Review of direct-acting antiviral agents for the treatment of chronic hepatitis C

Bibliography

• Gonzalez SA. Management of recurrent hepatitis C following liver transplantation. Gastroenterol Hepatol 2010;6(10):637-45
   Google Scholar
• Perz JF, Armstrong GL, Farrington LA, et al. The contributions of hepatitis B virus and hepatitis C virus infections to cirrhosis and primary liver cancer worldwide. J Hepatol 2006;45(4):529-38
   PubMed Web of Science ®Google Scholar
• WHO. Hepatitis C: global prevalence (update). Weekly Epidemiol Rec 1999;49(74):425-7. [Accessed July 2011]
   Google Scholar
• Lavanchy D. The global burden of hepatitis C. Liver Int 2009;29:74-81
   PubMed Web of Science ®Google Scholar
• Ghany MG, Strader DB, Thomas DL, et al. Diagnosis, management and treatment of hepatitis C, an update: AASLD guidelines. Hepatology 2009;49(4):1335-74
   Web of Science ®Google Scholar
• Victrelis (boceprevir). Full prescribing information. 2011. Available from: http://www.victrelis.com [Accessed 11 January 2012]
   Google Scholar
• Incivek (telaprevir). Full prescribing information. 2011. Available from: http://www.incivek.com [Accessed 11 January 2012]
   Google Scholar
• Jacobson IM, McHutchison JG, Dusheiko G, et al. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med 2011;364:2405-16
   PubMed Web of Science ®Google Scholar
• Poordad F, McCone JJ, Bacon RR, et al. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med 2011;364:1195-206
   PubMed Web of Science ®Google Scholar
• Bacon BR, Gordon SC, Lawitz E, et al. Boceprevir for previously treated chronic HCV genotype 1 infection. N Engl J Med 2011;364:1207-17
   PubMed Web of Science ®Google Scholar
• Zeuzem S, Andreone P, Pol S, et al. Telaprevir for retreatment of HCV infection. N Engl J Med 2011;364:2417-28
   PubMed Web of Science ®Google Scholar
• Zeuzem S, Arora S, Bacon B, et al. Pegylated interferon-lambda shows superior viral response with improved safety and tolerability versus pegIFN alpha-2a in HCV patients (G1/2/3/4): EMERGE PhaseIIb through week 12. J Hepatol 2011;54(Suppl 1):S538-S9
   PubMedGoogle Scholar
• Lauer GM, Walker BD. Hepatitis C virus infection. N Engl J Med 2001;345(1):41-52
   PubMed Web of Science ®Google Scholar
• Simmonds P, Bukh J, Combet C, et al. Consensus proposals for a unified system of nomenclature of hepatitis C virus genotypes. Hepatology 2005;42:962-73
   PubMed Web of Science ®Google Scholar
• Moradpour D, Penin F, Rice CM. Replication of hepatitis C virus. Nat Rev Microbiol 2007;5(6):453-63
   PubMed Web of Science ®Google Scholar
• Dubuisson J. Hepatitis C virus proteins. World J Gastroenterol 2007;13(17):2406-15
   PubMed Web of Science ®Google Scholar
• Pawlotsky JM, Chevaliez S, McHutchison JG. The hepatitis C virus life cycle as a target for new antiviral therapies. Gastroenterology 2007;132:1979-98
   PubMed Web of Science ®Google Scholar
• Rice CM. New insights into HCV replication: potential antiviral targets. Top Antivir Med 2011;19:117-20
   PubMedGoogle Scholar
• Blight KJ, Kolykhalov AA, Reed KE, et al. Molecular virology of hepatitis C virus: an update with respect to potential antiviral targets. Antivir Ther 1998;3(Suppl 3):71-81
   PubMedGoogle Scholar
• Pockros PJ. New direct-acting antivirals in the development for hepatitis C virus infection. Ther Adv Gastroenterol 2010;3(3):191-202
   PubMedGoogle Scholar
• Guedj J, Dahari H, Rong L, et al. Modeling shows that the NS5A inhibitor daclatasvir has two modes of action and yields a shorter estimate of the hepatitis C virus half-life. PNAS 2013;110:3991-6
   PubMed Web of Science ®Google Scholar
• Grebely J, Matthews GV, Dore GJ. Treatment of acute HCV infection. Nat Rev Gastroenterol Hepatol 2011;8(5):265-74
   PubMed Web of Science ®Google Scholar
• Doyle JS, Sacks-Davis R, Hellard ME. Acute hepatitis C infection: new approaches to surveillance, treatment and prevention. Curr Hepat Rep 2012;11(4):221-30
   Google Scholar
• Raney KD, Sharma SD, Moustafa IM, et al. Hepatitis C virus non-structural protein 3 (HCV NS3): a multifunctional antiviral target. J Biol Chem 2010;285:2275-31
   Web of Science ®Google Scholar
• Fried M, Buti M, Dore GJ, et al. TMC435 in combination with peginterferon and ribavirin in treatment-naive HCV genotype 1 patients: final analysis of the PILLAR phase IIb study. Hepatology 2011;54(Suppl):1429A
   Google Scholar
• Dieterich D, Asselah T, Guyader D, et al. SILEN-C3: treatment for 12 or 24 weeks with BI201335 combined with peginterferon alfa-2a and ribavirin (P/R) in treatment-naive patients with chronic genotype-1 HCV infection. Hepatology 2011;54(Suppl):378A
   PubMedGoogle Scholar
• Tellinghuisen TL, Foss KL, Treadaway J. Regulation of hepatitis C virion production via phosphorylation of the NS5A protein. PLoS Pathog 2008;4(3):e1000032
   PubMed Web of Science ®Google Scholar
• Tellinghuisen TL, Marcotrigiano J, Rice CM. Structure of the zinc-binding domain of an essential component of the hepatitis C virus replicase. Nature 2005;435:374-9
   PubMed Web of Science ®Google Scholar
• Foster TL, Gallay P, Stonehouse NJ, et al. Cyclophyllin A interacts with domain II of hepatitis C virus NS5A and stimulates RNA binding in an isomerase-dependent manner. J Virol 2011;85:7460-4
   PubMed Web of Science ®Google Scholar
• Sarrazin C, Zeuzem S. Resistance to direct antiviral agents in patients with hepatitis C virus infection. Gastroenterology 2010;138:447-62
   PubMed Web of Science ®Google Scholar
• Crabbe R, Vuagniaux G, Dumont JM, et al. An evaluation of the cyclophilin inhibitor Debio 025 and its potential as a treatment for chronic hepatitis C. Expert Opin Investig Drugs 2009;18(2):211-20
   PubMed Web of Science ®Google Scholar
• Ahmed-Belkacem A, Colliandre L, Ahnou N, et al. New cyclophilin inhibitors unrelated to cyclosporine potently inhibit HCV replication and revert HCV-induced mitochondrial dysfunction. AASLD: Boston; 2012
   Google Scholar
• Steinkuhler C, Biasiol G, Brunetti M, et al. Product inhibition of the hepatitis C virus NS3 protease. Biochemistry 1998;37:8899-905
   PubMed Web of Science ®Google Scholar
• Lin K, Perni RB, Kwong AD, et al. VX-950, a novel hepatitis C virus (HCV) NS3-4A protease inhibitor, exhibits potent antiviral activities in HCV replicon cells. Antimicrob Agents Chemother 2006;50:1813-22
   PubMed Web of Science ®Google Scholar
• Perni RB, Almquist SJ, Byrn RA, et al. Preclinical profile of VX-950, a potent, selective, and orally bioavailable inhibitor of hepatitis C virus NS3-4A serine protease. Antimicrob Agents Chemother 2006;50:899-909
   PubMed Web of Science ®Google Scholar
• Foster GR, Hezode C, Bronowicki JP, et al. Telaprevir alone or with peginterferon and ribavirin reduces HCV RNA in patients with chronic genotype 2 but not genotype 3 infections. Gastroenterology 2011;141:881-9; e1
   PubMed Web of Science ®Google Scholar
• U.S. Food and Drug Administration. Serious skin reactions after combination treatment with the Hepatitis C drugs Incivek (telaprevir), peginterferon alfa, and ribavirin, FDA Drug Safety Communication. 2012
   Google Scholar
• Mousa O, Langley G, Ly-Elaine P, et al. Consequences of current hepatitis C direct anti-viral agents on the health-related quality of life. AASLD: Boston; 2012
   Google Scholar
• Martel-Laferriere V, Brinkley S, Bichoupan K, et al. On-treatment responses to telaprevir-based hepatitis C treatment are similar in HIV/Hepatitis C virus co-infected and hepatitis C virus mono-infected patients. CROI: Atlanta; 2013
   Google Scholar
• Cotte L, Braun J, Lascoux-Combe C, et al. High Early Virological Response with Telaprevir-Pegylated-Interferon-Ribavirin in Treatment-experienced Hepatitis C Virus Genotype 1/HIV Co-infected Patients: ANRS HC26 TelapreVIH Study. CROI: Atlanta; 2013
   Google Scholar
• Poizot-Martin I, Bellissant E, Piroth L, et al. ANRS-HC27 BocepreVIH Interim Analysis: high Early Virologic Response with Boceprevir + Pegylated Interferon + Ribivirin in Hepatitis C Virus/HIV Co-infected Patients with Previous Failure to Pegylated Interferon + Ribivirin. CROI: Atlanta; 2013
   Google Scholar
• Bourlière M, Khaloun A, Wartelle-Bladou C, et al. Future treatment of patients with HCV cirrhosis. Liver Int 2012;32:113-19
   PubMed Web of Science ®Google Scholar
• Varun S, Lisa C, Elizabeth MW, et al. PI triple therapy in cirrhotics with compensated and mildly decompensated disease: implications for wait-listed patients. AASLD: Boston; 2012
   Google Scholar
• Mark S, Kenneth ES, Vincent S, et al. Telaprevir in Combination with Peginterferon Alfa-2a/Ribavirin in HCV/HIV Co-infected Patients: SVR24 Final Study Results. AASLD: Boston; 2012
   Google Scholar
• Pawlotsky JM. Treatment failure and resistance with direct-acting antiviral drugs against hepatitis C virus. Hepatology 2011;53:1742-51
   PubMed Web of Science ®Google Scholar
• Zeuzem S, Vierling JM, Esteban R, et al. Predictors of sustained virologic response among genotype 1 previous non-responders and relapsers to peginterferon/ribavirin when treated with boceprevir plus peginterferon/ribavirin. Gastroenterology 2011;140(Suppl 1):S-908-S-9
   Google Scholar
• Kieffer TL, Bartels DJ, Sullivan J, et al. Clinical virology results from telaprevir phase 3 study ADVANCE. Hepatology 2010;52:879A
   Web of Science ®Google Scholar
• Zeuzem S, Sulkowski MS, Zoulim F, et al. Long-term follow-up of patients with chronic hepatitis C treated with telaprevir in combination with peginterferon alfa-2a and ribavirin: interim analysis of the EXTEND study. Hepatology 2010;52:436A
   PubMed Web of Science ®Google Scholar
• Vierling JM, Ralston R, Lawitz EJ, et al. Long-term outcomes following combination treatment with boceprevir plus peg-intron/ribavirin (P/R) in patients with chronic hepatitis C, genotype 1 (CHC-G1). J Hepatol 2010;52:S470-1
   Web of Science ®Google Scholar
• Susser S, Vermehren J, Forestier N, et al. Analysis of long-term persistence of resistance mutations within the hepatitis C virus NS3 protease after treatment with telaprevir or boceprevir. J Clin Virol 2011;52:321-7
   PubMed Web of Science ®Google Scholar
• Susser S, Schelhorn S-E, Lange CM, et al. Deep sequencing analysis of hepatitis C virus NS3 protease resistance mutations A87T, R117H and S174H in patients treated with telaprevir or boceprevir. AASLD: Boston; 2012
   Google Scholar
• Velazquez C, Macartney MJ, Irish DN, et al. The impact of virologic resistance and adherence on treatment failure in a cohort of hepatitis C virus infected patients treated with telaprevir or boceprevir. AASLD: Boston; 2012
   Google Scholar
• Halfon O, Locarnini S. Hepatitis C virus resistance to protease inhibitors. J Hepatol 2011;55(1):192-206
   PubMed Web of Science ®Google Scholar
• Cummings MD, Lindberg J, Lin TI, et al. Induced-fit binding of the macrocyclic noncovalent inhibitor TMC 435 to its HCV NS3/NS4A protease target. Angew Chem Int Ed Engl 2010;49(9):1652-5
   PubMed Web of Science ®Google Scholar
• Reesink HW, Fanning GC, Farha KA, et al. Rapid HCV-RNA decline with once daily TMC435: a phase I study in healthy volunteers and hepatitis C patients. Gastroenterology 2010;138(3):913-21
   PubMed Web of Science ®Google Scholar
• Poordad F, Fried MW, Zeuzem S, et al. Efficacy and tolerability of TMC435 150 mg once daily with peginterferon α-2a and ribavirin for treatment of HCV genotype 1 infection in patients with Metavir score F3 and F4 (PILLAR and ASPIRE trials)
   Google Scholar
• Lenz O, Verbinnen T, Lin TI, et al. In vitro resistance profile of the hepatitis C virus NS3/4A protease inhibitor TMC435. Antimicrob Agents Chemother 2010;54(5):1878-87
   PubMed Web of Science ®Google Scholar
• Huisman M, Snoeys J, Monbaliu J, et al. In vitro studies investigating the mechanism of interaction between TMC435 and hepatic transporters. AASLD: 2010
   Google Scholar
• Sulkowski M, Ceasu E, Asselah T, et al. SILEN-C1: sustained virologic response (SVR) and safety of BI 201335 combined with peginterferon alfa-2a and ribavirin in treatment-naïve patients with chronic genotype 1 HCV. J Hepatol 2011;54(Suppl 1):S27
   Google Scholar
• Sulkowski M, Bourliere M, Bronowicki J, et al. SILEN-C2: sustained virologic response (SVR) and safety of BI201335 combined with peginterferon alfa 2a and ribavirin in chronic HCV genotype 1 patients with non-response to peg-RBV. J Hepatol 2011;54(Suppl 1):S30
   Google Scholar
• Cote-Martin A, Berger K, Cartier M, et al. HCV NS3 and NS5B variants that emerged in patients with virologic breakthrough and relapse from the phase II SOUND-C2 trial investigating interferon-free BI201335 and BI 207127 therapy +/- ribavirin. AASLD: Boston; 2012
   Google Scholar
• Berger K, Bethell R, Cartier M, et al. Analysis of baseline polymorphisms and persistence of emergent variants from phase Ib and II trials evaluating the HCV NS3 protease inhibitor BI201335. AASLD: Boston; 2012
   Google Scholar
• Rodriguez-Torres M, Lawitz E, Kowdley KV, et al. Once daily PSI-7977 plus PEG-RBV in HCV GT1: 98% rapid virologic response, complete early virologic response: the PROTON study. EASL; Berlin; 2011; and J Hepatol Nov 2012
   Google Scholar
• Lalezari J, Lawitz E Rodriguez-Torres M, et al. Once daily PSI-7977 plus PEG-IFN in a phase IIb trial: rapid virologic suppression in treatment naïve patients with HCV GT2/3. EASL; Berlin: 2011
   Google Scholar
• Kowdley KV, 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, randomised, multicentre phase 2 trial. Lancet 2013; [Epub ahead of print]
   Web of Science ®Google Scholar
• Mathias A, Cornpost M, Clemons D, et al. No clinically significant pharmacokinetic drug-drug interactions between sofosbuvir (GS-7977) and the immunosupressants, cyclosporine A or tacrolimus in healthy volunteers. AASLD: Boston; 2012
   Google Scholar
• Kirby B, Mathias A, Rossi S, et al. No clinically significant pharmacokinetic drug interactions between sofosbuvir and HIV antiretrovirals Atripla, rilpivirine, darunavir/ritonavir or raltegravir in healthy volunteers. AASLD: Boston; 2012
   Google Scholar
• Evgenia SS, Hadas D-S, Viktoria G, et al. Comprehensive resistance testing in patients who relapsed after treatment with sofosbuvir (GS-7977) - containing regimens in phase 2 studies. AASLD: Boston; 2012
   Google Scholar
• Han B, Mo H Wong KA, et al. In Vitro analyses of HCV NS5B S282T mutants in multiple HCV genotypes show low levels of reduced susceptibility to sofosbuvir, no cross resistance to other classes of DAAs and hypersensitivity to ribavirin. AASLD: Boston; 2012
   Google Scholar
• Hebner C, Lee Y-J, Han B, et al. In vitro pan-genotypic and combination activity of sofosbuvir (GS-7977) in stable replicon cell lines. AASLD: Boston; 2012
   Google Scholar
• Germa P, Mathias A, Pang PS, et al. Lack of a clinically significant pharmacokinetic drug-drug interaction between sofosbuvir (GS-7977) and GS-5885 or GS-9669 in healthy volunteers. AALSD; Boston; 2012
   Google Scholar
• Izumi N, Lataillade M, Chayama K et al. First Report of Peginterferon Lambda/Ribavirin in Combination with Either Daclatasvir or Asunaprevir in HCV Genotype 1 Japanese Subjects: Early Sustained Virologic Response (SVR4) Results From the D-LITE Japanese Sub-Study
   Google Scholar
• Lok A, Gardiner D, Lawitz E, et al. Quadruple therapy with BMS-790052 and BMS 650032 and PEG-RBV for 24 weeks results in 100 % SVR 12 in HCV genotype 1 null responders. J Hepatol 2011;54(Supp 1):S536
   Google Scholar
• Thompson AJ, Shiffman ML, Rossaro L, et al. Six weeks of a NS5A inhibitor (GS-5885), protease inhibitor (GS-9451) plus peginterferon/ribavirin achieves high SVR4 rates in genotype 1 IL28B CC treatment naïve HCV patients: Interim results of a prospective, randomized trial. AASLD: Boston; 2012
   Google Scholar
• Goelzer P, Morcos PN, Tran J, et al. Co-administration of ritonavir with the HCV protease inhibitor danoprevir substantially reduces reactive metabolite formation both in vitro and in vivo. AASLD: Boston; 2012
   Google Scholar
• Everson GT, Cooper C, Hezode C, et al. High SVR24 rates with ritonavir-boosted danoprevir plus pefIFNalpha-2a/RBV in HCV genotype 1 or 4 patients in the DAUPHINE study. AASLD: Boston; 2012
   Google Scholar
• Gane EJ, Rouzier R, Wiercinska-Drapalo A, et al. SVR rate of 67 % in HCV genotype 1 infected prior null responders treated with danoprevir/ritonavir in combination with peginterferon alfa-2a plus ribavirin. AASLD: Boston; 2012
   Google Scholar
• Jacobson IM, Jensen DM, Pol S. Safety and efficacy of ritonavir boosted danoprevir, peginterferon alpha 2a and ribavirin with or without mericitabine in HCV genotype-1 infected treatment-experienced patients with advanced hepatic fibrosis: MATTERHORN study. AASLD: Boston; 2012
   Google Scholar
• Pockros PJ, Jensen D, Tsai N, et al. JUMP-C: a randomized trial of mericitabine plus peginterferon alfa-2a/ribavirin for 24 weeks in treatment-naive HCV genotype 1/4 patients. Hepatology 2013; [Epub ahead of print]
   Google Scholar
• Tong X, Piso K, Haines K, et al. Lack of mericitabine resistance mutation NS5B S282T and low rate of a novel mericitabine double resistance mutant NS5B L159F+L320F in patients treated with mericitabine plus pegIFNalpha-2a/RBV provides further evidence for the high resistance barrier to mericitabine. AASLD: Boston; 2012
   Google Scholar
• Moreira S, Levi M, Kulkarni R, et al. No impact of cirrhosis on mericitabine pharmacokinetics and early antiviral activity in hepatitis C infected patients receiving mericitabine plus peginterferon alfa-2a/ribavirin. AASLD: Boston; 2012
   Google Scholar
• Lok AS, Gardiner DF, Lawitz E, et al. Preliminary study of two antiviral agents for hepatitis C genotype. N Engl J Med 2012;366(3):216-24
   PubMed Web of Science ®Google Scholar
• Christophe H, Gideon MH, Wayne G, et al. Daclatasvir, an NS5A Replication Complex Inhibitor, Combined With Peginterferon Alfa-2a and Ribavirin in Treatment-Naive HCV-Genotype 1 or 4 Subjects: Phase 2b COMMAND-1 SVR12 Results. AASLD: Boston; 2012
   Google Scholar
• Lok AS, Gardiner DF, Eley T, et al. Sustained Virologic Response in Chronic HCV Genotype (GT) 1-Infected Null Responders With Combination of Daclatasvir (DCV; NS5A Inhibitor) and Asunaprevir (ASV; NS3 Inhibitor) With or Without Peginterferon Alfa-2a/Ribavirin (PEG/RBV)
   Google Scholar
• McPhee F, Hernandez D, Zhou N, et al. Comparison of pre-existing and emerging resistance-associated variants in US, EU and Japanese HCV genotype 1b prior non-responders and IFN ineligible patients treated with daclatasvir and asunaprevir. AASLD: Boston; 2012
   Google Scholar
• Namiki I, Max L, Kazuaki C, et al. First report of peginterferon lambda/ribavirin in combination with either Asunaprevir or Daclatasvir in HCV genotype 1 Japanese subjects: early SVR4 results from D-LITE Japanese sub-study. AASLD: Boston; 2012
   Google Scholar
• Dore GJ, Lawitz E, Hezode C, et al. 12 or 16 week treatment with daclatasvir combined with peginterferon alfa and ribavirin for hepatitis C virus genotype 2 or 3 infections: Command Gt 2/3 study. AASLD: Boston; 2012
   Google Scholar
• Larrey D, Lohse A, de Ledinghen V, et al. 4 week therapy with the non-nucleosidic polymerase inhibitor BI207127 in combination with peginterferon alfa-2a and ribavirin in treatment naïve and experienced chronic HCV GT1 patients. J Hepatol 2010;52(Suppl 1):S466
   Google Scholar
• Lohse AW, Zarski J-P, Gerlach T, et al. Addition of the NS5B polymerase inhibitor BI207127 to pegylated interferon and ribavirin for 4 weeks followed by peg-IFN/RBV for 44 weeks improves SVR24 rates in treatment naïve patients with HCV genotype 1 and is well tolerated. AASLD: Boston; 2012
   Google Scholar
• Ira MJ, Mark SS, Edward JG, et al. VX-222, Telaprevir and Ribavirin in Treatment-Naïve Patients with Genotype 1 Chronic Hepatitis C: Results of the ZENITH Study Interferon-Free Regimen. AASLD: Boston; 2012
   Google Scholar
• Bisceglie AD, Sulkowski M, Gane E, et al. VX-222, telaprevir in combination peginterferon alfa-2a and ribavoirin in treatment naïve genotype 1 HCV patients treated for 12 weeks: ZENITH study, SVR12 interim analysis. Abstract A020 CDDW and CASL Meeting; Montreal: 2012
   Google Scholar
• Flisiak R, Feinman SV, Jablkowski M, et al. Efficacy and safety increasing doses of the cyclophilin inhibitor Debio 025 in combination with pegylated interferon alpha-2a in treatment naïve chronic HCV patients. J Hepatol 2008;48(Suppl 2):S6
   Google Scholar
• Flisiak R, Pawlotsky JM, Crabbe R, et al. Once daily alisporivir plus peg-IFN alfa 2a/ribavirin results in superior sustained virologic response (SVR24) in chronic hepatitis C genotype 1 treatment naïve patients. EASL: Berlin; 2011
   Google Scholar
• Jean-Michel P, Shiv KS, Graham RF, et al. Alisporivir plus ribavirin achieves high rates of sustained HCV clearance (SVR24) as interferon (IFN)-free or IFN-add-on regimen in treatment-naive patients with HCV GT2 or GT3: Final results from VITAL-1 study
   Google Scholar
• Gane EJ, Roberts SK, Stedman CA, et al. Oral combination therapy with a nucleoside polymerase inhibitor (RG7128) and danoprevir for chronic hepatitis C genotype 1 infection (INFORM-1): a randomized double-blind, placebo controlled dose-escalation trial. Lancet 2010;376:1467-75
   PubMed Web of Science ®Google Scholar
• Chayama K, Takahashi S, Kawakami Y, et al. Dual oral combination therapy with the NS5A inhibitor BMS-790052 and the NS3 protease inhibitor BMS- 650032 achieved 90% sustained virological response (SVR12) in HCV genotype 1b-infected null responders. Hepatology 2011;54(Suppl):1428A
   Google Scholar
• Pilot-Matias T, Tripathi RL, Gennadiy K, et al. Characterization of resistant variants in NS3 and NS5B detected in subjects treated with ABT/r, ribavirin and either ABT-072 or ABT-333 in the pilot and co-pilot studies who experienced virologic breakthrough or relapse. AASLD: Boston; 2012
   Google Scholar
• Lawitz E, Poordad F, Kowdley K, et al. A phase 2a trial of 12 week Interferon-free therapy with two direct-acting antivirals (ABT-450/r and ABT-072) and Ribavirin in IL28C/C patients with chronic hepatitis C genotype 1. J Hepatol 2013: In press
   Google Scholar
• Poordad F, Lawitz E, Kowdley KV, et al. Exploratory study of oral combination antiviral therapy for hepatitis C. N Engl J Med 2013;368:45-53
   PubMed Web of Science ®Google Scholar
• Kowdley KV, Poordad F, Lawitz E, et al. A 12-Week Interferon-free Treatment Regimen with ABT-450/r, ABT-267, ABT-333 and Ribavirin Achieves SVR12 Rates (Observed Data) of 99% in Treatment-Naïve Patients and 93% in Prior Null Responders with HCV Genotype1 Infection. AASLD: Boston; 2012
   Google Scholar
• Khatri A, Gaultier IA, Menon R, et al. Pharmacokinetics and safety of co-administered ABT-450 plus ritonavir, ABT-267, and ABT-333 as a single dose in subjects with normal hepatic function and in subjects with mild, moderate and sever hepatic impairment. AASLD: Boston; 2012
   Google Scholar
• Gane E, Stedman CA, Hyland RH, et al. Once daily PSI-7977 plus RBV: pegylated interferon-alfa not required for complete rapid viral response in treatment-naive patients with HCV GT2 or GT3. Hepatology 2011;54(Suppl):377A
   PubMedGoogle Scholar
• Edward G, Catherine S, Robert H, et al. Once Daily Sofosbuvir (GS-7977) plus Ribavirin in Patients with HCV Genotypes 1, 2, and 3: The ELECTRON Trial. AASLD: Boston; 2012
   Google Scholar
• Gane E, Hyland R, Ding X, et al. ELECTRON: 100 % suppression of viral load through 4 weeks post-treatment for sofosbuvir + ledipasvir + ribavirin in treatment naïve and experienced hepatitis C virus GT 1 patients. CROI; Atlanta: 2013
   Google Scholar
• Gane E, Lawitz E, Rodriguez-Torres M, et al. Phase 3 randomized controlled trial of all-oral treatment with sofosbuvir+ribavirin for 12 weeks compared to 24 weeks of peg+ribavirin in treatment-naive GT2/3 HCV-infected patients (FISSION). EASL; Amsterdam: 2013
   Google Scholar
• Nelson DR, Feld J, Kowdley KV, et al. All oral therapy with sofosbuvir+ribavirin for 12 or 16 weeks in treatment experienced GT2/3 HCV-infected patients: results of the phase 3 FUSION trial. EASL; Amsterdam: 2013
   Google Scholar
• Jacobson I, Yoshida EM, Sulkowski M, et al. Treatment with sofosbuvir+ribavirin for 12 weeks achieves SVR12 of 78% in GT2/3 interferon-ineligible, -intolerant, or -unwilling patients: results of the phase 3 POSITRON trial. EASL; Amsterdam: 2013
   Google Scholar
• Lawitz E, Mangia A, Wyles D, et al. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med 2013;368(20):1878-87
   PubMed Web of Science ®Google Scholar
• Sulkowski MS, Gardiner DF, Rodriguez-Torres M, et al. High Rate of Sustained Virologic Response with the All-Oral Combination of Daclatasvir (NS5A Inhibitor) Plus Sofosbuvir (Nucleotide NS5B Inhibitor), With or Without Ribavirin, in Treatment-Naïve Patients Chronically Infected With HCV Genotype 1, 2, or 3. AASLD: Boston; 2012
   Google Scholar
• Roberts JF, Marc B, Robert H, et al. First ever successful use of daclatasvir and GS-7977, an interferon-free oral regimen, in a liver transplant with sever recurrent hepatitis C. AASLD: Boston; 2012
   Google Scholar
• Zeuzem S, Soriano V, Asselah T et al. Interferon (IFN)-free combination treatment with the HCV NS3/4A protease inhibitor BI 201335 and the nonnucleoside NS5B inhibitor BI 207127 ± ribavirin (R): Final results of SOUND-C2 and predictors of response
   Google Scholar
• Sabo J, Boecher WO, Sane RS, et al. Pharmacokinetics of the interferon-free combination of BI207127 and BI 201335 plus ribavirin in treatment naïve patients with genotype 1 HCV: results from SOUND-C1 study. AASLD: Boston; 2012
   Google Scholar
• Lawitz E, Symonds WT. Once daily dual-nucleotide combination of PSI-938 and PI-7977 provides 94 % HCV RNA < LOD at day 14: first purine/pyrimidine clinical combination data (nuclear study)
   Google Scholar
• Mark SS, Maribel RT, Eric L et al. Complete SVR4 rates in treatment naïve HCV genotype 1a and 1b patients who achieved vRVR with an interferon-free oral regimen
   Google Scholar
• Everson GT, Lawitz E, Thompson A, et al. The NS5A inhibitor GS-5885 is safe and well tolerated in over 1000 patients treated in phase 2 studies. AASLD: Boston; 2012
   Google Scholar
• Everson GT, Sims KD, Rodriguez-Torres M, et al. An Interferon-free, Ribavirin-free 12-Week Regimen of Daclatasvir (DCV), Asunaprevir (ASV), and BMS-791325 Yielded SVR4 of 94% in Treatment-Naïve Patients with Genotype (GT) 1 Chronic Hepatitis C Virus (HCV) Infection. AASLD: Boston; 2012
   Google Scholar
• Hayashi N, Nakamura K, Barnard R, et al. SVR rates and resistance associated amino acid variants in genotype 1 HCV infected Japanese relapse patients treated with Vaniprevir (MK-7009) in combination with peg-IFN and RBV for 28 days. AASLD: Boston; 2012
   Google Scholar
• Fraser IP, Petry A, Van Dyck K, et al. Safety and antiviral activity of MK-5172, a next generation HCV NS3/4A protease inhibitor with a broad HCV genotypic activity spectrum and potent activity against known resistance mutants, in Genotype-1 and -3 HCV-infected patients. Global Antivir J 2011;7(Suppl 1):56
   Google Scholar
• Marcellin P, Vierling JM, Bacon BR, et al. Safety and SVR of MK-5172 for 12 weeks in combination with pegylated interferon alfa-2b and ribavirin for 24 weeks in HCV genotype 1 treatment naïve non-cirrhotic patients. AASLD: Boston; 2012
   Google Scholar
• Conference reports from NATAP. Inhibitex reports positive safety and antiviral data from its phase Ib study of HCV nucleotide inhibitor INX-189. Hepatology 2010;52(Suppl 4):1218A
   Google Scholar
• Lawitz E, Lalezari J, Freilich B, et al. BMS986094 (INX-08189) plus peginterferon alfa-2a and ribavirin results in increased rates of rapid virologic response (RVR) and eVR in treatment naïve HCV genotype 2/3 patients compared to peg-IFN alfa-2a and RBV: week 12 results. AASLD: Boston; 2012
   Google Scholar
• Lawitz E, Box TD, Pruitt R, et al. High rates of RVR and complete EVR with IDX184, pegylated interferon and ribavirin in genotype 1 HCV infected subjects: interim results. AASLD: Boston; 2012
   Google Scholar
• Mayers D, Vince B, Hill JM, et al. IDX719, HCV NS5A inhibitor, demonstrates pan-genotypic activity after 3 days of monotherapy in genotype 1, 2, 3, or 4 HCV-infected subjects. AASLD: Boston; 2012
   Google Scholar