Risk factors for liver injury in patients with acquired immunodeficiency syndrome treated with nevirapine

Objective To investigate the risk factors for hypersensitivity- associated liver injury induced by the combined antiretroviral therapy( c- ART) including nevirapine( NVP) in patients with acquired immunodeficiency syndrome. Methods The clinical data and blood samples of 132 patients who received the combined therapy including NVP in Zhongnan Hospital of Wuhan University from June 2008 to October 2015 were collected,and PCR- SSP was used to determine the genotypes of human leukocyte antigen( HLA) DRB1 and HLA-Cw. The patients who experienced hypersensitivity- associated liver injury induced by NVP within 6 weeks of c- ART were enrolled in the liver injury group( 41 patients),and those who did not experience liver injury were enrolled in the control group( 91 patients). The risk factors for liver injury induced by NVP hypersensitivity were analyzed. The t- test was used for comparison of continuous data between groups; the chi- square test was used for comparison of categorical data between groups. The univariate logistic regression method was used to analyze the risk factors for liver injury associated with NVP hypersensitivity,and the variables with P < 0. 10 were included in the multivariate logistic regression model to perform stepwise regression analysis. The Spearman correlation coefficient was used to analyze the correlation between the number of CD4 cells and alanine aminotransferase( ALT) level in patients experiencing hypersensitivity- associated liver injury. Results The results of the multivariate logistic regression analysis showed that male sex( OR = 12. 297,95% CI: 2. 467- 61. 300,P = 0. 002),a high CD4 cell count at baseline( OR = 1. 010,95% CI: 1. 001- 1. 018,P = 0. 022),HCV co- infection( OR = 10. 598,95%CI: 1. 411- 79. 613,P = 0. 022),and a HLA- Cw*03 carrier( OR = 34. 119,95% CI: 5. 543- 210. 023,P < 0. 001) were risk factors for liver injury associated with NVP hypersensitivity. In the patients with HCV co- infection or a high CD4 cell count( ≥200 / μl) or carrying HLA- Cw*03 allele,male patients had a significantly higher incidence rate of liver injury than female patients( 63. 9% vs 11. 6%,χ2= 23. 390,P < 0. 001). Baseline CD4 cell count was positively correlated with ALT level( r = 0. 583,P < 0. 001). Conclusion Male patients infected with human immunodeficiency virus who are co- infected with HCV and have a high CD4 cell count at baseline should avoid using NVP.The value of HLA- Cw*03 gene screening in predicting hepatotoxicity associated with NVP hypersensitivity awaits further investigation.