Incidence and Risk Factors of Nevirapine-Associated Severe Hepatitis Among HIV-Infected Patients with CD4 Cell Counts Less than 250 Cells/µL
Weerawat Manosuthi MD*, Somnuek Sungkanuparph MD**, Somsit Tansuphaswadikul MD*, Suthat Chottanapund MD*, Wiroj Mankatitham MD*, Sukanya Chimsuntorn MD*, Chayanan Sittibusaya MD*, Visal Moolasart MD*, Achara Chaovavanich MD*
Affiliation : * Bamrasnaradura Infectious Diseases Institute, Ministry of Public Health, Nonthaburi ** Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok
Objectives: To determine incidence and risk factors of nevirapine (NVP)-associated severe hepatitis that led
to NVP discontinuation among HIV-infected patients with CD4 < 250 cells/µL.
Material and Method: A retrospective cohort study was conducted among antiretroviral-naive HIV-infected
patients who had baseline CD4 < 250 cells/µL and were initiated NVP-based antiretroviral therapy (ART)
between January 2003 and October 2005. All patients were categorized to group A: occurred clinical hepatitis
and group B: did not occur clinical hepatitis. All were followed until 6 months after ART.
Results : There were 910 patients with a mean age of 35.4 years, 57% were males and median (IQR) CD4 cell
count was 27 (9-80) cells/µL; contributing 5,006 person-months of observations. Ten (1.1%) patients were in
group A and 900 (98.9%) patients were in group B. Incidence of clinical hepatitis was 2 per 1,000 person-
months. Probabilities of clinical hepatitis at 0.5, 1, 2, 3 and 6 months after ART were 0.2%, 0.5%, 0.7%, 0.8%
and 1.1%, respectively. By Cox regression analysis, baseline AST > 1.5 times of upper limit was associated
with higher incidence of clinical hepatitis (p = 0.019, HR = 5.83, 95% CI = 1.33-25.51).
Conclusion : Incidence of NVP-associated severe hepatitis that lead to NVP discontinuation among HIV-
infected patients with baseline CD4 < 250 cells/µL is low. The higher baseline AST is also associated with a
higher risk of severe hepatitis.
Keywords : HIV, Nevirapine, GPOvir, Hepatitis, Incidence, Risk factor
