Case series of acute hepatitis in a non-selected

liver411

AIDS 2003; 17(15):2209-2214

Case series of acute hepatitis in a non-selected group of HIV-infected
patients on nevirapine-containing antiretroviral treatment

Monique M. R. de Maat a; Rob ter Heine a; Eric C. M. van Gorp b; Jan W.
Mulder b; Albert T. A. Mairuhu b; Jos H. Beijnen a,c
Objective:
To evaluate the characteristics of patients who developed acute clinical
hepatitis in an unselected outpatient population.

Methods:
Patients who started a nevirapine-containing regimen in the period January
1999-February 2001 and presented with clinical symptoms in accordance with
increased transaminase values within 12 weeks of initiation of nevirapine
were considered possible cases of clinical hepatotoxicity. Patient
characteristics, co-medicated drugs, HIV-1 RNA levels and clinical chemistry
parameters were collected from outpatient medical records and clinical
medical records.

Results:
At the defined period, 306 patients started a nevirapine-containing regimen,
of whom eight developed an acute hepatitis (2.6%) in a median of 24 days
[interquartile range (IQR) 20-25 days]. Transaminases peaked at 28 days
(IQR, 27-32 days). Injury pattern was in general mixed-hepatocellular.
Withdrawal of the antiretroviral agent led to rapid restoration of
transaminase levels and resolution of clinical symptoms. The reason for
developing this hepatic reaction was not clear in every case as no specific
risk factor(s) covering all patients in this case series could be
identified.

Conclusions:
It is very important to monitor closely transaminase levels of all patients
starting a nevirapine-containing regimen, including patients with no
specific characteristics that put them at risk. The rapid onset of the
clinical symptoms pleads for transaminase monitoring at a very early stage
(i.e., within 2 weeks of initiation) of the nevirapine-containing regimen.

Keywords: nevirapine; acute clinical hepatitis; patient characteristics
From the aDepartment of Pharmacy and Pharmacology and the bDepartment of
Internal Medicine, Slotervaart Hospital, Amsterdam, and the cUniversity of
Utrecht, Faculty of Pharmaceutical Sciences, Utrecht, the Netherlands.

See also p. 2253

Correspondence to M.M.R. de Maat, Slotervaart Hospital, Department of
Pharmacy and Pharmacology, Louwesweg 6, 1066 EC Amsterdam, the Netherlands.

Received: 6 August 2002;
accepted: 16 April 2003.

Sponsorship: Supported by AGIS Health Insurances, Amsterdam, the
Netherlands.