Objectives Statins are commonly used to prevent coronary heart disease and stroke, but they may increase the risk of hepatotoxicity and muscle toxicity. Hepatitis B virus (HBV) infected patients are more susceptible to acute hepatitis. However, the safety of statins use in patients with HBV infection is unclear. The purpose of this study was to investigate the association between statins use and risk of hospitalizations related to acute hepatitis in patients with HBV infection.

Method Ours study was a population-based retrospective cohort study. We used a nationwide data of HBV-infected patient from 1999 to 2010 from the Taiwanese National Health Insurance database. Cox proportional hazards regression was used to calculate the hazard ratios (HRs) and 95% CIs for the association between statins use and the occurrence of acute hepatitis in the HBV-infected study cohort.

Results A total of 255 344 HBV-infected patients were included in the study cohort. Of these patients, 127,672 (50%) had used statins, and 283 (0.11%) were diagnosed with acute hepatitis within one year and incident rate of acute hepatitis in patients with HBV infection was 110.9 per 100000 person-years. After controlling for potential confounders, no association of acute hepatitis between statins user and non-statin user was found in different follow-up periods and doses within one year.

Conclusions Among patients with HBV infection, statins use may be not association with acute hepatitis regardless of larger cumulative dose, drug class of statins. Statins given to HBV-infection patients may not associate with severe liver injury.