Extrait

Background and study aims Hepatitis C is a type of liver disease, which is caused by the hepatitis C virus (HCV). Over time, the virus causes the liver to become irreversibly scarred (cirrhosis), eventually leading to liver failure. Traditional treatments for HCV involved long-term (6-12 months) treatment with drugs called interferons, which often caused severe side-effects. Newer treatments for HCV however can be taken for shorter periods of time, with much less severe side-effects. Almost all people are cured with 12 weeks of treatment, however it is not known what the minimum length of time treatment needs to be taken for to achieve a cure. The aim of this study is to establish what the minimum duration of treatment required is to a have a high chance of curing patients with HCV. Who can participate? Adults with HCV who do not have significant liver disease. What does the study involve? Participants are randomly allocated to one of two groups, one group receive a varying length of treatment between 4-6 weeks of the study drugs depending on the amount of virus in their blood, people with more virus will get more days of treatment. The second group receive a fixed treatment course of 8 weeks regardless of the amount of virus in their blood. Within each group, participants are also randomly allocated to either take ribavirin or not twice a day (the dosage is dependent on the participant’s weight). Participants attend study visits on day 3, 7, 14 and 28 after randomisation, every other week until 4 weeks after the end of the (first-line) treatment, 4 weekly until 12 weeks after the end of treatment, and then 24 weeks after end of treatment. At each visit a blood sample is taken in order to test for the levels of the HCV virus in order to see if they are cured. In addition participants are assessed by the clinic team and blood tests will be taken for standard safety tests. If the first line treatment is found to have failed at any time after 4 weeks of treatment, participants stop first line therapy and are treated with a fixed dose combination of sofosbuvir/ledispavir (Harvoni) once a day and ribavirin twice daily for 12 weeks. This is called the retreatment phase. For retreatment, participants attend on the day of retreatment, on week 2 and 4 of treatment, and then every 4 weeks until 24 weeks after the end of treatment. At each retreatment visit a blood sample is taken in order to test for the levels of the HCV virus, in addition participants are assessed by the clinic team and blood tests are taken for standard safety tests. What are the possible benefits and risks of participating? Participants may benefit from having their hepatitis C infection cured (either from first line or second round treatment) without the use of old treatments (injectable interferon-based) and their associated severe side effects and their much lower chances of cure. There are no notable risks involved with taking part in the study. Where is the study run from? At least 16 NHS Trusts in England and Wales (UK) When is the study starting and how long is it expected to run for? March 2016 to November 2019 Who is funding the study? National Institute for Health Research (UK) Who is the main contact? Ms Nafisah B Atako [email protected]

Critère d'inclusion

• Specialty: Infectious diseases and microbiology, Primary sub-specialty: Infectious diseases and microbiology (migration; UKCRC code/ Disease:

Liens

• ictrp
• isrctn