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Abstract Details
Development of sofosbuvir for the treatment of hepatitis C virus infection
Lawitz E1, Jacobson IM2, Nelson DR3, Zeuzem S4, Sulkowski MS5, Esteban R6, Brainard D7, McNally J7, Symonds WT7, McHutchison JG7, Dieterich D8, Gane E9. Ann N Y Acad Sci. 2015 Jul 31. doi: 10.1111/nyas.12832. [Epub ahead of print]
Author information
1Texas Liver Institute, University of Texas Health Science Center, San Antonio, Texas.
2Icahn School of Medicine at Mount Sinai, New York, New York.
3University of Florida, Gainesville, Florida.
4Medical Center, Johann Wolfgang Goethe University, Frankfurt am Main, Germany.
5Johns Hopkins University School of Medicine, Baltimore, Maryland.
6Hospital Universitario Val d'Hebron, Barcelona, Spain.
7Gilead Sciences, Foster City, California.
8Mount Sinai School of Medicine, New York, New York.
9Auckland City Hospital, Auckland, New Zealand.
Abstract
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.