Randomized phase 3 trial of ombitasvir/paritaprevir/ritonavir for hepatitis C virus genotype 1b-infected Japanese patients with or without cirrhosis

Hepatology

Volumn 62, Issue 4, 2015, Pages 1037-1046

  Kumada, Hiromitsu ^a   Chayama, Kazuaki ^b   Rodrigues, Lino ^c   Suzuki, Fumitaka ^a   Ikeda, Kenji ^a   Toyoda, Hidenori ^d   Sato, Ken ^e   Karino, Yoshiyasu ^f   Matsuzaki, Yasushi ^g   Kioka, Kiyohide ^h   Setze, Carolyn ^c   Pilot Matias, Tami ^c   Patwardhan, Meenal ^c   Vilchez, Regis A ^c   Burroughs, Margaret ^c   Redman, Rebecca ^c  

^a TORANOMON HOSPITAL   (Japan)

^b HIROSHIMA UNIVERSITY   (Japan)

^c ABBVIE INC   (United States)

^d OGAKI MUNICIPAL HOSPITAL   (Japan)

^e GUNMA UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^f Sapporo Kosei General Hospital   (Japan)

^g TOKYO MEDICAL UNIVERSITY   (Japan)

^h OSAKA CITY GENERAL HOSPITAL   (Japan)

Author keywords

[No Author keywords available]

Indexed keywords

BETAMETHASONE; GLUCOSE; OMBITASVIR PLUS PARITAPREVIR PLUS RITONAVIR; PLACEBO; VIRUS RNA; ABT-267; ABT-450; ANILIDE; ANTIVIRUS AGENT; CARBAMIC ACID DERIVATIVE; DRUG COMBINATION; MACROCYCLIC COMPOUND; RITONAVIR;

ADULT; AGED; ANURIA; ARTICLE; CLINICAL ARTICLE; CLINICAL EVALUATION; CONFIDENCE INTERVAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG WITHDRAWAL; FACE EDEMA; FEMALE; FEVER; GLUCOSE BLOOD LEVEL; HEADACHE; HEPATITIS C; HEPATITIS C VIRUS GENOTYPE 1; HEPATITIS C VIRUS GENOTYPE 1B; HUMAN; HYPERBILIRUBINEMIA; HYPERTRANSAMINASEMIA; HYPOTENSION; JAPANESE (PEOPLE); LIVER CIRRHOSIS; LUNG EDEMA; MALE; NAUSEA; PERIPHERAL EDEMA; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SIDE EFFECT; STATISTICAL ANALYSIS; SUSTAINED VIROLOGICAL RESPONSE; THROMBOCYTOPENIA; TREATMENT OUTCOME; TREATMENT RESPONSE; VIRUS LOAD; ASIAN CONTINENTAL ANCESTRY GROUP; CLASSIFICATION; CLINICAL TRIAL; COMPLICATION; DRUG COMBINATION; GENETICS; GENOTYPE; HEPACIVIRUS; HEPATITIS C, CHRONIC; MIDDLE AGED;

AGED; ANILIDES; ANTIVIRAL AGENTS; ASIAN CONTINENTAL ANCESTRY GROUP; CARBAMATES; DOUBLE-BLIND METHOD; DRUG COMBINATIONS; FEMALE; GENOTYPE; HEPACIVIRUS; HEPATITIS C, CHRONIC; HUMANS; LIVER CIRRHOSIS; MACROCYCLIC COMPOUNDS; MALE; MIDDLE AGED; RITONAVIR;

EID: 84940615706     PISSN: 02709139     EISSN: 15273350     Source Type: Journal    
DOI: 10.1002/hep.27972     Document Type: Article

References (35)

1. Chung H, Ueda T, Kudo M. Changing trends in hepatitis C infection over the past 50 years in Japan. Intervirology 2010;53:39-43.
2. Tanaka J, Kumagai J, Katayama K, Komiya Y, Mizui M, Yamanaka R, et al. Sex- and age-specific carriers of hepatitis B and C viruses in Japan estimated by the prevalence in the 3, 485, 648 first-time blood donors during 1995-2000. Intervirology 2004;47:32-40.
3. Takada A, Tsutsumi M, Okanoue T, Matsushima T, Komatsu M, Fujiyama S. Distribution of the different subtypes of hepatitis C virus in Japan and the effects of interferon: a nationwide survey. J Gastroenterol Hepatol 1996;11:201-207.
4. Hayashi N, Izumi N, Kumada H, Okanoue T, Tsubouchi H, Yatsuhashi H, et al. Simeprevir with peginterferon/ribavirin for treatment-naive hepatitis C genotype 1 patients in Japan: CONCERTO-1, a phase III trial. J Hepatol 2014;61:219-227.
5. Izumi N, Hayashi N, Kumada H, Okanoue T, Tsubouchi H, Yatsuhashi H, et al. Once-daily simeprevir with peginterferon and ribavirin for treatment-experienced HCV genotype 1-infected patients in Japan: the CONCERTO-2 and CONCERTO-3 studies. J Gastroenterol 2014;49:941-953.
6. Kumada H, Hayashi N, Izumi N, Okanoue T, Tsubouchi H, Yatsuhashi H, et al. Simeprevir (TMC435) once daily with peginterferon-alpha-2b and ribavirin in patients with genotype 1 hepatitis C virus infection: the CONCERTO-4 study. Hepatol Res 2015;45:501-513.
7. Ronzoni L, Aghemo A, Rumi MG, Prati G, Colancecco A, Porretti L, et al. Ribavirin suppresses erythroid differentiation and proliferation in chronic hepatitis C patients. J Viral Hepat 2014;21:416-423.
8. Sunvepra (asunaprevir) capsules prescribing information. Tokyo, Japan: Bristol-Myers KK; 2014.
9. Daklinza (daclatasvir) tablets prescribing information. Tokyo, Japan: Bristol-Myers KK; 2014.
10. Kumada H, Suzuki Y, Ikeda K, Toyota J, Karino Y, Chayama K, et al. Daclatasvir plus asunaprevir for chronic HCV genotype 1b infection. Hepatology 2014;59:2083-2091.
11. Chayama K, Notsumata K, Kurosaki M, Sato K, Rodrigues L Jr, Setze C, et al. Randomized trial of interferon- and ribavirin-free ombitasvir/paritaprevir/ritonavir in treatment-experienced HCV-infected patients. Hepatology 2015;61:1523-1532.
12. Mizokami M, Yokosuka O, Takehara T, Sakamoto N, Korenaga M, Mochizuki H, et al. Ledipasvir and sofosbuvir fixed-dose combination with and without ribavirin for 12 weeks in treatment-naive and previously treated Japanese patients with genotype 1 hepatitis C: an open-label, randomised, phase 3 trial. Lancet Infect Dis 2015;15:645-653.
13. Kati W, Koev G, Irvin M, Beyer J, Liu Y, Krishnan P, et al. In vitro activity and resistance profile of dasabuvir, a nonnucleoside hepatitis C virus polymerase inhibitor. Antimicrob Agents Chemother 2015;59:1505-1511.
14. Krishnan P, Beyer J, Mistry N, Koev G, Reisch T, DeGoey D, 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;59:979-987.
15. Pilot-Matias T, Tripathi R, Cohen D, Gaultier I, Dekhtyar T, Lu L, 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;59:988-997.
16. Menon R, Kapoor M, Dumas E, Badri P, Campbell A, Gulati P, et al. Multiple-dose pharmacokinetics and safety following coadministration of ABT-450/r, ABT-267 and ABT-333 in Caucasian, Japanese and Chinese subjects [Abstract]. In: Proceedings of the 23rd Conference of the Asian Pacific Association for the Study of the Liver; June 6-9, 2013; Singapore. Abstract 1497.
17. Drafting Committee for Hepatitis Management Guidelines, Japan Society of Hepatology. JSH Guidelines for the Management of Hepatitis C Virus Infection: A 2014 Update for Genotype 1. Hepatol Res 2014;(44 Suppl. S1):59-70.
18. Kumada H, Toyota J, Okanoue T, Chayama K, Tsubouchi H, Hayashi N. Telaprevir with peginterferon and ribavirin for treatment-naive patients chronically infected with HCV of genotype 1 in Japan. J Hepatol 2012;56:78-84.
19. Afdhal N, Reddy KR, Nelson DR, Lawitz E, Gordon SC, Schiff E, et al. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med 2014;370:1483-1493.
20. Afdhal N, Zeuzem S, Kwo P, Chojkier M, Gitlin N, Puoti M, et al. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med 2014;370:1889-1898.
21. Andreone P, Colombo MG, Enejosa JV, Koksal I, Ferenci P, Maieron A, et al. ABT-450, ritonavir, ombitasvir, and dasabuvir achieves 97% and 100% sustained virologic response with or without ribavirin in treatment-experienced patients with HCV genotype 1b infection. Gastroenterology 2014;147:359-365.
22. Everson GT, Sims KD, Rodriguez-Torres M, Hezode C, Lawitz E, Bourliere M, et al. Efficacy of an interferon- and ribavirin-free regimen of daclatasvir, asunaprevir, and BMS-791325 in treatment-naive patients with HCV genotype 1 infection. Gastroenterology 2014;146:420-429.
23. Feld JJ, Kowdley KV, Coakley E, Sigal S, Nelson DR, Crawford D, et al. Treatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. N Engl J Med 2014;370:1594-1603.
24. Ferenci P, Bernstein D, Lalezari J, Cohen D, Luo Y, Cooper C, et al. ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV. N Engl J Med 2014;370:1983-1992.
25. Lawitz E, Gane E, Pearlman B, Tam E, Ghesquiere W, Guyader D, et al. Efficacy and safety of 12 weeks versus 18 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin for hepatitis C virus genotype 1 infection in previously untreated patients with cirrhosis and patients with previous null response with or without cirrhosis (C-WORTHY): a randomised, open-label phase 2 trial. Lancet 2015;385:1075-1086.
26. Muir A, Poordad F, Lalezari JP, Everson GT, Dore GJ, Kwo P, et al. All-oral fixed-dose combination therapy with daclatasvir/asunaprevir/BMS-791325, ±ribavirin, for patients with chronic HCV genotype 1 infection and compensated cirrhosis: UNITY-2 phase 3 SVR12 results. Hepatology 2014;60(6 Suppl.):1267A.
27. Poordad F, Hezode C, Trinh R, Kowdley KV, Zeuzem S, Agarwal K, et al. ABT-450/r-ombitasvir and dasabuvir with ribavirin for hepatitis C with cirrhosis. N Engl J Med 2014;370:1973-1982.
28. Zeuzem S, Jacobson IM, Baykal T, Marinho RT, Poordad F, Bourliere M, et al. Retreatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. N Engl J Med 2014;370:1604-1614.
29. Kan T, Hashimoto S, Kawabe N, Murao M, Nakano T, Shimazaki H, et al. The clinical features of patients with a Y93H variant of hepatitis C virus detected by a PCR invader assay. J Gastroenterol 2015; doi:10.1007/s00535-015-1080-1.
30. Harvoni (ledipasvir and sofosbuvir) tablets prescribing information. Foster City, CA: Gilead Sciences; 2015.
31. Amlodin. Osaka, Japan: Dainippon Sumitomo Pharma; 2014.
32. Norvirr (ritonavir) tablets 100 mg. Tokyo, Japan: AbbVie GK; 2013.
33. Menon R, Badri P, Wang T, Polepally A, Zha J, Khatri A, et al. Drug-drug interaction profile of the all-oral anti-hepatitis C virus regimen of paritaprevir/ritonavir, ombitasvir and dasabuvir. J Hepatol 2015;63:20-29.
34. Behrends M, Martinez-Palli G, Niemann CU, Cohen S, Ramachandran R, Hirose R. Acute hyperglycemia worsens hepatic ischemia/reperfusion injury in rats. J Gastrointest Surg 2010;14:528-535.
35. Miyake Y, Eguchi H, Shinchi K, Oda T, Sasazuki S, Kono S. Glucose intolerance and serum aminotransferase activities in Japanese men. J Hepatol 2003;38:18-23.