Sustained virologic response rates with telaprevir-based therapy in treatment-naive patients evaluated by race or ethnicity

Journal of Clinical Gastroenterology

Volumn 49, Issue 4, 2015, Pages 336-344

  Flamm, Steven L ^a   Muir, Andrew J ^b   Fried, Michael W ^c   Rajender Reddy, K ^d   Nelson, David R ^e   Bzowej, Natalie H ^f   Sullivan, James C ^g   Bengtsson, Leif ^g   DeMasi, Ralph ^h   Wright, Christopher I ^g   Kieffer, Tara L ^g   George, Shelley ^g   Adda, Nathalie ^g   Dusheiko, Geoffrey M ⁱ  

^a NORTHWESTERN UNIVERSITY   (United States)

^b DUKE CLINICAL RESEARCH INSTITUTE   (United States)

^c UNIVERSITY OF NORTH CAROLINA   (United States)

^d UNIVERSITY OF PENNSYLVANIA   (United States)

^e UNIVERSITY OF FLORIDA COLLEGE OF MEDICINE   (United States)

^f CALIFORNIA PACIFIC MEDICAL CENTER   (United States)

^g VERTEX PHARMACEUTICALS   (United States)

^h JANSSEN RESEARCH AND DEVELOPMENT   (United States)

ⁱ ROYAL FREE AND UNIVERSITY COLLEGE MEDICAL SCHOOL   (United Kingdom)

Author keywords

Combination drug therapy; Ethnology; Hepatitis C virus; Liver diseases; Protease inhibitors

Indexed keywords

PEGINTERFERON ALPHA2A; RIBAVIRIN; TELAPREVIR; ALPHA INTERFERON; ANTIVIRUS AGENT; MACROGOL DERIVATIVE; OLIGOPEPTIDE; RECOMBINANT PROTEIN;

ADULT; AGED; ALASKA NATIVE; AMERICAN INDIAN; ANEMIA; ANTIVIRAL RESISTANCE; ANTIVIRAL THERAPY; ARTICLE; ASIAN; BLACK PERSON; CHRONIC HEPATITIS C; CONTROLLED STUDY; DRUG EFFICACY; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; ETHNICITY; FEMALE; HEPATITIS C VIRUS GENOTYPE 1; HISPANIC; HUMAN; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; NATIVE HAWAIIAN; NAUSEA; NEUTROPENIA; OUTCOME ASSESSMENT; PACIFIC ISLANDER; PHASE 3 CLINICAL TRIAL (TOPIC); POST HOC ANALYSIS; PRIORITY JOURNAL; PRURITUS; RACE; RANDOMIZED CONTROLLED TRIAL (TOPIC); RASH; RELAPSE; RETROSPECTIVE STUDY; TREATMENT RESPONSE; DRUG COMBINATION; DRUG EFFECTS; ETHNOLOGY; GENETICS; GENOTYPE; HEPACIVIRUS; HEPATITIS C, CHRONIC; VIRUS LOAD; YOUNG ADULT;

ADULT; AGED; ANTIVIRAL AGENTS; DRUG THERAPY, COMBINATION; FEMALE; GENOTYPE; HEPACIVIRUS; HEPATITIS C, CHRONIC; HUMANS; INTERFERON-ALPHA; MALE; MIDDLE AGED; OLIGOPEPTIDES; POLYETHYLENE GLYCOLS; RECOMBINANT PROTEINS; RETROSPECTIVE STUDIES; RIBAVIRIN; VIRAL LOAD; YOUNG ADULT;

EID: 84928362462     PISSN: 01920790     EISSN: 15392031     Source Type: Journal    
DOI: 10.1097/MCG.0000000000000150     Document Type: Article

References (26)

1. Rodriguez-Torres M. Latinos and chronic hepatitis C: a singular population. Clin Gastroenterol Hepatol. 2008;6: 484-490.
2. Alter MJ, Kruszon-Moran D, Nainan OV, et al. The prevalence of hepatitis C virus infection in the United States, 1988 through 1994. N Engl J Med. 1999;341:556-562.
3. Gaglio PJ, Rodriguez-Torres M, Herring R, et al. Racial differences in response rates to consensus interferon in HCV infected patients naive to previous therapy. J Clin Gastro-enterol. 2004;38:599-604.
4. Hepburn MJ, Hepburn LM, Cantu NS, et al. Differences in treatment outcome for hepatitis C among ethnic groups. Am J Med. 2004;117:163-168.
5. Cheung RC, Currie S, Shen H, et al. Chronic hepatitis C in Latinos: natural history, treatment eligibility, acceptance, and outcomes. Am J Gastroenterol. 2005;100:2186-2193.
6. Rodriguez-Torres M, Jeffers LJ, Sheikh MY, et al. Peginter-feron alfa-2a and ribavirin in Latino and non-Latino whites with hepatitis C. N Engl J Med. 2009;360:257-267.
7. Yu S, Douglass JM, Qualls C, et al. Response to therapy with pegylated interferon and ribavirin for chronic hepatitis C in hispanics compared to non-Hispanic whites. Am J Gastro-enterol. 2009;104:1686-1692.
8. Muir AJ, Bornstein JD, Killenberg PG. Peginterferon alfa-2b and ribavirin for the treatment of chronic hepatitis C in blacks and non-Hispanic whites. N Engl J Med. 2004;350:2265-2271.
9. Jeffers LJ, Cassidy W, Howell CD, et al. Peginterferon alfa-2a (40 kd) and ribavirin for black American patients with chronic HCV genotype 1. Hepatology. 2004;39:1702-1708.
10. Conjeevaram HS, Fried MW, Jeffers LJ, et al. Peginterferon and ribavirin treatment in African American and Caucasian American patients with hepatitis C genotype 1. Gastroentero-logy. 2006;131:470-477.
11. Reddy KR, Hoofnagle JH, Tong MJ, et al. Racial differences in responses to therapy with interferon in chronic hepatitis C. Consensus Interferon Study Group. Hepatology. 1999;30:787-793.
12. Manns MP, McHutchison JG, Gordon SC, 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.
13. Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002;347:975-982.
14. 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;140:346-355.
15. Blatt LM, Mutchnick MG, Tong MJ, et al. Assessment of hepatitis C virus RNA and genotype from 6807 patients with chronic hepatitis C in the United States. J Viral Hepat. 2000; 7:196-202.
16. Ge D, Fellay J, Thompson AJ, et al. Genetic variation in IL28B predicts hepatitis C treatment-induced viral clearance. Nature. 2009;461:399-401.
17. Angulo J, Pino K, Pavez C, et al. Genetic variations in host IL28B links to the detection of peripheral blood mononuclear cells-associated hepatitis C virus RNA in chronically infected patients. J Viral Hepat. 2013;20:263-272.
18. Jacobson IM, McHutchison JG, Dusheiko G, et al. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med. 2011;364:2405-2416.
19. Sherman KE, Flamm SL, Afdhal NH, et al. Response-guided telaprevir combination treatment for hepatitis C virus infection. N Engl J Med. 2011;365:1014-1024. [erratum: N Engl J Med. 2011;365:1551].
20. Kieffer TL, De MS, Bartels DJ, et al. Hepatitis C viral evolution in genotype 1 treatment-naive and treatment-experienced patients receiving telaprevir-based therapy in clinical trials. PLoS One. 2012;7:e34372.
21. Bedossa P, Poynard T. An algorithm for the grading of activity in chronic hepatitis C. The METAVIR Cooperative Study Group. Hepatology. 1996;24:289-293.
22. The French METAVIR Cooperative Study Group. Intra-observer and interobserver variations in liver biopsy interpretation in patients with chronic hepatitis C. Hepatology. 1994; 20:15-20.
23. Kwong AD, Frantz JD, Bartels DJ, et al. Patent application: methods for amplifying hepatitis C virile nucleic acids. May 24, 2012. Available at: http://www.faqs.org/patents/app/20120129155. Accessed September 17, 2013.
24. Vertex Pharmaceuticals Incorporated. Incivek (teleprevir) [package insert]. Cambridge, MA: Vertex Pharmaceuticals Incorporated; 2013.
25. Sullivan JC, De MS, Bartels DJ, et al. Evolution of treatment-emergent resistant variants in telaprevir phase 3 clinical trials. Clin Infect Dis. 2013;57:221-229.
26. Poordad F, McCone J Jr, Bacon BR, et al. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med. 2011;364:1195-1206.