Background and Aims
Liver function tests (alanine aminotransferase, ALT; gammaâglutamyltransferase, GGT) not always normalize after elimination of hepatitis C virus (HCV) by direct acting antivirals (DAAs), possibly indicating concomitant nonâviral liver diseases. We analysed factors determining the biochemical response (normalized ALT/GGT) of DAA therapy in a large realâworld cohort.
Method
The German Hepatitis CâRegistry is a national multicenter registry study. Normal ALT was defined â€35 U/L (female) and â€50 U/L (male) or, according to AASLD, â€19 U/L (female) and â€30 U/L (male), normal GGT â€40 U/L (female) and â€60 U/L (male).
Results
At baseline, ALT was elevated in 3705/4946 (74.9%), ALT (AASLD) in 4669/4946 (94.4%) and GGT in 3018/4906 (61.5%). In this study, 97% of patients achieved SVR12. At week 12 after end of therapy, ALT was elevated in 451/4946 (9.1%), ALT according to AASLD in 1906/4946 (38.5%) and GGT in 863/4879 (17.7%). Persistently elevated ALT after DAA therapy was independently associated with high body mass index (BMI), age <70Â years, liver cirrhosis, diabetes, alcohol consumption and not achieving SVR12. Using the stricter AASLD criteria, opioid substitution and male sex were additional predictors. Higher GGT at week 12 was associated with high BMI, age >70Â years, liver cirrhosis, diabetes, alcohol consumption, opioid substitution and nonâSVR. Importantly, persistently elevated liver tests after treatment, particularly GGT, were associated with hepatic decompensation and mortality during 4âyears followâup.
Conclusion
Risk factors at baseline (obesity, diabetes, liver cirrhosis, alcohol consumption) are independently associated with persistently elevated liver function tests after SVR, indicating that these patients warrant further hepatological followâup. Clinical trial registration: German Clinical Trials Register (DRKS; ID DRKS00009717).