PATH – Patient Access to HCV Registry Project

According to recent publications hepatitis C infection affects between 130 - 220 million people worldwide and is one of the main causes of chronic liver disease and commonest indication for liver transplantation [1, 2]. Prevalence of the disease in Western Europe range from 0.4% to 3%. The prevalence in Eastern Europe and Middle East is expected to be considerably higher; however, the exact figures are currently unknown [3].

The most common way of infection 20 years ago was blood transfusion, unsafe injection procedures and intravenous drug use. Since then, routine screening of blood products for HCV have been introduced which has led to shift of acquisition route. Recently the most common way of infection is intravenous and nasal drug use and in some regions unsafe medical or surgical procedures. The risk of perinatal and heterosexual transmission is relatively low.

In most cases (50-90%) an acute infection is asymptomatic and without treatment leads to chronic infection (50-90%) [4, 5]. Chronic infection is usually associated with the presence of hepatic inflammation and fibrosis. Without treatment the disease slowly progresses over several decades and between 10-40% of patients develop cirrhosis [6] and other hepatic as well as non hepatic complications.

HCV has become a leading cause of hepatocellular carcinoma. It is estimated that approximately 10-40% patients with chronic hepatitis C develop this complication at some stage of the disease. The mortality rates are above 30% during the first year after the diagnosis [7, 8].

According to the World Health Organization, hepatitis C is a major public health problem. The incidence of HCV on a global scale is not well known, because acute infection is generally asymptomatic. However, it is estimated that about 3% of the world’s population has been infected with HCV and that there are more than 170 million chronic carriers who are at risk of developing liver cirrhosis and/or liver cancer worldwide. HCV related data are more robust for developed countries such as USA, Canada, Australia, Japan and Western European countries. Data sources describing the situation in Eastern Europe, Middle East and Africa are fewer, often fragmentary.

In order to obtain consistent data on clinical management of HCV patients in the EEMEA region from the perspective of the personal, exposure, outcome domain and the potential confounders, standardized, observational data collection, is desirable. Given the variability of genotypes or approved indication or access for a given therapy across the region, patients who will be included in the registry may be treated with interferon plus ribavirin +/- direct acting antiviral based therapy which includes the PIs.

The registry is an observational collection of clinical data according to the agreed plan (protocol) in order to describe standard clinical practice from the perspective of the personal domain (patient demographics, medical history and health status), the exposure domain (patient's experience with the diagnostic procedures and treatment), the outcomes domain and the potential confounders.

Primary objectives of the project:

• Collecting relevant data on HCV-infected patients treated with Interferon (IFN), Pegylated Interferon (Peg IFN) Ribavirin (RBV) and/or protease inhibitors (PIs) drugs in order to describe the following:
  • Disease characteristics of HCV patients (e.g. HCV genotype/subtype, IL28B rs12979860 status, fibrosis stage, cirrhosis etc.)
  • Important co-morbidities, including HBV and HIV co-infections.
  • Criteria for the treatment selection.
  • Clinical management of patients in terms of diagnostic procedures, standard and specialized treatment procedures, HCV treatment discontinuation rates and reasons.

Secondary objectives of the project:

• Generation of brief reports that will provide top level descriptives of the recruited patients for internal Merck review and market access submissions.

Other important information:

• Partners: The registry will be initiated in 19 countries in the Eastern Europe, Middle East and Africa region. The following countries have been selected: Algeria, Bahrain, Cameroon, Iraq, Israel, Jordan, Kazakhstan, Kuwait, Lebanon, Libya, Morocco, Nigeria, Oman, Qatar, Saudi Arabia, Tunisia, Turkey, Ukraine, United Arab Emirates

References

1. Lavanchy D. The global burden of hepatitis C. Liver International 2009; 29(Suppl 1):74–81.
2. Shepard CW, Finelli L, Alter MJ. Global epidemiology of hepatitis C virus infection. The Lancet Infectious Diseases 2005; 5(9): 558–567.
3. Esteban JI, Sauleda S, Quer J. The changing epidemiology of hepatitis C virus infection in Europe. Journal of Hepatology 2008; 48(1): 148–162.
4. Santantonio T, Wiegand J, Gerlach JT. Acute hepatitis C: current status and remaining challenges. Journal of Hepatology 2008; 49(4): 625–633.
5. Wiegand J, Deterding K, Cornberg M, Wedemeyer H. Treatment of acute hepatitis C: the success of monotherapy with (pegylated) interferon alpha. Journal of Antimicrobial Chemotherapy 2008; 62(5):860–865.
6. Afdhal NH. The natural history of hepatitis C. Seminars in Liver Disease 2004; 24(Suppl 2):3–8.
7. Yang JD, Roberts LR. Hepatocellular carcinoma: A global view. Nature Reviews Gastroenterology & Hepatology 2010; 7(8):448–458.
8. Bartosch B, Thimme R, Blum HE, Zoulim F. Hepatitis C virus-induced hepatocarcinogenesis. Journal of Hepatology 2009; 51(4): 810–820.