PMID- 34933421
OWN - NLM
STAT- MEDLINE
DCOM- 20211223
LR  - 20211223
IS  - 1007-3418 (Print)
IS  - 1007-3418 (Linking)
VI  - 29
IP  - 11
DP  - 2021 Nov 20
TI  - [Twelve-week of sofosbuvir/velpatasvir therapeutic regimen for chronic hepatitis 
      C patients in northwest region of China: a real-world multicenter clinical 
      study].
PG  - 1046-1052
LID - 10.3760/cma.j.cn501113-20201010-00548 [doi]
AB  - Objective: To study the real-world outcome of China FDA-approved Sofosbuvir 
      (SOF)/Velpatasvir (VEL) in Northwest China. Methods: In this multicenter, 
      prospective, real-world cohort study, we recruited patients from 10 sites from 
      Northwest China, who were chronically infected with HCV GTs 1-6 from 06/2018 to 
      09/2019. Patients received SOF (400mg)/VEL (100mg) for 12 weeks, and with 
      ribavirin 900-1200 mg for GT3 cirrhosis and for any genotype decompensated 
      cirrhosis. The primary endpoint was sustained virological response at 12-weeks 
      post-treatment (SVR12) and safety. The secondary endpoint was the change of liver 
      function after the achievement of SVR12. Results: Totally, 143 patients were 
      enrolled in the study, four patients were lost to follow-up and one died during 
      the follow-up, 138 patients were included in per-protocol analysis. Of the 138 
      patients, the mean age 53 years, 53.6% male, 94.2% Han nationality, 53.6% liver 
      cirrhosis, 10.1% HBsAg(+), 6.5% renal dysfunction, 5.1% treatment-experienced, 
      and 16.7% patients received ribavirin treatment. The genotype distribution was as 
      follows: 35.5% GT1, 42.8% GT2, 15.9% GT3, and 5.8% un-typed. The SVR12 rate was 
      96.5% (138/143, 95%CI: 93.5%-99.6%) for intention-to-treat analysis, and in 
      per-protocol analysis, all 138 patients obtained SVR12 (100%). Compared with 
      baseline, the serum total bilirubin, ALT and AFP levels decreased (all P < 0.05), 
      as well as increased ALB and platelet count (all P < 0.001) at post-treatment 
      12-weeks. Overall adverse events (AEs) rate is 29.0%, and the most common AEs 
      were anemia (14.5%) and fatigue (8.0%). Severe side effects (edema and fatigue) 
      occurred in 2 patients, one of whom needed a short-term interruption of treatment 
      due to fatigue. Conclusion: In this real-world cohort study, 12-week SOF/VEL 
      regimen with or without ribavirin achieved high SVR12 rates (96.5%-100% overall) 
      with excellent safety profile among patients with HCV GT1/2/3 infection including 
      patients with GT3 and cirrhosis, and led to improvement of liver function.
FAU - Xu, Q
AU  - Xu Q
AD  - Hospital of Traditional Chinese Medicine Affiliated to Xinjiang Medical 
      University, Urumqi 830000, China.
FAU - Zhang, W
AU  - Zhang W
AD  - Xijing Hospital of Air Force Medical University, Xi'an 710032, China.
FAU - Ma, Y X
AU  - Ma YX
AD  - The Fourth People's Hospital of Qinghai Province, Xining 810000, China.
FAU - He, C N
AU  - He CN
AD  - The Second Affiliated Hospital of Xi'an, Xi'an Jiaotong University, Xi'an 710004, 
      China Shaanxi Provincial Shenmu Hospital, Yulin 719300, China.
FAU - Zhang, L T
AU  - Zhang LT
AD  - First Hospital of Lanzhou University, Lanzhou 730000, China.
FAU - Abulitifu, Yilihamu
AU  - Abulitifu Y
AD  - People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi 830001, China.
FAU - Li, Y
AU  - Li Y
AD  - Shaanxi Provincial People's Hospital, Xi'an 710068, China.
FAU - Wang, N
AU  - Wang N
AD  - The Affiliated Xi'an Central Hospital of Xi'an Jiaotong University, Xi'an 710003, 
      China.
FAU - Wang, H L
AU  - Wang HL
AD  - The Eighth hospital of Xi'an City, Xi'an 710061, China.
FAU - Zhao, Y Y
AU  - Zhao YY
AD  - The Second Affiliated Hospital of Xi'an, Xi'an Jiaotong University, Xi'an 710004, 
      China.
FAU - Gao, X
AU  - Gao X
AD  - The Second Affiliated Hospital of Xi'an, Xi'an Jiaotong University, Xi'an 710004, 
      China.
FAU - Gao, P G
AU  - Gao PG
AD  - The Second Affiliated Hospital of Xi'an, Xi'an Jiaotong University, Xi'an 710004, 
      China.
FAU - Su, X Y
AU  - Su XY
AD  - The Second Affiliated Hospital of Xi'an, Xi'an Jiaotong University, Xi'an 710004, 
      China.
FAU - Li, S
AU  - Li S
AD  - Shaanxi Provincial Centre for Disease Control and Prevention, Xi'an 710054, 
      China.
FAU - Liu, Y Y
AU  - Liu YY
AD  - The Affiliated Xi'an Central Hospital of Xi'an Jiaotong University, Xi'an 710003, 
      China.
FAU - Guo, F
AU  - Guo F
AD  - Hospital of Traditional Chinese Medicine Affiliated to Xinjiang Medical 
      University, Urumqi 830000, China.
FAU - Chen, Z Q
AU  - Chen ZQ
AD  - Xijing Hospital of Air Force Medical University, Xi'an 710032, China.
FAU - Liu, H L
AU  - Liu HL
AD  - Central Hospital of Xianyang City, Xianyang 712000, China.
FAU - Gao, X Q
AU  - Gao XQ
AD  - The Fourth People's Hospital of Qinghai Province, Xining 810000, China.
FAU - Fu, J J
AU  - Fu JJ
AD  - The Affiliated Xi'an Central Hospital of Xi'an Jiaotong University, Xi'an 710003, 
      China.
FAU - Yu, G Y
AU  - Yu GY
AD  - The Fourth People's Hospital of Qinghai Province, Xining 810000, China.
FAU - Wang, X Z
AU  - Wang XZ
AD  - Hospital of Traditional Chinese Medicine Affiliated to Xinjiang Medical 
      University, Urumqi 830000, China.
FAU - Wang, J P
AU  - Wang JP
AD  - Xijing Hospital of Air Force Medical University, Xi'an 710032, China.
FAU - Zhang, Y P
AU  - Zhang YP
AD  - People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi 830001, China.
FAU - Ji, F P
AU  - Ji FP
AD  - The Second Affiliated Hospital of Xi'an, Xi'an Jiaotong University, Xi'an 710004, 
      China National & Local Joint Engineering Research Center of Biodiagnosis and 
      Biotherapy, the Second Affiliated Hospital, Xi'an Jiaotong University, Xi'an 
      710004, China Shaanxi Provincial Clinical Medical Research Center of Infectious 
      Diseases, Xi'an 710049, China.
LA  - chi
GR  - 81300322/National Natural Science Foundation of China/
GR  - 305/National Elite candidate program of Medical School of Xi'an Jiaotong 
      University/
GR  - SJ202010698269/Innovation and entrepreneurship training program of Xi'an Jiaotong 
      University/
PT  - Journal Article
PT  - Multicenter Study
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  - 0 (Carbamates)
RN  - 0 (Heterocyclic Compounds, 4 or More Rings)
RN  - 49717AWG6K (Ribavirin)
RN  - KCU0C7RS7Z (velpatasvir)
RN  - WJ6CA3ZU8B (Sofosbuvir)
SB  - IM
MH  - Antiviral Agents/therapeutic use
MH  - Carbamates
MH  - Cohort Studies
MH  - Drug Therapy, Combination
MH  - Female
MH  - Genotype
MH  - Hepacivirus/genetics
MH  - *Hepatitis C, Chronic/drug therapy
MH  - Heterocyclic Compounds, 4 or More Rings
MH  - Humans
MH  - Liver Cirrhosis/drug therapy
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Ribavirin/therapeutic use
MH  - *Sofosbuvir/therapeutic use
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Chronic hepatitis C
OT  - Effectiveness
OT  - Genotype 3
OT  - Liver cirrhosis
OT  - Real world
OT  - Ribavirin
OT  - Sofosbuvir
OT  - Velpatasvir
EDAT- 2021/12/22 06:00
MHDA- 2021/12/24 06:00
CRDT- 2021/12/21 21:16
PHST- 2021/12/21 21:16 [entrez]
PHST- 2021/12/22 06:00 [pubmed]
PHST- 2021/12/24 06:00 [medline]
AID - 10.3760/cma.j.cn501113-20201010-00548 [doi]
PST - ppublish
SO  - Zhonghua Gan Zang Bing Za Zhi. 2021 Nov 20;29(11):1046-1052. doi: 
      10.3760/cma.j.cn501113-20201010-00548.