Extend-3 v2.6 (19.4.16)
Research type
Research Study
Full title
Response guided therapy with daclatasvir, sofosbuvir and ribavirin for 12 or 24 weeks in patients with genotype 3 chronic hepatitis C virus: is longer therapy worthwhile?
IRAS ID
200503
Contact name
Graham R Foster
Contact email
Sponsor organisation
Queen Mary University of London
Eudract number
2016-000599-87
Duration of Study in the UK
2 years, 1 months, 3 days
Research summary
Treatment for patients with chronic hepatitis C virus (HCV) infection is rapidly developing. Until recently, treatment required a weekly injection of pegylated interferon for 6-12 months, depending on the subtype of HCV infection. Interferon injections cause many side effects and are poorly tolerated by patients.
Most treatments now consist of orally-taken medications without the need for interferon injections. One of the most common subtypes of HCV infection in England is genotype 3 virus. For this virus subtype, NHS England offers an interferon-free combination of 3 oral medications – sofosbuvir (Sovaldi ®), daclatasvir (DaklinzaTM) and ribavirin. This treatment is funded for patients with significant liver scarring (advanced fibrosis or cirrhosis).
NHS England currently provides this treatment for a duration of 12 or 24 weeks. There is not enough research evidence to say which treatment duration is better. For most patients clinicians are recommended to prescribe 12 weeks, but it is unclear whether some patients who are harder to treat may have better outcomes using the 24 weeks treatment.
From earlier studies of a large group of patients with genotype 3 HCV treated with sofosbuvir-based treatments, we believe that patients with a slow treatment response (that is, their virus remain detectable after the first 2 weeks of treatment) are harder to treat, with a lower chance of cure. This trial will study the cure rates in such patients using 12 or 24 weeks of treatment, and compare their side effects, to see if the extended duration is worthwhile.
The results will help clinicians to improve treatment strategies for future patients. All oral anti-HCV treatments are expensive, and selecting the most effective duration for patients can optimise NHS resources. This study addresses an important research question, of whether clinicians can use a patient’s response during treatment to guide what duration of treatment is required.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
16/LO/0879
Date of REC Opinion
27 May 2016
REC opinion
Favourable Opinion