PMID- 34188161
OWN - NLM
STAT- MEDLINE
DCOM- 20211103
LR  - 20211103
IS  - 2045-2322 (Electronic)
IS  - 2045-2322 (Linking)
VI  - 11
IP  - 1
DP  - 2021 Jun 29
TI  - Real-world efficacy and safety of pangenotypic direct-acting antivirals against 
      hepatitis C virus infection in Taiwan.
PG  - 13543
LID - 10.1038/s41598-021-93095-x [doi]
LID - 13543
AB  - Clinical trials showed pangenotypic direct-acting antivirals' (DAAs) excellent 
      efficacy and safety when treating hepatitis C virus (HCV). Two pangenotypic 
      regimens were examined, glecaprevir/pibrentasvir (GLE/PIB) and 
      sofosbuvir/velpatasvir (SOF/VEL), in a real-world Taiwanese setting, including 
      all HCV patients treated with GLE/PIB or SOF/VEL from August 2018 to April 2020. 
      The primary endpoint was sustained virologic response 12 weeks after treatment 
      cessation (SVR12), including adverse events (AEs). A total of 1,356 HCV patients 
      received pangenotypic DAA treatment during the study: 742 and 614 received 
      GLE/PIB and SOF/VEL, respectively. The rates of SVR12 for GLE/PIB and SOF/VEL 
      were 710/718 (98.9%) and 581/584 (99.5%), respectively, by per-protocol analysis, 
      and 710/742 (95.7%) and 581/614 (94.6%), respectively, by evaluable population 
      analysis. Eleven (GLE/PIB: 8, SOF/VEL: 3) did not achieve SVR12. The most common 
      AEs for GLE/PIB and SOF/VEL were pruritus (17.4% vs. 2.9%), abdominal discomfort 
      (5.8% vs. 4.4%), dizziness (4.2% vs. 2%), and malaise (3.1% vs. 2.9%). Laboratory 
      abnormalities were uncommon; only < 1% exhibited elevated total bilirubin or 
      aminotransferase levels with both regimens. Five drug discontinuations occurred 
      due to AEs (bilirubin elevation: 3; dermatological issues: 2). Pangenotypic DAAs 
      GLE/PIB and SOF/VEL are effective and well tolerated, achieving high SVR12 rates 
      for patients with all HCV genotypes.
FAU - Chang, Kao-Chi
AU  - Chang KC
AD  - Division of Hepatology and Gastroenterology, Department of Internal Medicine, 
      Chang Gung Memorial Hospital, No. 6, Section West, Chiapu Road, Puzi, Chiayi, 
      613, Taiwan, ROC.
FAU - Tung, Shui-Yi
AU  - Tung SY
AD  - Division of Hepatology and Gastroenterology, Department of Internal Medicine, 
      Chang Gung Memorial Hospital, No. 6, Section West, Chiapu Road, Puzi, Chiayi, 
      613, Taiwan, ROC.
AD  - Chang Gung University College of Medicine, Taoyuan, Taiwan, ROC.
FAU - Wei, Kuo-Liang
AU  - Wei KL
AD  - Division of Hepatology and Gastroenterology, Department of Internal Medicine, 
      Chang Gung Memorial Hospital, No. 6, Section West, Chiapu Road, Puzi, Chiayi, 
      613, Taiwan, ROC.
AD  - Chang Gung University College of Medicine, Taoyuan, Taiwan, ROC.
FAU - Shen, Chen-Heng
AU  - Shen CH
AD  - Division of Hepatology and Gastroenterology, Department of Internal Medicine, 
      Chang Gung Memorial Hospital, No. 6, Section West, Chiapu Road, Puzi, Chiayi, 
      613, Taiwan, ROC.
FAU - Hsieh, Yung-Yu
AU  - Hsieh YY
AD  - Division of Hepatology and Gastroenterology, Department of Internal Medicine, 
      Chang Gung Memorial Hospital, No. 6, Section West, Chiapu Road, Puzi, Chiayi, 
      613, Taiwan, ROC.
AD  - Chang Gung University College of Medicine, Taoyuan, Taiwan, ROC.
FAU - Chen, Wei-Ming
AU  - Chen WM
AD  - Division of Hepatology and Gastroenterology, Department of Internal Medicine, 
      Chang Gung Memorial Hospital, No. 6, Section West, Chiapu Road, Puzi, Chiayi, 
      613, Taiwan, ROC.
FAU - Chen, Yi-Hsing
AU  - Chen YH
AD  - Division of Hepatology and Gastroenterology, Department of Internal Medicine, 
      Chang Gung Memorial Hospital, No. 6, Section West, Chiapu Road, Puzi, Chiayi, 
      613, Taiwan, ROC.
FAU - Chen, Chun-Hsien
AU  - Chen CH
AD  - Division of Hepatology and Gastroenterology, Department of Internal Medicine, 
      Chang Gung Memorial Hospital, No. 6, Section West, Chiapu Road, Puzi, Chiayi, 
      613, Taiwan, ROC.
FAU - Yen, Chi-Wei
AU  - Yen CW
AD  - Division of Hepatology and Gastroenterology, Department of Internal Medicine, 
      Chang Gung Memorial Hospital, No. 6, Section West, Chiapu Road, Puzi, Chiayi, 
      613, Taiwan, ROC.
FAU - Xu, Huang-Wei
AU  - Xu HW
AD  - Division of Hepatology and Gastroenterology, Department of Internal Medicine, 
      Chang Gung Memorial Hospital, No. 6, Section West, Chiapu Road, Puzi, Chiayi, 
      613, Taiwan, ROC.
FAU - Tung, Wei-Lin
AU  - Tung WL
AD  - Division of Hepatology and Gastroenterology, Department of Internal Medicine, 
      Chang Gung Memorial Hospital, No. 6, Section West, Chiapu Road, Puzi, Chiayi, 
      613, Taiwan, ROC.
FAU - Hung, Chao-Hung
AU  - Hung CH
AD  - Division of Hepatology and Gastroenterology, Department of Internal Medicine, 
      Chang Gung Memorial Hospital, No. 6, Section West, Chiapu Road, Puzi, Chiayi, 
      613, Taiwan, ROC.
AD  - Chang Gung University College of Medicine, Taoyuan, Taiwan, ROC.
FAU - Lu, Sheng-Nan
AU  - Lu SN
AD  - Division of Hepatology and Gastroenterology, Department of Internal Medicine, 
      Chang Gung Memorial Hospital, No. 6, Section West, Chiapu Road, Puzi, Chiayi, 
      613, Taiwan, ROC.
AD  - Chang Gung University College of Medicine, Taoyuan, Taiwan, ROC.
FAU - Chang, Te-Sheng
AU  - Chang TS
AD  - Division of Hepatology and Gastroenterology, Department of Internal Medicine, 
      Chang Gung Memorial Hospital, No. 6, Section West, Chiapu Road, Puzi, Chiayi, 
      613, Taiwan, ROC. cgmh3621@cgmh.org.tw.
AD  - Chang Gung University College of Medicine, Taoyuan, Taiwan, ROC. 
      cgmh3621@cgmh.org.tw.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20210629
PL  - England
TA  - Sci Rep
JT  - Scientific reports
JID - 101563288
RN  - 0 (Antiviral Agents)
SB  - IM
MH  - Aged
MH  - Antiviral Agents/*administration & dosage
MH  - Female
MH  - Hepacivirus/*genetics
MH  - *Hepatitis C, Chronic/drug therapy/epidemiology/genetics
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Retrospective Studies
MH  - *Sustained Virologic Response
MH  - Taiwan/epidemiology
PMC - PMC8241842
COIS- The authors declare no competing interests.
EDAT- 2021/07/01 06:00
MHDA- 2021/11/04 06:00
PMCR- 2021/06/29
CRDT- 2021/06/30 06:25
PHST- 2021/03/26 00:00 [received]
PHST- 2021/06/08 00:00 [accepted]
PHST- 2021/06/30 06:25 [entrez]
PHST- 2021/07/01 06:00 [pubmed]
PHST- 2021/11/04 06:00 [medline]
PHST- 2021/06/29 00:00 [pmc-release]
AID - 10.1038/s41598-021-93095-x [pii]
AID - 93095 [pii]
AID - 10.1038/s41598-021-93095-x [doi]
PST - epublish
SO  - Sci Rep. 2021 Jun 29;11(1):13543. doi: 10.1038/s41598-021-93095-x.