PMID- 26236925
OWN - NLM
STAT- MEDLINE
DCOM- 20160122
LR  - 20221207
IS  - 1007-3418 (Print)
IS  - 1007-3418 (Linking)
VI  - 23
IP  - 6
DP  - 2015 Jun
TI  - [High sustained virological response to optimized therapy for refractory chronic 
      hepatitis C treatment-na(i)ve patients: a multicenter randomized study].
PG  - 412-7
LID - cma.j.issn.1007-3418.2015.06 [pii]
LID - 10.3760/cma.j.issn.1007-3418.2015.06.004 [doi]
AB  - OBJECTIVE: To perform a prospective,multicenter,open,randomized study to 
      determine a treatment regimen for treatment-naive patients with refractory 
      chronic hepatitis C (RHC) using the predictive value (PV) of early virological 
      response (EVR). METHODS: A total of 438 patients from 18 hospitals were recruited 
      between December 2008 and December 2010 and administered peg-interferon/ribavirin 
      treatment for 12 weeks. Patients who achieved complete EVR (cEVR) were assigned 
      to group A for a 48-week course of treatment, while patients without cEVR were 
      randomly allocated to either group B 1 for a 72-week course of treatment or to 
      group B2 for a 96-week course of treatment. Serum hepatitis C virus RNA levels at 
      baseline,treatment weeks 4, 12 and 24, end of treatment, and post-treatment week 
      24 were measured and used to evaluate the efficiency of therapy. RESULTS: The 
      overall sustained virological response (SVR) rate was 85.1%. In all, 91.0% of 
      patients achieved cEVR and were assigned to group A, which had an SVR rate of 
      90.8%. There was no statistically significant difference in the SVR rates of 
      groups B1 and B2 (29.4% vs. 25.0%, P more than 0.05). The positive PV of rapid 
      virological response (RVR), cEVR and delayed virological response (DVR) for SVR 
      was 93.4%, 90.8% and 77.8% respectively, and the negative PV of RVR, EVR and DVR 
      for SVR was 28.0%, 93.3% and 100% respectively. Overall, 66.9% of the patients 
      experienced adverse events (AEs), but only 1.9% of patients experienced sevcre 
      AEs. CONCLUSION: The majority of Chinese RHC treatmentna(i)ve patients (91.0%) 
      can achieve cEVR and a high SVR rate with a low rate of severe AEs using the cEVR 
      guided personal treatment regimen.
FAU - Chen, Xinyue
AU  - Chen X
AD  - International Medical Department, Youan Hospital, Capital Medical University, 
      Beijing 100069, China.
FAU - Shang, Jia
AU  - Shang J
FAU - Yang, Ruifeng
AU  - Yang R
FAU - Xie, Qing
AU  - Xie Q
FAU - Gao, Zhiliang
AU  - Gao Z
FAU - Xu, Xiaoyuan
AU  - Xu X
FAU - Dou, Xiaoguang
AU  - Dou X
FAU - Gong, Guozhong
AU  - Gong G
FAU - Chen, Guofeng
AU  - Chen G
FAU - Li, Jun
AU  - Li J
FAU - Chen, Hong
AU  - Chen H
FAU - Zhang, Dazhi
AU  - Zhang D
FAU - Feng, Yinong
AU  - Feng Y
FAU - Niu, Junqi
AU  - Niu J
FAU - Hou, Jinlin
AU  - Hou J
FAU - You, Hong
AU  - You H
FAU - Wu, Yun
AU  - Wu Y
FAU - Zhao, Peili
AU  - Zhao P
FAU - Rao, Huiying
AU  - Rao H
FAU - Wei, Lai
AU  - Wei L
LA  - chi
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - China
TA  - Zhonghua Gan Zang Bing Za Zhi
JT  - Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of 
      hepatology
JID - 9710009
RN  - 0 (Antiviral Agents)
RN  - 49717AWG6K (Ribavirin)
SB  - IM
MH  - Antiviral Agents
MH  - Asian People
MH  - Drug Therapy, Combination
MH  - *Hepatitis C, Chronic
MH  - Humans
MH  - Ribavirin
EDAT- 2015/08/04 06:00
MHDA- 2016/01/23 06:00
CRDT- 2015/08/04 06:00
PHST- 2015/08/04 06:00 [entrez]
PHST- 2015/08/04 06:00 [pubmed]
PHST- 2016/01/23 06:00 [medline]
AID - cma.j.issn.1007-3418.2015.06 [pii]
AID - 10.3760/cma.j.issn.1007-3418.2015.06.004 [doi]
PST - ppublish
SO  - Zhonghua Gan Zang Bing Za Zhi. 2015 Jun;23(6):412-7. doi: 
      10.3760/cma.j.issn.1007-3418.2015.06.004.