Boceprevir-based Therapy to Rescue HCV Genotype 1/HBV Infected Patients Refractory to Combination Therapy

Summary

The aim of this study is to explore the efficacy and safety of boceprevir -based triple therapy to rescue HCV genotype 1 (HCV GT1)/HBV dually infected patients refractory to previous peginterferon (PEG-IFN) plus ribavirin (RBV) combination therapy.

Timeline

Start

2013-11

Primary completion

2016-09

Completion

2016-09

Publications

• Background Chuang WL, Chang WY, Lu SN, Lin ZY, Chen SC, Hsieh MY, Wang LY, You SL, Chen CJ. The role of hepatitis C virus in chronic hepatitis B virus infection. Gastroenterol Jpn. 1993 May;28 Suppl 5:23-7. doi: 10.1007/BF02989199.
• Background Chen DS, Wang JT, Chen PJ, Wang TH, Sung JL. Hepatitis C virus infection in Taiwan. Gastroenterol Jpn. 1991 Jul;26 Suppl 3:164-6. doi: 10.1007/BF02779290.
• Background European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of hepatitis C virus infection. J Hepatol. 2011 Aug;55(2):245-64. doi: 10.1016/j.jhep.2011.02.023. Epub 2011 Mar 1. No abstract available.
• Background Papatheodoridis GV, Manolakopoulos S, Liaw YF, Lok A. Follow-up and indications for liver biopsy in HBeAg-negative chronic hepatitis B virus infection with persistently normal ALT: a systematic review. J Hepatol. 2012 Jul;57(1):196-202. doi: 10.1016/j.jhep.2011.11.030. Epub 2012 Mar 23.
• Background Chen DS, Sung JL. Studies on the subtypes of hepatitis B surface antigen-demonstration of vertical and intrafamilial transmission of hepatitis B virus. Taiwan Yi Xue Hui Za Zhi. 1978 Mar;77(3):263-71. No abstract available.
• Background Stevens CE, Beasley RP, Tsui J, Lee WC. Vertical transmission of hepatitis B antigen in Taiwan. N Engl J Med. 1975 Apr 10;292(15):771-4. doi: 10.1056/NEJM197504102921503.
• Background Sheu JC, Wang JT, Wang TH, Wang CY, Yang PM, Huang GT, Shih LN, Lee HS, Chen DS. Prevalence of hepatitis C viral infection in a community in Taiwan. Detection by synthetic peptide-based assay and polymerase chain reaction. J Hepatol. 1993 Feb;17(2):192-8. doi: 10.1016/s0168-8278(05)80037-6.
• Background Yang JF, Lin CI, Huang JF, Dai CY, Lin WY, Ho CK, Hsieh MY, Lee LP, Ho NJ, Lin ZY, Chen SC, Hsieh MY, Wang LY, Yu ML, Chuang WL, Chang WY. Viral hepatitis infections in southern Taiwan: a multicenter community-based study. Kaohsiung J Med Sci. 2010 Sep;26(9):461-9. doi: 10.1016/S1607-551X(10)70073-5.
• Background Liu CJ, Chen PJ, Chen DS. Dual chronic hepatitis B virus and hepatitis C virus infection. Hepatol Int. 2009 Dec;3(4):517-25. doi: 10.1007/s12072-009-9147-9. Epub 2009 Aug 8.
• Background Huang YT, Jen CL, Yang HI, Lee MH, Su J, Lu SN, Iloeje UH, Chen CJ. Lifetime risk and sex difference of hepatocellular carcinoma among patients with chronic hepatitis B and C. J Clin Oncol. 2011 Sep 20;29(27):3643-50. doi: 10.1200/JCO.2011.36.2335. Epub 2011 Aug 22.
• Background Liu CJ, Chuang WL, Lee CM, Yu ML, Lu SN, Wu SS, Liao LY, Chen CL, Kuo HT, Chao YC, Tung SY, Yang SS, Kao JH, Liu CH, Su WW, Lin CL, Jeng YM, Chen PJ, Chen DS. Peginterferon alfa-2a plus ribavirin for the treatment of dual chronic infection with hepatitis B and C viruses. Gastroenterology. 2009 Feb;136(2):496-504.e3. doi: 10.1053/j.gastro.2008.10.049. Epub 2008 Oct 29.
• Background Potthoff A, Wedemeyer H, Boecher WO, Berg T, Zeuzem S, Arnold J, Spengler U, Gruengreiff K, Kaeser T, Schuchmann M, Bergk A, Forestier N, Deterding K, Manns MP, Trautwein C; Hep-Net B/C Co-infection Study Group. The HEP-NET B/C co-infection trial: A prospective multicenter study to investigate the efficacy of pegylated interferon-alpha2b and ribavirin in patients with HBV/HCV co-infection. J Hepatol. 2008 Nov;49(5):688-94. doi: 10.1016/j.jhep.2008.03.028. Epub 2008 Apr 29.
• Background Yu JW, Sun LJ, Zhao YH, Kang P, Gao J, Li SC. Analysis of the efficacy of treatment with peginterferon alpha-2a and ribavirin in patients coinfected with hepatitis B virus and hepatitis C virus. Liver Int. 2009 Nov;29(10):1485-93. doi: 10.1111/j.1478-3231.2009.02080.x. Epub 2009 Jul 7.
• Background Bacon BR, Gordon SC, Lawitz E, Marcellin P, Vierling JM, Zeuzem S, Poordad F, Goodman ZD, Sings HL, Boparai N, Burroughs M, Brass CA, Albrecht JK, Esteban R; HCV RESPOND-2 Investigators. Boceprevir for previously treated chronic HCV genotype 1 infection. N Engl J Med. 2011 Mar 31;364(13):1207-17. doi: 10.1056/NEJMoa1009482.
• Background Zeuzem S, Andreone P, Pol S, Lawitz E, Diago M, Roberts S, Focaccia R, Younossi Z, Foster GR, Horban A, Ferenci P, Nevens F, Mullhaupt B, Pockros P, Terg R, Shouval D, van Hoek B, Weiland O, Van Heeswijk R, De Meyer S, Luo D, Boogaerts G, Polo R, Picchio G, Beumont M; REALIZE Study Team. Telaprevir for retreatment of HCV infection. N Engl J Med. 2011 Jun 23;364(25):2417-28. doi: 10.1056/NEJMoa1013086.
• Background Yu ML, Lee CM, Chen CL, Chuang WL, Lu SN, Liu CH, Wu SS, Liao LY, Kuo HT, Chao YC, Tung SY, Yang SS, Kao JH, Su WW, Lin CL, Yang HC, Chen PJ, Chen DS, Liu CJ; Taiwan Liver-Net Consortium. Sustained hepatitis C virus clearance and increased hepatitis B surface antigen seroclearance in patients with dual chronic hepatitis C and B during posttreatment follow-up. Hepatology. 2013 Jun;57(6):2135-42. doi: 10.1002/hep.26266. Epub 2013 Apr 26.

Drugs

Indications