Antiretroviral therapy hepatotoxicity: Prevalence, risk factors, and clinical characteristics in a cohort of Han Chinese

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Hepatology Research

Early View (Articles online in advance of print)

Published Online: 11 Jan 2010

© 2010 The Japan Society of Hepatology

Antiretroviral therapy hepatotoxicity: Prevalence, risk factors, and clinical

characteristics in a cohort of Han Chinese

Shicheng Gao, Xi-en Gui, Lipin Deng, Yongxi Zhang, Ke Liang, Rongrong Yang,

Yajun Yan and Yupin Rong

Department of Infectious Diseases, Zhongnan Hospital of Wuhan University, Wuhan,

Hubei, China

Correspondence to Professor Xi-en Gui, No. 169 Donghu Road, Wuhan 430071,

Hubei, China. Email: znact@...

The Japan Society of Hepatology

KEYWORDS

acquired immunodeficiency syndrome • combined anti-retroviral therapy •

hepatotoxicity

ABSTRACT

Aim: To investigate the incidence and risk factors of hepatotoxicity in Han

Chinese patients with acquired immunodeficiency syndrome on combined

anti-retroviral therapy (cART).

Methods: A retrospective study was conducted.

Results: Among 330 subjects on cART in the cohort, 75.2% infected HIV due to

improper plasma donations, 67.3% was either hepatitis C virus (HCV) or hepatitis

B virus (HBV) co-infected and 46.4% had at least one episode of ALT elevation

during a median 23 months follow-up time. Baseline alanine aminotransferase

(ALT) elevation (P = 0.004, OR = 9.560), receiving nevirapine (NVP) based cART

regimen (P = 0.007, OR = 2.470), HCV co-infection (P = 0.000, OR = 3.433) were

risk factors for cART related hepatotoxicity, while greater increased CD4+

T(CD4) cell count was protective against hepatotoxicity development (P = 0.000,

OR = 0.996). Patients co-infected with HCV who received NVP based cART had the

greatest probability of hepatotoxicity (Log rank: x2 = 27.193, P = 0.000).

Twenty-five of the 153 subjects (16.3%) with cART related hepatotoxicity

discontinued cART temporarily or shifted NVP to efavirenz (EFV). There was no

difference in CD4 cell count (t = 0.526, P = 0.599), CD4 cell count change from

baseline (t = 0.442, P = 0.659) and all-cause mortality (x2 = 0.259, P = 0.611)

between subjects with and without hepatotoxicity during a median 38 months of

follow-up time.

Conclusion: cART induced hepatotoxicity was common among subjects in this

cohort. Baseline ALT elevation, HCV co-infection and the use of NVP based cART

regimens were associated statistically with the development of hepatotoxicity.

Hepatotoxicity, led to some of the subjects discontinuing cART temporarily or

switching to other regimens, had no impact on immune restore and survival in

this cohort of patients during a median 38 months of follow-up time.

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Received 11 July 2009; revision 14 August 2009; accepted 23 August 2009.

DIGITAL OBJECT IDENTIFIER (DOI)

10.1111/j.1872-034X.2009.00608