HARM

 Directory of registries
HARM

Multicentre, non-interventional, retrospective and prospective monitoring of patients with chronic HCV infection who have been treated with direct-acting antiviral agents (DAAs) or with standard therapy.

start of the project: June 2016

HCV infection is a blood-borne diseases. The main ways of spreading HCV infection involve:

  • transfusion of unscreened blood and blood products,
  • unsafe injection practices,
  • regular dialysis treatments,
  • professional exposure to HCV,
  • sexual contact with a HCV-positive person,
  • family contact with a HCV-positive person,
  • vertical transfer from a HCV-positive mother to a newborn (perinatal transfer),
  • iatrogenic transfer,
  • transfer during organ transplantation.

Studies on the natural course of HCV infection have shown that 55–85% of patients infected with HCV are not able to eliminate the virus naturally, and that HCV infection becomes chronic. Over the next 20–25 years, approximately 5–20% of patients with chronic HCV will develop hepatic cirrhosis. Persons with chronic HCV infection who develop hepatic cirrhosis have an increased risk of developing irreversible liver failure (approx. 30% in a 10-year period) or hepatocellular carcinoma (HCC, approx. 2–13% in a 5-year period).

The previous treatment standard for patients with chronic HCV infection was the combination of pegylated interferon (PEG-IFN) and ribavirin (RBV). The duration of combined therapy is 48 weeks for HCV genotypes 1, 4, 5 and 6; and 24 weeks for HCV genotypes 2 and 3. This procedure leads to a sustained viral response (SVR) in 40–50% of patients infected with HCV 1, and in 80% (or even higher percentage) of patients infected with HCV 2 and 3.

Since the last update of Czech standard diagnostic and therapeutic approaches to chronic hepatitis C virus infection [1], two significant changes have been made:

  • direct-acting antiviral agents (DAAs) have been developed and introduced to clinical practice,
  • single-nucleotide polymorphisms (SNPs) have been identified, relating to both spontaneous and therapy-induced elimination of the virus.

HARM is a multicentre, non-interventional, retrospective and prospective observational study of patients with chronic HCV infection who have been treated with direct-acting antiviral agents (DAAs) or with standard therapy. It is a clinical-epidemiological study.

Primary objectives of the project:

  • to collect epidemiological and clinical data on patients with chronic HCV infection who have been treated with DAAs or with standard therapy starting from 2016,
  • to assess data on treatment of HCV patients.

Secondary objectives of the project:

  • to evaluate data on patients' treatment response.

Other important information:

  • Expert guarantor: Prof Petr Urbanek, MD, PhD
  • Partners: centres for the treatment of viral hepatitis C, as defined by the Czech Society of Hepatology and the Czech Society for Infectious Diseases (you can find more detailed information on the website of the HARM project)
  • Brief overview of results: you can find more detailed information on the website of the HARM project
HARM: multicentre, non-interventional, retrospective and prospective monitoring of patients with chronic HCV infection who have been treated with at least one direct-acting antiviral agent (DAA) or with standard therapy

References

  1. Urbánek P, Husa P, Šperl J, Fraňková S, Plíšek S, Rožnovský L, Kümpel P. Standard diagnostic and therapeutic approaches to chronic hepatitis C virus infection [article in Czech]. Gastroenterologie a hepatologie 2015; 69(5): 455-71. Available from WWW [in Czech language only]: http://www.infekce.cz/DoporVHC14.htm.