Combination of Vaniprevir With Peginterferon and Ribavirin Significantly Increases the Rate of SVR in Treatment-Experienced Patients With Chronic HCV Genotype 1 Infection and Cirrhosis

Clinical Gastroenterology and Hepatology

Volumn 12, Issue 6, 2014, Pages 1029-1037.e5

  Rodriguez Torres, Maribel ^a   Stoehr, Albrecht ^b   Gane, Edward J ^c   Serfaty, Lawrence ^d   Lawitz, Eric ^e   Zhou, Amy ^f   Bourque, Michael ^f   Bhanja, Sanhita ^f   Strizki, Julie ^f   Barnard, Richard J O ^f   Hwang, Peggy M T ^f   DiNubile, Mark J ^f   Mobashery, Niloufar ^f  

^a Department of Hematology and Oncology   (Puerto Rico)

^b Ifi Institute for Interdisciplinary Infectiology   (Germany)

^c Auckland Clinical Studies Ltd   (New Zealand)

^d SORBONNE UNIVERSITÉ   (France)

^e UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO   (United States)

^f MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Clinical trial; Direct acting antiviral agent; Fibrosis

Indexed keywords

ERYTHROPOIETIN; HEMOGLOBIN; PEGINTERFERON; PLACEBO; PROTEINASE; RIBAVIRIN; VANIPREVIR; ALPHA INTERFERON; ANTIVIRUS AGENT; INDOLE DERIVATIVE; MK-7009;

ADULT; AGED; ANEMIA; ARTICLE; BRAIN ISCHEMIA; CONFUSION; CONTROLLED STUDY; DIARRHEA; DISEASE COURSE; DOUBLE BLIND PROCEDURE; DRUG DOSE REDUCTION; DRUG EFFECT; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; FEVER; HEPATITIS C; HEPATITIS C VIRUS GENOTYPE 1; HUMAN; LIVER BIOPSY; LIVER CIRRHOSIS; MAJOR CLINICAL STUDY; MALE; NAUSEA; NON INVASIVE PROCEDURE; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SUSTAINED VIROLOGIC RESPONSE; TREATMENT RESPONSE; VIRUS RESISTANCE; VIRUS VIRULENCE; VOMITING; ADOLESCENT; CLASSIFICATION; CLINICAL TRIAL; COMPLICATION; DRUG COMBINATION; GENETICS; GENOTYPE; HEPACIVIRUS; HEPATITIS C, CHRONIC; ISOLATION AND PURIFICATION; MIDDLE AGED; PHASE 2 CLINICAL TRIAL; PROCEDURES; TREATMENT OUTCOME; VIROLOGY; VIRUS LOAD; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; ANTIVIRAL AGENTS; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; GENOTYPE; HEPACIVIRUS; HEPATITIS C, CHRONIC; HUMANS; INDOLES; INTERFERON-ALPHA; LIVER CIRRHOSIS; MALE; MIDDLE AGED; PLACEBOS; RIBAVIRIN; TREATMENT OUTCOME; VIRAL LOAD; YOUNG ADULT;

EID: 84901244528     PISSN: 15423565     EISSN: 15427714     Source Type: Journal    
DOI: 10.1016/j.cgh.2013.09.067     Document Type: Article

References (18)

1. Manns M.P., McHutchison J.G., Gordon S.C., et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet 2001, 358:958-965.
2. Fried M.W., Shiffman M.L., Reddy K.R., et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. NEngl J Med 2002, 347:975-982.
3. Poordad F., McCone J., Bacon B.R., et al. Boceprevir for untreated chronic HCV genotype 1 infection. NEngl J Med 2011, 364:1195-1206.
4. Jacobson I.M., McHutchison J.G., Dusheiko G., et al. Telaprevir for previously untreated chronic hepatitis C virus infection. NEngl J Med 2011, 364:2405-2416.
5. Sherman K.E., Flamm S.L., Afdhal N.H., et al. Response-guided telaprevir combination treatment for hepatitis C virus infection. NEngl J Med 2011, 365:1014-1024.
6. Bacon B.R., Gordon S.C., Lawitz E., et al. Boceprevir for previously treated chronic HCV genotype 1 infection. NEngl J Med 2011, 364:1207-1217.
7. Zeuzem S., Andreone P., Pol S., et al. Telaprevir for retreatment of HCV infection. NEngl J Med 2011, 364:2417-2428.
8. Ghany M.G., Nelson D.R., Strader D.B., et al. 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.
9. Ribeiro R.M., Li H., Wang S., et al. Quantifying the diversification of hepatitis C virus (HCV) during primary infection: estimates of the invivo mutation rate. PLoS Pathog 2012, 8:e1002881.
10. Sarrazin C., Zeuzem S. Resistance to direct antiviral agents in patients with hepatitis C virus infection. Gastroenterology 2010, 138:447-462.
11. Gambarin-Gelwan M., Jacobson I.M. Resistance-associated variants in chronic hepatitis C patients treated with protease inhibitors. Curr Gastroenterol Rep 2012, 14:47-54.
12. Welsch C., Zeuzem S. Clinical relevance of HCV antiviral drug resistance. Curr Opin Virol 2012, 2:651-655.
13. Lawitz E., Rodriguez-Torres M., Stoehr A., et al. Aphase 2b study of MK-7009 (vaniprevir) in patients with genotype 1 HCV infection who have failed previous pegylated interferon and ribavirin treatment. JHepatol 2013, 59:11-17.
14. Miettinen O., Nurminen M. Comparative analysis of two rates. Stat Med 1985, 4:213-226.
15. Ludmerer S.W., Graham D.J., Patel M., et al. Atransient cell-based phenotype assay for hepatitis C NS3/4A protease: application to potency determinations of a novel macrocyclic inhibitor against diverse protease sequences isolated from plasma infected with HCV. JVirol Methods 2008, 151:301-307.
16. Barnard R.J.O., McHale C.M., Newhard W., et al. Emergence of resistance-associated variants after failed triple therapy with vaniprevir in treatment-experienced patients with hepatitis C-genotype 1 infection: a population and clonal analysis. Virology 2013, 443:278-284.
17. Bruno S., Vierling J.M., Esteban R., et al. Efficacy and safety of boceprevir plus peginterferon-ribavirin in patients with HCV G1 infection and advanced fibrosis/cirrhosis. JHepatol 2013, 58:479-487.
18. Jacobson I.M., Marcellin P., Zeuzem S., et al. Refinement of stopping rules during treatment of hepatitis C genotype 1 infection with boceprevir and peginterferon/ribavirin. Hepatology 2012, 56:567-575.