Investigators

Doctor Joseph Doyle

Supervisors

Professor Gregory Dore, Professor Margaret Hellard, Doctor Alex Thompson

Background

Globally, an estimated 180 million people are infected with hepatitis C virus (HCV), with an estimated three to four million new infections each year. In the developed world, the primary at-risk population for HCV infection is people who inject drugs (PWID), with 86% of new infections in Australia attributed to injecting drug use. Acute infection with HCV is characterized by the detection of viremia, subsequent development of HCV-specific antibodies, a high likelihood of persistent viremia and chronic infection. Identification and treatment of HCV soon after initial infection increases the probability of successful cure, and might prevent chronic HCV infection and its complications. However, very little is known about the health of people with previous HCV infection years following therapy, and whether HCV treatment at an early stage continues to be beneficial.

Aims

To determine whether early treatment of hepatitis C virus infection is worthwhile clinically and economically.

More specifically:

1. To determine overall treatment response and factors influencing response to treatment of recently acquired HCV infection;
2. To evaluate changes in quality of life and social functioning during treatment of recently acquired HCV infection;
3. To assess the impact of quality of life and social functioning on treatment adherence and injecting behaviour; and,
4. To evaluate the effect of successful prior treatment or spontaneous clearance of recently acquired HCV infection on long-term quality of life, social functioning, and liver health;
5. To assess the incidence of HCV re-infection following prior treatment induced clearance or spontaneous clearance of recently acquired HCV infection;
6. To determine the cost-effectiveness and cost-utility of treatment for recently acquired HCV treatment.

Methods

This research project will utilize data from:

·  The Australian Study of Acute Hepatitis C (ATAHC) cohortThe Australian Trial in Acute Hepatitis C (ATAHC) was a prospective study of the natural history and treatment of recently acquired hepatitis C virus (HCV) infection, acquired primarily through injection drug use. It recruited individuals from 2004 to 2008 from several sites in Australia.

·  The International Collaboration of Incident Hepatitis C in Injecting Cohorts (InC3)Incorporating data from the ATAHC cohort and nine other cohorts of PWID, the InC3 Collaborative Group was established in 2008 to create a merged multi-cohort project of pooled data from well characterized cohorts of PWID with acute HCV infection and to facilitate new in-depth studies not possible from each individual study.

Investigations will include:

·  The ATAHC Recall StudyThe ATAHC Recall Study is a long-term follow up study of individuals who previously participated in the ATAHC study (5-8 years ago). It will involve prospective recruitment and will be conducted at the three sites that had the highest participation in the ATAHC study, including The Alfred/Burnet Institute.

·  Literature review for additional economic modelling inputs

The cost-utility and cost-effectiveness evaluation will be conducted using utilities derived from the ATAHC quality of life analysis, treatment outcomes from the InC3 analysis, and long-term re-infection and behavioural data from the ATAHC Recall Study. In additional, further information on input costs will be derived from a thorough review of previously published economic models (in the chronic HCV setting), and government costings (from Medicare and the Pharmaceutical Benefits Scheme).

Publications

1.  Doyle JS, Apsinall E, Liew D, Thompson AJ, Hellard ME. Current and emerging antiviral treatments for hepatitis C infection. Br J Clin Pharmacol 2012; in press. doi:10.1111/j.1365-2125.2012.04419.x.

2.  Doyle JS, Thompson AJ, Hellard ME.  The role of viral and host genetics in natural history and treatment of chronic HCV infection. Best Pract Res Clin Gastroenterol 2012;26(4): in press. doi:10.1016/j.bpg.2012.09.004

3.  Doyle JS, Sacks-Davis R, Hellard ME.  Acute Hepatitis C Infection: New Approaches to Surveillance, Treatment and Prevention. Curr Hepatitis Rep 2012; in press. doi:10.1007/s11901-012-0143-5

Timeline

Contact

For more information relating to this project, please contact Joseph Doyle:

• Email: j.doyle@burnet.edu.au
• Telephone: +613 8506 2324