Background: Liver fibrosis and related hepatic dysfunction are among major medical issues in patients with chronic hepatitis B (CHB). It finally may lead to cirrhosis, hepatocellular carcinoma (HCC), and liver-related death. Objectives: This study aimed to investigate the effects of adding atorvastatin to the standard antiviral therapy on the hepatic fibrosis and progression of cirrhosis in CHB patients.

In this double-blinded clinical trial, 77 CHB patients referring to the gastroenterology and hepatology clinics in Qom, Iran, were selected by simple random sampling from 2016 to 2017. The participants were randomly divided into an intervention group that received tenofovir (300 mg) with atorvastatin (20 mg) daily and a control group that received tenofovir (300 mg) and placebo of atorvastatin daily.

According to the findings, changes in the aspartate aminotransferase (AST) level were not significant in the control (P = 0.771) and intervention (P = 0.266) groups. Changes in the alanine aminotransferase (ALT) level were non-significant in the control group (P = 0.893) but significant in the intervention group (P = 0.018). Changes in the liver fibrosis were significant in the intervention group (P = 0.001) and between the two groups (P < 0.001).

According to the study results, adding atorvastatin to the standard antiviral regimen improves the liver function and reduces liver fibrosis in CHB patients. Therefore, it is suggested that atorvastatin be used as complementary therapy.