STOP-HCV-1 version 1.0
Research type
Research Study
Full title
Stratified Treatment OPtimisation for HCV-1 (STOPHCV-1)
IRAS ID
191299
Contact name
Graham Cooke
Contact email
Sponsor organisation
Imperial College London
Eudract number
2015-005004-28
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
New treatments for Hepatitis C (HCV) can be taken for shorter periods of time, with less severe side-effects compared to previous treatments (6-12 months). Almost all people are cured with 12 weeks of treatment; it is unknown what the minimum duration of treatment could be in order to achieve cure, there have been limited investigations into shorter treatments.
The protocol has been designed as a platform protocol to look at varying (intervention) 4-6 weeks vs fixed (control) 8 weeks of first-line combined Direct Acting Antivirals (DAA) treatment with or without ribavirin for patients with mono- Hepatitis or co-infection (HIV/HCV) with genotype (GT) 1a/1b and mild disease:
A fixed dose triple combination of 3 novel direct acting antivirals (DAA); the Abbvie combination ombitasvir/paritaprevir/ritonavir (12.5mg/75mg/50mg) co-formulated film-coated tablets once daily (total daily dosage: 25/150/100mg) plus one dasabuvir 250 mg tablet twice daily (total daily dosage: 500mg) will be used plus or minus ribavirin (Ribavirin will be dosed twice daily, adjusted for weight).
The intervention duration will be stratified by baseline HCV RNA on a sliding scale, duration will be determined by estimated time for HCV RNA to decline to reduce levels to ~1 copy in the whole body at the end of treatment. If viral failure is detected at any time from 4 weeks post-randomisation (first-line failure) patients will stop first line therapy and be treated with a fixed dose combination of sofosbuvir/ledispavir (400mg/90mg) once a day and ribavirin twice daily adjusted for by weight.
Visits will be on day 3, 7, 14 and 28 after randomisation, then every other week until 4 weeks post end of (first-line) treatment (EOT), then 4 weekly until 12 weeks post EOT, then 24 weeks after EOT a similar schedule will be followed for retreatment visits. Each visit will include a clinical assessment for adverse event outcomes and blood draw for standard safety tests and to check the level of virus.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
15/EE/0435
Date of REC Opinion
29 Dec 2015
REC opinion
Further Information Favourable Opinion