PMID- 34053916
OWN - NLM
STAT- MEDLINE
DCOM- 20211119
LR  - 20211203
IS  - 2005-1212 (Electronic)
IS  - 1976-2283 (Print)
IS  - 1976-2283 (Linking)
VI  - 15
IP  - 6
DP  - 2021 Nov 15
TI  - Efficacy and Safety of Glecaprevir/Pibrentasvir in Korean Patients with Chronic 
      Hepatitis C: A Pooled Analysis of Five Phase II/III Trials.
PG  - 895-903
LID - 10.5009/gnl20321 [doi]
AB  - BACKGROUND/AIMS: Glecaprevir/pibrentasvir (G/P) is the first pan-genotypic 
      direct-acting antiviral combination therapy approved in Korea. An integrated 
      analysis of five phase II and III trials was conducted to evaluate the efficacy 
      and safety of G/P in Korean patients with chronic hepatitis C virus (HCV) 
      infection. METHODS: The study analyzed pooled data on Korean patients with HCV 
      infection enrolled in the ENDURANCE 1 and 2, SURVEYOR II part 4 and VOYAGE I and 
      II trials, which evaluated the efficacy and safety of 8 or 12 weeks of G/P 
      treatment. The patients were either treatment-naive or had received sofosbuvir or 
      interferon-based treatment. Efficacy was evaluated by assessing the rate of 
      sustained virologic response at 12 weeks posttreatment (SVR12). Safety was 
      evaluated by monitoring adverse events (AEs) and laboratory assessments. RESULTS: 
      The analysis included 265 patients; 179 (67.5%) were HCV treatment-naive, and 
      most patients were either subgenotype 1B (48.7%) or 2A (44.5%). In the 
      intention-to-treat population, 262 patients (98.9%) achieved SVR12. Three 
      patients did not achieve SVR12: one had virologic failure and two had 
      non-virologic failures. Most AEs were grade 1/2; eight patients (3.0%) 
      experienced at least one grade >/=3 AE. No serious AEs related to G/P treatment 
      were reported, and grade >/=3 hepatic laboratory abnormalities were rare (0.8%). 
      CONCLUSIONS: G/P therapy was highly efficacious and well tolerated in Korean 
      patients with HCV infection, with most patients achieving SVR12. The safety 
      profile was comparable to that observed in a pooled analysis of a global 
      pan-genotypic population of patients with HCV infection who received G/P.
FAU - Heo, Jeong
AU  - Heo J
AUID- ORCID: 0000-0003-0961-7851
AD  - Department of Internal Medicine, Pusan National University College of Medicine 
      and Medical Research Institute, Pusan National University Hospital, Busan, Korea.
FAU - Kim, Yoon Jun
AU  - Kim YJ
AUID- ORCID: 0000-0001-9141-7773
AD  - Department of Internal Medicine and Liver Research Institute, Seoul National 
      University College of Medicine, Seoul, Korea.
FAU - Lee, Jin-Woo
AU  - Lee JW
AUID- ORCID: 0000-0002-7227-4938
AD  - Department of Internal Medicine, Inha University School of Medicine, Incheon, 
      Korea.
FAU - Kim, Ji Hoon
AU  - Kim JH
AUID- ORCID: 0000-0002-4427-3997
AD  - Department of Internal Medicine, Korea University College of Medicine, Seoul, 
      Korea.
FAU - Lim, Young-Suk
AU  - Lim YS
AUID- ORCID: 0000-0002-1544-577X
AD  - Department of Gastroenterology, Asan Medical Center, University of Ulsan College 
      of Medicine, Seoul, Korea.
FAU - Han, Kwang-Hyub
AU  - Han KH
AUID- ORCID: 0000-0003-3960-6539
AD  - Department of Internal Medicine, Yonsei University College of Medicine, Seoul, 
      Korea.
FAU - Jeong, Sook-Hyang
AU  - Jeong SH
AUID- ORCID: 0000-0002-4916-7990
AD  - Department of Internal Medicine, Seoul National University Bundang Hospital, 
      Seoul National University College of Medicine, Seongnam, Korea.
FAU - Cho, Mong
AU  - Cho M
AUID- ORCID: 0000-0002-0498-6300
AD  - Department of Internal Medicine, Pusan National University Yangsan Hospital, 
      Pusan National University College of Medicine, Yangsan, Korea.
FAU - Yoon, Ki Tae
AU  - Yoon KT
AUID- ORCID: 0000-0002-8580-0239
AD  - Department of Internal Medicine, Pusan National University Yangsan Hospital, 
      Pusan National University College of Medicine, Yangsan, Korea.
FAU - Bae, Si Hyun
AU  - Bae SH
AUID- ORCID: 0000-0003-1727-7842
AD  - Department of Internal Medicine, College of Medicine, The Catholic University of 
      Korea, Seoul, Korea.
FAU - Crown, Eric D
AU  - Crown ED
AUID- ORCID: 0000-0002-5157-1095
AD  - Abbvie Inc., North Chicago, IL, USA.
FAU - Fredrick, Linda M
AU  - Fredrick LM
AUID- ORCID: 0000-0001-7596-0784
AD  - Abbvie Inc., North Chicago, IL, USA.
FAU - Alami, Negar Niki
AU  - Alami NN
AUID- ORCID: 0000-0003-4455-5780
AD  - Abbvie Inc., North Chicago, IL, USA.
FAU - Asatryan, Armen
AU  - Asatryan A
AUID- ORCID: 0000-0003-2812-4243
AD  - Abbvie Inc., North Chicago, IL, USA.
FAU - Kim, Do Hyun
AU  - Kim DH
AUID- ORCID: 0000-0003-0064-1732
AD  - AbbVie Korea, Ltd., Korea.
FAU - Paik, Seung Woon
AU  - Paik SW
AUID- ORCID: 0000-0002-6746-6652
AD  - Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of 
      Medicine, Seoul, Korea.
FAU - Lee, Youn-Jae
AU  - Lee YJ
AUID- ORCID: 0000-0003-3854-3388
AD  - Department of Internal Medicine, Inje University Busan Paik Hospital, Inje 
      University College of Medicine, Busan, Korea.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, Non-U.S. Gov't
PL  - Korea (South)
TA  - Gut Liver
JT  - Gut and liver
JID - 101316452
RN  - 0 (Aminoisobutyric Acids)
RN  - 0 (Antiviral Agents)
RN  - 0 (Benzimidazoles)
RN  - 0 (Cyclopropanes)
RN  - 0 (Lactams, Macrocyclic)
RN  - 0 (Pyrrolidines)
RN  - 0 (Quinoxalines)
RN  - 0 (Sulfonamides)
RN  - 2WU922TK3L (pibrentasvir)
RN  - 9DLQ4CIU6V (Proline)
RN  - GMW67QNF9C (Leucine)
RN  - K6BUU8J72P (glecaprevir)
SB  - IM
MH  - Aminoisobutyric Acids
MH  - Antiviral Agents/adverse effects
MH  - Benzimidazoles
MH  - Clinical Trials, Phase III as Topic
MH  - Cyclopropanes
MH  - Drug Therapy, Combination
MH  - Genotype
MH  - Hepacivirus/genetics
MH  - *Hepatitis C, Chronic/drug therapy
MH  - Humans
MH  - Lactams, Macrocyclic
MH  - Leucine/analogs & derivatives
MH  - Proline/analogs & derivatives
MH  - Pyrrolidines
MH  - Quinoxalines
MH  - Republic of Korea
MH  - Sulfonamides
MH  - Sustained Virologic Response
MH  - Treatment Outcome
PMC - PMC8593501
OTO - NOTNLM
OT  - Glecaprevir and pibrentasvir
OT  - Hepatitis C virus
OT  - Korea
OT  - Pan-genotypic antivirals
COIS- CONFLICTS OF INTEREST Y.S.L. is an advisory board member of Bayer Healthcare and 
      Gilead Sciences. E.D.C., L.M.F., and N.N.A. are employees of AbbVie, Inc. and may 
      hold stock or stock options. A.A. and D.H.K. are former employees of AbbVie, Inc. 
      and may hold stock or stock options. Other authors have no conflicts of interest 
      to declare. Y.J.K. is an editorial board member of the journal but was not 
      involved in the peer reviewer selection, evaluation, or decision process of this 
      article. No other potential conflicts of interest relevant to this article were 
      reported.
EDAT- 2021/06/01 06:00
MHDA- 2021/11/20 06:00
PMCR- 2021/11/15
CRDT- 2021/05/31 05:56
PHST- 2020/10/28 00:00 [received]
PHST- 2020/12/24 00:00 [revised]
PHST- 2021/01/04 00:00 [accepted]
PHST- 2021/06/01 06:00 [pubmed]
PHST- 2021/11/20 06:00 [medline]
PHST- 2021/05/31 05:56 [entrez]
PHST- 2021/11/15 00:00 [pmc-release]
AID - gnl20321 [pii]
AID - gnl-15-6-895 [pii]
AID - 10.5009/gnl20321 [doi]
PST - ppublish
SO  - Gut Liver. 2021 Nov 15;15(6):895-903. doi: 10.5009/gnl20321.