The era of direct-acting antivirals (DAAs) has transformed the treatment landscape for chronic hepatitis C virus (HCV) infection. Primarily this is due to the approval of multiple DAAs that are highly efficacious with improved safety profiles that became available within a short time span.1 Regulatory agencies have a public health responsibility to ensure the safety and efficacy of approved drug products. Although the demonstrated safety and efficacy of the drugs in registrational trials is paramount, the continued safety and effectiveness of drugs and treatment outcomes in diverse clinical care settings after a drug’s approval are of great importance.