Authors' objectives: To assess the available evidence on the efficacy, safety and aspects related to coverage polices on the use of sofosbuvir and simeprevir schemes for the management of patients with chronic hepatitis C. Chronic hepatitis C virus (HCV) infection is one of the main causes of cirrhosis and hepatocelullar carcinoma worldwide. HCV is an ARN virus with six genotypes (1 to 6); genotype 1 being the most common in Argentina (70%). The main objective of this therapy is to cure infection. This is called sustained virologic response (SVR) and it is reflected by measuring undetectable HCV ARN in blood once therapy is completed. Treatment with pegylated interferon (PegIFN) + ribavirin (RBV) has been the main management scheme for many years. New, more efficacious and safer schemes such as sofosbuvir (SOF), simeprevir (SIM), daclatasvir and ledipasvir among others have currently appeared; they can even be administered to subjects with decompensated cirrhosis. The use of SOF and SIM schemes has been proposed for the treatment of chronic hepatitis C because higher SVRs could be obtained, with lower adverse effect rates and shorter treatment length compared with the standard treatment. SOF is a virus RNA analogue polymerase inhibitor, whereas SIM is an NS3-4a serine protease HCV inhibitor. These two drugs have been evaluated in combination with other drugs for hepatitis C management, that is to say, they are not administered as monotherapy.

Authors' recommendations: There is plenty of evidence found and its good quality. Schemes with sofosbuvir and simeprevir combined with other drugs to manage hepatitis C have demonstrated to be better when compared with the standard treatment or triple therapy with telaprevir or boceprevir in different patient groups. Although they are considered in the different clinical practice guidelines and health technology assessment documents, their high cost may limit their treatment availability in the different countries.

Project Status: Completed

Year Published: 2015

URL for published report: http://www.iecs.org.ar/publicacion/?id=5504

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Argentina

Organisation Name: Institute for Clinical Effectiveness and Health Policy

Contact Address: Dr. Emilio Ravignani 2024, Buenos Aires - Argentina, C1414 CABA

Contact Name: info@iecs.org.ar

Contact Email: info@iecs.org.ar

Copyright: Institute for Clinical Effectiveness and Health Policy (IECS)