PMID- 31520460
OWN - NLM
STAT- MEDLINE
DCOM- 20210322
LR  - 20220110
IS  - 1365-2893 (Electronic)
IS  - 1352-0504 (Linking)
VI  - 27
IP  - 1
DP  - 2020 Jan
TI  - Safety and efficacy of coblopasvir and sofosbuvir in patients with genotypes 1, 
      2, 3 and 6 HCV infections without or with compensated cirrhosis.
PG  - 45-51
LID - 10.1111/jvh.13208 [doi]
AB  - A simple, pangenotypic and effective treatment regimen for patients with a broad 
      range of chronic hepatitis C virus (HCV) infections remains an unmet medical 
      need. We conducted a phase 2, randomized, open study involving untreated patients 
      with chronic HCV genotypes 1, 2, 3, or 6 infections. Patients without cirrhosis 
      were randomly assigned in a 1:2 ratio to receive capsules of the NS5A inhibitor 
      coblopasvir at a dose of 30 or 60 mg plus tablets of the nucleotide polymerase 
      inhibitor sofosbuvir (400 mg) once daily for 12 weeks. Patients with cirrhosis 
      received 60 mg coblopasvir plus sofosbuvir for 12 weeks. The primary endpoint was 
      the sustained virologic response at 12 weeks after the end of therapy (SVR12). Of 
      the 110 patients who were enrolled in the study, 59 were male, 62.7% had HCV 
      genotype 1, 24.5% had genotype 2, 6.4% had genotype 3, and 6.4% had genotype 6. 
      The average age was 45.5 years. A total of 10.9% of patients had compensated 
      cirrhosis. The rate of SVR12 was 98.2% in the intention-to-treat (ITT). One 
      genotype 6 patient with cirrhosis experienced virologic relapse. One genotype 2 
      patient without cirrhosis failed to complete the follow-up and quit the study. 
      Serious adverse events (SAEs) were reported in 2 patients and were not related to 
      coblopasvir and sofosbuvir. Most adverse events (AEs) did not require treatment. 
      Coblopasvir plus sofosbuvir taken once daily for 12 weeks provided high rates of 
      sustained virologic response (SVR) and had a good safety profile among patients 
      with HCV genotypes 1, 2, 3, or 6 infections, including those with compensated 
      cirrhosis.
CI  - (c) 2019 John Wiley & Sons Ltd.
FAU - Rao, Huiying
AU  - Rao H
AD  - Beijing Key Laboratory for Hepatitis C and Immunotherapy for Liver Disease, 
      Peking University People's Hospital, Peking University Hepatology Institute, 
      Beijing, China.
FAU - Song, Guangjun
AU  - Song G
AD  - Hepatology Department, Peking University People's Hospital, Beijing, China.
FAU - Li, Guangming
AU  - Li G
AD  - Zhengzhou Municipal Sixth People's Hospital, Zhengzhou, China.
FAU - Yang, Yongfeng
AU  - Yang Y
AD  - Nanjing Municipal Second Hospital, Nanjing, China.
FAU - Wu, Xiaofeng
AU  - Wu X
AD  - Shenyang Municipal Sixth People's Hospital, Shenyang, China.
FAU - Guan, Yujuan
AU  - Guan Y
AD  - Guangzhou Municipal Eighth People's Hospital, Guanzhou, China.
FAU - Mao, Qing
AU  - Mao Q
AD  - Chinese PLA Third Military Medical University First Affiliated Hospital, 
      Chongqing, China.
FAU - Jiang, Xiangjun
AU  - Jiang X
AD  - Qingdao Municipal Hospital, Qingdao, China.
FAU - Wang, Changyuan
AU  - Wang C
AD  - Ji'nan Municipal Hospital of Infectious Disease, Ji'nan, Shandong, China.
FAU - Zhang, Ying
AU  - Zhang Y
AD  - Dalian Municipal Sixth People's Hospital, Dalian, China.
FAU - Jia, Jidong
AU  - Jia J
AD  - Capital Medical University Affiliated Beijing Friendship Hospital, Beijing, 
      China.
FAU - Guo, Xiaolin
AU  - Guo X
AD  - Jilin University First Hospital, Changchun, China.
FAU - Li, Chenghao
AU  - Li C
AD  - Yanbian University Affiliated Hospital, Yanji, China.
FAU - Ning, Jing
AU  - Ning J
AD  - Beijing Kawin Technology Share-holding Co., Ltd., Beijing, China.
FAU - Qin, Hong
AU  - Qin H
AD  - Beijing Kawin Technology Share-holding Co., Ltd., Beijing, China.
FAU - Pan, Hai
AU  - Pan H
AD  - Beijing Kawin Technology Share-holding Co., Ltd., Beijing, China.
FAU - Wei, Lai
AU  - Wei L
AUID- ORCID: 0000-0003-2326-1257
AD  - Hepatopancreatobiliary Center, Beijing Tsinghua Changgung Hospital, Tsinghua 
      University, Beijing, China.
LA  - eng
SI  - ClinicalTrials.gov/NCT03416491
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20191002
PL  - England
TA  - J Viral Hepat
JT  - Journal of viral hepatitis
JID - 9435672
RN  - 0 (Antiviral Agents)
RN  - 0 (Viral Nonstructural Proteins)
RN  - EC 2.7.7.48 (NS-5 protein, hepatitis C virus)
RN  - WJ6CA3ZU8B (Sofosbuvir)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antiviral Agents/*therapeutic use
MH  - Drug Therapy, Combination
MH  - Female
MH  - Genotype
MH  - Hepacivirus/drug effects/genetics
MH  - Hepatitis C, Chronic/*drug therapy
MH  - Humans
MH  - Liver Cirrhosis/complications/*virology
MH  - Male
MH  - Middle Aged
MH  - Sofosbuvir/*therapeutic use
MH  - Treatment Outcome
MH  - Viral Nonstructural Proteins/antagonists & inhibitors
MH  - Young Adult
OTO - NOTNLM
OT  - coblopasvir
OT  - direct-acting antiviral
OT  - hepatitis C virus
OT  - pangenotypic
OT  - sofosbuvir
EDAT- 2019/09/15 06:00
MHDA- 2021/03/23 06:00
CRDT- 2019/09/15 06:00
PHST- 2018/12/25 00:00 [received]
PHST- 2019/08/03 00:00 [revised]
PHST- 2019/08/15 00:00 [accepted]
PHST- 2019/09/15 06:00 [pubmed]
PHST- 2021/03/23 06:00 [medline]
PHST- 2019/09/15 06:00 [entrez]
AID - 10.1111/jvh.13208 [doi]
PST - ppublish
SO  - J Viral Hepat. 2020 Jan;27(1):45-51. doi: 10.1111/jvh.13208. Epub 2019 Oct 2.