Stratified Treatment Optimisation for HCV-1
Can we cure people with hepatitis C virus genotype 1 and minimal liver damage with a shorter course (between 28-49 days) of new oral treatments using their hepatitis C virus level to guide the exact number of days of treatment?
What is this study about?
We are at the beginning of a new era in the treatment of hepatitis C (HCV). While it has been possible to treat HCV for some years, treatments that included the previous treatment, interferon, were long (6-12 months), poorly tolerated, with a lot of side-effects, and had limited cure rates even in those who managed to complete the full course. The new all oral direct acting antiviral (DAA) treatments are taken for a shorter duration (12 weeks or less), are well tolerated and have very high cure rates. However, three months of therapy is still quite a long time for many patients and, as the cost of these drugs is currently very high, access to them through the NHS is restricted. Most patients will be overtreated with current recommended therapy and as we move to treat more patients who will require support through therapy, ensuring that patients do not get more therapy than they need will be increasingly important.
In STOP-HCV-1, we are using two different licensed, approved DAA treatment combinations. Both of these DAA combinations are safe, well tolerated and very effective in the many thousands of patients worldwide who have been treated with them.
We know these DAAs can be effective at curing HCV genotype 1 when given for between 8 and 12 weeks; importantly, some smaller studies have suggested that even shorter courses could be used and still achieve HCV cure.
In STOP-HCV-1, we are aiming to confirm which patients can be cured by much shorter courses (between 4 to 7 weeks) of the DAAs and how we might use new techniques in molecular medicine to predict this. We will also be testing whether the addition of another, older drug, ribavirin, taken by mouth, has added value in ensuring HCV cure with these very short courses of treatment.
If we show that very short courses of DAA can cure the majority of patients with HCV genotype 1 or 4, this will be a great advance, increasing access, reducing the risk of potential side-effects from longer courses of treatment, and making treatment much more convenient for people with HCV genotype 1 or 4, not just in the UK, but globally.
If, however, a participant’s HCV isn’t cured with the first course of DAAs, a second different combination of DAAs is given for 12 weeks (the standard duration of a treatment course). This safeguard, as an intrinsic part of the study, will ensure very high HCV cure rates overall, even if some people in the study need the retreatment course of DAAs.
Type of study
Who is funding the study?
Efficacy and Mechanism Evaluation (EME) programme, an MRC and NIHR partnership.
When is it taking place?
01-Feb-2016 to 31-Jan-2019
Where is it taking place?
Singleton Hospital, Swansea
Leicester Royal Infirmary
St Mary's Hosptial, London
Royal Free Hospital, London
Queens Medical Centre, Nottingham
Royal Surrey County Hospital, Guildford
Brighton & Sussex University Hospital, Brighton
John Radcliffe Hospital, Oxford
Glasgow Royal Infirmary
Freeman Hospital, Newcastle
Chelsea & Westminster Hospital, London
Mortimer Market Centre, London
Royal Hallamshire Hospital, Sheffield
Western General Hospital, Edinburgh
St George’s Hospital, London
Who is included?
Adults (≥18 years) infected with HCV genotype 1a/1b/4 for ≥6 months, with detectable plasma HCV RNA and mild liver disease (Fibroscan score F0-F1 or biopsy proven minimal fibrosis), HCV viral load 24 weeks on anti-HIV drugs.
Trial to stop Hepatitis C opens
15 Mar 2016