Persistent long-term risk of liver related complications in HCV patients after antiviral therapy - Data from the German Hepatitis C-Registry

Background and aims Direct acting antivirals against hepatitis C improve the short-term outcome of patients with chronic hepatitis C. The long-term clinical course after interferon-free treatment of chronic hepatitis C has rarely been studied in large real-world cohorts. We here present data on 10,448 patients being followed for up to 7 years after DAA therapy in the German Hepatitis C-Registry.

Method The DHC-R (German Hepatitis C-Registry) is a national multicentre real-world registry currently including about 17,700 patients recruited by more than 250 centres. Data were analysed as of Jan 01, 2021. The present analysis is based on patients treated with DAAs since February 2014.

Results About 1/3 (32 %) of the patients had liver cirrhosis at baseline. 26 % (2,712/10,448) had a follow up of at least three years after end of treatment. Antiviral treatment containing ribavirin (RBV) were given to 2,359 patients, while 8,089 patients received a regimen without RBV. The overall sustained virological response rates were 95 % (9,951/10,448) and 97 % (9,824/10,157) in intention-to-treat and per protocol analysis, respectively. During long-term follow-up, 181 patients died. Liver-related clinical events (liver transplantation, hepatocellular carcinoma (HCC), hepatic decompensation or increase in MELD score by ≥3 points) occurred in 416 (5.7 %) patients. The overall incidence for de novo HCC was 0.6 %/year. In patients with liver cirrhosis the annual HCC risk was 1.2 % in the first two years after treatment and 0.8 % from year 3-7. In multivariate analysis, parameters associated with the development of liver-related endpoints in SVR patients with high significance (p< 0.01) were previous antiviral therapy, male sex, baseline hemoglobin, eGFR and alkaline phosphatase. Liver cirrhosis and treatment experience were the only factors being associated with de novo HCC development with high significance (p< 0.01).

Conclusion This large real-world cohort confirmed that patients with chronic hepatitis C and liver cirrhosis are still at risk to develop complications of liver disease even beyond 3 years after HCV cure. We still strongly recommend a regular long-term monitoring in particular in treatment-experienced patients with liver cirrhosis.

Publication History

Article published online:
07 September 2021