (400 mg twice daily) was added under fasting conditions for 5 days to the successful ritonavir-boosted protease inhibitor-based ARV regimen. The trial was registered in the ClinicalTrials.gov database (NCT01289951) (LIVERAL). RESULTS: Raltegravir AUC0-12 and C12 were increased 1.72-fold (90% CI, 1.02 to 2.92) and 6.58-fold (90% CI, 2.92 to14.85), respectively, in patients with advanced liver cirrhosis. No safety issues were identified and raltegravir was well tolerated by all patients. CONCLUSIONS: Raltegravir plasma levels are increased in HIV/HCV-coinfected patients with advanced liver cirrhosis (Child-Pugh C). Despite the higher exposure, raltegravir was safe and well tolerated.

Full Text

Cited Authors

  • Hernández-Novoa, B; Moreno, A; Pérez-Elías, MJ; Quereda, C; Dronda, F; Casado, JL; Madrid-Elena, N; Aguilar, M; Fumero, E; Moltó, J; Moreno, S

Published Date

  • February 2014

Published In

Volume / Issue

  • 69 / 2

Start / End Page

  • 471 - 475

PubMed ID

  • 24097843

Pubmed Central ID

  • 24097843

Electronic International Standard Serial Number (EISSN)

  • 1460-2091

International Standard Serial Number (ISSN)

  • 0305-7453

Digital Object Identifier (DOI)

  • 10.1093/jac/dkt386

Language

  • eng