What is the role of sofosbuvir in the treatment of hepatitis C virus (HCV) infection?

Updated: Dec 09, 2020
  • Author: David C Wolf, MD, FACP, FACG, AGAF, FAASLD; Chief Editor: Michael Stuart Bronze, MD  more...
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Sofosbuvir is an orally administered nucleotide analogue inhibitor of the HCV NS5B polymerase. [11] It received FDA approval in December 2013 for use in patients infected with HCV genotypes 1, 2, 3, and 4. At that time, the FDA's approval of combination therapy with sofosbuvir and ribavirin for patients with genotypes 2 and 3 marked the first time that all-oral therapy was available for HCV-infected patients in the United States.

In October 2014, the FDA approved the first oral combination drug for chronic hepatitis C, ledipasvir/sofosbuvir (Harvoni). Ledipasvir was the first NS5A replication complex inhibitor to receive approval for use in the United States. Combination ledipasvir/sofosbuvir treatment of genotype 1 patients for 12 weeks was associated with an SVR of 96-99% in noncirrhotic patients and 94% in cirrhotic patients. An SVR of 97% was achieved when ledipasvir/sofosbuvir was administered for 8 weeks in patients with genotype 1 and a viral load below 6 million IU/mL. In previously treated patients, SVR rates of rates of 94% were seen in noncirrhotic patients who were treated with ledipasvir/sofosbuvir for 12 weeks and 99% in cirrhotic patients who were treated with ledipasvir/sofosbuvir for 24 weeks. [12, 13, 14] Ledipasvir/sofosbuvir subsequently received FDA approval for use in patients with genotypes 4, 5, and 6, patients with HCV/HIV coinfection; liver transplant recipients infected with genotype 1 or 4; and patients with genotype 1 and decompensated cirrhosis.

In November 2014, the FDA approved an all-oral regimen of simeprevir plus sofosbuvir for treatment-naïve or treatment-experienced patients (with or without cirrhosis). [15] The approval for simeprevir plus sofosbuvir was based on the COSMOS study, an open-label, randomized phase II clinical trial. For all patients (treatment-naïve and treatment-experienced, with or without cirrhosis), 93% achieved SVR12 after 12 weeks of treatment, and 97% achieved SVR12 after 24 weeks of treatment. [15]

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