Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options

Ira M. Jacobson, Stuart C. Gordon, Kris V. Kowdley, Eric M. Yoshida, Maribel Rodriguez-Torres, Mark Sulkowski, Mitchell L. Shiffman, Eric Lawitz, Gregory Everson, Michael Bennett, Eugene Schiff, M. Tarek Al-Assi, G. Mani Subramanian, Di An, Ming Lin, John McNally, Diana Brainard, William T. Symonds, John G. McHutchison, Keyur PatelJordan Feld, Stephen Pianko, David R. Nelson

Research output: Contribution to journalArticle

Abstract

BACKGROUND: Patients chronically infected with hepatitis C virus (HCV) genotype 2 or 3 for whom treatment with peginterferon is not an option, or who have not had a response to prior interferon treatment, currently have no approved treatment options. In phase 2 trials, regimens including the oral nucleotide polymerase inhibitor sofosbuvir have shown efficacy in patients with HCV genotype 2 or 3 infection. METHODS: We conducted two randomized, phase 3 studies involving patients with chronic HCV genotype 2 or 3 infection. In one trial, patients for whom treatment with peginterferon was not an option received oral sofosbuvir and ribavirin (207 patients) or matching placebo (71) for 12 weeks. In a second trial, patients who had not had a response to prior interferon therapy received sofosbuvir and ribavirin for 12 weeks (103 patients) or 16 weeks (98). The primary end point was a sustained virologic response at 12 weeks after therapy. RESULTS: Among patients for whom treatment with peginterferon was not an option, the rate of a sustained virologic response was 78% (95% confidence interval [CI], 72 to 83) with sofosbuvir and ribavirin, as compared with 0% with placebo (P

Original languageEnglish (US)
Pages (from-to)1867-1877
Number of pages11
JournalNew England Journal of Medicine
Volume368
Issue number20
DOIs
StatePublished - May 16 2013

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Hepatitis C
Genotype
Ribavirin
Hepacivirus
Therapeutics
Interferons
Placebos
Sofosbuvir
Chronic Hepatitis C
Infection
Nucleotides
Confidence Intervals

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Jacobson, I. M., Gordon, S. C., Kowdley, K. V., Yoshida, E. M., Rodriguez-Torres, M., Sulkowski, M., ... Nelson, D. R. (2013). Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options. New England Journal of Medicine, 368(20), 1867-1877. https://doi.org/10.1056/NEJMoa1214854

Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options. / Jacobson, Ira M.; Gordon, Stuart C.; Kowdley, Kris V.; Yoshida, Eric M.; Rodriguez-Torres, Maribel; Sulkowski, Mark; Shiffman, Mitchell L.; Lawitz, Eric; Everson, Gregory; Bennett, Michael; Schiff, Eugene; Al-Assi, M. Tarek; Subramanian, G. Mani; An, Di; Lin, Ming; McNally, John; Brainard, Diana; Symonds, William T.; McHutchison, John G.; Patel, Keyur; Feld, Jordan; Pianko, Stephen; Nelson, David R.

In: New England Journal of Medicine, Vol. 368, No. 20, 16.05.2013, p. 1867-1877.

Research output: Contribution to journalArticle

Jacobson, IM, Gordon, SC, Kowdley, KV, Yoshida, EM, Rodriguez-Torres, M, Sulkowski, M, Shiffman, ML, Lawitz, E, Everson, G, Bennett, M, Schiff, E, Al-Assi, MT, Subramanian, GM, An, D, Lin, M, McNally, J, Brainard, D, Symonds, WT, McHutchison, JG, Patel, K, Feld, J, Pianko, S & Nelson, DR 2013, 'Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options', New England Journal of Medicine, vol. 368, no. 20, pp. 1867-1877. https://doi.org/10.1056/NEJMoa1214854
Jacobson IM, Gordon SC, Kowdley KV, Yoshida EM, Rodriguez-Torres M, Sulkowski M et al. Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options. New England Journal of Medicine. 2013 May 16;368(20):1867-1877. https://doi.org/10.1056/NEJMoa1214854
Jacobson, Ira M. ; Gordon, Stuart C. ; Kowdley, Kris V. ; Yoshida, Eric M. ; Rodriguez-Torres, Maribel ; Sulkowski, Mark ; Shiffman, Mitchell L. ; Lawitz, Eric ; Everson, Gregory ; Bennett, Michael ; Schiff, Eugene ; Al-Assi, M. Tarek ; Subramanian, G. Mani ; An, Di ; Lin, Ming ; McNally, John ; Brainard, Diana ; Symonds, William T. ; McHutchison, John G. ; Patel, Keyur ; Feld, Jordan ; Pianko, Stephen ; Nelson, David R. / Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options. In: New England Journal of Medicine. 2013 ; Vol. 368, No. 20. pp. 1867-1877.
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AU - Gordon, Stuart C.

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AU - Rodriguez-Torres, Maribel

AU - Sulkowski, Mark

AU - Shiffman, Mitchell L.

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AU - Symonds, William T.

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AU - Pianko, Stephen

AU - Nelson, David R.

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N2 - BACKGROUND: Patients chronically infected with hepatitis C virus (HCV) genotype 2 or 3 for whom treatment with peginterferon is not an option, or who have not had a response to prior interferon treatment, currently have no approved treatment options. In phase 2 trials, regimens including the oral nucleotide polymerase inhibitor sofosbuvir have shown efficacy in patients with HCV genotype 2 or 3 infection. METHODS: We conducted two randomized, phase 3 studies involving patients with chronic HCV genotype 2 or 3 infection. In one trial, patients for whom treatment with peginterferon was not an option received oral sofosbuvir and ribavirin (207 patients) or matching placebo (71) for 12 weeks. In a second trial, patients who had not had a response to prior interferon therapy received sofosbuvir and ribavirin for 12 weeks (103 patients) or 16 weeks (98). The primary end point was a sustained virologic response at 12 weeks after therapy. RESULTS: Among patients for whom treatment with peginterferon was not an option, the rate of a sustained virologic response was 78% (95% confidence interval [CI], 72 to 83) with sofosbuvir and ribavirin, as compared with 0% with placebo (P

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