PMID- 26835876
OWN - NLM
STAT- MEDLINE
DCOM- 20171116
LR  - 20220318
IS  - 1478-3231 (Electronic)
IS  - 1478-3223 (Print)
IS  - 1478-3223 (Linking)
VI  - 36
IP  - 8
DP  - 2016 Aug
TI  - A phase 3b study of sofosbuvir plus ribavirin in Taiwanese patients with chronic 
      genotype 2 hepatitis C virus infection.
PG  - 1101-7
LID - 10.1111/liv.13082 [doi]
AB  - BACKGROUND & AIMS: In Taiwan, patients with chronic hepatitis C virus (HCV) 
      infection are currently treated with pegylated interferon-alpha plus ribavirin, 
      but interferon-based regimens can be poorly tolerated, especially by those with 
      advanced liver disease and the elderly. Sofosbuvir, an oral nucleotide analogue 
      inhibitor of HCV NS5B polymerase, is approved in Europe, the USA and Japan for 
      treating chronic HCV infection. This phase 3b study examined the efficacy and 
      safety of sofosbuvir plus ribavirin in Taiwanese patients with chronic genotype 2 
      HCV infection +/- compensated cirrhosis. METHODS: In this multicentre, open-label, 
      phase 3b (NCT02021643) study, 87 patients (n = 43, treatment-naive; n = 44, 
      treatment-experienced) received 12 weeks of treatment with sofosbuvir plus 
      weight-based ribavirin. The primary efficacy endpoint was the proportion of 
      patients with sustained virological response 12 weeks after treatment 
      discontinuation (SVR12). Safety and pharmacokinetic data were also collected. 
      RESULTS: All 87 patients (100%; 95% confidence interval, 92-100%) achieved SVR12, 
      including the 13 patients with compensated cirrhosis. The most common 
      treatment-emergent adverse events (AEs) were insomnia (16%, 14/87) and upper 
      respiratory tract infection (16%, 14/87). No grade 3 or grade 4 AE was reported. 
      There was one serious AE (biliary colic), which was deemed unrelated to study 
      treatment. Laboratory abnormalities other than ribavirin-related reductions in 
      haemoglobin were uncommon. CONCLUSIONS: The results from this phase 3b study 
      demonstrate that 12 weeks of treatment with the interferon-free regimen 
      sofosbuvir plus ribavirin is effective and well tolerated in both treatment-naive 
      and treatment-experienced Taiwanese patients with chronic genotype 2 HCV 
      infection.
CI  - (c) 2016 The Authors. Liver International Published by John Wiley & Sons Ltd.
FAU - Kao, Jia-Horng
AU  - Kao JH
AD  - National Taiwan University College of Medicine and Hospital, Taipei, Taiwan.
FAU - Chien, Rong-Nan
AU  - Chien RN
AD  - Liver Research Unit, Chang Gung Memorial Hospital-Keelung, Keelung, Taiwan.
FAU - Chang, Ting-Tsung
AU  - Chang TT
AD  - Department of Internal Medicine, National Cheng Kung University Hospital, Tainan, 
      Taiwan.
FAU - Peng, Cheng-Yuan
AU  - Peng CY
AD  - Department of Internal Medicine, School of Medicine, China Medical University, 
      Taichung, Taiwan.
FAU - Hu, Tsung-Hui
AU  - Hu TH
AD  - Chang Gung Medical Foundation, Kaohsiung, Taiwan.
FAU - Lo, Gin-Ho
AU  - Lo GH
AD  - Department of Medicine, E-Da Hospital, Kaohsiung, Taiwan.
FAU - Wang, Horng-Yuan
AU  - Wang HY
AD  - Department of Internal Medicine, Mackay Memorial Hospital, Taipei, Taiwan.
FAU - Chen, Jyh-Jou
AU  - Chen JJ
AD  - Department of Internal Medicine, Chi Mei Hospital, Liouying, Tainan, Taiwan.
FAU - Yang, Jenny C
AU  - Yang JC
AD  - Gilead Sciences, Inc., Foster City, CA, USA.
FAU - Knox, Steven J
AU  - Knox SJ
AD  - Gilead Sciences, Inc., Foster City, CA, USA.
FAU - Han, Lingling
AU  - Han L
AD  - Gilead Sciences, Inc., Foster City, CA, USA.
FAU - Mo, Hongmei
AU  - Mo H
AD  - Gilead Sciences, Inc., Foster City, CA, USA.
FAU - Mathias, Anita
AU  - Mathias A
AD  - Gilead Sciences, Inc., Foster City, CA, USA.
FAU - Brainard, Diana M
AU  - Brainard DM
AD  - Gilead Sciences, Inc., Foster City, CA, USA.
FAU - Sheen, I-Shyan
AU  - Sheen IS
AD  - Chang Gung Memorial Hospital and Medical College, Chang Gung University, Taoyuan, 
      Taiwan.
FAU - Hsu, Yu-Chun
AU  - Hsu YC
AD  - Department of Gastroenterology, Changhua Christian Hospital, Changhua, Taiwan.
FAU - Chu, Chi-Jen
AU  - Chu CJ
AD  - Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.
AD  - School of Medicine, National Yang-Ming University, Taipei, Taiwan.
FAU - Chuang, Wan-Long
AU  - Chuang WL
AD  - Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, 
      Taiwan.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20160323
PL  - United States
TA  - Liver Int
JT  - Liver international : official journal of the International Association for the 
      Study of the Liver
JID - 101160857
RN  - 0 (Antiviral Agents)
RN  - 49717AWG6K (Ribavirin)
RN  - WJ6CA3ZU8B (Sofosbuvir)
SB  - IM
CIN - Liver Int. 2016 Aug;36(8):1093-5. PMID: 27059163
MH  - Adult
MH  - Aged
MH  - Antiviral Agents/*administration & dosage/adverse effects
MH  - Drug Therapy, Combination
MH  - Female
MH  - Hepacivirus/genetics
MH  - Hepatitis C, Chronic/complications/*drug therapy
MH  - Humans
MH  - Liver Cirrhosis/virology
MH  - Male
MH  - Middle Aged
MH  - Ribavirin/*administration & dosage/adverse effects
MH  - Sofosbuvir/*administration & dosage/adverse effects
MH  - Taiwan
MH  - Treatment Outcome
MH  - Viral Load
MH  - Young Adult
PMC - PMC5071670
OTO - NOTNLM
OT  - Taiwan
OT  - genotype 2
OT  - hepatitis C virus (HCV)
OT  - ribavirin
OT  - sofosbuvir
EDAT- 2016/02/03 06:00
MHDA- 2017/11/29 06:00
PMCR- 2016/10/20
CRDT- 2016/02/03 06:00
PHST- 2015/09/09 00:00 [received]
PHST- 2016/01/25 00:00 [accepted]
PHST- 2016/02/03 06:00 [entrez]
PHST- 2016/02/03 06:00 [pubmed]
PHST- 2017/11/29 06:00 [medline]
PHST- 2016/10/20 00:00 [pmc-release]
AID - LIV13082 [pii]
AID - 10.1111/liv.13082 [doi]
PST - ppublish
SO  - Liver Int. 2016 Aug;36(8):1101-7. doi: 10.1111/liv.13082. Epub 2016 Mar 23.