M Kraus

Current clinical evaluation of the patient with HCV genotype 1 infection before antiviral treatment in German routine clinical practice

Background: Invasive and noninvasive tests in patients (pts) with chronic HCV genotype 1 (G1) infection are aimed to assess the severity of liver disease, in particular the stage of fibrosis, and to detect other potential coexisting liver diseases such as hemochromatosis or diseases which can be aggravated by antiviral treatment such as thyroid dysfunctions. The aim of the present interim analysis of the German NOVUS observational study was to investigate the current clinical evaluation of the patient with chronic HCV G1 infection in German routine clinical practice before antiviral treatment with boceprevir. Methods: From April 2012 until January 2014, 536 pts with G1 infection were recruited in the ongoing NOVUS study by 97 practices and hospitals in Germany. Until now, diagnostic tests and imaging techniques performed before triple therapy of HCV G1 infection with boceprevir were documented for 497 pts (treatment-naive N= 329, pretreated N = 168). Results: HCV G1 subtypes and HCV-RNA levels were reported for all pts. Serum ALT, AST and gamma-GT levels as well as complete blood cell counts including hemoglobin values were obtained with a frequency of 90%-95%. Baseline levels of bilirubin and creatinine were determined in 85% while thyroid function was tested by TSH measurement in 75%. In contrast, metabolic parameters such as triglycerides, cholesterol and glucose were tested with a frequency of 43%-58%. IL28B genotype was determined in only 22% and HCC screening by alpha-fetoprotein was documented for 32% of pts. Serum ferritin levels were obtained in 37%. Of these 27% and 3% had pathological high/low ferritin levels > 300 and < 15 µg/dL. Abdominal ultrasound was performed in 77% and liver elastography in only 13%. Liver biopsy findings were documented for only 19% of pts and 50% of liver biopsy specimens were obtained within the last 24 weeks. Conclusions: In routine clinical practice standard laboratory test such as determination of HCV-RNA levels, liver enzymes and blood cell counts are performed with a high frequency. However, there is only scarce information about the stage of liver fibrosis or coexisting liver diseases such as hemochromatosis or nonalcoholic steatohepatitis. This is mainly related to a low frequency of liver biopsies and liver elastografies in the daily routine. Corresponding author: Bilzer, Manfred E-Mail:manfred.bilzer@bilzer-consulting.de