VX-222, a non-nucleoside NS5B polymerase inhibitor, in telaprevir-based regimens for genotype 1 hepatitis C virus infection

European Journal of Gastroenterology and Hepatology

Volumn 26, Issue 7, 2014, Pages 761-773

  Di Bisceglie, Adrian M ^a   Sulkowski, Mark ^b   Gane, Ed ^f   Jacobson, Ira M ^c   Nelson, David ^d   Desouza, Cynthia ^e   Alves, Katia ^e,g   George, Shelley ^e   Kieffer, Tara ^e   Zhang, Eileen Z ^e   Kauffman, Robert ^e   Asmal, Mohammed ^e   Koziel, Margaret J ^e,h  

^a Saint Louis University   (United States)

^b JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c WEILL CORNELL MEDICAL COLLEGE   (United States)

^d UNIVERSITY OF FLORIDA   (United States)

^e VERTEX PHARMACEUTICALS   (United States)

^f UNIVERSITY OF AUCKLAND   (New Zealand)

^g MERCK RESEARCH LABORATORIES   (United States)

^h UNIVERSITY OF MASSACHUSETTS MEDICAL SCHOOL   (United States)

Author keywords

Antiviral agent; Clinical trial; Combination drug therapy; Protease inhibitor

Indexed keywords

CREATININE; LOMIBUVIR; PEGINTERFERON ALPHA2A; RIBAVIRIN; TELAPREVIR; ALPHA INTERFERON; ANTIVIRUS AGENT; CYCLOHEXANOL DERIVATIVE; MACROGOL DERIVATIVE; NS-5 PROTEIN, HEPATITIS C VIRUS; OLIGOPEPTIDE; RECOMBINANT PROTEIN; THIOPHENE DERIVATIVE; VIRUS PROTEIN; VX-222;

ADULT; ANEMIA; ANTIVIRAL ACTIVITY; ANXIETY; ARTICLE; CHILL; CLINICAL ARTICLE; CONTROLLED STUDY; COUGHING; CREATININE BLOOD LEVEL; DIARRHEA; DIZZINESS; DRUG ERUPTION; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DRY SKIN; FATIGUE; FEMALE; FRACTURE; GENOTYPE; HEPATITIS C; HEPATITIS C VIRUS; HUMAN; INFLUENZA; INJECTION SITE ERYTHEMA; INSOMNIA; MALE; MIDDLE AGED; MULTICENTER STUDY; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PRURITUS; PSYCHOSIS; RANDOMIZED CONTROLLED TRIAL; SEPTIC SHOCK; TREATMENT RESPONSE; VISUAL ACUITY; VOMITING; ADOLESCENT; AGED; ANTAGONISTS AND INHIBITORS; CLINICAL TRIAL; DRUG COMBINATION; DRUG EFFECTS; GENETICS; HEPACIVIRUS; HEPATITIS C, CHRONIC; TREATMENT OUTCOME; VIROLOGY; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; ANTIVIRAL AGENTS; CYCLOHEXANOLS; DRUG THERAPY, COMBINATION; FEMALE; GENOTYPE; HEPACIVIRUS; HEPATITIS C, CHRONIC; HUMANS; INTERFERON-ALPHA; MALE; MIDDLE AGED; OLIGOPEPTIDES; POLYETHYLENE GLYCOLS; RECOMBINANT PROTEINS; RIBAVIRIN; THIOPHENES; TREATMENT OUTCOME; VIRAL NONSTRUCTURAL PROTEINS; YOUNG ADULT;

EID: 84902169210     PISSN: 0954691X     EISSN: 14735687     Source Type: Journal    
DOI: 10.1097/MEG.0000000000000084     Document Type: Article

References (24)

1. Lavanchy D. The global burden of hepatitis C. Liver Int 2009; 29 (Suppl 1):74-81.
2. Chou R, Hartung D, Rahman B, Wasson N, Cottrell EB, Fu R. Comparative effectiveness of antiviral treatment for hepatitis C virus infection in adults: a systematic review. Ann Intern Med 2013; 158:114-123.
3. Wiesner RH, Sorrell M, Villamil F. International Liver Transplantation Society Expert Panel. Report of the first International Liver Transplantation Society expert panel consensus conference on liver transplantation and hepatitis C. Liver Transpl 2003; 9:S1-S9.
4. Adam R, McMaster P, O'Grady JG, Castaing D, Klempnauer JL, Jamieson N, et al. Evolution of liver transplantation in Europe: report of the European Liver Transplant Registry. Liver Transpl 2003; 9:1231-1243.
5. Ghany MG, Nelson DR, Strader DB, Thomas DL, Seeff LB. American Association for Study of Liver Diseases. An update on treatment of genotype 1 chronic hepatitis C virus infection: 2011 practice guideline by the American Association for the Study of Liver Diseases. Hepatology 2011; 54:1433-1444.
6. Backus LI, Boothroyd DB, Phillips BR, Belperio P, Halloran J, Mole LA. A sustained virologic response reduces risk of all-cause mortality in patients with hepatitis C. Clin Gastroenterol Hepatol 2011; 9:509-516.
7. Morgan TR, Ghany MG, Kim HY, Snow KK, Shiffman ML, De Santo JL, et al. Outcome of sustained virological responders with histologically advanced chronic hepatitis C. Hepatology 2010; 52:833-844.
8. George SL, Bacon BR, Brunt EM, Mihindukulasuriya KL, Hoffmann J, Di Bisceglie AM. Clinical, virologic, histologic, and biochemical outcomes after successful HCV therapy: a 5-year follow-up of 150 patients. Hepatology 2009; 49:729-738.
9. Incivek. Incivek [package insert]. Cambridge, MA: Vertex Pharmaceuticals Incorporated; 2013.
10. Legrand-Abravanel F, Nicot F, Izopet J. New NS5B polymerase inhibitors for hepatitis C. Expert Opin Investig Drugs 2010; 19:963-975.
11. Rodriguez-Torres M, Lawitz E, Conway B, Kaita K, Sheikh AM, Ghalib R, et al. Safety and antiviral activity of the HCV non-nucleoside polymerase inhibitor VX-222 in treatment-naive genotype 1 HCV-infected patients [abstract]. J Hepatol 2010; 52:S14.
12. Rodriguez-Torres M, Lawitz E, Conway B, Kaita K, Sheikh AM, Ghalib R, et al. Safety and antiviral activity of the HCV non-nucleoside polymerase inhibitor VX-222 in treatment-naive genotype 1 HCV-infected patients [oral presentation] [abstract]. Presented at the International Liver Congress/45th Annual Meeting of the European Association for the Study of the Liver; Vienna, Austria; 14-18 April 2010.
13. Di Bisceglie AM, Nelson DR, Gane E, Alves K, Koziel MJ, De Souza C, et al. VX-222 with TVR alone or in combination with peginterferon alfa-2a and ribavirin in treatment-naive patients with chronic hepatitis C: ZENITH study interim results [abstract 1363]. J Hepatol 2011; 54 (Suppl 1):S540.
14. Division of AIDS table for grading the severity of adult and pediatric adverse events, version 1.0, December 2004; clarification August 2009. Available at: http://rsc.tech-res.com/ Document/safetyandpharmacovigilance/Table-for- Grading-Severity-of- Adult-Pediatric-Adverse-Events.pdf. [Accessed 11 April 2013].
15. Kieffer TL, De Meyer S, Bartels DJ, Sullivan JC, Zhang EZ, Tigges A, et al. Hepatitis C viral evolution in genotype 1 treatment-naive and treatmentexperienced patients receiving telaprevir-based therapy in clinical trials. PLoS One 2012; 7:e34372.
16. Jacobson IM, McHutchison JG, Dusheiko G, Di Bisceglie AM, Reddy KR, Bzowej NH, et al. ADVANCE Study Team. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med 2011; 364:2405-2416.
17. Pegasys. Pegasys [package insert]. South San Francisco, CA: Genentech USA Inc.; 2011.
18. Copegus. Copegus [package insert]. South San Francisco, CA: Genentech USA Inc.; 2013.
19. Yamada I, Suzuki F, Kamiya N, Aoki K, Sakurai Y, Kano M, et al. Safety, pharmacokinetics and resistant variants of telaprevir alone for 12 weeks in hepatitis C virus genotype 1b infection. J Viral Hepat 2012; 19: e112-e119.
20. Sarrazin C, Kieffer TL, Bartels D, Hanzelka B, Müh U, Welker M, et al. Dynamic hepatitis C virus genotypic and phenotypic changes in patients treated with the protease inhibitor telaprevir. Gastroenterology 2007; 132:1767-1777.
21. Zeuzem S, Soriano V, Asselah T, Bronowicki JP, Lohse AW, Mullhaupt B, et al. Faldaprevir and deleobuvir for HCV genotype 1 infection. N Engl J Med 2013; 369:630-639.
22. Poordad F, Lawitz E, Kowdley KV, Cohen DE, Podsadecki T, Siggelkow S, et al. Exploratory study of oral combination antiviral therapy for hepatitis C. N Engl J Med 2013; 368:45-53.
23. Hézode C, Forestier N, Dusheiko G, Ferenci P, Pol S, Goeser T, et al. Telaprevir and peginterferon with or without ribavirin for chronic HCV infection. N Engl J Med 2009; 360:1839-1850.
24. McHutchison JG, Everson GT, Gordon SC, Jacobson IM, Sulkowski M, Kauffman R, et al. PROVE1 Study Team. Telaprevir with peginterferon and ribavirin for chronic HCV genotype 1 infection. N Engl J Med 2009; 360:1827-1838.