Pegylated interferon alpha 2a for the treatment of hepatitis C virus infection

References

• Petruzziello A, Marigliano S, Loquercio G, et al. Global epidemiology of hepatitis C virus infection: an up-date of the distribution and circulation of hepatitis C virus genotypes. World J Gastroenterol. 2016;22(34):7824–7840.
   PubMed Web of Science ®Google Scholar
• Smith BD, Morgan RL, Beckett GA, et al. Recommendations for the identification of chronic hepatitis C virus infection among persons born during 1945–1965. MMWR Morb Mortal Wkly Rep. 2012;61( Rr-4):1–32.
   Google Scholar
• Millman AJ, Nelson NP, Vellozzi C. Hepatitis C: review of the epidemiology, clinical care, and continued challenges in the direct acting antiviral era. Curr Epidemiol Rep. 2017;4(2):174–185.
   PubMedGoogle Scholar
• Scott N, Doyle JS, Wilson DP, et al. Reaching hepatitis C virus elimination targets requires health system interventions to enhance the care cascade. Int J Drug Policy. 2017;47:107–116.
   PubMed Web of Science ®Google Scholar
• Grebely J, Oser M, Taylor LE, et al. Breaking down the barriers to hepatitis C virus (HCV) treatment among individuals with HCV/HIV coinfection: action required at the system, provider, and patient levels. J Infect Dis. 2013;207(Suppl 1):S19–25.
   PubMed Web of Science ®Google Scholar
• Cheinquer H, Sette-Jr H, Wolff FH, et al. Treatment of chronic HCV infection with the new direct acting antivirals (DAA): first report of a real world experience in Southern Brazil. Ann Hepatol. 2017;16(5):727–733.
   PubMed Web of Science ®Google Scholar
• Calleja JL, Crespo J, Rincon D, et al. Effectiveness, safety and clinical outcomes of direct-acting antiviral therapy in HCV genotype 1 infection: results from a Spanish real-world cohort. J Hepatol. 2017;66(6):1138–1148.
   PubMed Web of Science ®Google Scholar
• Ahmed KT, Almashhrawi AA, Ibdah JA, et al. Is the 25-year hepatitis C marathon coming to an end to declare victory? World J Hepatol. 2017;9(21):921–929.
   PubMed Web of Science ®Google Scholar
• Choo QL, Kuo G, Weiner AJ, et al. Isolation of a cDNA clone derived from a blood-borne non-A, non-B viral hepatitis genome. Science (New York, N.Y.). 1989;244(4902):359–362.
   PubMed Web of Science ®Google Scholar
• Dieterich D, Rockstroh JK, Orkin C, et al. Simeprevir (TMC435) with pegylated interferon/ribavirin in patients coinfected with HCV genotype 1 and HIV-1: a phase 3 study. Clin Infect Dis. 2014;59(11):1579–1587.
   PubMed Web of Science ®Google Scholar
• Andersohn F, Claes AK, Kulp W, et al. Simeprevir with pegylated interferon alfa 2a plus ribavirin for treatment of hepatitis C virus genotype 1 in patients with HIV: a meta-analysis and historical comparison. BMC Infect Dis. 2016;16:10.
   PubMed Web of Science ®Google Scholar
• Asmuth DM, Utay NS, Pollard RB. Peginterferon alpha-2a for the treatment of HIV infection. Expert Opin Investig Drugs. 2016;25(2):249–257.
   PubMed Web of Science ®Google Scholar
• Heathcote EJ, Shiffman ML, Cooksley WG, et al. Peginterferon alfa-2a in patients with chronic hepatitis C and cirrhosis. N Engl J Med. 2000;343(23):1673–1680.
   PubMed Web of Science ®Google Scholar
• Perry CM, Jarvis B. Spotlight on peginterferon-alpha-2a (40KD) in chronic hepatitis C. BioDrugs. 2002;16(3):213–217.
   PubMed Web of Science ®Google Scholar
• Poordad F, McCone J Jr., Bacon BR, et al. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med. 2011;364(13):1195–1206.
   PubMed Web of Science ®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(25):2405–2416.
   PubMed Web of Science ®Google Scholar
• Jacobson IM, Lawitz E, Gane EJ, et al. Efficacy of 8 weeks of sofosbuvir, velpatasvir, and voxilaprevir in patients with chronic HCV infection: 2 phase 3 randomized trials. Gastroenterology. 2017;153(1):113–122.
   PubMed Web of Science ®Google Scholar
• Chahine EB, Sucher AJ, Hemstreet BA. Sofosbuvir/velpatasvir: the first pangenotypic direct-acting antiviral combination for hepatitis C. The Annals of pharmacotherapy. 2016;51(1):44–53.
   PubMed Web of Science ®Google Scholar
• Latt NL, Yanny BT, Gharibian D, et al. Eight-week ledipasvir/sofosbuvir in non-cirrhotic, treatment-naive hepatitis C genotype-1 patients with hepatitis C virus-RNA < 6 million: single center, real world effectiveness and safety. World J Gastroenterol. 2017;23(26):4759–4766.
   PubMed Web of Science ®Google Scholar
• Isaacs A, Lindenmann J. Virus interference. I. The interferon. Proc Royal Soc London. Ser B, Biol Sciences. 1957;147(927):258–267.
   PubMed Web of Science ®Google Scholar
• Siegal FP, Kadowaki N, Shodell M, et al. The nature of the principal type 1 interferon-producing cells in human blood. Science (New York, N.Y.). 1999;284(5421):1835–1837.
   PubMed Web of Science ®Google Scholar
• Roche. PEGASYS® (peginterferon alfa-2a): drug prescribing information. (Ed.^(Eds) (September 2008)
   Google Scholar
• Noureddin M, Ghany MG. Pharmacokinetics and pharmacodynamics of peginterferon and ribavirin: implications for clinical efficacy in the treatment of chronic hepatitis C. Gastroenterol Clin North Am. 2010;39(3):649–658.
   PubMed Web of Science ®Google Scholar
• Samuel CE. Antiviral actions of interferons. Clin Microbiol Rev. 2001;14(4): 778–809. table of contents.
   PubMed Web of Science ®Google Scholar
• Lamb M, Marks I, Wynohradnyk L, et al. 40 kDa peginterferon alfa-2a (PEGASYS (R)) can be administered safely in patients with end-stage renal disease. In: Hepatology. (Ed.^(Eds) (WB SAUNDERS CO INDEPENDENCE SQUARE WEST CURTIS CENTER, STE 300, PHILADELPHIA, PA 19106-3399 USA, 2001) 326A-326A.
   Google Scholar
• Zheng L, Li MP, Gou ZP, et al. A pharmacokinetic and pharmacodynamic comparison of a novel pegylated recombinant consensus interferon-alpha variant with peginterferon-alpha-2a in healthy subjects. Br J Clin Pharmacol. 2015;79(4):650–659.
   PubMed Web of Science ®Google Scholar
• Garcia-Garcia I, Gonzalez-Delgado CA, Valenzuela-Silva CM, et al. Pharmacokinetic and pharmacodynamic comparison of two “pegylated” interferon alpha-2 formulations in healthy male volunteers: a randomized, crossover, double-blind study. BMC Pharmacol. 2010;10(15):15.
   PubMedGoogle Scholar
• Bruno R, Sacchi P, Ciappina V, et al. Viral dynamics and pharmacokinetics of peginterferon alpha-2a and peginterferon alpha-2b in naive patients with chronic hepatitis c: a randomized, controlled study. Antivir Ther. 2004;9(4):491–497.
   PubMed Web of Science ®Google Scholar
• Chen Y, Xu HX, Wang LJ, et al. Meta-analysis: IL28B polymorphisms predict sustained viral response in HCV patients treated with pegylated interferon-alpha and ribavirin. Aliment Pharmacol Ther. 2012;36(2):91–103.
   PubMed Web of Science ®Google Scholar
• Hadziyannis SJ, Sette H Jr., 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(5):346–355.
   PubMed Web of Science ®Google Scholar
• Sherman KE, Flamm SL, Afdhal NH, et al. Response-guided telaprevir combination treatment for hepatitis C virus infection. N Engl J Med. 2011;365(11):1014–1024.
   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(25):2417–2428.
   PubMed Web of Science ®Google Scholar
• Jacobson IM, Dore GJ, Foster GR, et al. Simeprevir 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 trial. Lancet (London, England). 2014;384(9941):403–413.
   PubMed Web of Science ®Google Scholar
• Manns M, Marcellin P, Poordad F, et al. Simeprevir 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 trial. Lancet (London, England). 2014;384(9941):414–426.
   PubMed Web of Science ®Google Scholar
• Forns X, Lawitz E, Zeuzem S, et al. Simeprevir with peginterferon and ribavirin leads to high rates of SVR in patients with HCV genotype 1 who relapsed after previous therapy: a phase 3 trial. Gastroenterology. 2014;146(7):1669–1679.e1663.
   PubMed Web of Science ®Google Scholar
• Reddy KR, Zeuzem S, Zoulim F, et al. Simeprevir versus telaprevir with peginterferon and ribavirin in previous null or partial responders with chronic hepatitis C virus genotype 1 infection (ATTAIN): a randomised, double-blind, non-inferiority phase 3 trial. Lancet Infect Dis. 2015;15(1):27–35.
   PubMed Web of Science ®Google Scholar
• Hezode C, Hirschfield GM, Ghesquiere W, et al. Daclatasvir plus peginterferon alfa and ribavirin for treatment-naive chronic hepatitis C genotype 1 or 4 infection: a randomised study. Gut. 2015;64(6):948–956.
   PubMed Web of Science ®Google Scholar
• Dore GJ, Lawitz E, Hezode C, et al. Daclatasvir plus peginterferon and ribavirin is noninferior to peginterferon and ribavirin alone, and reduces the duration of treatment for HCV genotype 2 or 3 infection. Gastroenterology. 2015;148(2):355–366.e351.
   PubMed Web of Science ®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):1878–1887.
   PubMed Web of Science ®Google Scholar
• Lawitz E, Lalezari JP, Hassanein T, et al. Sofosbuvir 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 trial. Lancet Infect Dis. 2013;13(5):401–408.
   PubMed Web of Science ®Google Scholar
• Lawitz E, Poordad F, Brainard DM, et al. Sofosbuvir with peginterferon-ribavirin for 12 weeks in previously treated patients with hepatitis C genotype 2 or 3 and cirrhosis. Hepatology. 2015;61(3):769–775.
   PubMed Web of Science ®Google Scholar
• Xu Z. Single-dose safety/tolerability and pharmacokinetic/pharmacodynamics (PK/PD) following administration of ascending subcutaneous doses of pegylated-interferon (PEG-IFN) and interferon α-2a (IFN α-2a) to healthy subjects. Hepatology. 1998;28:702A.
   Web of Science ®Google Scholar
• Algranati N, Sy S, Modi M. A branched methoxy 40 KDA polyethylene glycol (PEG) moiety optimizes the pharmacokinetics (PK) of peginter-feron alpha-2A (PEG-IFN) and may explain its enhanced efficacy in chronic hepatitis C (CHC). In: Hepatology. (Ed.^(Eds) (WB SAUNDERS CO INDEPENDENCE SQUARE WEST CURTIS CENTER, STE 300, Philadelphia, PA 19106-3399 USA, 1999) 190A-190A.
   Google Scholar
• Sulkowski M, Reindollar R, Thomas DL, et al. Peginterferon-alpha-2a (40kD) and ribavirin in patients with chronic hepatitis C: a phase II open-label study. BioDrugs. 2002;16(2):105–109.
   PubMed Web of Science ®Google Scholar
• Zeuzem S, Feinman SV, Rasenack J, et al. Peginterferon alfa-2a in patients with chronic hepatitis C. N Engl J Med. 2000;343(23):1666–1672.
   PubMed Web of Science ®Google Scholar
• Pockros PJ, Carithers R, Desmond P, et al. Efficacy and safety of two-dose regimens of peginterferon alpha-2a compared with interferon alpha-2a in chronic hepatitis C: a multicenter, randomized controlled trial. Am J Gastroenterol. 2004;99(7):1298–1305.
   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. 2002;347(13):975–982.
   PubMed Web of Science ®Google Scholar
• Witthoft T, Moller B, Wiedmann KH, et al. Safety, tolerability and efficacy of peginterferon alpha-2a and ribavirin in chronic hepatitis C in clinical practice: the German Open Safety Trial. J Viral Hepat. 2007;14(11):788–796.
   PubMed Web of Science ®Google Scholar
• Pol S, Ghalib RH, Rustgi VK, et al. Daclatasvir for previously untreated chronic hepatitis C genotype-1 infection: a randomised, parallel-group, double-blind, placebo-controlled, dose-finding, phase 2a trial. Lancet Infect Dis. 2012;12(9):671–677.
   PubMed Web of Science ®Google Scholar
• Gane EJ, Stedman CA, Hyland RH, et al. Nucleotide polymerase inhibitor sofosbuvir plus ribavirin for hepatitis C. N Engl J Med. 2013;368(1):34–44.
   PubMed Web of Science ®Google Scholar
• Ferenci P, Caruntu FA, Lengyel G, et al. Boceprevir plus peginterferon alfa-2a/ribavirin in treatment-naive hepatitis C virus genotype 1 patients: international phase IIIb/IV TriCo trial. Infect Dis Therapy. 2016;5(2):113–124.
   PubMed Web of Science ®Google Scholar
• Alsaran K, Sabry A, Molhem A. Treatment of chronic hepatitis C with peginterferon alfa-2b, plus ribavirin in end stage renal disease patients treated by hemodialysis: single Saudi center experience. Ren Fail. 2013;35(10):1305–1309.
   PubMed Web of Science ®Google Scholar
• Liu CH, Huang CF, Liu CJ, et al. Pegylated interferon-alpha2a with or without low-dose ribavirin for treatment-naive patients with hepatitis C virus genotype 1 receiving hemodialysis: a randomized trial. Ann Intern Med. 2013;159(11):729–738.
   PubMed Web of Science ®Google Scholar
• Liu CH, Liu CJ, Huang CF, et al. Peginterferon alfa-2a with or without low-dose ribavirin for treatment-naive patients with hepatitis C virus genotype 2 receiving haemodialysis: a randomised trial. Gut. 2015;64(2):303–311.
   PubMed Web of Science ®Google Scholar
• Boglione L, Cardellino CS, Cusato J, et al. Treatment with PEG-IFN and ribavirin in patients with chronic hepatitis C, low grade of hepatic fibrosis, genotype 1 and 4 and favorable IFNL3 genotype: a pharmacogenetic prospective study. Infect Genet Evol. 2017;51:167–172.
   PubMed Web of Science ®Google Scholar
• Wu R, Chi X, Wang X, et al. IFNL4 ss469415590 polymorphism contributes to treatment decisions in patients with chronic hepatitis C virus genotype 1b, but not 2a, infection. Infect Genet Evol. 2016;39:132–140.
   PubMed Web of Science ®Google Scholar
• Kalafateli M, Buzzetti E, Thorburn D, et al. Pharmacological interventions for acute hepatitis C infection: an attempted network meta-analysis. Cochrane Database Syst Rev. 2017;3:Cd011644.
   PubMed Web of Science ®Google Scholar
• Liu CH, Liang CC, Liu CJ, et al. Pegylated interferon alfa-2a monotherapy for hemodialysis patients with acute hepatitis C. Clin Infect Dis. 2010;51(5):541–549.
   PubMed Web of Science ®Google Scholar
• Zhang B, Nguyen NH, Yee BE, et al. Treatment of acute hepatitis C infection with pegylated interferon and ribavirin in patients coinfected with human immunodeficiency virus: a systematic review and meta-analysis. Intervirology. 2015;58(4):242–249.
   PubMed Web of Science ®Google Scholar