140
Views
14
CrossRef citations to date
0
Altmetric
Review

Simeprevir for the treatment of hepatitis C virus infection

, , , , &
Pages 241-249 | Published online: 14 Aug 2014

References

  • LavanchyDThe global burden of hepatitis CLiver Int200929Suppl 1748119207969
  • JacobsonIMMcHutchisonJGDusheikoGADVANCE Study TeamTelaprevir for previously untreated chronic hepatitis C virus infectionN Engl J Med2011364252405241621696307
  • ZeuzemSAndreonePPolSREALIZE Study TeamTelaprevir for retreatment of HCV infectionN Engl J Med2011364252417242821696308
  • BaconBRGordonSCLawitzEHCV RESPOND-2 InvestigatorsBoceprevir for previously treated chronic HCV genotype 1 infectionN Engl J Med2011364131207121721449784
  • PoordadFMcConeJJrBaconBRSPRINT-2 InvestigatorsBoceprevir for untreated chronic HCV genotype 1 infectionN Engl J Med2011364131195120621449783
  • HayashiNSetoCKatoMKomadaYGotoSOnce-daily simeprevir (TMC435) with peginterferon/ribavirin for treatment-naïve hepatitis C genotype 1-infected patients in Japan: the DRAGON studyJ Gastroenterol201449113814724005956
  • BunchorntavakulCChavalitdhamrongDTanwandeeTHepatitis C genotype 6: a concise review and response-guided therapy proposalWorld J Hepatol20135949650424073301
  • FriedMWShiffmanMLReddyKRPeginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infectionN Engl J Med20023471397598212324553
  • McHutchisonJGLawitzEJShiffmanMLIDEAL Study TeamPeginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infectionN Engl J Med2009361658059319625712
  • AsselahTMarcellinPDirect acting antivirals for the treatment of chronic hepatitis C: one pill a day for tomorrowLiver Int201232Suppl 18810222212578
  • SarrazinCHézodeCZeuzemSPawlotskyJMAntiviral strategies in hepatitis C virus infectionJ Hepatol201256Suppl 1S88S10022300469
  • KimCWChangKMHepatitis C virus: virology and life cycleClin Mol Hepatol2013191172523593605
  • BartenschlagerRLohmannVPeninFThe molecular and structural basis of advanced antiviral therapy for hepatitis C virus infectionNat Rev Microbiol201311748249623748342
  • LiangYIshidaHLenzOAntiviral suppression vs restoration of RIG-I signaling by hepatitis C protease and polymerase inhibitorsGastroenterology2008135517101718. e218725224
  • SarrazinCZeuzemSResistance to direct antiviral agents in patients with hepatitis C virus infectionGastroenterology2010138244746220006612
  • LinTILenzOFanningGIn vitro activity and preclinical profile of TMC435350, a potent hepatitis C virus protease inhibitorAntimicrob Agents Chemother20095341377138519171797
  • LenzOVijgenLMorenoCVirologic response and characterization of HCV genotypes 2 to 6 under TMC435 monotherapy (study TMC435-C202)Poster presented at: International Workshop on HIV and Hepatitis Virus Drug Resistance and Curative StrategiesJune 7–11, 2011Los Cabos, Mexico Poster 16
  • TanwarSTremblingPMDusheikoGMTMC435 for the treatment of chronic hepatitis CExpert Opin Investig Drugs201221811931209
  • HuismanMTSnoeysJMonbaliuJIn vitro studies investigating the mechanism of interaction between TMC435 and hepatic transportersPoster presented at: 61st Annual Meeting of the American Association for the Study of Liver DiseasesOctober 29–November 2, 2010Boston, MA Poster 278
  • ReesinkHWFanningGCFarhaKARapid HCV-RNA decline with once daily TMC435: a phase I study in healthy volunteers and hepatitis C patientsGastroenterology2010138391392119852962
  • MedivirABOlysio™ (simeprevir) capsule. Highlights of Prescribing Information [prescribing information]StockholmMedivir AB2013 Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205123s001lbl.pdfAccessed December 1, 2013
  • YouDMPockrosPJSimeprevir for the treatment of chronic hepatitis CExpert Opin Pharmacother201314182581258924138198
  • VerloesRShishidoAPhase I safety and PK of TMC435 in healthy volunteers and safety, PK and short-term efficacy in chronic hepatitis C infected individualsPaper presented at: Japanese Hepatology CongressJune 4–5, 2009Kobe, Japan Abstract O-32 4–5
  • SekarVVerloesRMeyvischPSpittaelsKAkumaSHSmedtGDEvaluation of metabolic interactions for TMC435 via cytochrome P450 (CYP) enzymes in healthy volunteersPoster presented at: 45th Annual Meeting of the European Association for the Study of the LiverApril 14–18, 2010Vienna, Austria
  • Janssen Research and Development LLCSimeprevir, Application Number 205123Orig1s000. Clinical Pharmacology and Biopharmaceutics Review(s)2013 Available from: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205123Orig1s000ClinPharmR.pdfAccessed September 1, 2013
  • LenzOVerbinnenTLinTIIn vitro resistance profile of the hepatitis C virus NS3/4A protease inhibitor TMC435Antimicrob Agents Chemother20105451878188720176898
  • BaeASunSCQiXSusceptibility of treatment-naive hepatitis C virus (HCV) clinical isolates to HCV protease inhibitorsAntimicrob Agents Chemother201054125288529720855726
  • FriedMWButiMDoreGJOnce-daily simeprevir (TMC435) with pegylated interferon and ribavirin in treatment-naïve genotype 1 hepatitis C: the randomized PILLAR studyHepatology20135861918192923907700
  • ZeuzemSBergTGaneESimeprevir increases rate of sustained virologic response among treatment-experienced patients with HCV genotype-1 infection: a phase IIb trialGastroenterology20141462430441. e624184810
  • FornsXLawitzEZeuzemSSimeprevir with peginterferon and ribavirin leads to high rates of SVR in patients with HCV genotype 1 who relapsed after previous therapy: a Phase 3 trialGastroenterology2014146716691679. e324602923
  • JacobsonIMDoreGJFosterGRSimeprevir with pegylated interferon alfa 2a plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection (QUEST-1): a phase 3, randomised, double-blind, placebo-controlled trialLancet Epub632014
  • MannsMMarcellinPPoordadFSimeprevir with pegylated interferon alfa 2a or 2b plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection (QUEST-2): a randomised, double-blind, placebo-controlled phase 3 trialLancet Epub632014
  • LenzOde BruijneJVijgenLEfficacy of re-treatment with TMC435 as combination therapy in hepatitis C virus-infected patients following TMC435 monotherapyGastroenterology2012143511761178. e122885330
  • MannsMReesinkHBergTRapid viral response of once-daily TMC435 plus pegylated interferon/ribavirin in hepatitis C genotype-1 patients: a randomized trialAntivir Ther20111671021103322024518
  • HayashiNIzumiNKumadaHSimeprevir with peginterferon/ribavirin for treatment-naïve hepatitis C genotype 1 patients in Japan: CONCERTO-1, a phase III trialJ Hepatol Epub4122014
  • IzumiNHayashiNKumadaHOnce-daily simeprevir with peginterferon and ribavirin for treatment-experienced HCV genotype 1-infected patients in Japan: the CONCERTO-2 and CONCERTO-3 studiesJ Gastroenterol201449594195324626851
  • ToyodaHKumadaTTakaguchiKShimadaNTanakaJChanges in hepatitis C virus genotype distribution in JapanEpidemiol Infect20141524598252
  • MaekawaSEnomotoNOnce-daily simeprevir in combination with pegylated-interferon and ribavirin: a new horizon in the era of direct-acting antiviral agent therapy for chronic hepatitis CJ Gastroenterol201449116316424356811
  • HezodeCFontaineHDorivalCCUPIC Study GroupEffectiveness of telaprevir or boceprevir in treatment-experienced patients with HCV genotype 1 infection and cirrhosisGastroenterology Epub432014
  • SulkowskiMJacobsonIMGhalibROnce-daily simeprevir (TMC435) plus sofosbuvir (GS-7977) with or without ribavirin in HCV genotype 1 Prior null responders with metavir f0–2: COSMOS study subgroup analysisJ Hepatol201460Suppl 1S4
  • ZeuzemSHezodeCBronowickiJ-PPDaclatasvir in combination with simeprevir ± ribavirin for hepatitis C virus genotype 1 infection. Abstract presented at: 21st Conference on Retroviruses and Opportunistic InfectionsTopics Antiviral Med201422Issue e-115
  • MorenoCHezodeCMarcellinPOnce-daily simeprevir (TMC435) with peginterferon/ribavirin in treatment-naive or treatment-experienced chronic HCV genotype 4-infected patients: final results of a phase III trial. Poster presented at: 49th Annual meeting of the European Association for the Study of the LiverJ Hepatology201460Suppl 1S535