Evaluation of the Hepatitis C Prevention, Support and Research Program 1999/2000 – 2005/2006

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1. Introduction

This document is a summary of the findings of the evaluation of the Hepatitis C Prevention, Support and Research Program (the Program).

The evaluation fulfills the requirements to report on the activities completed during the period 1999/2000 – 2003/04 as well as the Program's extension periods (fiscal years 2004-05 and 2005-06). It demonstrates the progress made toward the Program goals and stated outcomes and identifies the priorities for future work in this area. The report provides an understanding of not only the accomplishments of the Hepatitis C Program, but its contribution to the overall mission, mandate and goals of the Public Health Agency of Canada (PHAC).

The information gathered was evaluated in order to inform any future federal government policy and/or programmatic efforts. The results were analysed in the context of reach, results, successes (process, capacity; knowledge development & translation, spin-offs), gaps including lessons learned, challenges including lessons learned in order to form specific and directive recommendations.

2. Background

Hepatitis C is a disease of the liver caused by the hepatitis C virus (HCV). It is estimated that 123-170 million people worldwide are living with HCV infection.

Before 1989, many cases of viral hepatitis could not be attributed to either hepatitis A or B viruses since the agent causing the hepatitis was unknown and such cases were simply termed non-A, non-B viral hepatitis. It was not until 1989 that a new strain of hepatitis virus, called the hepatitis C virus (HCV), was isolated in pure culture and characterized in the laboratory setting. Hepatitis C infection is a liver disease caused by HCV, an enveloped, single-stranded linear RNA virus belonging to the Flaviviridae family. Six genotypes of the virus have been identified.

The precise number of cases of hepatitis C infection is currently unknown, but it is estimated that between 210,000 and 275,000 people in Canada carry the virus¹, where an estimated one-third do not know they are infected. About 0.8% of people in Canada are infected and there is a large hidden epidemic of some 90,000 people.

Although the majority (60-70%) will have no discernible symptoms after initial infection, between 75-85% will become chronically infected. Of these, perhaps 10-20% are expected to develop cirrhosis (severe scarring of the liver) following a long latency period of 20-30 years. Among those with cirrhosis, 1%-5% per year are expected to develop hepatocellular carcinoma (liver cancer)². It is predicted that the number of cases of hepatitis C infection requiring liver transplants will triple by the year 2008. Furthermore, cases of cirrhosis and end-stage liver disease are also expected to double. It is clear that a significant burden could be placed on Canada's health care system in the upcoming years³.

HCV is mainly transmitted by direct contact with blood or blood products. Since the implementation of modern screening techniques, transmission of HCV via the public blood system has been virtually eliminated. However, other behavioural risk factors (such as the sharing of contaminated needles and other instruments among drug users) are becoming a major population health issue. Indeed, injection drug use (IDU) is associated with at least half of new HCV infections⁴ . Although HCV can also be spread through sexual activity the chance of this occurring is rare: risk increases if individuals have sexually transmitted infections present, allowing direct contact with blood during intercourse.

Research indicates that the key factors associated with high risk of HCV infection include⁵:

• Any history of IDU
• Contaminated blood or blood products or organ transplantation before July 1990
• Incarceration
• Needle stick or sharp injuries
• Procedures (e.g., injection, vaccination, surgery, transfusion, ceremonial rituals) involving reuse or sharing of contaminated equipment in parts of the world with high HCV prevalence
• Nonsterile contaminated tattooing or body piercing equipment
• Receiving hemodialysis
• Sharing personal items contaminated with blood with an HCV-infected person (e.g., razors, nail clippers, tooth brush)
• Sharing contaminated intranasal cocaine equipment
• Hepatitis B virus infection
• Children born to mothers with HCV infection
• Undiagnosed liver disease
• Immigrants (endemic countries)

There are currently no vaccines for HCV, although vaccine research is underway. There have been important advances in hepatitis C antiviral therapy in the last decade. Depending on the genotype, pegylated Interferon and Ribavirin combination treatment clears the virus in about 45%-80% of patients.⁶ However, these drugs are expensive and can produce severe side effects, such as fatigue, bone marrow suppression and neuropsychiatric effects (i.e. apathy and depression)⁷.

Since the isolation of HCV in 1989, different levels of government have taken a number of important steps to prevent and care for those infected, affected and at risk of contracting the virus. In December 1994, the Laboratory Centre for Disease Control (LCDC) held a national conference discussing the prevention and control of hepatitis C. On March 27, 1998, federal, provincial and territorial (F/P/T) governments announced an offer of financial assistance to those infected with HCV through the blood system between 1986 and 1990. In July 2006, the federal government announced that persons infected before 1986 and after July 1, 1990 through the blood system would also receive compensation.

2.1 Surveillance

In Canada, viral hepatitis incidence and prevalence data are collected through both routine and enhanced surveillance as well as through targeted studies of specific populations and groups at risk of contracting viral hepatitis.

The routine collection of data on viral hepatitis, including hepatitis C, is achieved through a national surveillance system. The National Notifiable Disease Reporting System (NNDRS) regularly reports on diseases under national surveillance. The completeness of notifiable disease reporting varies over time and by province or territory.

Due to limitations in the NNDRS, the Enhanced Hepatitis Strain Surveillance System (EHSSS) was established in 1998 to determine trends in disease incidence and recent patterns of HCV transmission in Canada⁸. Based on demographic, clinical and potential risk factor information on newly acquired HCV infection (collected using standardized questionnaires from 1998 to 2004), the reported incidence of newly acquired HCV infection declined by 36.4% from 3.3 cases per 100,000 in 1998 to 2.1 cases per 100,000 in 2004 (Chart 1).⁹ Disease incidence peaked at 15 to 39 years of age, confirming IDU as the most frequent route of transmission. The proportion of cases attributed to health-care acquired HCV infection decreased over this time period.¹⁰

2.2 Economic Burden

While there are only limited data on the direct costs of hepatitis C in Canada (such as detecting the infection, diagnosing, testing, managing and treating hepatitis, and managing associated or resulting conditions such as liver cancer and liver transplants, and providing terminal care), indirect costs (such as those associated with productivity losses and added pressure on Canada's social support systems), and personal costs (such as negative impact on quality of life), there is every indication that they could be significant. In 2000, the direct and indirect cost of HCV was estimated at $500M annually and projected to increase to $1B annually by 2010.^11,12

The cumulative burden of hepatitis C is high. Given that the transmission of HCV is related to behaviours that are modifiable, HCV infection can and should be prevented. Furthermore, serious health sequelae may not manifest themselves for many years following infection, which presents particular challenges for the health sector. As a result, the federal government committed financial support for hepatitis C prevention, research, public education and community-based support, evaluated and reported herein.

References

1. Remis, R. Estimating the number of blood transfusion recipients infected by hepatitis C virus in Canada, 1960-85 and 1990-92, Health Canada, 1998.
2. Centers for Disease Control and Prevention. Recommendations for prevention and control of hepatitis C virus (HCV) infection and HCV-related chronic disease. MMWR October 16, 1998/47 (RR19): 1-39.
3. Medical Research Council. Identification of a research agenda for the diagnosis, care and prevention of hepatitis C in Canada. Ottawa: Medical Research Council; 1999: 9-10.
4. Gully, P.R. and Tepper, M.L. Hepatitis C. CMA 1997; 1197; 156: 1427.
5. Wong, Tom and Lee, Samuel S. Hepatitis C: a review for primary care physicians. CMAJ 2006; 174(5): 659
6. Ibid., Wong and Lee, 2006.
7. Op. cit., Center for Disease Control, 1998.
8. Enhanced surveillance of newly acquired hepatitis c virus infection in Canada, 2005. Scandinavian Journal of Infectious Diseases.
9. Wu, Hong-Xing. Overview of EHSSS Data. Annual site Investigators Meeting, March 9-10, 2006.
10. Mid-term Evaluation Report, p.4.
11. Responding to the Epidemic, Recommendations for a Canadian Hepatitis C Strategy, September 2005.
12. McGregor et al. Should the McGill University Health Centre initiate an antiviral treatment programme for patients with Chronic Hepatitis C? A Technology Assessment, October 8, 2002

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