Globally, 3-4 million new hepatitis C virus (HCV) infections are estimated to occur annually. People who inject drugs (PWID) and HIV-positive men-who-have-sex-with-men (MSM) are two groups at highest risk of transmitting and acquiring HCV infection. The advent of DAAs has changed the therapeutic landscape for individuals with chronic HCV infection with IFN-free therapy offering high efficacy and tolerability, even in “difficult-to-treat” populations. Given the burden of HCV-related disease among PWID and HIV-positive MSM, strategies to enhance HCV assessment, treatment and prevention in these groups are urgently needed.
The REACT study will compare the efficacy and safety of sofosbuvir/velpatasvir administered for 6 or 12 weeks in individuals with recent HCV infection. The role and activity of potent DAA regimens in acute HCV infection requires evaluation, with the potential to be given as highly efficacious, short course IFN-sparing regimens, maximising acceptability to patients, encouraging uptake of treatment, limiting further transmission and preventing progression to chronic liver disease.
A total of 250 participants with recent HCV infection will be enrolled from drug and alcohol clinics, tertiary liver and infectious diseases clinics and community health centres across Australia, Canada, Germany, New Zealand, Switzerland, The Netherlands, the United Kingdom and the United States. The study aims to show that six weeks of treatment with sofosbuvir/velpatasvir is non-inferior to twelve weeks of treatment with sofosbuvir/velpastavir as assessed by sustained virological response at 12 weeks post treatment. Participants will be randomised to receive either 6 weeks or 12 weeks of treatment. Participants will also be followed for reinfection.
It is anticipated that the results from REACT study will support shortened treatment duration and the use of a new highly efficacious treatment for people with recently acquired HCV infection. The availability of an oral once-daily short course interferon-free combination therapy will maximise acceptability to patients, encourage uptake of treatment, limit further transmission and prevent progression to chronic liver disease.
The availability of an oral once-daily short course interferon-free combination therapy for recently acquired HCV infection will maximise acceptability to patients, encourage uptake of treatment, limit further transmission and prevent progression to chronic liver disease.