1. Case Management in HCV Infected People Who Inject Drugs in Belgium.
Good morning everyone, I am dr. Rob Bielen, I started my PhD last august at University of Hasselt in cooperation with ZOL Genk, and I want to discuss with you all the main topic of my research: case management in HCV infected people who inject drugs (or PWIDs)
Rob Bielen, MD
Co-promotor: Frederik Nevens, MD, PhD
Promotor: Geert Robaeys, MD, PhD

2. Introduction Belgium: Anti HCV prevalence general population: 0,87%.1
2010: 22,900 viremic individuals diagnosed2
± 2900 new viremic HCV diagnosis annually2
As you all know, Hepatitis C is still one of the leading causes of chronic liver disease, with million people infected globally according to the WHO.
The prevalence in Belgium is low in the general population, and the last consensus, based on a study of the Knowledge center in 2012, states that is estimated around 0,87% (HCV antibodies). In this study, it was also estimated that approximately 22,900 were diagnosed with HCV, with nearly 3000 new diagnoses annually.
As you can see on the figure: there is a peak in diagnosed men and women between the ages 25 and 60. This distribution can be explained by the ways of transmission, which is by blood-blood contact (eg: blood transfusions, or needle sharing in drug use). As risk-seeking behaviour is more prevalent in men, this can also explain the higher prevalence in men, and at younger age.
Age and gender distribution of anti-HCV prevalence, Belgium, 2004
P. Van Damme, W. Laleman, P. Stärkel, H. Van Vlierberghe, D. Vandijck, S.J. Hindman, H. Razavi, C. Moreno: Hepatitis C Epidemiology in Belgium. Acta gastroenterol. belg., 2014, 77,

3. Introduction Revolution in HCV treatment! SVR rate 93-100%3
Limited side effects3
- High cost3
Moving on to treatment, as you surely know, this has been revolutionized recent years, and all the treatment regimens on the right side have been made available for treatment in the real-life setting, if patients fit into the reimbursement criteria.
You also know that these drugs have a high success rate, with limited side-effects, and as only side effect the high costs

4. Introduction
Treatment of HCV in an early phase could be cost-effective4-8
Although the treatment is very expensive, models globally propose that treatment for HCV in an early phase can be cost-effective.5-8 For Belgium, the following model was published last year:
It is based on the standard of care in 2015, for which it was estimated that approximately 900 patients were treated DAAs, with treatment restricted to ≥ F3 patients9. Than, different scenarios were proposed, and the outcome is visualised by the different graphics. We see a decline in viremic cases, and in advanced outcomes of liver diseases.
The authors proposed that scenario 2, in which 4,300 patients need to be treated annually by 2018 ( Starting treatment for zero fibrosis in 2020) without increasing the number diagnosed, would provide the most favorable balance of outcomes (90% reduction in viremic prevalence and advanced outcomes) and realistic requirements for implementation (gradual increase in treatment, delayed incorporation of patients with no/mild fibrosis).
P. Stärkel, D. Vandijck, W. Laleman, P. Van Damme, C. Moreno, S. Blach, H. Razavi, H. Van Vlierberghe: The Disease Burden of Hepatitis C in Belgium : An update of a realistic disease control strategy. Acta gastroenterol. belg., 2015, 78,

5. Problem definition
Seroprevalence of HCV-antibody ± 0,87% in general population1 Seroprevalence of HCV-antibody 60-80% in people who inject drugs (PWID)10,11
To reach the goals of the previous model, we should increase treatment annually with more than 3000 patients. This is in part possible by expanding the reimbursement criteria. However, as the population who was infected with hepatitis C by blood transfusion lowers, because of treatment for HCV and screening of blood products, the greatest reservoir of hepatitis C is found in the PWID community. In this community, uptake for treatment is very low as illustrated in the figure of Razavi.

6. Problem definition How can we… Improve uptake for screening?
Improve uptake for therapy?
In PWID?
Thus the question remains:

7. Hepatitis C care continuum
To increase the uptake for treatment in people who inject drugs, we first must understand the HCV care continuum.
This figure by Meyer et al of last year, shows the steps, necessary for successful treatment, and also the interventions which have been studied in the past to improve each step,
So first we need to diagnose people, than link them to the healthcare system, prescribe treatment, and achieve SVR.
All these steps are necessary, and especially in the PWID community, who often are not eager to address the regular health care pathway, help is necessary.
This has been studied in the past: but often in small samples, with risk of bias and drop out, which is a consequence of the study population.
However: all systematic reviews conclude that:
The most effective way to improve screening, is by additional screening on-site
To improve linkage to care, continuous communication between health care workers responsible for screening and the treating physician is necessary
Overview of the continuum of care for chronic Hepatitis C virus with targeted interventions. HCV, Hepatitis C virus; SVR, sustained virologic response.
Meyer JP, Moghimi Y, Marcus R, Lim JK, Litwin AH, Altice FL. Evidence-based interventions to enhance assessment, treatment, and adherence in the chronic Hepatitis C care continuum. Int J Drug Policy, 26 (2015) 922–935

8. Case management Definition:
Case management is a collaborative process of assessment, planning, facilitation, care coordination, evaluation and advocacy for options and services to meet an individual’s and family’s comprehensive health needs through communication and available resources to promote quality costeffective outcomes’. (CMSA, 2010, p. 8).
Chronic care setting in America12
HIV setting13
1 trial with HCV (Masson et al., 2013)14
We want to test if we can address all the steps in the HCV care continuum, by creating a HCV case manager.
Case management is defined as …
It is mostly used in the chronic care setting in America, but has also been tested in the HIV setting, and there has been 1 trial in the hepatitis C setting. In this trial, merely focussed on linkage-to-care, case management services were provided for 1 group in comparison to care as usual. The group with case management services were 4 times more likely to visit a hepatology center;
We want to test if this function is effective in improving uptake for screening/treatment and prevention of reinfection.

9. Case manager Inform and motivate PWID HCV screening on site (upon IC)
Storage and transport of samples
Collect results + feedback
Database
Inform and educate HCV RNA positive PWID
Follow up of appointments
Follow up of compliance and results
Prevention of reinfection
If we apply the functions and tasks of case management to the population of PWID, these are the tasks that should be executed by the case manager.

10. Method Prospective interventional cohort trial: n=300 Endpoints
Results will be compared to the international literature and the standard of care in other regions of Belgium
Uptake for screening
Uptake for treatment assesment
Uptake for treatment
Compliance
SVR
Reinfection

11. Preliminary results screening Limburg 2015
Rob Bielen CONFIDENTIAL /02/2016
Doctoral School for Medicine & Life Sciences - Physiology – Biochemistry – Immunology

12. Future research Case management by nurse Expansion of screening
Basic research?

13. References
1. Beutels M, Van Damme P, Aelvoet W, et al. Prevalence of hepatitis A, B and C in the Flemish population. Eur J Epidemiol 1997; 13(3):
2. Gerkens S MN, Thiry N, Hulstaert F. . Hepatitis C: Screening and Prevention. Brussels: Belgian Health Care Knowledge Center (KCE) 2012.
3. EASL Recommendations on Treatment of Hepatitis C J Hepatol 2015; 63(1):
4. Nevens F, Colle I, Michielsen P, et al. Resource use and cost of hepatitis C-related care. Eur J Gastroenterol Hepatol 2012; 24(10):
5. Zhang S, Bastian ND, Griffin PM. Cost-effectiveness of sofosbuvir-based treatments for chronic hepatitis C in the US. BMC Gastroenterol 2015; 15: 98.
6. San Miguel R, Gimeno-Ballester V, Blazquez A, Mar J. Cost-effectiveness analysis of sofosbuvir-based regimens for chronic hepatitis C. Gut 2015; 64(8):
7. Chhatwal J, He T, Lopez-Olivo MA. Systematic Review of Modelling Approaches for the Cost Effectiveness of Hepatitis C Treatment with Direct-Acting Antivirals. Pharmacoeconomics 2016.
8. P. Stärkel, D. Vandijck, W. Laleman, P. Van Damme, C. Moreno, S. Blach, H. Razavi, H. Van Vlierberghe: The Disease Burden of Hepatitis C in Belgium : An update of a realistic disease control strategy. Acta gastroenterol. belg., 2015, 78,
9. Matheï C, Robaeys G, van Damme P, Buntinx F, Verrando R. Prevalence of hepatitis C in drug users in Flanders: determinants and geographic differences. Epidemiol Infect 2005; 133(1):
10. Micalessi MI, Gérard C, Ameye L, Plasschaert S, Brochier B, Vranckx R. Distribution of hepatitis C virus genotypes among injecting drug users in contact with treatment centers in Belgium, J Med Virol 2008; 80(4):
12. Hudon C, Chouinard MC, Diadiou F, Lambert M, Bouliane D. Case Management in Primary Care for Frequent Users of Health Care Services With Chronic Diseases: A Qualitative Study of Patient and Family Experience. Ann Fam Med 2015; 13(6):
13. Gardner LI, Metsch LR, Anderson-Mahoney P, et al. Efficacy of a brief case management intervention to link recently diagnosed HIV-infected persons to care. AIDS 2005; 19(4):
14. Masson CL, Delucchi KL, McKnight C, et al. A randomized trial of a hepatitis care coordination model in methadone maintenance treatment. Am J Public Health 2013; 103(10): e81-8.

14. This research is part of the
Limburg Clinical Research Program UHasselt-ZOL-Jessa,
supported by: