PMID- 33021009
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20210125
IS  - 1386-6346 (Print)
IS  - 1386-6346 (Linking)
VI  - 51
IP  - 1
DP  - 2021 Jan
TI  - Real-world efficacy and safety of 12-week sofosbuvir/velpatasvir treatment for 
      patients with decompensated liver cirrhosis caused by hepatitis C virus 
      infection.
PG  - 51-61
LID - 10.1111/hepr.13576 [doi]
AB  - AIM: This study aimed to evaluate the real-world efficacy and safety of 12-week 
      sofosbuvir/velpatasvir (SOF/VEL) treatment for patients with decompensated liver 
      cirrhosis caused by hepatitis C virus (HCV) infection. METHODS: A total 72 of 
      patients with Child-Pugh (CP) class B or C were enrolled. We evaluated the 
      sustained virologic response at 12 weeks after the end of treatment (SVR12), 
      adverse events (AEs), and changes in the liver function. RESULTS: All 
      participants had genotype 1 or 2 HCV infection. At baseline, the numbers of 
      patients with CP class B and C were 59 and 13, respectively. The overall SVR12 
      rate was 95.8% (69/72); 94.9% (56/59) in CP class B and 100% (13/13) in CP class 
      C. The serum albumin level, prothrombin time and ascites were significantly 
      improved (P < 0.01); however, the serum bilirubin level and encephalopathy did 
      not improve. Among patients who achieved SVR12, 75.0% showed an improvement in 
      their CP score, while 5.9% showed a worsening. The presence of large 
      portosystemic shunt (diameter >/=6 mm) and hyperbilirubinemia (>/=2.0 mg/dL) were 
      independent factors that interfered with the improvement in the CP score 
      (P < 0.05). The most common AEs were encephalopathy (15.3%) and skin symptoms 
      (7.9%). Two patients discontinued SOF/VEL due to AEs. CONCLUSIONS: Treatment with 
      SOF/VEL for 12 weeks was relatively safe and effective for patients with 
      decompensated cirrhosis. An SVR provided an improvement of the liver function in 
      the majority of patients. However, large portosystemic shunt and 
      hyperbilirubinemia were independent factors that interfered with the improvement 
      in the CP score.
CI  - (c) 2020 The Japan Society of Hepatology.
FAU - Takaoka, Yoshinari
AU  - Takaoka Y
AD  - Department of Medicine, Division of Gastroenterology, Jichi Medical University, 
      Shimotsuke, Japan.
AD  - Department of Gastroenterology, Koga Red Cross Hospital, Koga, Japan.
FAU - Miura, Kouichi
AU  - Miura K
AD  - Department of Medicine, Division of Gastroenterology, Jichi Medical University, 
      Shimotsuke, Japan.
FAU - Morimoto, Naoki
AU  - Morimoto N
AUID- ORCID: 0000-0001-9600-7407
AD  - Department of Medicine, Division of Gastroenterology, Jichi Medical University, 
      Shimotsuke, Japan.
FAU - Ikegami, Tadashi
AU  - Ikegami T
AD  - Department of Gastroenterology, Ibaraki Medical Center, Tokyo Medical University, 
      Ami, Japan.
FAU - Kakizaki, Satoru
AU  - Kakizaki S
AUID- ORCID: 0000-0002-1508-584X
AD  - Department of Gastroenterology and Hepatology, Gunma University Graduate School 
      of Medicine, Maebashi, Japan.
FAU - Sato, Ken
AU  - Sato K
AUID- ORCID: 0000-0002-3202-7983
AD  - Department of Gastroenterology and Hepatology, Gunma University Graduate School 
      of Medicine, Maebashi, Japan.
AD  - Department of Hepatology, Heisei Hidaka Clinic, Takasaki, Japan.
FAU - Ueno, Takashi
AU  - Ueno T
AD  - Department of Internal Medicine, Isesaki Municipal Hospital, Isesaki, Japan.
FAU - Naganuma, Atsushi
AU  - Naganuma A
AD  - Department of Gastroenterology, National Hospital Organization Takasaki General 
      Medical Center, Takasaki, Japan.
FAU - Kosone, Takashi
AU  - Kosone T
AD  - Department of Gastroenterology and Hepatology, Kusunoki Hospital, Fujioka, Japan.
FAU - Arai, Hirotaka
AU  - Arai H
AD  - Department of Gastroenterology, Maebashi Red Cross Hospital, Maebashi, Japan.
FAU - Hatanaka, Takeshi
AU  - Hatanaka T
AUID- ORCID: 0000-0003-3656-285X
AD  - Department of Gastroenterology, Gunma Saiseikai Maebashi Hospital, Maebashi, 
      Japan.
FAU - Tahara, Toshiyuki
AU  - Tahara T
AD  - Department of Gastroenterology, Saiseikai Utsunomiya Hospital, Utsunomiya, Japan.
FAU - Tano, Shigeo
AU  - Tano S
AD  - Department of Gastroenterology, Shin-Oyama City Hospital, Oyama, Japan.
FAU - Ohtake, Takaaki
AU  - Ohtake T
AD  - Department of Gastroenterology, International University of Health and Welfare 
      Hospital, Nasushiobara, Japan.
FAU - Murohisa, Toshimitsu
AU  - Murohisa T
AD  - Department of Gastroenterology, Ashikaga Red Cross Hospital, Ashikaga, Japan.
FAU - Namikawa, Masashi
AU  - Namikawa M
AD  - Department of Internal Medicine, Kiryu Kosei General Hospital, Kiryu, Japan.
FAU - Asano, Takeharu
AU  - Asano T
AD  - Department of Gastroenterology, Saitama Medical Center, Jichi Medical University, 
      Saitama, Japan.
FAU - Kamoshida, Toshiro
AU  - Kamoshida T
AD  - Department of Gastroenterology, Hitachi General Hospital, Hitachi, Japan.
FAU - Horiuchi, Katsuhiko
AU  - Horiuchi K
AD  - Department of Gastroenterology, Gunma Chuo Hospital, Japan Community Health care 
      Organization, Maebashi, Japan.
FAU - Nihei, Takeshi
AU  - Nihei T
AD  - Department of Gastroenterology, Mito Saiseikai General Hospital, Mito, Japan.
FAU - Soeda, Atsuko
AU  - Soeda A
AD  - Department of Gastroenterology, Tsukuba Memorial Hospital, Tsukuba, Japan.
FAU - Kurata, Hidekazu
AU  - Kurata H
AD  - Department of Gastroenterology, Tochigi Medical Center Shimotsuga, Tochigi, 
      Japan.
FAU - Fujieda, Takeshi
AU  - Fujieda T
AD  - Department of Internal Medicine, Kitaibaraki City Hospital, Kitaibaraki, Japan.
FAU - Ohtake, Toshiya
AU  - Ohtake T
AD  - Department of Gastroenterology, Josai Hospital, Yuki, Japan.
FAU - Fukaya, Yukimura
AU  - Fukaya Y
AD  - Department of Internal Medicine, Nasu Minami Hospital, Nasukarasuyama, Japan.
FAU - Iijima, Makoto
AU  - Iijima M
AD  - Department of Gastroenterology, Dokkyo Medical University, Mibu, Japan.
FAU - Watanabe, Shunji
AU  - Watanabe S
AD  - Department of Medicine, Division of Gastroenterology, Jichi Medical University, 
      Shimotsuke, Japan.
FAU - Isoda, Norio
AU  - Isoda N
AD  - Department of Medicine, Division of Gastroenterology, Jichi Medical University, 
      Shimotsuke, Japan.
FAU - Yamamoto, Hironori
AU  - Yamamoto H
AD  - Department of Medicine, Division of Gastroenterology, Jichi Medical University, 
      Shimotsuke, Japan.
CN  - Liver Investigators in the Northern Kanto Study (LINKS) group
LA  - eng
PT  - Journal Article
DEP - 20201020
PL  - Netherlands
TA  - Hepatol Res
JT  - Hepatology research : the official journal of the Japan Society of Hepatology
JID - 9711801
OTO - NOTNLM
OT  - Child-Pugh
OT  - decompensated liver cirrhosis
OT  - hepatitis C virus
OT  - portosystemic shunt
OT  - sofosbuvir
OT  - velpatasvir
EDAT- 2020/10/07 06:00
MHDA- 2020/10/07 06:01
CRDT- 2020/10/06 05:35
PHST- 2020/07/19 00:00 [received]
PHST- 2020/08/30 00:00 [revised]
PHST- 2020/09/17 00:00 [accepted]
PHST- 2020/10/07 06:00 [pubmed]
PHST- 2020/10/07 06:01 [medline]
PHST- 2020/10/06 05:35 [entrez]
AID - 10.1111/hepr.13576 [doi]
PST - ppublish
SO  - Hepatol Res. 2021 Jan;51(1):51-61. doi: 10.1111/hepr.13576. Epub 2020 Oct 20.