Hepatic safety of efavirenz in HIV/hepatitis C virus-coinfected patients with advanced liver fibrosis - 15/01/12

Doi : 10.1016/j.jinf.2011.10.016

Juan A. Pineda ^a,^⁎,^{^{o
On behalf of the COINS study team.}} , Karin Neukam ^a,^{^{o
On behalf of the COINS study team.}}, Josep Mallolas ^b,^{^{o
On behalf of the COINS study team.}}, Luis F. López-Cortés ^c,^d,^{^{o
On behalf of the COINS study team.}}, José A. Cartón ^e,^{^{o
On behalf of the COINS study team.}}, Pere Domingo ^f,^{^{o
On behalf of the COINS study team.}}, Santiago Moreno ^g,^{^{o
On behalf of the COINS study team.}}, José A. Iribarren ^h,^{^{o
On behalf of the COINS study team.}}, Bonaventura Clotet ^i,^{^{o
On behalf of the COINS study team.}}, Manuel Crespo ^j,^{^{o
On behalf of the COINS study team.}}, Ignacio de Los Santos ^k,^{^{o
On behalf of the COINS study team.}}, Enrique Ortega ^l,^{^{o
On behalf of the COINS study team.}}, Hernando Knobel ^m,^{^{o
On behalf of the COINS study team.}}, María J. Jiménez-Expósito ^n,^{^{o
On behalf of the COINS study team.}}, Juan Macías ^a,^{^{o
On behalf of the COINS study team.}}
^a Unit of Infectious Diseases and Microbiology, Hospital Universitario de Valme, Avenida de Bellavista S/N, 41014 Seville, Spain
^b Unit of Infectious Diseases, Hospital Clínic, Calle Villaroel 170, 08036 Barcelona, Spain
^c Unit of Infectious Diseases, Hospitales Universitarios Virgen del Rocío, Avenida Manuel Siurot, 41013 Seville, Spain
^d Instituto de Biomedicina de Sevilla, Calle de la Aviacion 12, Seville, Spain
^e Unit of Infectious Diseases, Hospital Universitario Central de Asturias, Celestino Villamil S/N, 33006 Oviedo, Spain
^f Department of Internal Medicine, Hospital Universitario de la Santa Creu i Sant Pau, Calle Sant Antoni Maria Claret, 08025 Barcelona, Spain
^g Department of Infectious Diseases, Hospital Universitario Ramón y Cajal, Carretera Colmenar Viejo, KM 9, 28049 Madrid, Spain
^h Unit of Infectious Diseases, Hospital Donostia, Paseo Doctor Begiristain 107, 20014 San Sebastian, Spain
ⁱ Unit of HIV, Hospital Germans Trias i Pujol, Carretero Canyet S/N, 08916 Badalona, Spain
^j Unit of Infectious Diseases, Hospital Vall d’Hebron, Passeig Vall d’Hebron 119-129, 08035 Barcelona, Spain
^k Unit of Infectious Diseases, Hospital Universitario de La Princesa, Diego de León 62, 28006 Madrid, Spain
^l Unit of Infectious Diseases, Hospital General Universitario de Valencia, Avenida Tres Cruces 2 46014 Valencia, Spain
^m Department of Infectious Diseases, Hospital del Mar, Passeig Marítim 25-29, 08003 Barcelona, Spain
ⁿ Bristol-Meyers Squibb, Calle Almansa 101, 28040 Madrid, Spain

Corresponding author. Tel.: +34 955015684; fax: +34 955015787.

Summary

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.

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Keywords : HIV, Hepatitis C, Liver fibrosis, Cirrhosis, Efavirenz, Transaminase elevations

Plan

Introduction

Methods

Patients

Diagnosis of liver toxicity

Liver fibrosis assessment

Statistical analysis

Ethical issues

Results

Characteristics of the population

Clinical, immunological and virological outcomes

Liver events

Discussion

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Vol 64 - N° 2

P. 204-211 - février 2012 Retour au numéro

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Hepatic safety of efavirenz in HIV/hepatitis C virus-coinfected patients with advanced liver fibrosis - 15/01/12

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