Overview of the PROVE studies evaluating the use of telaprevir in chronic hepatitis C genotype 1 patients

References

• Shepard CW, Finelli L, Alter MJ. Global epidemiology of hepatitis C virus infection. Lancet Infect. Dis.5(9), 558–567 (2005).
   PubMed Web of Science ®Google Scholar
• Armstrong GL, Alter MJ, McQuillan GM, Margolis HS. The past incidence of hepatitis C virus infection: implications for the future burden of chronic liver disease in the United States. Hepatology31(3), 777–782 (2000).
   PubMed Web of Science ®Google Scholar
• Alter MJ, Kruszon-Moran D, Nainan OV et al. The prevalence of hepatitis C virus infection in the United States, 1988 through 1994. N. Engl. J. Med.341(8), 556–562 (1999).
   PubMed Web of Science ®Google Scholar
• Rustgi VK. The epidemiology of hepatitis C infection in the United States. J. Gastroenterol.42(7), 513–521 (2007).
   PubMed Web of Science ®Google Scholar
• Bosetti C, Levi F, Lucchini F, Zatonski WA, Negri E, La Vecchia C. Worldwide mortality from cirrhosis: an update to 2002. J. Hepatol.46(5), 827–839 (2007).
   PubMed Web of Science ®Google Scholar
• Salomon JA, Weinstein MC, Hammitt JK, Goldie SJ. Cost–effectiveness of treatment for chronic hepatitis C infection in an evolving patient population. JAMA290(2), 228–237 (2003).
   PubMed Web of Science ®Google Scholar
• Hassan MM, Zaghloul AS, El-Serag HB et al. The role of hepatitis C in hepatocellular carcinoma – a case control study among Egyptian patients. J. Clin. Gastroenterol.33(2), 123–126 (2001).
   PubMed Web of Science ®Google Scholar
• McDonald SA, Hutchinson SJ, Mills PR et al. The influence of hepatitis C and alcohol on liver-related morbidity and mortality in Glasgow’s injecting drug user population. J. Viral Hepat. DOI: 10.1111/j.1365-2893.2010.01380.x. (2010) (Epub ahead of print).
   Google Scholar
• Jacobson IM, Davis GL, El-Serag H, Negro F, Trepo C. Prevalence and challenges of liver diseases in patients with chronic hepatitis C virus infection. Clin. Gastroenterol. Hepatol.8(11), 924–933 (2010).
   PubMed Web of Science ®Google Scholar
• Davis GL, Roberts WL. The healthcare burden imposed by liver disease in aging Baby Boomers. Curr. Gastroenterol. Rep.12(1), 1–6 (2010).
   PubMedGoogle Scholar
• Kim WR, Poterucha JJ, Hermans JE et al. Cost–effectiveness of 6 and 12 months of interferon-α therapy for chronic hepatitis C. Ann. Intern. Med.127(10), 866–874 (1997).
   PubMed Web of Science ®Google Scholar
• Kim WR, Poterucha JJ, Gross JB Jr. Cost–effectiveness of interferon alfa 2b and ribavirin in the treatment of chronic hepatitis C. Hepatology31(3), 807 (2000).
   PubMedGoogle Scholar
• Kim WR. Epidemiology of hepatitis B in the United States. Hepatology49(S5), S28–S34 (2009).
   PubMed Web of Science ®Google Scholar
• Kim WR, Gross JB Jr, Poterucha JJ, Locke GR III, Dickson ER. Outcome of hospital care of liver disease associated with hepatitis C in the United States. Hepatology33(1), 201–206 (1901).
   Google Scholar
• Zeuzem S, Gane E, Liaw YF et al. Baseline characteristics and early on-treatment response predict the outcomes of 2 years of telbivudine treatment of chronic hepatitis B. J. Hepatol.51(1), 11–20 (2009).
   PubMed Web of Science ®Google Scholar
• Hoofnagle JH, Seeff LB. Peginterferon and ribavirin for chronic hepatitis C. N. Engl. J. Med.355(23), 2444–2451 (2006).
   PubMed Web of Science ®Google Scholar
• Poynard T, Colombo M, Bruix J et al. Peginterferon alfa-2b and ribavirin: effective in patients with hepatitis C who failed interferon alfa/ribavirin therapy. Gastroenterology136(5), 1618–1628 (2009).
   PubMed Web of Science ®Google Scholar
• Bruno S, Stroffolini T, Colombo M et al. Sustained virological response to interferon-α is associated with improved outcome in HCV-related cirrhosis: a retrospective study. Hepatology45(3), 579–587 (2007).
   PubMed Web of Science ®Google Scholar
• Sherman KE. New paradigms in the management of hepatitis C virus co-infections. Nat. Clin. Pract. Gastroenterol. Hepatol.4(Suppl. 1), S10–S16 (2007).
   PubMedGoogle Scholar
• Nelson DR, Davis GL, Jacobson I et al. Hepatitis C virus: a critical appraisal of approaches to therapy. Clin. Gastroenterol. Hepatol.7(4), 397–414 (2009).
   PubMedGoogle Scholar
• Ferenci P, Fried MW, Shiffman ML et al. Predicting sustained virological responses in chronic hepatitis C patients treated with peginterferon alfa-2a (40KD)/ribavirin. J. Hepatol.43(3), 425–433 (2005).
   PubMed Web of Science ®Google Scholar
• Fried MW, Shiffman ML, Reddy KR et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N. Engl. J. Med.347(13), 975–982 (2002).
   PubMed Web of Science ®Google Scholar
• Zeuzem S, Berg T, Moeller B et al. Expert opinion on the treatment of patients with chronic hepatitis C. J. Viral Hepat.16(2), 75–90 (2009).
   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. Gastroenterology132(5), 1979–1998 (2007).
   PubMed Web of Science ®Google Scholar
• McHutchison JG, Bartenschlager R, Patel K, Pawlotsky JM. The face of future hepatitis C antiviral drug development: recent biological and virologic advances and their translation to drug development and clinical practice. J. Hepatol.44(2), 411–421 (2006).
   PubMed Web of Science ®Google Scholar
• Manns MP, Foster GR, Rockstroh JK, Zeuzem S, Zoulim F, Houghton M. The way forward in HCV treatment – finding the right path. Nat. Rev. Drug Discov.6(12), 991–1000 (2007).
   PubMed Web of Science ®Google Scholar
• Jensen DM, Marcellin P, Freilich B et al. Re-treatment of patients with chronic hepatitis C who do not respond to peginterferon-α2b: a randomized trial. Ann. Intern. Med.150(8), 528–540 (2009).
   PubMed Web of Science ®Google Scholar
• Lin K, Perni RB, Kwong AD, Lin C. VX-950, a novel hepatitis C virus (HCV) NS3-4A protease inhibitor, exhibits potent antiviral activities in HCv replicon cells. Antimicrob. Agents Chemother.50(5), 1813–1822 (2006).
   PubMed Web of Science ®Google Scholar
• Lin C, Kwong AD, Perni RB. Discovery and development of VX-950, a novel, covalent, and reversible inhibitor of hepatitis C virus NS3.4A serine protease. Infect. Disord. Drug Targets6(1), 3–16 (2006).
   PubMedGoogle Scholar
• Lang L. Combination therapy with telaprevir and pegylated interferon suppresses both wild-type and resistant hepatitis C virus. Gastroenterology132(1), 5–6 (2007).
   Google Scholar
• Sigal S, Jacobson I. Future therapies for hepatitis C: where do we go from here? Nat. Clin. Pract. Gastroenterol. Hepatol.4(2), 60–61 (2007).
   PubMedGoogle Scholar
• Lawitz E, Rodriguez-Torres M, Muir AJ et al. Antiviral effects and safety of telaprevir, peginterferon alfa-2a, and ribavirin for 28 days in hepatitis C patients. J. Hepatol.49(2), 163–169 (2008).
   PubMed Web of Science ®Google Scholar
• Zeuzem S. Telaprevir, peginterferon alfa-2a, and ribavirin for 28 days in chronic hepatitis C patients. J. Hepatol.49(2), 157–159 (2008).
   PubMedGoogle Scholar
• De CE. Emerging antiviral drugs. Expert Opin. Emerg. Drugs13(3), 393–416 (2008).
   PubMed Web of Science ®Google Scholar
• Lopez-Labrador FX. Hepatitis C virus NS3/4A protease inhibitors. Recent Pat. Antiinfect. Drug Discov.3(3), 157–167 (2008).
   PubMedGoogle Scholar
• McHutchison JG, Everson GT, Gordon SC et al. Telaprevir with peginterferon and ribavirin for chronic HCV genotype 1 infection. N. Engl. J. Med.360(18), 1827–1838 (2009).
   PubMed Web of Science ®Google Scholar
• Hezode C, Forestier N, Dusheiko G et al. Telaprevir and peginterferon with or without ribavirin for chronic HCV infection. N. Engl. J. Med.360(18), 1839–1850 (2009).
   PubMed Web of Science ®Google Scholar
• Hoofnagle JH. A step forward in therapy for hepatitis C. N. Engl. J. Med.360(18), 1899–1901 (2009).
   PubMed Web of Science ®Google Scholar
• Brown NA. Progress towards improving antiviral therapy for hepatitis C with hepatitis C virus polymerase inhibitors. Part I: nucleoside analogues. Expert Opin. Investig. Drugs18(6), 709–725 (2009).
   PubMed Web of Science ®Google Scholar
• Kronenberger B, Zeuzem S. Current and future treatment options for HCV. Ann. Hepatol.8(2), 103–112 (2009).
   PubMedGoogle Scholar
• Nelson DR. Hepatitis C drug development at a crossroads. Hepatology50(4), 997–999 (2009).
   PubMedGoogle Scholar
• Baiocchi L, Lenci I, Carbone M, Angelico M. Comment on the PROVE1 and PROVE2 clinical trials: “I was taking a picture of rapid virological response with telaprevir, but the background is unfocused!”. Hepatology50(5), 1676–1677 (2009).
   PubMedGoogle Scholar
• Gentile I, Carleo MA, Borgia F, Castaldo G, Borgia G. The efficacy and safety of telaprevir – a new protease inhibitor against hepatitis C virus. Expert Opin. Investig. Drugs19(1), 151–159 (2010).
   PubMed Web of Science ®Google Scholar
• Lange CM, Sarrazin C, Zeuzem S. Review article: specifically targeted anti-viral therapy for hepatitis C – a new era in therapy. Aliment Pharmacol. Ther.32(1), 14–28 (2010).
   PubMed Web of Science ®Google Scholar
• McHutchison JG, Manns MP, Muir AJ et al. Telaprevir for previously treated chronic HCV infection. N. Engl. J. Med.362(14), 1292–1303 (2010).
   PubMed Web of Science ®Google Scholar
• Shiffman ML. Treatment of hepatitis C in 2011: what can we expect? Curr. Gastroenterol. Rep.12(1), 70–75 (2010).
   PubMedGoogle Scholar
• Opar A. Excitement grows for potential revolution in hepatitis C virus treatment. Nat. Rev. Drug Discov.9(7), 501–503 (2010).
   PubMedGoogle Scholar
• Milazzo L, Antinori S. STAT-C: a full revolution or just a step forward? Lancet376(9742), 662–663 (2010).
   PubMedGoogle Scholar
• Aghemo A, Colombo M. Telaprevir for hepatitis C re-treatment: an open door on a long and winding road. Gastroenterology139(4), 1412–1416 (2010).
   PubMedGoogle Scholar
• Rodriguez-Torres M. On the cusp of change: new therapeutic modalities for HCV. Ann. Hepatol.9(Suppl.), 123–131 (2010).
   PubMedGoogle Scholar
• Sarrazin C, Shiffman ML, Hadziyannis SJ et al. Definition of rapid virologic response with a highly sensitive real-time PCR-based HCV RNA assay in peginterferon alfa-2a plus ribavirin response-guided therapy. J. Hepatol.52(6), 832–838 (2010).
   PubMedGoogle Scholar
• Sarrazin C, Zeuzem S. Resistance to direct antiviral agents in patients with hepatitis C virus infection. Gastroenterology138(2), 447–462 (2010).
   PubMed Web of Science ®Google Scholar
• Susser S, Welsch C, Wang Y et al. Characterization of resistance to the protease inhibitor boceprevir in hepatitis C virus-infected patients. Hepatology50(6), 1709–1718 (2009).
   PubMed Web of Science ®Google Scholar
• Balagopal A, Thomas DL, Thio CL. IL28B and the control of hepatitis C virus infection. Gastroenterology DOI:10.1053/j.gastro.2010.10.004 (2010) (Epub ahead of print).
   PubMedGoogle Scholar
• Urban TJ, Thompson AJ, Bradrick SS et al. IL28B genotype is associated with differential expression of intrahepatic interferon-stimulated genes in patients with chronic hepatitis C. Hepatology DOI: 10.1002/hep.23912 (2010) (Epub ahead of print).
   Google Scholar
• Thompson AJ, Muir AJ, Sulkowski MS et al. Interleukin-28B polymorphism improves viral kinetics and is the strongest pretreatment predictor of sustained virologic response in genotype 1 hepatitis C virus. Gastroenterology139(1), 120–129 (2010).
   PubMedGoogle Scholar
• Ge D, Fellay J, Thompson AJ et al. Genetic variation in IL28B predicts hepatitis C treatment-induced viral clearance. Nature461(7262), 399–401 (2009).
   PubMed Web of Science ®Google Scholar
• Kieffer TL, Sarrazin C, Miller JS et al. Telaprevir and pegylated interferon-α-2a inhibit wild-type and resistant genotype 1 hepatitis C virus replication in patients. Hepatology46(3), 631–639 (2007).
   PubMed Web of Science ®Google Scholar
• Zhou Y, Bartels DJ, Hanzelka BL et al. Phenotypic characterization of resistant Val36 variants of hepatitis C virus NS3–4A serine protease. Antimicrob. Agents Chemother.52(1), 110–120 (2008).
   PubMed Web of Science ®Google Scholar
• Tong X, Bogen S, Chase R et al. Characterization of resistance mutations against HCV ketoamide protease inhibitors. Antiviral Res.77(3), 177–185 (2008).
   PubMed Web of Science ®Google Scholar
• Welsch C, Domingues FS, Susser S et al. Molecular basis of telaprevir resistance due to V36 and T54 mutations in the NS3–4A protease of the hepatitis C virus. Genome Biol.9(1), R16 (2008).
   Web of Science ®Google Scholar
• Kuntzen T, Timm J, Berical A et al. Naturally occurring dominant resistance mutations to hepatitis C virus protease and polymerase inhibitors in treatment-naive patients. Hepatology48(6), 1769–1778 (2008).
   PubMed Web of Science ®Google Scholar