U.S. FDA approves oral anti-hepatitis C drug (reprint)Zhu Kongxi, Department of Gastroenterology, Second Hospital of Shandong UniversityThe FDA formally approved Gilead’s Sovaldi (sofosbuvir) on December 6, 2013, for the treatment of chronic hepatitis C virus (HCV) infections.Sofosbuvir is the first effective and safe drug used to treat certain types of HCV infections without concomitant use of interferon.The FDA approved sofosbuvir in combination with ribavirin for the treatment of genotype 2 and genotype 3 chronic hepatitis C (HCV). Sofosbuvir is the first effective and safe medication for the treatment of certain types of HCV infections without the concomitant use of interferon. sofosbuvir is approved by the FDA in combination with ribavirin for the treatment of adult patients with genotypes 2 and 3 chronic hepatitis C. The FDA has also approved sofosbuvir for the treatment of chronic hepatitis C infection. The FDA also approved sofosbuvir in combination with pegylated interferon (PEG-IFN) and ribavirin for the treatment of adult patients with genotype 1 and genotype 4 chronic hepatitis C in the first-ever (treat-naive) setting. sofosbuvir is a nucleoside inhibitor of the HCV-specific NS5B polymerase. Sofosbuvir targets the highly conserved activation site of HCV-specific NS5B polymerase, where the nucleoside analog is phosphorylated in host hepatocytes to become an active nucleoside triphosphate and competes with nucleosides used for HCV RNA replication, leading to the termination of HCV genome replication.The approval of Sofosbuvir was based on four phase 3 studies (NEUTRINO, FISSION, POSITRON, and FISSION). , POSITRON, and FUSION). During the FDA review period, 2 new Phase 3 studies (VALENCE and PHOTON-1) were added to the New Drug Application (NDA) for sofosbuvir. sofosbuvir was granted Breakthrough Therapy Designation by the FDA based on these data and was ultimately approved through the FDA Priority Review process. Multiple clinical trials have shown that sofosbuvir is capable of achieving a very high percentage of sustained virologic responses (clinical cure). Even more revolutionary is the fact that sofosbuvir remains highly effective without Peg- IFN&alPHa; for example, sofosbuvir in combination with RBV can achieve a SVR rate of up to 100% in patients with genotypes 2 and 3 CHC who have been initially treated with sofosbuvir, and sofosbuvir targets very conserved sites, which results in a very high threshold of resistance to the drug. threshold for resistance to the drug is very high. In the U.S., the Wholesaler Acquisition Cost (WAC) cost for a 28-tablet/bottle pack of Sovaldi is$28,000, or$1,000 per tablet, and most patients would need to be treated for 12 weeks, which would total$84,000 in costs. Sofosbuvir is an inhibitor of NS5B polymerase, which acts on the virus’ RNA polymerase to inhibit RNA synthesis and thereby block viral replication. Sofosbuvir, a new anti-hepatitis C drug developed by Gilead, was approved on December 6, 2013 by the U.S. Food and Drug Administration (FDA). New Hepatitis C drug Sovaldi (sofosbuvir, 400mg tablets) Image source: oneyao.net Simeprevir (Simeprevir) is a next-generation NS3/4A protease inhibitor jointly developed by Medivir and Janssen for the treatment of adult patients with chronic hepatitis C in the context of compensated liver disease, including all stages of liver fibrosis. It works by inhibiting the replication of the hepatitis C virus in liver cells by blocking the enzyme protease. Sovriad (simeprevir) approved for marketing in Japan for the treatment of Hepatitis C Image Source: oneyao.net