Short summary

END-HEP is a two year program investigating the prevalence of Hepatitis B, C and HIV in young drug users seeking treatment for dependency.

It is conducted in collaboration with the municipalities in Funen and conducts on-site testing of young drug users. The participants is tested for blood borne infections by a dried blood spot test (finger prick test) and fills out a questionnaire on different risk behavior.

The secondary aims of the study is evaluate test uptake if conventional venous blood draws are replaced with dried blood spots in young drug users and to describe risk behavior and risk reduction potential in young drug users.

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Rationale

People who use drugs (PWUD) are the driving force of maintaining spread of hepatitis C (HCV) in the western world, especially among those who inject drugs. Any effort to limit new infections and decrease chronic hepatitis C (CHC) prevalence must address this population. However the population is considered hard to reach both with regards to testing and treatment.

WHO has in 2016 set up ambitious goals for the reducing the prevalence and incidence of hepatitis C with 90% by 2030.  Reaching this goal in Denmark is only possible if we substantially increase our efforts to test and treat PWUD. It also requires a paradigm shift from treating only patient with advanced/symptomatic disease to treating the infection to prevent spread - The treatment as prevention (TaP) concept.

 We assume that approximately 20000 persons have CHC in Denmark and that approximately 500 persons gets infected each year and of these will 300 develop CHC.

Odense University Hospital has for the past 10 years had outreach clinics at drug treatment centers (DTCs) in the region of Funen. The clinics provide evaluation by venous blood tests, lever fibrosis evaluation (by Fibroscan), and infectious disease specialist consultation at a regular basis. If treatment is indicated by national guidelines (currently F2 fibrosis), treatment is delivered concomitant with opium substitution therapy (OST). Testing uptake is in general good with more than 90% of persons on OST being tested. Co-infection with HIV and Hepatitis B is below 1%. Currently a clinical trial with 4 weeks of treatment (Abstract submitted for AASLD 2016) has treated about 20% of the infected (30) at one site. An equivalent number of patients fulfilling the national treatment criteria are either treated or in evaluation for treatment. Treating patients on OST at DTCs is feasible even in a clinical trial. There is however a significant lag from the time at person becomes at risk of acquiring CHC (eg. injecting or snorting drugs), to testing time, to evaluation and treatment. In the mentioned study treating persons on OST with a mean age of 39 years, the mean time since start of injecting was 14 years and 75% started before the age of 25 years. The first positive test was a mean 6 years after start of injecting and for half of the population the first test ever was positive.

Assessing persons that come into contact with drug use counselling at a low threshold is therefore crucial if TaP is on the agenda. Treating infected persons earlier may diminish the spread of the disease. Testing as early as possible (and offer treatment) needs to be implemented.

We have however very little knowledge about the young population with regards to risk behavior, test uptake and infection prevalence. Further knowledge about the feasibility of treating young drug users (younger than 30 years old) for hepatitis C is also needed.

In our setting young drug users under the age of 25 (30) has special services as long they are not on OST. However the testing uptake (conventional blood test) is very low at an estimated 15%. The main barrier is presumed to be to prioritize to go to the GP or hospital laboratory for testing.

In the national health surveys and investigations into young persons drug use it is estimated that about 4% of 15-16 year olds have tried snorting drug (ESPAD 2015). The use of drugs that can be injected or snorted starts in the late teens in the majority of people (MULD2008). 11,9% of Danish males and 3,9%% of females disclose "ever used amfetamine" (SYSY 2013 ).

At Odense municipality alone there are 150 persons above 18 and under the age of 30 entering into a drug use program each year. The majority of these persons use cannabis only but about 20 % disclose amfetamine or cocaine use.

In 2015 the Department of Clinical Immunology at Odense University Hospital validated dried blood spots (DBS), a finger-prick test, as a testing option. It provides serology for Hepatitis B, C and HIV as well as qualitative HBV DNA, HCV RNA and HIV RNA. The sensitivity of anti HCV was 96,6% and the specificity 100%,  for HbsAg 96.5% and 99,4% respectively and for anti HIV, 98,3% and 99,7%.

This technique has been instrumental in increasing test up take in a variety of settings and we hypothesize that it will serve as a lever for engaging young PWUD into a testing and treatment program

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Description of the cohort

There is an estimated 250 persons under the age of 30 seeking advice or treatment for drug dependency in the region of Funen each year. With a 80% test uptake we aim at getting consent to test 400 persons in the study period of 2 years.

Persons participating must be between 18 and 30 years and seek treatment or advice for drug use at center in the study.

Persons are seen twice - one time for questionnaire and testing and a second time for answer and linkage to care /immunization.

Data and biological material

We collect the following data:

Participant generated:

Demographics, past and present drug and alcohol use, additional risk factors associated with blood borne infections (tattoos, travelling, sexual practices) and

Lab data:  outcomes for HIV, Hepatitis C and B test.

Patients positive for hepatitis C will have a sample stored in a biobank for phylogenetic studies.

Collaborating researchers and departments

Center for drug dependency, Odense

• Consultant Inge Birkemose

Center for drug dependency, Svendborg

• Consultant Lars Frey

Center for drug dependency, Faaborg and Nyborg

• Consultant Jan Buttrup Larsen

Department of Clinical Immunology, Odense University Hospital

• Cand.Scient, Dorte Kinggaard Holm
• Consultant Søren Thue Lillevang