A phase 3b study of sofosbuvir plus ribavirin in treatment-naive and treatment-experienced Korean patients chronically infected with genotype 2 hepatitis C virus

Journal of Viral Hepatitis

Volumn 23, Issue 5, 2016, Pages 358-365

  Ahn, S H ^a   Lim, Y S ^b   Lee, K S ^c   Paik, S W ^d   Lee, Y J ^e   Jeong, S H ^f   Kim, J H ^g   Yoon, S K ^h   Yim, H J ⁱ   Tak, W Y ^j   Han, S Y ^k   Yang, J C ^l   Mo, H ^l   Mathias, A ^l   Han, L ^l   Knox, S J ^l   Brainard, D M ^l   Kim, Y J ^m   Byun, K S ⁿ   Kim, Y S ^o   Heo, J ^p   Han, K H ^a   more..

^a Yonsei University College of Medicine   (South Korea)

^b University of Ulsan College of Medicine   (South Korea)

^c Yonsei University College of Medicine   (South Korea)

^d Samsung Medical Center   (South Korea)

^e Inje University College of Medicine   (South Korea)

^f Seoul National University Bundang Hospital   (South Korea)

^g Gachon University   (South Korea)

^h The Catholic University of Korea   (South Korea)

ⁱ Korea University   (South Korea)

^j Kyungpook National University Hospital   (South Korea)

^k Dong A University   (South Korea)

^l GILEAD SCIENCES   (United States)

^m Seoul National University Hospital   (South Korea)

ⁿ Korea University College of Medicine   (South Korea)

^o Soonchunhyang University   (South Korea)

^p Pusan National University School of Medicine   (South Korea)

more..

Author keywords

hepatitis C virus (HCV); Korea; phase 3; ribavirin; sofosbuvir

Indexed keywords

DRUG METABOLITE; PEGINTERFERON ALPHA; RIBAVIRIN; SOFOSBUVIR; ANTIVIRUS AGENT;

ABNORMAL LABORATORY RESULT; ACUTE CHOLECYSTITIS; ADULT; AGED; ANEMIA; AREA UNDER THE CURVE; ARTICLE; CEREBELLUM INFARCTION; CHRONIC HEPATITIS C; CONCUSSION; CONTROLLED STUDY; DIZZINESS; DRUG EFFICACY; DRUG ERUPTION; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG TREATMENT FAILURE; DYSPEPSIA; FATIGUE; FEMALE; HEADACHE; HEPATITIS C VIRUS GENOTYPE 2; HUMAN; INJURY; INSOMNIA; ISCHEMIC COLITIS; KOREAN (PEOPLE); LIVER CIRRHOSIS; LUNG TUMOR; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; MULTICENTER STUDY; MYALGIA; NAUSEA; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PRURITUS; RHINOPHARYNGITIS; SEROPREVALENCE; SINGLE BLIND PROCEDURE; TREATMENT DURATION; URETER STONE; VOMITING; ADOLESCENT; ADVERSE EFFECTS; ASIAN CONTINENTAL ANCESTRY GROUP; CLASSIFICATION; CLINICAL TRIAL; COMBINATION DRUG THERAPY; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; GENETICS; GENOTYPE; HEPACIVIRUS; HEPATITIS C, CHRONIC; ISOLATION AND PURIFICATION; MIDDLE AGED; PATHOLOGY; PROCEDURES; TREATMENT OUTCOME; VERY ELDERLY; VIRUS LOAD; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTIVIRAL AGENTS; ASIAN CONTINENTAL ANCESTRY GROUP; DRUG THERAPY, COMBINATION; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FEMALE; GENOTYPE; HEPACIVIRUS; HEPATITIS C, CHRONIC; HUMANS; MALE; MIDDLE AGED; RIBAVIRIN; SOFOSBUVIR; TREATMENT OUTCOME; VIRAL LOAD; YOUNG ADULT;

EID: 84958279224     PISSN: 13520504     EISSN: 13652893     Source Type: Journal    
DOI: 10.1111/jvh.12499     Document Type: Article

References (32)

1. Lavanchy D,. Evolving epidemiology of hepatitis C virus. Clin Microbiol Infect 2011; 17: 107-115.
2. Kim MN, Kim BK, Han KH,. Hepatocellular carcinoma in patients with chronic hepatitis C virus infection in the Asia-Pacific region. J Gastroenterol 2013; 48: 681-688.
3. Kim do Y, Kim IH, Jeong SH, et al,. A nationwide seroepidemiology of hepatitis C virus infection in South Korea. Liver Int 2013; 33: 586-594.
4. Oh DJ, Park YM, Seo YI, Lee JS, Lee JY,. Prevalence of hepatitis C virus infections and distribution of hepatitis C virus genotypes among Korean blood donors. Ann Lab Med 2012; 32: 210-215.
5. Cho EJ, Jeong SH, Han BH, Lee SU, Yun BC, Park ET,. Hepatitis C virus (HCV) genotypes and the influence of HCV subtype 1b on the progression of chronic hepatitis C in Korea: a single center experience. Clin Mol Hepatol 2012; 18: 219-224.
6. Kim YS, Ahn YO, Lee HS,. Risk factors for hepatitis C virus infection among Koreans according to the hepatitis C virus genotype. J Korean Med Sci 2002; 17: 187-192.
7. Korean Association for the Study of the Liver (KASL). KASL clinical practice guidelines: management of hepatitis C. Clin Mol Hepatol 2014; 20: 89-136.
8. Park SY, Rim MY, Yo IK,. et al. [Efficacy of peginterferon and ribavirin combination therapy of chronic hepatitis C: a pooled analysis]. Korean J Gastroenterol 2012; 60: 306-314.
9. Conjeevaram HS, Fried MW, Jeffers LJ, et al,. Virahep-C Study Group. Peginterferon and ribavirin treatment in African American and Caucasian American patients with hepatitis C genotype 1. Gastroenterology 2006; 131: 470-477.
10. Muir AJ, Bornstein JD, Killenberg PG,. Atlantic Coast Hepatitis Treatment Group. 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.
11. 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.
12. Hadziyannis SJ, Sette H Jr, Morgan TR, et al,. PEGASYS International Study Group. 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.
13. Lyoo K, Song MJ, Hur W, et al,. Polymorphism near the IL28B gene in Korean hepatitis C virus-infected patients treated with peg-interferon plus ribavirin. J Clin Virol 2011; 52: 363-366.
14. Jung YK, Kim JH, Ahn SM, et al,. Role of interleukin 28B-related gene polymorphisms in chronic hepatitis C and the response to antiviral therapy in Koreans. J Clin Gastroenterol 2013; 47: 644-650.
15. Thomas DL, Thio CL, Martin MP, et al,. Genetic variation in IL28B and spontaneous clearance of hepatitis C virus. Nature 2009; 461: 798-801.
16. Kim SU, Song KJ, Chang HY, et al,. Association between IL28B polymorphisms and spontaneous clearance of hepatitis B virus infection. PLoS One 2013; 8: e69166.
17. Ghany MG, Strader DB, Thomas DL, Seeff LB,. American Association for the Study of Liver Diseases. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology 2009; 49: 1335-1374.
18. Höroldt B, Haydon G, O'Donnell K, Dudley T, Nightingale P, Mutimer D,. Results of combination treatment with pegylated interferon and ribavirin in cirrhotic patients with hepatitis C infection. Liver Int 2006; 26: 650-659.
19. Carrión JA, Martínez-Bauer E, Crespo G, et al,. Antiviral therapy increases the risk of bacterial infections in HCV-infected cirrhotic patients awaiting liver transplantation: A retrospective study. J Hepatol 2009; 50: 719-728.
20. Huang CF, Yang JF, Dai CY, et al,. Efficacy and safety of pegylated interferon combined with ribavirin for the treatment of older patients with chronic hepatitis C. J Infect Dis 2010; 201: 751-759.
21. Thabut D, Le Calvez S, Thibault V, et al,. Hepatitis C in 6,865 patients 65 yr or older: a severe and neglected curable disease? Am J Gastroenterol 2006; 101: 1260-1267.
22. Nudo CG, Wong P, Hilzenrat N, Deschênes M,. Elderly patients are at greater risk of cytopenia during antiviral therapy for hepatitis C. Can J Gastroenterol 2006; 20: 589-592.
23. Gilead Sciences, Inc. SOVALDI (sofosbuvir) prescribing information. Foster City, CA: Gilead Sciences, Inc., 2014.
24. Gilead Sciences International Ltd. SOVALDI (sofosbuvir) summary of product characteristics. Carrigtwohill, Ireland: Gilead Sciences International Ltd., 2015.
25. Omata M, Nishiguchi S, Ueno Y, et al,. Sofosbuvir plus ribavirin in Japanese patients with chronic genotype 2 HCV infection: an open-label, phase 3 trial. J Viral Hepat 2014; 21: 762-768.
26. Lawitz E, Mangia A, Wyles D, et al,. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med 2013; 368: 1878-1887.
27. Clopper CJ, Pearson ES,. The use of confidence or fiducial limits illustrated in the case of the binomial. Biometrika 1934; 26: 404-413.
28. García-Samaniego J, Romero M, Granados R, et al,. Factors associated with early virological response to peginterferon-α-2a/ribavirin in chronic hepatitis C. World J Gastroenterol 2013; 19: 1943-1952.
29. Bressler BL, Guindi M, Tomlinson G, Heathcote J,. High body mass index is an independent risk factor for nonresponse to antiviral treatment in chronic hepatitis C. Hepatology 2003; 38: 639-644.
30. Zeuzem S, Dusheiko GM, Salupere R, et al,. Sofosbuvir and ribavirin in HCV genotypes 2 and 3. N Engl J Med 2014; 370: 1993-2001.
31. Genentech. Ribavirin (COPEGUS) prescribing information. South San Francisco, CA: Genentech USA, Inc., 2013.
32. Jacobson IM, Gordon SC, Kowdley KV, et al,. Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options. N Engl J Med 2013; 368: 1867-1877.