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

The Lancet Infectious Diseases

Volumn 15, Issue 6, 2015, Pages 645-653

  Mizokami, Masashi ^a   Yokosuka, Osamu ^b   Takehara, Tetsuo ^c   Sakamoto, Naoya ^d   Korenaga, Masaaki ^a   Mochizuki, Hitoshi ^e   Nakane, Kunio ^f   Enomoto, Hirayuki ^g   Ikeda, Fusao ^h   Yanase, Mikio ⁱ   Toyoda, Hidenori ^j   Genda, Takuya ^k   Umemura, Takeji ^l   Yatsuhashi, Hiroshi ^m   Ide, Tatsuya ⁿ   Toda, Nobuo ^o   Nirei, Kazushige ^p   Ueno, Yoshiyuki ^q   Nishigaki, Yoichi ^r   Betular, Juan ^s   Gao, Bing ^s   Ishizaki, Akinobu ^u   Omote, Masa ^u   Mo, Hongmei ⁱ   Garrison, Kim ⁱ   Pang, Phillip S ⁱ   Knox, Steven J ⁱ   Symonds, William T ⁱ   McHutchison, John G ⁱ   Izumi, Namiki ^t   Omata, Masao ^e,f   more..

^a National Center for Global Health and Medicine   (Japan)

^b CHIBA UNIVERSITY   (Japan)

^c OSAKA UNIVERSITY   (Japan)

^d HOKKAIDO UNIVERSITY   (Japan)

^e Yamanashi Prefectural Central Hospital   (Japan)

^f Akita City Hosp   (Japan)

^g HYOGO COLLEGE OF MEDICINE   (Japan)

^h OKAYAMA UNIVERSITY   (Japan)

ⁱ NATIONAL CENTER FOR GLOBAL HEALTH AND MEDICINE   (Japan)

^j OGAKI MUNICIPAL HOSPITAL   (Japan)

^k JUNTENDO UNIVERSITY SHIZUOKA HOSPITAL   (Japan)

^l SHINSHU UNIVERSITY   (Japan)

^m NATIONAL HOSPITAL ORGANIZATION NAGASAKI MEDICAL CENTER   (Japan)

ⁿ KURUME UNIVERSITY   (Japan)

^o MITSUI MEMORIAL HOSPITAL   (Japan)

^p NIHON UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^q YAMAGATA UNIVERSITY   (Japan)

^r Gifu Municipal Hospital   (Japan)

^s GILEAD SCIENCES   (United States)

^t MUSASHINO RED CROSS HOSPITAL   (Japan)

^u Gilead Sciences KK   (Japan)

more..

Author keywords

[No Author keywords available]

Indexed keywords

FALDAPREVIR; LEDIPASVIR; PEGINTERFERON ALPHA; PEGINTERFERON ALPHA2B; RIBAVIRIN; SIMEPREVIR; SOFOSBUVIR; TELAPREVIR; VANIPREVIR; VIRUS RNA; ANTIVIRUS AGENT; BENZIMIDAZOLE DERIVATIVE; FLUORENE DERIVATIVE; URIDINE PHOSPHATE;

ACUTE HEART INFARCTION; ADULT; ANEMIA; ANTIVIRAL THERAPY; AREA UNDER THE CURVE; ARTICLE; CHRONIC GASTRITIS; CONTROLLED STUDY; CREATININE CLEARANCE; DIABETES MELLITUS; DRUG INDUCED HEADACHE; DRUG WITHDRAWAL; FEMALE; FOLLOW UP; HEPATITIS C; HEPATITIS C VIRUS GENOTYPE 1; HUMAN; JAPANESE (PEOPLE); LIVER CIRRHOSIS; LUNG FIBROSIS; MAJOR CLINICAL STUDY; MALAISE; MALE; MAXIMUM PLASMA CONCENTRATION; MIDDLE AGED; MULTICENTER STUDY; OPEN STUDY; PHASE 3 CLINICAL TRIAL; PLASMA CONCENTRATION-TIME CURVE; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RASH; RHINOPHARYNGITIS; SARCOIDOSIS; SPLENECTOMY; STOMATITIS; THROMBOCYTE COUNT; TREATMENT DURATION; AGED; ANALOGS AND DERIVATIVES; ASIAN CONTINENTAL ANCESTRY GROUP; CLASSIFICATION; CLINICAL TRIAL; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; GENETICS; GENOTYPE; HEPACIVIRUS; HEPATITIS C, CHRONIC; ISOLATION AND PURIFICATION; JAPAN; ORAL DRUG ADMINISTRATION; PATHOLOGY; TIME; TREATMENT OUTCOME; VERY ELDERLY; VIROLOGY; YOUNG ADULT;

ADMINISTRATION, ORAL; ADULT; AGED; AGED, 80 AND OVER; ANTIVIRAL AGENTS; ASIAN CONTINENTAL ANCESTRY GROUP; BENZIMIDAZOLES; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FEMALE; FLUORENES; GENOTYPE; HEPACIVIRUS; HEPATITIS C, CHRONIC; HUMANS; JAPAN; MALE; MIDDLE AGED; RIBAVIRIN; TIME FACTORS; TREATMENT OUTCOME; URIDINE MONOPHOSPHATE; YOUNG ADULT;

EID: 84929513365     PISSN: 14733099     EISSN: 14744457     Source Type: Journal    
DOI: 10.1016/S1473-3099(15)70099-X     Document Type: Article

References (18)

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. JSH Guidelines for the Management of Hepatitis C Virus Infection: a 2014 update for genotype 1. Hepatol Res 2014, 44(suppl 1):59-70. Drafting Committee for Hepatitis Management Guidelines, the Japan Society of Hepatologythe Japan Society of Hepatology.
3. Hayashi N, Izumi N, Kumada H, et al. Simeprevir with peginterferon/ribavirin for treatment-naïve hepatitis C genotype 1 patients in Japan: CONCERTO-1, a phase III trial. J Hepatol 2014, 61:219-227.
4. Izumi N, Hayashi N, Kumada 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.
5. Kumada H, Hayashi N, Izumi N, et al. Simeprevir (TMC435) once daily with peginterferon-α-2b and ribavirin in patients with genotype 1 hepatitis C virus infection: The CONCERTO-4 study. Hepatol Res 2014, published online June 24. 10.1111/hepr.12375.
6. Zeuzem S, Berg T, Gane E, et al. Simeprevir increases rate of sustained virologic response among treatment-experienced patients with HCV genotype-1 infection: a phase IIb trial. Gastroenterology 2014, 146:430-441.
7. Gane E Hepatitis C beware-the end is nigh. Lancet 2014, 384:1557-1560.
8. Kumada H, Suzuki Y, Ikeda K, et al. Daclatasvir plus asunaprevir for chronic HCV genotype 1b infection. Hepatology 2014, 59:2083-2091.
9. Daklinza (daclatasvir) tablets: Japanese prescribing information (accessed Jan 28, 2015). Tokyo: Bristol-Myers Squibb. http://www.kodc.or.kr/home/drug_info/readDownloadFile.do;jsessionid=C5A2DAD4B6EE55414F79E40385C244B1?kdcode=Z40000418&drugCd=B003301&type=eng.
10. Sunvepra (asunaprevir) capsules: Japanese prescribing information (accessed Jan 28, 2015). http://www.kodc.or.kr/home/drug_info/readDownloadFile.do;jsessionid=26C94468C2AEC9926592D5D1A6B96767?kdcode=Z40000419&drugCd=B003311&type=eng.
11. Sovaldi (sofosbuvir) tablets: US prescribing information (accessed Jan 28, 2015). Foster City: Gilead Sciences. http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/sovaldi/sovaldi_pi.pdf.
12. Lawitz EJ, Gruener D, Hill JM, et al. A phase 1, randomized, placebo-controlled, 3-day, dose-ranging study of GS-5885, an NS5A inhibitor, in patients with genotype 1 hepatitis C. J Hepatol 2012, 57:24-31.
13. Afdhal N, Zeuzem S, Kwo P, et al. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med 2014, 370:1889-1898.
14. Afdhal N, Reddy KR, Nelson DR, et al. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med 2014, 370:1483-1493.
15. Kowdley KV, Gordon SC, Reddy KR, et al. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J Med 2014, 370:1879-1888.
16. Kirby B, German P, Shen G, et al. No ethnic differences in the pharmacokinetics of sofosbuvir or sofosbuvir/ledipasvir fixed dose combination in Japanese and Caucasian subjects. Hepatol Res 2013, 7(suppl):S375-S376.
17. Rebetol (ribavirin) capsules: US prescribing information 2003, Merck Sharp & Dohme, NJ.
18. 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.