Strategic Treatment Reduction in Very Early liver disease: STRIVE4
The capacity to eliminate hepatitis C (HCV) through direct acting antiviral (DAA) therapy scale-up would be enhanced by shortened duration therapy in key populations. Shortened duration DAA therapy of four or six weeks has been evaluated among people with chronic HCV, with variable outcomes [sustained virologic response (SVR) 29%-92%].
The combination of sofosbuvir (400 mg) + glecaprevir-pibrentasvir (300 mg-120 mg) has not been evaluated as a shortened duration triple class DAA regimen. It has been evaluated as a 12 and 16-week regimen in combination with ribavirin for treatment of prior glecaprevir-pibrentasvir virological failure, with very high efficacy of 96% and good tolerability.
STRIVE4 is an open-label multicentre pilot study of sofosbuvir plus glecaprevir-pibrentasvir for four weeks among people with chronic hepatitis C virus (HCV) infection and early liver disease.
To evaluate the proportion of participants with SVR4 [defined as HCV RNA below the lower limit of quantification (LLOQ) at 4 weeks post-treatment] following sofosbuvir (400 mg) plus glecaprevir-pibrentasvir (300 mg-120 mg) for four weeks among treatment-naïve participants with chronic HCV infection and no significant fibrosis.
The pilot study will provide valuable insight to new treatment strategies for people with chronic HCV and very early liver disease. If short course DAA therapy is successful, it is likely to offer the wider HCV community significant advantages in regard to efficacy, treatment duration, cost and toxicity.
