Randomized Phase 3 Trial of Ombitasvir/Paritaprevir/Ritonavir and Ribavirin for Hepatitis C Virus Genotype 2-Infected Japanese Patients

Advances in Therapy

Volumn 34, Issue 6, 2017, Pages 1449-1465

  Sato, Ken ^a   Chayama, Kazuaki ^b   Alves, Katia ^c   Toyoda, Hidenori ^d   Suzuki, Fumitaka ^e   Kato, Koji ^c   Rodrigues, Lino ^c   Zhang, Xinyan ^c   Setze, Carolyn ^c   Pilot Matias, Tami ^c   Burroughs, Margaret ^c   Redman, Rebecca ^c   Kumada, Hiromitsu ^e  

^a GUNMA UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^b HIROSHIMA UNIVERSITY   (Japan)

^c ABBVIE INC   (United States)

^d OGAKI MUNICIPAL HOSPITAL   (Japan)

^e TORANOMON HOSPITAL   (Japan)

Author keywords

Co formulated ombitasvir paritaprevir ritonavir; Direct acting antiviral; HCV genotype 2; IFN free; Japan

Indexed keywords

ALKALINE PHOSPHATASE; ALPHA INTERFERON; ASPARTATE AMINOTRANSFERASE; BETA INTERFERON; BILIRUBIN; CALCIUM CHANNEL BLOCKING AGENT; CHORIONIC GONADOTROPIN BETA SUBUNIT; CREATININE; HEMOGLOBIN; INTERLEUKIN 28B; NONSTRUCTURAL PROTEIN 3; NONSTRUCTURAL PROTEIN 4A; NONSTRUCTURAL PROTEIN 5A; OMBITASVIR PLUS PARITAPREVIR PLUS RITONAVIR; PEGINTERFERON; RIBAVIRIN; VIRUS RNA; ABT-267; ABT-450; ANILIDE; ANTIVIRUS AGENT; CARBAMIC ACID DERIVATIVE; MACROCYCLIC COMPOUND; RITONAVIR;

AGED; ALCOHOLIC GASTRITIS; ALKALINE PHOSPHATASE BLOOD LEVEL; ANEMIA; ANTIVIRAL RESISTANCE; ANTIVIRAL THERAPY; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BILIRUBIN BLOOD LEVEL; BRONCHOPNEUMONIA; CHRONOPHARMACOLOGY; COMBINATION DRUG THERAPY; CONTROLLED STUDY; CREATININE CLEARANCE; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG FATALITY; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG TOLERABILITY; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; ESTIMATED GLOMERULAR FILTRATION RATE; FEMALE; GASTRITIS; HEADACHE; HEMOGLOBIN BLOOD LEVEL; HEPATITIS C; HEPATITIS C VIRUS GENOTYPE 2; HUMAN; INCISIONAL HERNIA; INTENTION TO TREAT ANALYSIS; JAPANESE (PEOPLE); LIVER DYSFUNCTION; LIVER FUNCTION TEST; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OPEN STUDY; PATIENT HISTORY OF THERAPY; PERIPHERAL EDEMA; PHASE 3 CLINICAL TRIAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; REBOUND; RECOMMENDED DRUG DOSE; RELAPSE; RHINOPHARYNGITIS; SIDE EFFECT; SINGLE NUCLEOTIDE POLYMORPHISM; SUSTAINED VIROLOGIC RESPONSE; TREATMENT DURATION; TREATMENT INTERRUPTION; TREATMENT RESPONSE; UVEITIS; VIRUS LOAD; CLINICAL TRIAL; DRUG COMBINATION; GENETICS; GENOTYPE; HEPACIVIRUS; JAPAN; MIDDLE AGED;

AGED; ANILIDES; ANTIVIRAL AGENTS; CARBAMATES; DRUG COMBINATIONS; DRUG THERAPY, COMBINATION; FEMALE; GENOTYPE; HEPACIVIRUS; HEPATITIS C; HUMANS; JAPAN; MACROCYCLIC COMPOUNDS; MALE; MIDDLE AGED; RIBAVIRIN; RITONAVIR; SUSTAINED VIROLOGIC RESPONSE;

EID: 85019945802     PISSN: 0741238X     EISSN: 18658652     Source Type: Journal    
DOI: 10.1007/s12325-017-0506-y     Document Type: Article

References (33)

1. Messina JP, Humphreys I, Flaxman A, et al. Global distribution and prevalence of hepatitis C virus genotypes. Hepatology. 2015;61:77–87.
2. GBD 2013 Mortality and Causes of Death Collaborators. Global, regional, and national age-sex specific all-cause and cause-specific mortality for 240 causes of death, 1990–2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015;385:117–71.
3. Gower E, Estes C, Blach S, Razavi-Shearer K, Razavi H. Global epidemiology and genotype distribution of the hepatitis C virus infection. J Hepatol. 2014;61:S45–57.
4. Matsuo J, Mizui M, Okita H, et al. Follow up of the 987 blood donors found with hepatitis C virus infection over 9–18 years. Hepatol Res. 2012;42:637–47.
5. Westbrook RH, Dusheiko G. Natural history of hepatitis C. J Hepatol. 2014;61:S58–68.
6. Chung H, Ueda T, Kudo M. Changing trends in hepatitis C infection over the past 50 years in Japan. Intervirology. 2010;53:39–43.
7. Sibley A, Han KH, Abourached A, et al. The present and future disease burden of hepatitis C virus infections with today’s treatment paradigm—volume 3. J Viral Hepat. 2015;22(Suppl 4):21–41.
8. Ikai I, Arii S, Okazaki M, et al. Report of the 17th Nationwide Follow-up Survey of Primary Liver Cancer in Japan. Hepatol Res. 2007;37:676–91.
9. Akuta N, Suzuki F, Seko Y, et al. Association of IL28B genotype and viral response of hepatitis C virus genotype 2 to interferon plus ribavirin combination therapy. J Med Virol. 2012;84:1593–9.
10. Kawaoka T, Kawakami Y, Tsuji K, et al. Dose comparison study of pegylated interferon-alpha-2b plus ribavirin in naive Japanese patients with hepatitis C virus genotype 2: a randomized clinical trial. J Gastroenterol Hepatol. 2009;24:366–71.
11. Kawaoka T, Hayes CN, Ohishi W, et al. Predictive value of the IL28B polymorphism on the effect of interferon therapy in chronic hepatitis C patients with genotypes 2a and 2b. J Hepatol. 2011;54:408–14.
12. Watanabe T, Konishi I, Shigematsu S, et al. Sustained virological response of patients with hepatitis C virus genotype 2 depends on pegylated interferon compliance. Hepatol Res. 2011;41:722–30.
13. Inoue Y, Hiramatsu N, Oze T, et al. Factors affecting efficacy in patients with genotype 2 chronic hepatitis C treated by pegylated interferon alpha-2b and ribavirin: reducing drug doses has no impact on rapid and sustained virological responses. J Viral Hepat. 2010;17:336–44.
14. Japan Society of Hepatology. JSH guidelines for the management of hepatitis C virus infection, version 4.1 (in Japanese). 2015. http://www.jsh.or.jp/. Accessed 23 March 2016.
15. Krishnan P, Beyer J, Mistry N, et al. In vitro and in vivo antiviral activity and resistance profile of ombitasvir, an inhibitor of hepatitis C virus NS5A. Antimicrob Agents Chemother. 2015;59:979–87.
16. Pilot-Matias T, Tripathi R, Cohen D, et al. In vitro and in vivo antiviral activity and resistance profile of the hepatitis C virus NS3/4A protease inhibitor ABT-450. Antimicrob Agents Chemother. 2015;59:988–97.
17. Chayama K, Notsumata K, Kurosaki M, et al. Randomized trial of interferon- and ribavirin-free ombitasvir/paritaprevir/ritonavir in treatment-experienced hepatitis C virus-infected patients. Hepatology. 2015;61:1523–32.
18. Lawitz E, Sullivan G, Rodriguez-Torres M, et al. Exploratory trial of ombitasvir and ABT-450/r with or without ribavirin for HCV genotype 1, 2, and 3 infection. J Infect. 2015;70:197–205.
19. Ziol M, Handra-Luca A, Kettaneh A, et al. Noninvasive assessment of liver fibrosis by measurement of stiffness in patients with chronic hepatitis C. Hepatology. 2005;41:48–54.
20. Imbert-Bismut F, Ratziu V, Pieroni L, et al. Biochemical markers of liver fibrosis in patients with hepatitis C virus infection: a prospective study. Lancet. 2001;357:1069–75.
21. Manning DS, Afdhal NH. Diagnosis and quantitation of fibrosis. Gastroenterology. 2008;134:1670–81.
22. Sebastiani G, Vario A, Guido M, et al. Stepwise combination algorithms of non-invasive markers to diagnose significant fibrosis in chronic hepatitis C. J Hepatol. 2006;44:686–93.
23. Ikeda K, Saitoh S, Kobayashi M, et al. Distinction between chronic hepatitis and liver cirrhosis in patients with hepatitis C virus infection. Practical discriminant function using common laboratory data. Hepatol Res. 2000;18:252–66.
24. National Cancer Institute (NCI). Common terminology criteria for adverse events, Version 4.0. NCI. 2010. http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_8.5x11.pdf. Accessed April 2016.
25. Sulkowski MS, Shiffman ML, Afdhal NH, et al. Hepatitis C virus treatment-related anemia is associated with higher sustained virologic response rate. Gastroenterology. 2010;139:1602–11 (1611.e1).
26. Asselah T, Hassanein TI, Roula B, et al. Efficacy and safety of ombitasvir/paritaprevir/ritonavir co-administered with ribavirin in adults with genotype 4 chronic hepatitis C infection and cirrhosis (AGATE-I). Hepatology. 2015;62(Suppl):563–4A.
27. Hezode C, Asselah T, Reddy K, et al. Ombitasvir plus paritaprevir plus ritonavir with or without ribavirin in treatment-naive and treatment-experienced patients with genotype 4 chronic hepatitis C virus infection (PEARL-I): a randomised, open-label trial. Lancet. 2015;385:2502–9.
28. Esmat GE, Doss WH, Qaqish RB, et al. Efficacy and safety of co-formulated ombitasvir/paritaprevir/ritonavir with ribavirin in adults with chronic HCV genotype 4 infection in Egypt (AGATE-II). Hepatology. 2015;62(Suppl):560A.
29. Kumada H, Chayama K, Rodrigues L Jr, et al. Randomized phase 3 trial of ombitasvir/paritaprevir/ritonavir for hepatitis C virus genotype 1b-infected Japanese patients with or without cirrhosis. Hepatology. 2015;62:1037–46.
30. Chayama K, Hayes CN, Ohishi W, Kawakami Y. Treatment of chronic hepatitis C virus infection in Japan: update on therapy and guidelines. J Gastroenterol. 2013;48:1–12.
31. Honda T, Katano Y, Shimizu J, et al. Efficacy of peginterferon-alpha-2b plus ribavirin in patients aged 65 years and older with chronic hepatitis C. Liver Int. 2010;30:527–37.
32. Huang CF, Chuang WL, Yu ML. Chronic hepatitis C infection in the elderly. Kaohsiung J Med Sci. 2011;27:533–7.
33. Toyoda H, Kumada T, Takaguchi K, Shimada N, Tanaka J. Changes in hepatitis C virus genotype distribution in Japan. Epidemiol Infect. 2014;142:2624–8.