Given the burden of hepatitis C virus (HCV) related disease among persons with injecting drug use and HIV positive men-who-have-sex-with-men (MSM), strategies to enhance HCV assessment, treatment and prevention in these groups are urgently needed. Much of what is known about the timing of treatment initiation, regimen choice and duration of therapy in acute HCV infection comes from small observational studies and randomised controlled trials in selected populations with limited data on treatment in persons with injecting drug use and HIV coinfection. With recent rapid advances in HCV therapeutics, management strategies for acute HCV will evolve rapidly over the next few years.
The REACT Study will compare the efficacy and safety of sofosbuvir/velpatasvir administered for 6 weeks vs standard 12 weeks in individuals with recently acquired HCV infection (with or without HIV coinfection).
To evaluate the proportion of patients with HCV RNA below the level of quantitation (target not detected [TND] or target detected, not quantifiable [TDnq]) at 12 weeks post end of treatment (SVR12) following sofosbuvir/velpatasvir therapy for 6 weeks (short treatment duration) compared with 12 weeks (standard treatment duration) in people with recent HCV infection. The study will also look at whether patients get reinfected with HCV and if so, why.
A shortened course of 6-week therapy for hepatitis C infection appeared to be less effective than a standard 12-week course in people with recently acquired hepatitis C 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 interferon sparing regimens, maximising acceptability to patients, encouraging uptake of treatment, limiting further transmission and preventing progression to chronic liver disease.
If 6 weeks of treatment with sofosbuvir/velpatasvir is shown to be equivalent to 12 weeks in patients with recently acquired hepatitis C then benefits to the wider community will be; shortened treatment, reduced costs and highly effective treatment.
The REACT study was funded by National Institutes of Health. Study medication was provided by Gilead Sciences Inc.