Development of sofosbuvir for the treatment of hepatitis C virus infection

Eric Lawitz, Ira M. Jacobson, David R. Nelson, Stefan Zeuzem, Mark S. Sulkowski, Rafael Esteban, Diana Brainard, John Mcnally, William T. Symonds, John G. Mchutchison, Douglas Dieterich, Edward Gane

Research output: Contribution to journalArticlepeer-review

31 Scopus citations


The nucleotide analog NS5B polymerase inhibitor sofosbuvir was approved by the U.S. Food and Drug Administration (FDA) in December 2013 for the treatment of chronic hepatitis C virus (HCV) infection in combination with ribavirin or peginterferon and ribavirin. Sofosbuvir was developed to meet an urgent medical need for shorter, safer, simplified, more effective HCV treatment regimens and to reduce or eliminate the need for peginterferon. New treatment regimens were especially required for patient populations with limited treatment options, including patients who had failed prior HCV therapy, those with compensated and decompensated cirrhosis, and those who were either intolerant of or had contraindications to interferon. Sofosbuvir plus ribavirin for patients with genotype 2 or 3 HCV infection was the first approved all-oral treatment option. Sofosbuvir is also the backbone of the first regimen available for patients awaiting liver transplantation to prevent HCV recurrence, as well as the first oral interferon-free regimen for patients coinfected with HCV and HIV. This paper describes the development of sofosbuvir up to its original FDA approval.

Original languageEnglish (US)
Pages (from-to)56-67
Number of pages12
JournalAnnals of the New York Academy of Sciences
Issue number1
StatePublished - Nov 1 2015


  • Direct acting antivirals
  • Drug development
  • Hepatitis C
  • Sofosbuvir

ASJC Scopus subject areas

  • General Biochemistry, Genetics and Molecular Biology
  • General Neuroscience
  • History and Philosophy of Science


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