Benefit–risk assessment of new and emerging treatments for hepatitis C: focus on simeprevir and sofosbuvir

References

• ChakETalalAHShermanKESchiffERSaabSHepatitis C virus infection in USA: an estimate of true prevalenceLiver Int20113181090110121745274
   PubMed Web of Science ®Google Scholar
• Institute of Medicine Report BriefHepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and CWashington, DCNational Academy of Sciences2010 Available from: http://www.iom.edu/viralhepatitisAccessed January 10, 2014
   Google Scholar
• AsraniSKLarsonJJYawnBTherneauTMKimWRUnderestimation of liver-related mortality in the United StatesGastroenterology20131452375382e1e223583430
   PubMed Web of Science ®Google Scholar
• HolmbergSDSpradlingPRMoormanACDennistonMMHepatitis C in the United StatesN Engl J Med2013368201859186123675657
   PubMed Web of Science ®Google Scholar
• WardJWLokASThomasDLEl-SeragHBKimWRReport on a single-topic conference on “Chronic viral hepatitis – strategies to improve effectiveness of screening and treatment”Hepatology201255130731522105599
   PubMedGoogle Scholar
• LeeGPiperDEWangZNovel inhibitors of hepatitis C virus RNA-dependent RNA polymerasesJ Mol Biol200635741051105716476448
   PubMed Web of Science ®Google Scholar
• BiswalBKWangMCherneyMMNon-nucleoside inhibitors binding to hepatitis C virus NS5B polymerase reveal a novel mechanism of inhibitionJ Mol Biol20063611334516828488
   PubMed Web of Science ®Google Scholar
• INCIVEK® (telaprevir) [package insert]Cambridge, MAVertex Pharmaceuticals Incorporated2013
   Google Scholar
• PoordadFMcConeJJrBaconBRSPRINT-2 InvestigatorsBoceprevir for untreated chronic HCV genotype 1 infectionN Engl J Med2011364131195120621449783
   PubMed Web of Science ®Google Scholar
• BaconBRGordonSCLawitzEHCV RESPOND-2 InvestigatorsBoceprevir for previously treated chronic HCV genotype 1 infectionN Engl J Med2011364131207121721449784
   PubMed Web of Science ®Google Scholar
• JacobsonIMMcHutchisonJGDusheikoGADVANCE Study TeamTelaprevir for previously untreated chronic hepatitis C virus infectionN Engl J Med2011364252405241621696307
   PubMed Web of Science ®Google Scholar
• ShermanKEFlammSLAfdhalNHTelaprevir in combination with peginterferon alfa2a and ribavirin for 24 or 48 weeks in treatment-naïve genotype 1 HCV patients who achieved an extended rapid viral response: final results of phase 3 ILLUMINATE study. AASLD 2010: 61st Annual Meeting for the American Association for the Study of Liver Disease; October 29–November 2, 2010; Boston, MAHepatol-ogy2010524401A402A
   Web of Science ®Google Scholar
• GaetanoJNReauNHepatitis C: management of side effects in the era of direct-acting antiviralsCurr Gastroenterol Rep201315130523269576
   PubMedGoogle Scholar
• LesburgCACableMBFerrariEHongZMannarinoAFWeberPCCrystal structure of the RNA-dependent RNA polymerase from hepatitis C virus reveals a fully encircled active siteNat Struct Biol199961093794310504728
   PubMedGoogle Scholar
• AliSLevequeVLe PogamSSelected replicon variants with low-level in vitro resistance to the hepatitis C virus NS5B polymerase inhibitor PSI-6130 lack cross-resistance with R1479Antimicrob Agents Chemother200852124356436918838588
   PubMed Web of Science ®Google Scholar
• PowdrillMHBernatchezJAGötteMInhibitors of the hepatitis C virus RNA-dependent RNA polymerase NS5BViruses20102102169219521994615
   PubMed Web of Science ®Google Scholar
• GaoMAntiviral activity and resistance of HCV NS5A replication complex inhibitorsCurr Opin Virol20133551452023896281
   PubMed Web of Science ®Google Scholar
• FriedMWButiMDoreGJOnce-daily simeprevir (TMC435) with pegylated interferon and ribavirin in treatment-naïve genotype 1 hepatitis C: the randomized PILLAR studyHepatology20135861918192923907700
   PubMed Web of Science ®Google Scholar
• JacobsonIDoreGJFosterGRSimeprevir (TMC435) with peginterferon/ribavirin for chronic HCV genotype 1 infection in treatment-naïve patients: results from QUEST-1, a phase III trial. The International Liver Congress™ 2013, 48th Annual Meeting of the European Association for the Study of the Liver; April 24–28, 2013; Amsterdam, The NetherlandsJ Hepatol Suppl201358Suppl 1S574
   Google Scholar
• MannsMMarcellinPPoordadFPSimeprevir (TMC435) with peginterferon/ribavirin for treatment of chronic HCV genotype-1 infection in treatment-naıve patients: results from QUEST-2, a phase III trial. The International Liver Congress™ 2013, 48th Annual Meeting of the European Association for the Study of the Liver; April 24–28, 2013; Amsterdam, The NetherlandsJ Hepatol Suppl201358Suppl 1S568
   Google Scholar
• JacobsonIMDoreGJFosterGRSimeprevir (TMC435) with peginterferon/ribavirin for treatment of chronic HCV genotype 1 infection in treatment-naïve patients: efficacy in difficult-to-treat patient sub-populations in the QUEST 1 and 2 phase III trials. AASLD 2013: 64th Annual Meeting of the American Association for the Study of Liver Diseases: The Liver Meeting 2013; November 1–5, 2013; Washington, DCHepatology201358S1756A757A
   Google Scholar
• LawitzEFornsXZeuzemSSimeprevir (TMC435) with peginterferon/ribavirin for treatment of chronic HCV Genotype 1 Infection in patients who relapsed after previous interferon-based therapy: results from PROMISE, a Phase III trial. Digestive Disease Week 2013; May 18–21, 2013; Orlando, FLGastroenterology20131445 Suppl 1S–151
   Web of Science ®Google Scholar
• FornsXLawitzEZeuzemSSimeprevir (TMC435) with peg-interferon α-2a/ribavirin for treatment of chronic HCV genotype 1 infection in patients who relapsed after previous interferon-based therapy: efficacy and safety in patient sub-populations in the PROMISE phase III trial. AASLD 2013: 64th Annual Meeting of the American Association for the Study of Liver Diseases: The Liver Meeting 2013; November 1–5, 2013; Washington, DCHepatology201358S1737A738A
   Google Scholar
• BrydenPAQuigleyJMPadhiarACerriKScottDAThe relative efficacy and safety of simeprevir-based triple therapy compared to boceprevir and telaprevir in treatment naïve patients chronically infected with genotype-1 hepatitis C virus: Bayesian network meta-analyses. AASLD 2013: 64th Annual Meeting of the American Association for the Study of Liver Diseases: The Liver Meeting 2013; November 1–5, 2013; Washington, DCHepatology201358S1756A
   Google Scholar
• KowdleyKVLawitzECrespoISofosbuvir with pegylated interferon alfa-2a and ribavirin for treatment-naive patients with hepatitis C genotype-1 infection (ATOMIC): an open-label, randomised, multicentre phase 2 trialLancet201338198832100210723499440
   PubMed Web of Science ®Google Scholar
• OsinusiAMeissnerEGLeeYJSofosbuvir and ribavirin for hepatitis C genotype 1 in patients with unfavorable treatment characteristics: a randomized clinical trialJAMA2013310880481123982366
   PubMed Web of Science ®Google Scholar
• LawitzELalezariJPHassaneinTSofosbuvir in combination with peginterferon alfa-2a and ribavirin for non-cirrhotic, treatment-naive patients with genotypes 1, 2, and 3 hepatitis C infection: a randomised, double-blind, phase 2 trialLancet Infect Dis201313540140823499158
   PubMed Web of Science ®Google Scholar
• LawitzEMangiaAWylesDSofosbuvir for previously untreated chronic hepatitis C infectionN Engl J Med2013368201878188723607594
   PubMed Web of Science ®Google Scholar
• JacobsonIMGordonSCKowdleyKVPOSITRON Study; FUSION StudySofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment optionsN Engl J Med2013368201867187723607593
   PubMed Web of Science ®Google Scholar
• Antiviral Drugs Advisory Committee Meeting Briefing DocumentSofosbuvir for Treatment of Chronic Hepatitis C InfectionFoster City, CAGilead Sciences, Inc.20139194 Available from: http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/antiviraldrugsadvisorycommittee/ucm371877.pdfAccessed March 1, 2014
   Google Scholar
• LawitzEGhalibRRodriguez-TorresMYounossiZCorregidorAJacobsonICOSMOS Study: SVR4 results of a once-daily regimen of simeprevir (TMC435) plus sofosbuvir (GS-7977) with or without ribavirin in HCV genotype 1 null responders20th Conference on Retroviruses and Opportunistic Infections (CROI)March 3–6, 2013Atlanta, GA
   Google Scholar
• SulkowskiMSGardinerDFRodriguez-TorresMAI444040 Study GroupDaclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infectionN Engl J Med2014370321122124428467
   PubMed Web of Science ®Google Scholar
• LawitzEPoordadFFPangPSSofosbuvir and ledipasvir fixed-dose combination with and without ribavirin in treatment-naive and previously treated patients with genotype 1 hepatitis C virus infection (LONESTAR): an open-label, randomised, phase 2 trialLancet2014383991651552324209977
   PubMed Web of Science ®Google Scholar
• KowdleyKVLawitzEPoordadFPhase 2b trial of interferon-free therapy for hepatitis C virus genotype 1N Engl J Med2014370322223224428468
   PubMed Web of Science ®Google Scholar
• ReauNSJensenDMSticker shock and the price of new therapies for hepatitis C: Is it worth it?Hepatology2014
   Web of Science ®Google Scholar
• Transplant LivingCosts [homepage on the Internet]Richmond, VAUnited Network for Organ Sharing2014 Available from: http://www.transplantliving.org/before-the-transplant/financing-a-transplant/the-costs/Accessed February 20, 2014
   Google Scholar
• National Digestive Diseases Information Clearinghouse (NDDIC)Liver Transplantation [homepage on the Internet]Bethesda, MDNational Institute of Diabetes and Digestive and Kidney Diseases Available from: http://www.digestive.niddk.nih.gov/ddiseases/pubs/livertransplantAccessed February 20, 2014
   Google Scholar