Hepatic safety of efavirenz in HIV/hepatitis C virus-coinfected patients with advanced liver fibrosis.

Abstract

OBJECTIVE:

To assess the frequency of severe liver toxicity in HIV/hepatitis C (HCV)-coinfected patients with advanced liver fibrosis receiving efavirenz (EFV)-based antiretroviral combinations.

METHODS:

One hundred and eighty-nine previously antiretroviral naïve, HIV/HCV-coinfected patients, who started a regimen including two nucleoside analogues plus EFV, and in whom the presence or absence of advanced liver fibrosis could be established, were retrospectively analyzed. Liver fibrosis was evaluated according to a stepwise algorithm including liver biopsy, transient elastography and FIB-4 index.

RESULTS:

Fifty-six patients had advanced fibrosis - 25 with cirrhosis - and 133 did not. Three (5.4%) subjects with and 9 (6.8%) (p=0.717) without advanced fibrosis developed grade 3-4 transaminase elevation (TE). Grade 4 total bilirubin elevation was seen in 5 (8.9%) patients with advanced fibrosis and in 1 (0.8%) without it (p=0.003). Liver events led to EFV discontinuation in 10 (5.3%) patients, 6 (10.7%) with and 4 (3%) without advanced fibrosis (p=0.031).

CONCLUSIONS:

The hepatic tolerability of EFV was good in HIV/HCV-coinfected patients with advanced liver fibrosis. The frequency of grade 3-4 TE was similar to that observed in patients without advanced fibrosis, there was no death attributable to liver failure caused by drug toxicity and the rate of EFV discontinuations due to liver events was low.

• Authors: Juan A Pineda, Karin Neukam, Josep Mallolas, Luis F López-Cortés, José A Cartón, Pere Domingo, Santiago Moreno, José A Iribarren, Bonaventura Clotet, Manuel Crespo, Ignacio de Los Santos, Enrique Ortega, Hernando Knobel, María J Jiménez-Expósito, Juan Macías
• Journal: The Journal of infection (J Infect) Vol. 64 Issue 2 Pg. 204-11 (Feb 2012) ISSN: 1532-2742 [Electronic] England
• PMID: 22138553 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2011 The British Infection Association. Published by Elsevier Ltd. All rights reserved.

Chemical References

• Alkynes
• Anti-HIV Agents
• Benzoxazines
• Cyclopropanes
• efavirenz

Topics

• Adult
• Alkynes
• Anti-HIV Agents (adverse effects, therapeutic use)
• Benzoxazines (adverse effects, therapeutic use)
• Coinfection
• Cyclopropanes
• Female
• HIV Infections (complications, drug therapy)
• Hepatitis C (complications)
• Humans
• Liver (drug effects, pathology, virology)
• Liver Cirrhosis (complications, pathology)
• Male
• Middle Aged