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Volumn 48, Issue 8, 2014, Pages 1019-1029

Sofosbuvir: A Nucleotide NS5B Inhibitor for the Treatment of Chronic Hepatitis C Infection

Author keywords

chronic hepatitis C infection; GS 7977; NS5B polymerase inhibitor; sofosbuvir

Indexed keywords

ANTIVIRUS AGENT; BOCEPREVIR; DACLATASVIR; INTERFERON; NONSTRUCTURAL PROTEIN 5B INHIBITOR; PEGINTERFERON; RIBAVIRIN; SIMEPREVIR; SOFOSBUVIR; TELAPREVIR; UNCLASSIFIED DRUG;

EID: 84904507580     PISSN: 10600280     EISSN: 15426270     Source Type: Journal    
DOI: 10.1177/1060028014534194     Document Type: Review
Times cited : (55)

References (70)
  • 1
    • 84904484626 scopus 로고    scopus 로고
    • World Health Organization. Global alert and response (GAR): hepatitis C Accessed April 17
    • World Health Organization. Global alert and response (GAR): hepatitis C. http://www.who.int/csr/disease/hepatitis/whocdscsrlyo2003/en/index4.html. Accessed April 17, 2014.
    • (2014)
  • 2
    • 84904484627 scopus 로고    scopus 로고
    • World Health Organization. Prevention and control of viral hepatitis infection: framework for global action Accessed April 17
    • World Health Organization. Prevention and control of viral hepatitis infection: framework for global action. http://www.who.int/csr/disease/hepatitis/GHP_Framework_En.pdf. Accessed April 17, 2014.
    • (2014)
  • 3
    • 33646852746 scopus 로고    scopus 로고
    • The prevalence of hepatitis C virus infection in the United States, 1999 through 2002
    • Armstrong GL,Wasley AM,Simard EP,et al.The prevalence of hepatitis C virus infection in the United States, 1999 through 2002.Ann Intern Med. 2006;144:705-714.
    • (2006) Ann Intern Med , vol.144 , pp. 705-714
    • Armstrong, G.L.1    Wasley, A.M.2    Simard, E.P.3
  • 4
    • 79961199944 scopus 로고    scopus 로고
    • Hepatitis C virus infection in USA: an estimate of true prevalence
    • Chak E,Talal AH,Sherman KE,Schiff ER,Saab S.Hepatitis C virus infection in USA: an estimate of true prevalence.Liver Int. 2011;31:1090-1101.
    • (2011) Liver Int , vol.31 , pp. 1090-1101
    • Chak, E.1    Talal, A.H.2    Sherman, K.E.3    Schiff, E.R.4    Saab, S.5
  • 5
    • 23944485662 scopus 로고    scopus 로고
    • Evasion of intracellular host defense by hepatitis C virus
    • Gale M,Foy EM.Evasion of intracellular host defense by hepatitis C virus.Nature. 2005;18:939-945.
    • (2005) Nature , vol.18 , pp. 939-945
    • Gale, M.1    Foy, E.M.2
  • 6
    • 84880285547 scopus 로고    scopus 로고
    • Regulation of hepatic innate immunity by hepatitis C virus
    • Horner SM,Gale M.Regulation of hepatic innate immunity by hepatitis C virus.Nat Med. 2013;19:879-888.
    • (2013) Nat Med , vol.19 , pp. 879-888
    • Horner, S.M.1    Gale, M.2
  • 7
    • 33748114343 scopus 로고    scopus 로고
    • The contributions of hepatitis B and hepatitis C virus infections to cirrhosis and primary liver cancer worldwide
    • Perz JF,Armstrong GL,Farrington LA,Hutin YJ,Bell BP.The contributions of hepatitis B and hepatitis C virus infections to cirrhosis and primary liver cancer worldwide.J Hepatol. 2006;45:529-538.
    • (2006) J Hepatol , vol.45 , pp. 529-538
    • Perz, J.F.1    Armstrong, G.L.2    Farrington, L.A.3    Hutin, Y.J.4    Bell, B.P.5
  • 8
    • 27644542713 scopus 로고    scopus 로고
    • Chronic hepatitis C: an age wave of disease burden
    • McHutchison JG,Bacon BR.Chronic hepatitis C: an age wave of disease burden.Am J Manag Care. 2005;11:S286-S295.
    • (2005) Am J Manag Care , vol.11
    • McHutchison, J.G.1    Bacon, B.R.2
  • 9
    • 79958717571 scopus 로고    scopus 로고
    • The global health burden of hepatitis C virus infection
    • Negro F,Alberti A.The global health burden of hepatitis C virus infection.Liver Int. 2011;31:1-3.
    • (2011) Liver Int , vol.31 , pp. 1-3
    • Negro, F.1    Alberti, A.2
  • 10
    • 68249154875 scopus 로고    scopus 로고
    • Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection
    • McHutchison JG,Lawitz EJ,Shiffman ML,et al.Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection.N Engl J Med. 2009;361:580-693.
    • (2009) N Engl J Med , vol.361 , pp. 580-693
    • McHutchison, J.G.1    Lawitz, E.J.2    Shiffman, M.L.3
  • 11
    • 1542378867 scopus 로고    scopus 로고
    • Peginterferon-alpha2a and ribavirin combination therapy in chronic hepatitis C: a randomized study of treatment duration and ribavirin dose
    • Hadziyannis SJ,Sette H,Morgan TR,et al.Peginterferon-alpha2a and ribavirin combination therapy in chronic hepatitis C: a randomized study of treatment duration and ribavirin dose.Ann Intern Med. 2004;140:346-355.
    • (2004) Ann Intern Med , vol.140 , pp. 346-355
    • Hadziyannis, S.J.1    Sette, H.2    Morgan, T.R.3
  • 12
    • 0035934568 scopus 로고    scopus 로고
    • Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomized trial
    • Manns MP,McHutchinson JG,Gordon SC,et al.Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomized trial.Lancet. 2001;358:958-965.
    • (2001) Lancet , vol.358 , pp. 958-965
    • Manns, M.P.1    McHutchinson, J.G.2    Gordon, S.C.3
  • 13
    • 79957597421 scopus 로고    scopus 로고
    • Telaprevir: an NS3/4A protease inhibitor for the treatment of chronic hepatitis C
    • Smith LS,Nelson M,Naik S,Woten J.Telaprevir: an NS3/4A protease inhibitor for the treatment of chronic hepatitis C.Ann Pharmacother. 2011;45:639-648.
    • (2011) Ann Pharmacother , vol.45 , pp. 639-648
    • Smith, L.S.1    Nelson, M.2    Naik, S.3    Woten, J.4
  • 14
    • 79953173221 scopus 로고    scopus 로고
    • SPRINT-2 Investigators. Boceprevir for untreated chronic HCV genotype 1 infection
    • Poordad F,McCone J,Bacon BR,et al.SPRINT-2 Investigators. Boceprevir for untreated chronic HCV genotype 1 infection.N Engl J Med. 2011;364:1195-1206.
    • (2011) N Engl J Med , vol.364 , pp. 1195-1206
    • Poordad, F.1    McCone, J.2    Bacon, B.R.3
  • 15
    • 80053339008 scopus 로고    scopus 로고
    • An update on treatment of genotype 1 chronic hepatitis C virus infection: 2011 practice guideline by the American Association for the Study of Liver Diseases
    • Ghany MG,Nelson DR,Strader DB,Thomas DL,Seeff LB.An update on treatment of genotype 1 chronic hepatitis C virus infection: 2011 practice guideline by the American Association for the Study of Liver Diseases.Hepatology. 2011;54:1433-1444.
    • (2011) Hepatology , vol.54 , pp. 1433-1444
    • Ghany, M.G.1    Nelson, D.R.2    Strader, D.B.3    Thomas, D.L.4    Seeff, L.B.5
  • 16
    • 79959438789 scopus 로고    scopus 로고
    • Telaprevir for previously untreated chronic hepatitis C virus infection
    • Jacobson IM,McHutchison JG,Dusheiko G,et al.Telaprevir for previously untreated chronic hepatitis C virus infection.N Engl J Med. 2011;364:2405-2416.
    • (2011) N Engl J Med , vol.364 , pp. 2405-2416
    • Jacobson, I.M.1    McHutchison, J.G.2    Dusheiko, G.3
  • 17
    • 84893780463 scopus 로고    scopus 로고
    • Virologic outcomes and adherence to treatment algorithms in a longitudinal study of patients with chronic hepatitis C treated with boceprevir (BOC) or telaprevir (TVR) in the United States (HCV-TARGET)
    • Di Bisceglie AM,Kuo A,Rustgi VK,et al.Virologic outcomes and adherence to treatment algorithms in a longitudinal study of patients with chronic hepatitis C treated with boceprevir (BOC) or telaprevir (TVR) in the United States (HCV-TARGET).Hepatology. 2013;58:227A-228A.
    • (2013) Hepatology , vol.58
    • Di Bisceglie, A.M.1    Kuo, A.2    Rustgi, V.K.3
  • 18
    • 84893701238 scopus 로고    scopus 로고
    • The clinical significance of drug drug interactions in the era of direct-acting anti-viral agents against chronic hepatitis C
    • Massoumy B,Port K,Calle Serrano B,et al.The clinical significance of drug drug interactions in the era of direct-acting anti-viral agents against chronic hepatitis C.Aliment Pharmacol Ther. 2013;38:1365-1372.
    • (2013) Aliment Pharmacol Ther , vol.38 , pp. 1365-1372
    • Massoumy, B.1    Port, K.2    Calle Serrano, B.3
  • 19
    • 79959381354 scopus 로고    scopus 로고
    • Telaprevir for retreatment of HCV infection
    • Zeuzem S,Andreone P,Pol S,et al.Telaprevir for retreatment of HCV infection.N Engl J Med. 2011;364:2417-2428.
    • (2011) N Engl J Med , vol.364 , pp. 2417-2428
    • Zeuzem, S.1    Andreone, P.2    Pol, S.3
  • 20
    • 77954646871 scopus 로고    scopus 로고
    • PSI-7851, a pronucleotide of beta-D-2′-deoxy-2′-fluoro-2′C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication
    • Lam AM,Murakami E,Espiritu C,et al.PSI-7851, a pronucleotide of beta-D-2′-deoxy-2′-fluoro-2′C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication.Antimicrob Agents Chemother. 2010;54:3187-3196.
    • (2010) Antimicrob Agents Chemother , vol.54 , pp. 3187-3196
    • Lam, A.M.1    Murakami, E.2    Espiritu, C.3
  • 21
    • 80052070428 scopus 로고    scopus 로고
    • The HCV NS5B nucleoside and non-nucleoside inhibitors
    • Membreno FE,Lawitz EJ.The HCV NS5B nucleoside and non-nucleoside inhibitors.Clin Liver Dis. 2011;15:611-626.
    • (2011) Clin Liver Dis , vol.15 , pp. 611-626
    • Membreno, F.E.1    Lawitz, E.J.2
  • 22
    • 84875200293 scopus 로고    scopus 로고
    • Sofosbuvir, a nucleotide polymerase inhibitor, for the treatment of chronic hepatitis C virus infection
    • Herbst DA,Reddy KR.Sofosbuvir, a nucleotide polymerase inhibitor, for the treatment of chronic hepatitis C virus infection.Expert Opin Investig Drugs. 2013;22:527-536.
    • (2013) Expert Opin Investig Drugs , vol.22 , pp. 527-536
    • Herbst, D.A.1    Reddy, K.R.2
  • 23
    • 84899047097 scopus 로고    scopus 로고
    • Sofosbuvir, a NS5B polymerase inhibitor in the treatment of hepatitis C: a review of its clinical potential
    • Stedman C.Sofosbuvir, a NS5B polymerase inhibitor in the treatment of hepatitis C: a review of its clinical potential.Ther Adv Gastroenterol. 2014;7:131-140.
    • (2014) Ther Adv Gastroenterol , vol.7 , pp. 131-140
    • Stedman, C.1
  • 24
    • 77957913871 scopus 로고    scopus 로고
    • Discovery of a β-d-2′-deoxy-2′-α-fluoro-2′-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus
    • Sofia MJ,Bao D,Chang W,et al.Discovery of a β-d-2′-deoxy-2′-α-fluoro-2′-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus.J Med Chem. 2010;53:7202-7218.
    • (2010) J Med Chem , vol.53 , pp. 7202-7218
    • Sofia, M.J.1    Bao, D.2    Chang, W.3
  • 25
    • 78049375232 scopus 로고    scopus 로고
    • Mechanism of activation of PSI-7851 and its diastereoisomer PSI-7977
    • Murakami E,Tolstykh T,Bao H,et al.Mechanism of activation of PSI-7851 and its diastereoisomer PSI-7977.J Biol Chem. 2010;285:34337-34347.
    • (2010) J Biol Chem , vol.285 , pp. 34337-34347
    • Murakami, E.1    Tolstykh, T.2    Bao, H.3
  • 26
    • 84861109960 scopus 로고    scopus 로고
    • Genotype and subtype profiling of PSI-7977 as a nucleotide inhibitor of hepatitis C virus
    • Lam AM,Espiritu C,Bansal S,et al.Genotype and subtype profiling of PSI-7977 as a nucleotide inhibitor of hepatitis C virus.Antimicrob Agents Chemother. 2012;56:3359-3368.
    • (2012) Antimicrob Agents Chemother , vol.56 , pp. 3359-3368
    • Lam, A.M.1    Espiritu, C.2    Bansal, S.3
  • 27
    • 84904484616 scopus 로고    scopus 로고
    • IFNL4-ΔG genotype is associated with slower viral clearance in hepatitis C, genotype-1 patients treated with sofosbuvir and ribavirin
    • Meissner EG,Bon D,Prokunina-Olsson L,et al.IFNL4-ΔG genotype is associated with slower viral clearance in hepatitis C, genotype-1 patients treated with sofosbuvir and ribavirin.J Infect Dis.
    • J Infect Dis
    • Meissner, E.G.1    Bon, D.2    Prokunina-Olsson, L.3
  • 28
    • 84879602208 scopus 로고    scopus 로고
    • Comprehensive resistance testing in patients who relapsed after treatment with sofosbuvir (GS-7997) containing regimens in phase 2 studies [abstract no. 753]
    • Svarovskaia ES,Dvory-Sobol H,Gontcharova V,et al.Comprehensive resistance testing in patients who relapsed after treatment with sofosbuvir (GS-7997) containing regimens in phase 2 studies [abstract no. 753].Hepatology. 2012;56:551A.
    • (2012) Hepatology , vol.56
    • Svarovskaia, E.S.1    Dvory-Sobol, H.2    Gontcharova, V.3
  • 29
    • 84893786201 scopus 로고    scopus 로고
    • No resistance in four phase 3 clinical studies in HCV genotype 1-6 of sofosbuvir + ribavirin with or without peginterferon
    • Svarovskaia ES,Dvory HS,Hebner C,et al.No resistance in four phase 3 clinical studies in HCV genotype 1-6 of sofosbuvir + ribavirin with or without peginterferon.Hepatology. 2013;58:1091A-1092A.
    • (2013) Hepatology , vol.58
    • Svarovskaia, E.S.1    Dvory, H.S.2    Hebner, C.3
  • 30
    • 84876740954 scopus 로고    scopus 로고
    • Sofosbuvir in combination with peginterferon alfa-2a and ribavirin for non-cirrhotic, treatment-naïve patients with genotypes 1, 2, and 3 hepatitis C infection: a randomized, double-blind, phase 2 trial [PROTON]
    • Lawitz E,Lalezar JP,Hassanein T,et al.Sofosbuvir in combination with peginterferon alfa-2a and ribavirin for non-cirrhotic, treatment-naïve patients with genotypes 1, 2, and 3 hepatitis C infection: a randomized, double-blind, phase 2 trial [PROTON].Lancet Infect Dis. 2013;13:401-408.
    • (2013) Lancet Infect Dis , vol.13 , pp. 401-408
    • Lawitz, E.1    Lalezar, J.P.2    Hassanein, T.3
  • 31
    • 84871814966 scopus 로고    scopus 로고
    • Nucleotide polymerase inhibitor sofosbuvir plus ribavirin for hepatitis C [ELECTRON PHASE 1]
    • Gane EJ,Stedman CA,Hyland RH,et al.Nucleotide polymerase inhibitor sofosbuvir plus ribavirin for hepatitis C [ELECTRON PHASE 1].N Engl J Med. 2013;368:34-44.
    • (2013) N Engl J Med , vol.368 , pp. 34-44
    • Gane, E.J.1    Stedman, C.A.2    Hyland, R.H.3
  • 32
    • 84878976866 scopus 로고    scopus 로고
    • Sofosbuvir with pegylated interferon alfa-2a and ribavirin for treatment-naïve patients with hepatitis C genotype-1 infection (ATOMIC): an open-label, randomized, multicentre phase 2 trial
    • Kowdley KK,Lawitz E,Crespo I,et al.Sofosbuvir with pegylated interferon alfa-2a and ribavirin for treatment-naïve patients with hepatitis C genotype-1 infection (ATOMIC): an open-label, randomized, multicentre phase 2 trial.Lancet. 2013;381:2100-2107.
    • (2013) Lancet , vol.381 , pp. 2100-2107
    • Kowdley, K.K.1    Lawitz, E.2    Crespo, I.3
  • 33
    • 84877730954 scopus 로고    scopus 로고
    • Sofosbuvir for previously untreated chronic hepatitis C infection
    • Lawitz E,Mangia A,Wyles D,et al.Sofosbuvir for previously untreated chronic hepatitis C infection.N Engl J Med. 2013;368:1878-1887.
    • (2013) N Engl J Med , vol.368 , pp. 1878-1887
    • Lawitz, E.1    Mangia, A.2    Wyles, D.3
  • 34
    • 84877739274 scopus 로고    scopus 로고
    • Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options
    • Jacobson IM,Gordon SC,Kowdley KV,et al.Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options.N Engl J Med. 2013;368:1867-1877.
    • (2013) N Engl J Med , vol.368 , pp. 1867-1877
    • Jacobson, I.M.1    Gordon, S.C.2    Kowdley, K.V.3
  • 35
    • 84895757657 scopus 로고    scopus 로고
    • In vitro analyses of HCV NS5B S282T mutants in multiple HCV genotypes show low levels of reduced susceptibility to sofosbuvir (GS-7977), no cross resistance to other classes of direct-acting antivirals, and hypersensitivity to ribavirin
    • Han B,Mo H,Wong KA.In vitro analyses of HCV NS5B S282T mutants in multiple HCV genotypes show low levels of reduced susceptibility to sofosbuvir (GS-7977), no cross resistance to other classes of direct-acting antivirals, and hypersensitivity to ribavirin.Hepatology. 2012;56:711A-712A.
    • (2012) Hepatology , vol.56
    • Han, B.1    Mo, H.2    Wong, K.A.3
  • 36
    • 84893793538 scopus 로고    scopus 로고
    • Sofosbuvir selects the NS5B S282T mutation in vitro in genotype 1-6 replicons and is not cross-resistant to resistance associated variants selected by other classes of antiviral inhibitors
    • Rajyaguru S,Xu S,Hebner C,et al.Sofosbuvir selects the NS5B S282T mutation in vitro in genotype 1-6 replicons and is not cross-resistant to resistance associated variants selected by other classes of antiviral inhibitors.Hepatology. 2013;58:739A.
    • (2013) Hepatology , vol.58
    • Rajyaguru, S.1    Xu, S.2    Hebner, C.3
  • 37
    • 84874063173 scopus 로고    scopus 로고
    • Pharmacokinetics, safety and tolerability of GS-9851, a nucleotide analog polymerase inhibitor for hepatitis C virus, following single ascending doses in healthy subjects
    • Denning J,Cornpropst M,Flach SD,Berrey MM,Symonds WT.Pharmacokinetics, safety and tolerability of GS-9851, a nucleotide analog polymerase inhibitor for hepatitis C virus, following single ascending doses in healthy subjects.Antimicrob Agents Chemother. 2013;57:1201-1208.
    • (2013) Antimicrob Agents Chemother , vol.57 , pp. 1201-1208
    • Denning, J.1    Cornpropst, M.2    Flach, S.D.3    Berrey, M.M.4    Symonds, W.T.5
  • 38
    • 84874043353 scopus 로고    scopus 로고
    • Pharmacokinetics, pharmacodynamics, and tolerability of GS-9851, a nucleotide analog polymerase inhibitor, following multiple ascending doses in patients with chronic hepatitis C infection
    • Lawitz E,Rodriguez-Torres M,Denning J,et al.Pharmacokinetics, pharmacodynamics, and tolerability of GS-9851, a nucleotide analog polymerase inhibitor, following multiple ascending doses in patients with chronic hepatitis C infection.Antimicrob. Agents Chemother. 2013;57:1209-1217.
    • (2013) Antimicrob. Agents Chemother , vol.57 , pp. 1209-1217
    • Lawitz, E.1    Rodriguez-Torres, M.2    Denning, J.3
  • 39
    • 84872045267 scopus 로고    scopus 로고
    • The effect of hepatic impairment on the pharmacokinetics and antiviral activity of PSI-7977 in hepatitis C infected subjects treated for seven days [abstract 1130]
    • Lawitz E,Rodriguez-Torres M,Cornpropst MT,et al.The effect of hepatic impairment on the pharmacokinetics and antiviral activity of PSI-7977 in hepatitis C infected subjects treated for seven days [abstract 1130].J Hepatol. 2012;56:S445-S446.
    • (2012) J Hepatol , vol.56
    • Lawitz, E.1    Rodriguez-Torres, M.2    Cornpropst, M.T.3
  • 40
    • 84871213049 scopus 로고    scopus 로고
    • The effect of renal impairment and end stage renal disease on the single-dose pharmacokinetics of PSI-7977
    • Cornpropst MT,Denning JM,Clemons D,et al.The effect of renal impairment and end stage renal disease on the single-dose pharmacokinetics of PSI-7977.J Hepatol. 2012;56:S433.
    • (2012) J Hepatol , vol.56
    • Cornpropst, M.T.1    Denning, J.M.2    Clemons, D.3
  • 41
    • 84870169549 scopus 로고    scopus 로고
    • Predictors of response to chronic hepatitis C treatment
    • Ridruejo E.Predictors of response to chronic hepatitis C treatment.Future Virol. 2012;7:1089-1101.
    • (2012) Future Virol , vol.7 , pp. 1089-1101
    • Ridruejo, E.1
  • 42
    • 79953741413 scopus 로고    scopus 로고
    • Sustained virologic response to antiviral therapy for chronic hepatitis C virus infection: a cure and so much more
    • Pearlman BL,Traub N.Sustained virologic response to antiviral therapy for chronic hepatitis C virus infection: a cure and so much more.Clin Infect Dis. 2011;52:889-900.
    • (2011) Clin Infect Dis , vol.52 , pp. 889-900
    • Pearlman, B.L.1    Traub, N.2
  • 43
    • 84877782905 scopus 로고    scopus 로고
    • Earlier sustained virologic response end points for regulatory approval and dose selection of hepatitis C therapies
    • Chen J,Florian J,Carter W,et al.Earlier sustained virologic response end points for regulatory approval and dose selection of hepatitis C therapies.Gastroenterology. 2013;144:1450-1455.
    • (2013) Gastroenterology , vol.144 , pp. 1450-1455
    • Chen, J.1    Florian, J.2    Carter, W.3
  • 44
    • 84904484617 scopus 로고    scopus 로고
    • US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). Guidance for Industry. Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment. Rockville, MD: US FDA CDER; 2013 Accessed February 10
    • US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). Guidance for Industry. Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment. Rockville, MD: US FDA CDER; 2013. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM225333.pdf. Accessed February 10, 2014.
    • (2014)
  • 45
    • 84880964894 scopus 로고    scopus 로고
    • Sofosbuvir (GS-7977) plus peginterferon/ribavirin in treatment-naïve patients with HCV genotype 1: a randomized, 28-day, dose-ranging trial
    • Rodriguez-Torres M,Lawitz E,Kowdley KV,et al.Sofosbuvir (GS-7977) plus peginterferon/ribavirin in treatment-naïve patients with HCV genotype 1: a randomized, 28-day, dose-ranging trial.J Hepatol. 2013;58:663-668.
    • (2013) J Hepatol , vol.58 , pp. 663-668
    • Rodriguez-Torres, M.1    Lawitz, E.2    Kowdley, K.V.3
  • 46
    • 66149128046 scopus 로고    scopus 로고
    • GT-1a or GT-1b subtype-specific resistance profiles for hepatitis C virus inhibitors telaprevir and HCV-796
    • McCown MF,Rajyaguru S,Kular S,Cammack N,Najera I.GT-1a or GT-1b subtype-specific resistance profiles for hepatitis C virus inhibitors telaprevir and HCV-796.Antimicrob Agents Chemother. 2009;53:2129-2132.
    • (2009) Antimicrob Agents Chemother , vol.53 , pp. 2129-2132
    • McCown, M.F.1    Rajyaguru, S.2    Kular, S.3    Cammack, N.4    Najera, I.5
  • 47
    • 84894297488 scopus 로고    scopus 로고
    • Efficacy of nucleotide polymerase inhibitor sofosbuvir plus the NS5A inhibitor ledipasvir or the NS5B non-nucleoside inhibitor GS-9669 against HCV genotype 1 infection [ELECTRON PHASE 2]
    • Gane EJ,Stedman CA,Hyland RH,et al.Efficacy of nucleotide polymerase inhibitor sofosbuvir plus the NS5A inhibitor ledipasvir or the NS5B non-nucleoside inhibitor GS-9669 against HCV genotype 1 infection [ELECTRON PHASE 2].Gastroenterology. 2014;146:736-743.
    • (2014) Gastroenterology , vol.146 , pp. 736-743
    • Gane, E.J.1    Stedman, C.A.2    Hyland, R.H.3
  • 48
    • 84894621765 scopus 로고    scopus 로고
    • Sofosbuvir and ledipasvir fixed-dose combination with and without ribaviran in treatment-naïve and previously treated patients with genotype 1 hepatitis C virus infection (LONESTAR): an open-label, randomized, phase 2 trial
    • Lawitz E,Poordad FF,Pang PS,et al.Sofosbuvir and ledipasvir fixed-dose combination with and without ribaviran in treatment-naïve and previously treated patients with genotype 1 hepatitis C virus infection (LONESTAR): an open-label, randomized, phase 2 trial.Lancet. 2014;383:515-523.
    • (2014) Lancet , vol.383 , pp. 515-523
    • Lawitz, E.1    Poordad, F.F.2    Pang, P.S.3
  • 49
    • 84895736477 scopus 로고    scopus 로고
    • SVR results of a once-daily regimen of simeprevir (TMC435) plus sofosbuvir (GS-7977) with or without ribavirin in cirrhotic and non-cirrhotic HCV genotype 1 treatment-naïve and prior null responder patients: The COSMOS study
    • Program and Abstracts of the 64th Annual Meeting of the American Association for the Study of Liver Diseases; Washington, DC; 2013
    • Jacobson I,Ghalib RH,Rodriguez-Torres M,et al.SVR results of a once-daily regimen of simeprevir (TMC435) plus sofosbuvir (GS-7977) with or without ribavirin in cirrhotic and non-cirrhotic HCV genotype 1 treatment-naïve and prior null responder patients: The COSMOS study. Program and Abstracts of the 64th Annual Meeting of the American Association for the Study of Liver Diseases; 2013Washington, DC; 2013.
    • (2013)
    • Jacobson, I.1    Ghalib, R.H.2    Rodriguez-Torres, M.3
  • 50
    • 84892619580 scopus 로고    scopus 로고
    • Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection
    • Sulkowski MS,Gardiner DF,Rodriguez-Torres M,et al.Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection.N Engl J Med. 2014;370:211-221.
    • (2014) N Engl J Med , vol.370 , pp. 211-221
    • Sulkowski, M.S.1    Gardiner, D.F.2    Rodriguez-Torres, M.3
  • 51
    • 84892751187 scopus 로고    scopus 로고
    • Sofosbuvir + ribavirin for 12 or 24 weeks for patients with HCV genotype 2 or 3: the VALENCE trial
    • Zeuzem S,Dusheiko GM,Salupere R,et al.Sofosbuvir + ribavirin for 12 or 24 weeks for patients with HCV genotype 2 or 3: the VALENCE trial.Hepatology. 2013;58:733A-734A.
    • (2013) Hepatology , vol.58
    • Zeuzem, S.1    Dusheiko, G.M.2    Salupere, R.3
  • 52
    • 84886411535 scopus 로고    scopus 로고
    • Lack of effect of the nucleotide analog polymerase inhibitor PSI-7997 on methadone pharmacokinetics and pharmacodynamics
    • Denning JM,Cornpropst M,Clemons D,et al.Lack of effect of the nucleotide analog polymerase inhibitor PSI-7997 on methadone pharmacokinetics and pharmacodynamics.Hepatology. 2011;54:544A.
    • (2011) Hepatology , vol.54
    • Denning, J.M.1    Cornpropst, M.2    Clemons, D.3
  • 53
    • 84895746948 scopus 로고    scopus 로고
    • Lack of a clinically significant pharmacokinetic drug drug interaction between sofosbuvir and GS-5816 in healthy volunteers
    • Mogalian E,German P,Brainard DM,et al.Lack of a clinically significant pharmacokinetic drug drug interaction between sofosbuvir and GS-5816 in healthy volunteers.Hepatology. 2013;58:431A.
    • (2013) Hepatology , vol.58
    • Mogalian, E.1    German, P.2    Brainard, D.M.3
  • 54
    • 84895754580 scopus 로고    scopus 로고
    • Lack of clinically significant pharmacokinetic drug-drug interaction between sofosbuvir (GS-7977) and GS-5885 or GS9669 in healthy volunteers
    • German P,Mathias A,Pang PS,et al.Lack of clinically significant pharmacokinetic drug-drug interaction between sofosbuvir (GS-7977) and GS-5885 or GS9669 in healthy volunteers.Hepatology. 2012;56:1072A-1073A.
    • (2012) Hepatology , vol.56
    • German, P.1    Mathias, A.2    Pang, P.S.3
  • 55
    • 84885328446 scopus 로고    scopus 로고
    • No clinically significant pharmacokinetic drug interactions between sofosbuvir (GS-7977) and HIV antiretrovirals Atripla®, rilpivirine, darunavir/ritonavir or raltegravir in healthy volunteers
    • Kirby B,Mathias A,Rossi S,Moyer C,Shen G,Kearny BP.No clinically significant pharmacokinetic drug interactions between sofosbuvir (GS-7977) and HIV antiretrovirals Atripla®, rilpivirine, darunavir/ritonavir or raltegravir in healthy volunteers.Hepatology. 2012;56:1067A.
    • (2012) Hepatology , vol.56
    • Kirby, B.1    Mathias, A.2    Rossi, S.3    Moyer, C.4    Shen, G.5    Kearny, B.P.6
  • 56
    • 84885319302 scopus 로고    scopus 로고
    • No clinically significant pharmacokinetic drug-drug interactions between sofosbuvir (GS-7997) and the immunosuppressants, cyclosporine A or tacrolimus in healthy volunteers
    • Mathias A,Cornpropst M,Clemons D,Denning J,Symonds WT.No clinically significant pharmacokinetic drug-drug interactions between sofosbuvir (GS-7997) and the immunosuppressants, cyclosporine A or tacrolimus in healthy volunteers.Hepatology. 2012;56:1063A-1064A.
    • (2012) Hepatology , vol.56
    • Mathias, A.1    Cornpropst, M.2    Clemons, D.3    Denning, J.4    Symonds, W.T.5
  • 57
    • 84895729593 scopus 로고    scopus 로고
    • Lack of clinically important pharmacokinetic interaction norgestimate/ethinyl estradiol and sofosbuvir (SOF) or ledipasvir (LDV) in HCV-uninfected female subjects
    • German P,Moorehead L,Pang PS,Vimal M,Mathias A.Lack of clinically important pharmacokinetic interaction norgestimate/ethinyl estradiol and sofosbuvir (SOF) or ledipasvir (LDV) in HCV-uninfected female subjects.Hepatology. 2013;58:433A.
    • (2013) Hepatology , vol.58
    • German, P.1    Moorehead, L.2    Pang, P.S.3    Vimal, M.4    Mathias, A.5
  • 58
    • 84969286477 scopus 로고    scopus 로고
    • Foster City, CA: Gilead Sciences, Inc
    • Foster City, CA: Gilead Sciences, Inc. 2013;:.
    • (2013)
  • 59
    • 84892737595 scopus 로고    scopus 로고
    • All oral therapy with sofosbuvir plus ribavirin for the treatment of HCV genotype 1, 2, and 3 infection in patients co-infected with HIV (PHOTON-1)
    • Sulkowski MS,Rodriguez-Torres M,Lalezari JP,et al.All oral therapy with sofosbuvir plus ribavirin for the treatment of HCV genotype 1, 2, and 3 infection in patients co-infected with HIV (PHOTON-1).Hepatology. 2013;58:313A-314A.
    • (2013) Hepatology , vol.58
    • Sulkowski, M.S.1    Rodriguez-Torres, M.2    Lalezari, J.P.3
  • 60
    • 70449094345 scopus 로고    scopus 로고
    • Transplantation in the patient with hepatitis C
    • Dominguez-Gil B,Morales JM.Transplantation in the patient with hepatitis C.Transpl Int. 2009;22:1117-1131.
    • (2009) Transpl Int , vol.22 , pp. 1117-1131
    • Dominguez-Gil, B.1    Morales, J.M.2
  • 61
    • 58849128803 scopus 로고    scopus 로고
    • The natural history of recurrent hepatitis C and what influences this
    • Gane EJ.The natural history of recurrent hepatitis C and what influences this.Liver Transpl. 2008;14:S36-S44.
    • (2008) Liver Transpl , vol.14
    • Gane, E.J.1
  • 62
    • 84892718437 scopus 로고    scopus 로고
    • Pre-transplant sofosbuvir and ribavirin to prevent recurrence of HCV infection after liver transplantation
    • Curry MP,Forns X,Chung RT,et al.Pre-transplant sofosbuvir and ribavirin to prevent recurrence of HCV infection after liver transplantation.Hepatology. 2013;58:314A-315A.
    • (2013) Hepatology , vol.58
    • Curry, M.P.1    Forns, X.2    Chung, R.T.3
  • 63
    • 84893735355 scopus 로고    scopus 로고
    • Initial evaluation of the sofosbuvir compassionate use program for patients with severe recurrent HCV following liver transplantation
    • Forns X,Fontana RJ,Moonka D,et al.Initial evaluation of the sofosbuvir compassionate use program for patients with severe recurrent HCV following liver transplantation.Hepatology. 2013;58:732A-733A.
    • (2013) Hepatology , vol.58
    • Forns, X.1    Fontana, R.J.2    Moonka, D.3
  • 64
    • 84904484619 scopus 로고    scopus 로고
    • Sofosbuvir and ribavirin for the treatment of established recurrent hepatitis C infection after liver transplantation: preliminary results of a prospective multi-center study
    • Program and abstracts of the 64th Annual Meeting of the American Association for the Study of Liver Diseases; Washington, DC; 2013
    • Charlton MR,Gane EJ,Manns MP,et al.Sofosbuvir and ribavirin for the treatment of established recurrent hepatitis C infection after liver transplantation: preliminary results of a prospective multi-center study. Program and abstracts of the 64th Annual Meeting of the American Association for the Study of Liver Diseases; 2013Washington, DC; 2013.
    • (2013)
    • Charlton, M.R.1    Gane, E.J.2    Manns, M.P.3
  • 65
    • 84857144025 scopus 로고    scopus 로고
    • The increasing burden of mortality from viral hepatitis in the United States between 1999 and 2007
    • Ly KN,Xing J,Klevins RM,Jiles RB,Ward JW,Holmberg SD.The increasing burden of mortality from viral hepatitis in the United States between 1999 and 2007.Ann Intern Med. 2012;156:271-278.
    • (2012) Ann Intern Med , vol.156 , pp. 271-278
    • Ly, K.N.1    Xing, J.2    Klevins, R.M.3    Jiles, R.B.4    Ward, J.W.5    Holmberg, S.D.6
  • 66
    • 84863116884 scopus 로고    scopus 로고
    • New protease inhibitors for the treatment of chronic hepatitis C: a cost-effectiveness analysis
    • Liu S,Cipriano LE,Holodniy M,Owens DK,Goldhaber-Fiebert JD.New protease inhibitors for the treatment of chronic hepatitis C: a cost-effectiveness analysis.Ann Intern Med. 2012;156:279-290.
    • (2012) Ann Intern Med , vol.156 , pp. 279-290
    • Liu, S.1    Cipriano, L.E.2    Holodniy, M.3    Owens, D.K.4    Goldhaber-Fiebert, J.D.5
  • 67
    • 84904484620 scopus 로고    scopus 로고
    • Gilead. US Food and Drug Administration Approves Gilead's Sovaldi™ (sofosbuvir) for the treatment of chronic hepatitis C Accessed December 6
    • Gilead. US Food and Drug Administration Approves Gilead's Sovaldi™ (sofosbuvir) for the treatment of chronic hepatitis C. http://www.gilead.com/news/press-releases/2013/12/us-food-and-drug-administration-approves-gileads-sovaldi-sofosbuvir-for-the-treatment-of-chronic-hepatitis-c#sthash.T9uTbSWK.dpuf. Accessed December 6, 2013.
    • (2013)
  • 68
    • 84904484621 scopus 로고    scopus 로고
    • Cost analysis of sofosbuvir/ribavirin versus sofosbuvir/simeprevir for genotype 1 HCV in interferon ineligible/intolerant individuals
    • Hagan LM,Sulkowski MS,Schinazi RF.Cost analysis of sofosbuvir/ribavirin versus sofosbuvir/simeprevir for genotype 1 HCV in interferon ineligible/intolerant individuals.Hepatology.
    • Hepatology
    • Hagan, L.M.1    Sulkowski, M.S.2    Schinazi, R.F.3
  • 69
    • 84904484622 scopus 로고    scopus 로고
    • Cost-effectiveness of sofosbuvir-based triple therapy for untreated patients with genotype 1 chronic hepatitis C
    • Petta S,Cabibbo G,Enea M,et al.Cost-effectiveness of sofosbuvir-based triple therapy for untreated patients with genotype 1 chronic hepatitis C.Hepatology.
    • Hepatology
    • Petta, S.1    Cabibbo, G.2    Enea, M.3
  • 70
    • 84904484611 scopus 로고    scopus 로고
    • AASLD and IDSA. Recommendations for testing, managing, and treating hepatitis C Accessed February 1
    • AASLD and IDSA. Recommendations for testing, managing, and treating hepatitis C. http://www.hcvguidelines.org/full-report/initial-treatment-hcv-infection-patients-starting-treatment. Accessed February 1, 2013.
    • (2013)


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