Evaluating the Population Impact of Hepatitis C Direct Acting Antiviral Treatment as Prevention for People Who Inject Drugs - EPIToPe

An estimated 200,000 people in the UK have been infected with the Hepatitis C Virus (HCV), which is an important cause of liver disease, cancer and death.  Most HCV infections in the UK are in people who inject drugs.  New HCV drugs cure over 90% of patients within 12 weeks with few side-effects, but are expensive (over £20,000) and currently restricted to people with moderate or severe liver disease. 

Mathematical models suggest that HCV 'Treatment as Prevention', i.e. treating people who inject drugs and have mild liver disease for HCV, can reduce the overall number of new HCV infections in the population, even though some people who inject drugs may also become re-infected.  Further, if HCV treatment is increased sufficiently, then HCV will eventually be 'eliminated'  from the UK population.  However, the findings from these models need to be tested out in patients.  This is what we aim to address.

Design

In the first study, our target is to treat at least 500 people who inject drugs in Dundee/NHS Tayside over two years.  This large rapid increase in HCV treatment will be delivered across multiple sites in the community, including pharmacies, addiction services, and prisons.  We estimate that this will reduce chronic HCV in people who inject drugs in Dundee by two thirds, from nearly 30% to less than 10%.  To measure changes in HCV in the population, we need to increase the data available from surveys of people who inject drugs in Tayside and the rest of the UK, and develop novel statistical methods that can provide unbiased estimates of whether HCV has changed over time.

We will interview services providers in Dundee/NHS Tayside to identify key barriers and facilitators that can help other sites successfully scale-up HCV treatment.  We will interview patients following treatment, and link to administrative databases to assess if being cured from HCV also helps people who inject drugs stay in specialist drug treatment and recover from addiction.  We also will estimate whether the increase in HCV treatment to people who inject drugs is cost-effective to the NHS.

Finally, as the number of HCV treatments increase in England, we will co-design a second and larger evaluation of HCV 'Treatment as Prevention' with regional HCV clinical services.  We will use evidence gathered from our first study to show how we can scale up HCV treatment in the community, and determine whether HCV infections reduce more in sites with greater scale-up than in sites with less intense scale-up of HCV treatment.

Dissemination

Our results will guide clinical practice and policy, and support decision-making by the NHS on whether people who inject drugs with mild liver disease should receive early treatment.


Matt Hickman (co-Principal Investigator), Sharon Hutchinson (co-Principal Investigator), John Dillon, Daniela De Angelis, Lawrie Elliott, Graham Foster, David Goldberg, Natasha Martin, Ann Eriksen, Peter Donnan, Sema Mandal, Peter Vickerman, William Hollingworth, David Liddell, Paul Flowers, Samreen Ijaz, Magdalena Harris.

NIHR PGfAR RP-PG-0616-20008; 2018-23; £2.8 million

Workstreams

  • Scaling up HCV treatment
  • Treatment as Prevention outcomes through enhancing routine surveillance and record linkage
  • Understanding the barriers and facilitators to scaling-up community-based HCV treatment
  • Modelling impact and cost-effectiveness
  • HCV Treatment as Prevention trial in England

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