SCH 503034, a Novel Hepatitis C Virus Protease Inhibitor, Plus Pegylated Interferon α-2b for Genotype 1 Nonresponders

Gastroenterology

Volumn 132, Issue 4, 2007, Pages 1270-1278

  Sarrazin, Christoph ^a,f   Rouzier, Regine ^b   Wagner, Frank ^c   Forestier, Nicole ^a,f   Larrey, Dominique ^d   Gupta, Samir K ^e   Hussain, Musaddeq ^e   Shah, Amrik ^e   Cutler, David ^e   Zhang, Jenny ^e   Zeuzem, Stefan ^a,f  

^a SAARLAND UNIVERSITY   (Germany)

^b Centre CAP   (France)

^c CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^d UNIV MONTPELLIER   (France)

^e MERCK RESEARCH LABORATORIES   (United States)

^f UNIVERSITY HOSPITAL FRANKFURT   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

PEGINTERFERON ALPHA2B; PROTEINASE INHIBITOR; RIBAVIRIN; SCH 503034; UNCLASSIFIED DRUG;

ABDOMINAL PAIN; ADULT; ANEMIA; AREA UNDER THE CURVE; ARTICLE; BACKACHE; CLINICAL ARTICLE; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG BIOAVAILABILITY; DRUG CLEARANCE; DRUG MECHANISM; DRUG PROTEIN BINDING; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPEPSIA; DYSURIA; FATIGUE; FEMALE; FEVER; FLU LIKE SYNDROME; GENOTYPE; HEADACHE; HEPATITIS C; HUMAN; INJECTION SITE INFLAMMATION; INJECTION SITE REACTION; LEUKOPENIA; MALE; MENTAL INSTABILITY; MONOTHERAPY; MULTICENTER STUDY; MYALGIA; NAUSEA; NEUTROPENIA; OPEN STUDY; PHARMACODYNAMICS; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; QT PROLONGATION; RANDOMIZED CONTROLLED TRIAL; RIGOR; TASTE DISORDER; VOMITING; WEAKNESS;

EID: 34247205808     PISSN: 00165085     EISSN: None     Source Type: Journal    
DOI: 10.1053/j.gastro.2007.01.041     Document Type: Article

References (26)

1. Zeuzem S., Buti M., Ferenci P., Sperl J., Horsmans Y., Cianciara J., Ibraniyi E., Weiland O., Noviello S., Brass C., and Albrecht J. Efficacy of 24 weeks treatment with peginterferon alfa-2b plus ribavirin in patients with chronic hepatitis C infected with genotype 1 and low pretreatment viremia. J Hepatol 44 (2006) 97-103
2. Manns M.P., McHutchison J.G., Gordon S.C., Rustigi V.K., Shiffman M., Reindollar R., Goodman Z.D., Koury K., Ling M., and Albrecht J.K. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet 358 (2001) 958-965
3. Scotto G., Fazio V., Palumbo E., Cibelli D.C., Saracino A., and Angarano G. Treatment of genotype 1B HCV-related chronic hepatitis: efficacy and toxicity of three different interferon alfa-2b/ribavirin combined regimens in naive patients. New Microbiol 28 (2005) 23-29
4. Muir A.J., Bornstein J.D., and Killenberg P.G. Peginterferon alfa-2b and ribavirin for the treatment of chronic hepatitis C in blacks and non-Hispanic whites. New Engl J Med 350 (2004) 2265-2271
5. Hadziyannis S.J., Sette Jr. H., Morgan T.R., Balan V., Diago M., Marcellin P., Ramadori G., Bodenheimer Jr. H., Bernstein D., Rizzetto M., Zeuzem S., Pockros P.J., Lin A., Ackrill A.M., and PEGASYS International Study Group. Peginterferon-α2a and ribavirin combination therapy in chronic hepatitis C: a randomized study of treatment duration and ribavirin dose. Ann Intern Med 140 (2004) 346-355
6. Fried M.W., Shiffman M.L., Reddy R., Smith C., Marinos G., Gonçales F.L., Häussinger D., Diago M., Carosi G., Dhumeaux D., Craxi A., Lin A., Hoffman J., and Yu J. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. New Engl J Med 347 (2002) 975-982
7. Poynard T., Schiff E., Terg G., Goncales F., Diago M., Reichen J., Moreno R., Bedossa P., Burrhough M., and Albrecht J. Sustained virologic response (SVR) in the EPIC3 trial: week twelve virology predicts SVR in previous interferon/ribavirin treatment failures receiving PEG-Intron/Rebetrol (PR) weight-based dosing (WBD). J Hepatol 42 Suppl 2 (2005) 40A
8. Lamarre D., Anderson P.C., Bailey M., Beaulieu P., Bolger G., Boneau P., Bos M., Camceron D.R., Cartier M., Cordingley M.G., Faucher A.M., Goudreau N., Kawai S.H., Kukolj G., Lagace L., LaPlante S.R., Narjes H., Poupart M.A., Rancourt J., Sentjens R.E., St. George R., Simoneau B., Steinmann G., Thibeault D., Tsantrizos Y.S., Weldon S.M., Yong C.L., and Llinas-Brunet M. An NS3 protease inhibitor with antiviral effects in humans infected with hepatitis C virus. Nature 426 (2003) 186-189
9. Hinrichsen H., Benhamou Y., Wedemeyer H., Reiser M., Sentjens R.E., Calleja J.L., Forns X., Erhardt A., Cronlein J., Chaves R.L., Yong C.L., Nehmiz G., and Steinmann G.G. Short-term antiviral efficacy of BILN 2061, a hepatitis C virus serine protease inhibitor, in hepatitis C genotype 1 patients. Gastroenterology 127 (2004) 1347-1355
10. Reiser M., Hinrichsen H., Benhamou Y., Reesink H.W., Wedemeyer H., Avendano C., Riba N., Yong C.L., Nehmiz G., and Steinmann G.G. Antiviral efficacy of NS3-serine protease inhibitor BILN-2061 in patients with chronic genotype 2 and 3 heptitis C. Hepatology 41 (2005) 832-835
11. Reesink H.W., Forestier N., Weegink C.J., Zeuzem S., McNari L., Purdy S., Chu H.-M., and Jansen P.L.M. Initial results of a 14-day study of the hepatitis C virus inhibitor protease VX-950, in combination with peginterferon-α-2a. J Hepatol 44 Suppl 2 (2006) S272
12. Reesink H.W., Zeuzem S., Weegink C.J., Forestier N., van Vliet A., van de Wetering de Rooij J., McNair L., Purdy S., Kauffman R., Alam J., and Jansen P.L. Rapid decline of viral RNA in hepatitis C patients treated with VX-950: a phase Ib, placebo-controlled, randomized study. Gastroenterology 131 (2006) 997-1002
13. Afdhal N., O'Brien C., Godofsky E., Rodriguez-Torres M., Pappas S.C., Pockros P., Lawitz E., Bzowej N., Rustgi V., Sulkowski M., Sherman K., Jacobson I., Chao G., Knox S., Pietropaolo K., and Brown N. Valopicitabine (NM283), alone or with peg-interferon, compared to peg interferon/ribavirin (PEGIFN/RBV) retreatment in hepatitis C patients with prior non-response to PEGIFN/RBV: week 24 results. J Hepatol 44 Suppl 2 (2006) S19
14. Dieterich D., Lawitz E., Nguyen T., Younes Z., Santoro J., Gitlin N., McEniry D., Chasen R., Goff J., Knox S., Kleber K., Belanger B., and Brown N. Early clearance of HCV RNA with valopicitabine (NM283) plus peg-interferon in treatment-naive patients with HCV-1 infection: first results from a Phase IIb trial. J Hepatol 44 Suppl 2 (2006) S271
15. Roberts S., Cooksley G., Shaw D., Berns H.K., Brandl M.T., Fettner S.H., Hill G., Ipe D., Klumpp K., Mannino M., O'Mara E., Tu Y., and Washington C.B. Interim results of a multiple ascending dose study of R1626, a novel nucleoside analog targeting HCV polymerase in chronic HCV patients. J Hepatol 44 Suppl 2 (2006) S269
16. Gale Jr. M., and Foy E.M. Evasion of intracellular host defence by hepatitis C virus. Nature 436 (2005) 939-945
17. Reed K.E., and Rice C.M. Overview of hepatitis C virus genome structure, polyprotein processing, and protein properties. Curr Top Microbiol Immunol 242 (2000) 55-84
18. Meylan E., Curran J., Hofmann K., Moradpour D., Binder M., Bartenschlager R., and Tschopp J. Cardif is an adaptor protein in the RIG-1 antiviral pathway and is targeted by hepatitis C virus. Nature 437 (2005) 1167-1172
19. Li K., Foy E., Ferreon J.C., Nakamura M., Ferreon A.C.M., Ikeda M., Ray S.C., Gale Jr. M., and Lemon S.M. Immune evasion by hepatitis C virus NS3/4A protease-mediated cleavage of the Toll-like receptor 3 adaptor protein TRIF. Proc Natl Acad Sci U S A 102 (2005) 2992-2997
20. Foy E., Li K., Wang C., Sumpter Jr. R., Ikeda M., Lemon S.M., and Gale Jr. M. Regulation of interferon regulatory factor-3 by the hepatitis C virus serine protease. Science 300 (2003) 1145-1148
21. Lin K., Kwong A.D., and Lin C. Combination of a hepatitis C virus NS3-NS4A protease inhibitor and α interferon synergistically inhibits viral RNA replication and facilitates viral RNA clearance in replicon cells. Antimicrob Agents Chemother 48 (2004) 4784-4792
22. Malcolm B.A., Liu R., Lahser F., Agrawal S., Belanger B., Butkiewicz N., Chase R., Gheyas F., Hart A., Hesk D., Ingravallo P., Jiang C., Kong R., Lu J., Pichardo J., Prongay A., Skelton A., Tong X., Venkatraman S., Xia E., Girijavallabhan V., and Njoroge G.F. SCH 503034, a mechanism-based inhibitor of hepatitis C virus NS3 protease, suppresses polyprotein maturation and enhances the antiviral activity of α interferon in replicon cells. Antimicrob Agents Chemother 50 (2006) 1013-1020
23. Cancer Therapy Evaluation Program. Common terminology criteria for adverse events v3.0 (CTCAE). Publish Date: December 12, 2003. Available at: http://ctep.cancer.gov. Accessed May 29, 2006.
24. Glue P., Rouzier-Panis R., Raffanel C., Sabo C., Gupta S.K., Salfi M., Jacobs S., and Clement R.P. A dose-ranging study of pegylated interferon alfa-2b and ribavirin in chronic hepatitis C. Hepatology 32 (2000) 647-653
25. Silva M., Poo J., Wagner F., Jackson M., Cutler D., Grace M., Bordens R., Cullen C., Harvey J., and Laughlin M. A randomised trial to compare the pharmacokinetic, pharmacodynamic, and antiviral effects of peginterferon alfa-2b and peginterferon alfa-2a in patients with chronic hepatitis C (COMPARE). J Hepatol 45 (2006) 204-213
26. Gosert R., Egger D., Lohmann V., Bartenschlager R., Blum H.E., Bienz K., and Moradpour D. Identification of the hepatitis C virus RNA replication complex in Huh-7 cells harboring subgenomic replicons. J Virol 77 (2003) 5487-5492