Incidence and risk factors of nevirapine-associated severe hepatitis among HIV-infected patients with CD4 cell counts less than 250 cells/microL.
OBJECTIVE
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/microL.


METHODS
A retrospective cohort study was conducted among antiretroviral-naïve HIV-infected patients who had baseline CD4 < 250 cells/microL 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/microL; 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 > or = 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).


CONCLUSIONS
Incidence of NVP-associated severe hepatitis that lead to NVP discontinuation among HIV-infected patients with baseline CD4 < 250 cells/microL is low. The higher baseline AST is also associated with a higher risk of severe hepatitis.
Manosuthi
Weerawat
W
Bamrasnaradura Infectious Diseases Institute, Ministry of Public Health, Nonthaburi, Thailand. idweerawat@yahoo.com
Sungkanuparph
Somnuek
S
Tansuphaswadikul
Somsit
S
Chottanapund
Suthat
S
Mankatitham
Wiroj
W
Chimsuntorn
Sukanya
S
Sittibusaya
Chayanan
C
Moolasart
Visal
V
Chaovavanich
Achara
A
D000328:Adult; D000410:Alanine Transaminase / Q000032:analysis; D019380:Anti-HIV Agents / Q000009:adverse effects*; D044966:Anti-Retroviral Agents / Q000009:adverse effects*; D001219:Aspartate Aminotransferases / Q000032:analysis; D018791:CD4 Lymphocyte Count; D005260:Female; D015658:HIV Infections / Q000150:complications* / Q000503:physiopathology; D006505:Hepatitis / Q000209:etiology* / Q000503:physiopathology; D006801:Humans; D015994:Incidence; D008297:Male; D019829:Nevirapine / Q000009:adverse effects*; D012189:Retrospective Studies; D012307:Risk Factors; D018434:Sickness Impact Profile
D019380:Anti-HIV Agents; D044966:Anti-Retroviral Agents; D019829:Nevirapine; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase