STOP-HCV-1 (Stratified Treatment OPtimisiation for Hepatitis C)

What is changing in hepatitis C treatment?

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 include interferon are long (6-12 months), toxic and have limited cure rates even in those who tolerate them for the full course. The new oral direct acting antiviral (DAA) treatments are taken for shorter duration (12 weeks or less), are well tolerated and offer a much better chance of cure. However, three months of therapy is still a lot for many patients and, as the cost of these drugs is currently very high (over £25,000 for 12 weeks’ treatment), it’s more difficult to access them.

 

What is the question we are testing in patients with Hepatitis C genotype 1 and mild liver disease?

We are using two NICE approved DAA treatment combinations (DAA combination 1 is ombitasvir/dasabuvir/paritaprevir/ritonavir; DAA combination 2 is sofosbuvir/ledipasvir). Both of these DAA combinations have been safe, well tolerated and very effective in the 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. We are aiming to discover which patients may be cured by shorter courses (for some as short as 4 weeks) of therapy 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) has value in short course treatment. If we show that very short courses of DAA can cure the majority of patients with HCV this will be a great advance, as it will avoid unnecessary cost and inconvenience to both patients and those providing care. The safeguards in the study include a retreatment phase with DAA combination 2 (as listed above). So for patients who don’t achieve HCV cure after completing the first round of treatment, they will be guaranteed to receive further treatment with sofosbuvir/ledipasvir/ribavarin for 12 weeks (study design).

 

Trial update

The trial closed to recruitment on 31-Aug-2018 after enrolling 204 participants at 15 centres over England, Wales and Scotland. All of these participants will be followed up until 24 weeks after their last treatment dose.

 

 

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This project is funded by the Efficacy and Mechanism Evaluation (EME) Programme,an MRC and NIHR partnership.

The views expressed in this publication are those of the author(s) and not necessarily those of the MRC, NHS, NIHR or the Department of Health.