{"id":3973,"date":"2013-04-10T07:14:40","date_gmt":"2013-04-10T11:14:40","guid":{"rendered":"http:\/\/blogs.nejm.org\/?p=3973"},"modified":"2015-06-04T14:33:45","modified_gmt":"2015-06-04T18:33:45","slug":"simeprevir-and-sofosbuvir-submitted-to-fda-clock-ticking-on-boceprevir-telaprevir-even-interferon","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/simeprevir-and-sofosbuvir-submitted-to-fda-clock-ticking-on-boceprevir-telaprevir-even-interferon\/2013\/04\/10\/","title":{"rendered":"Simeprevir and Sofosbuvir Submitted to FDA — Clock Ticking on Boceprevir, Telaprevir, Even Interferon"},"content":{"rendered":"

\"\"<\/a>Two weeks, two companies, two press releases, two future HCV drugs that begin with “S”:<\/p>\n

    \n
  1. March 28, 2013:<\/a>\u00a0Janssen Research & Development\u00a0announced that\u00a0it has submitted a New Drug Application to the FDA seeking approval for simeprevir<\/strong> (TMC435), an investigational NS3\/4A protease inhibitor, administered as a 150 mg capsule once daily with pegylated interferon and ribavirin for the treatment of genotype 1 chronic\u00a0HCV in adult patients.<\/li>\n
  2. April 8, 2013:<\/a>\u00a0Gilead Sciences announced that it has submitted a New Drug Application to the FDA for approval of sofosbuvir<\/strong>, a once-daily oral nucleotide analogue for the treatment of chronic\u00a0HCV infection. The data submitted in this NDA support the use of sofosbuvir and ribavirin as an all-oral therapy for patients with genotype 2 and 3 HCV infection, and for sofosbuvir in combination with\u00a0ribavirin and pegylated interferon for treatment-na\u00efve patients with genotype 1, 4, 5 and 6 HCV infection.<\/li>\n<\/ol>\n

    For several years now, all clinicians who see patients with hepatitis C have been promising them better treatments “soon”, with admittedly little precision about exactly what this “soon” actually means.<\/p>\n

    But with these filings, we have a pretty good idea. It will be less than a year — maybe much<\/em> less. Why is that?<\/p>\n