PMID- 30421537
OWN - NLM
STAT- MEDLINE
DCOM- 20200528
LR  - 20211204
IS  - 1365-2893 (Electronic)
IS  - 1352-0504 (Print)
IS  - 1352-0504 (Linking)
VI  - 26
IP  - 3
DP  - 2019 Mar
TI  - Glecaprevir/Pibrentasvir in patients with chronic HCV genotype 3 infection: An 
      integrated phase 2/3 analysis.
PG  - 337-349
LID - 10.1111/jvh.13038 [doi]
AB  - Glecaprevir coformulated with pibrentasvir (G/P) is approved to treat hepatitis C 
      virus (HCV) infection and was highly efficacious in phase 2 and 3 studies. 
      Treating HCV genotype (GT) 3 infection remains a priority, as these patients are 
      harder to cure and at a greater risk for liver steatosis, fibrosis progression 
      and hepatocellular carcinoma. Data were pooled from five phase 2 or 3 trials that 
      evaluated 8-, 12- and 16-week G/P in patients with chronic HCV GT3 infection. 
      Patients without cirrhosis or with compensated cirrhosis were either 
      treatment-naive or experienced with interferon- or sofosbuvir-based regimens. 
      Safety and sustained virologic response 12 weeks post-treatment (SVR12) were 
      assessed. The analysis included 693 patients with GT3 infection. SVR12 was 
      achieved by 95% of treatment-naive patients without cirrhosis receiving 8-week 
      (198/208) and 12-week (280/294) G/P. Treatment-naive patients with cirrhosis had 
      a 97% (67/69) SVR12 rate with 12-week G/P. Treatment-experienced, noncirrhotic 
      patients had SVR12 rates of 90% (44/49) and 95% (21/22) with 12- and 16-week G/P, 
      respectively; 94% (48/51) of treatment-experienced patients with cirrhosis 
      treated for 16 weeks achieved SVR12. No serious adverse events (AEs) were 
      attributed to G/P; AEs leading to study drug discontinuation were rare (<1%). G/P 
      was well-tolerated and efficacious for patients with chronic HCV GT3 infection, 
      regardless of cirrhosis status or prior treatment experience. Eight- and 12-week 
      durations were efficacious for treatment-naive patients without cirrhosis and 
      with compensated cirrhosis, respectively; 16-week G/P was efficacious in patients 
      with prior treatment experience irrespective of cirrhosis status.
CI  - (c) 2018 The Authors. Journal of Viral Hepatitis Published by John Wiley & Sons 
      Ltd.
FAU - Flamm, Steven
AU  - Flamm S
AD  - Northwestern Feinberg School of Medicine, Chicago, Illinois.
FAU - Mutimer, David
AU  - Mutimer D
AD  - Queen Elizabeth Hospital and NIHR Liver Biomedical Research Unit, Birmingham, UK.
FAU - Asatryan, Armen
AU  - Asatryan A
AD  - AbbVie Inc, North Chicago, Illinois.
FAU - Wang, Stanley
AU  - Wang S
AD  - AbbVie Inc, North Chicago, Illinois.
FAU - Rockstroh, Jurgen
AU  - Rockstroh J
AD  - Universitatsklinikum Bonn, Bonn, Germany.
FAU - Horsmans, Yves
AU  - Horsmans Y
AD  - Cliniques Universitaires Saint-Luc, UCL, Brussels, Belgium.
FAU - Kwo, Paul Y
AU  - Kwo PY
AD  - Division of Gastroenterology and Hepatology, Stanford University, Palo Alto, 
      California.
FAU - Weiland, Ola
AU  - Weiland O
AUID- ORCID: 0000-0002-6934-9724
AD  - Karolinska University Hospital Huddinge at Karolinska Institute, Stockholm, 
      Sweden.
FAU - Villa, Erica
AU  - Villa E
AD  - University of Modena and Reggio Emilia, Modena, Italy.
FAU - Heo, Jeong
AU  - Heo J
AD  - Department of Internal Medicine, College of Medicine, Pusan National University 
      and Medical Research Institute, Pusan National University Hospital, Busan, 
      Republic of Korea.
FAU - Gane, Edward
AU  - Gane E
AD  - Liver Unit, Auckland City Hospital, Auckland, New Zealand.
FAU - Ryder, Stephen D
AU  - Ryder SD
AD  - NIHR Nottingham Biomedical Research Centre and Nottingham University Hospitals 
      NHS Trust, Nottingham, UK.
FAU - Welzel, Tania M
AU  - Welzel TM
AD  - JW Goethe University Hospital, Frankfurt, Germany.
FAU - Ruane, Peter J
AU  - Ruane PJ
AD  - Ruane Medical & Liver Health Institute, Los Angeles, California.
FAU - Agarwal, Kosh
AU  - Agarwal K
AUID- ORCID: 0000-0002-4754-828X
AD  - Institute of Liver Studies, Kings College Hospital, London, UK.
FAU - Ng, Teresa I
AU  - Ng TI
AD  - AbbVie Inc, North Chicago, Illinois.
FAU - Xue, Zhenyi
AU  - Xue Z
AD  - AbbVie Inc, North Chicago, Illinois.
FAU - Lovell, Sandra S
AU  - Lovell SS
AD  - AbbVie Inc, North Chicago, Illinois.
FAU - Krishnan, Preethi
AU  - Krishnan P
AD  - AbbVie Inc, North Chicago, Illinois.
FAU - Kopecky-Bromberg, Sarah
AU  - Kopecky-Bromberg S
AD  - AbbVie Inc, North Chicago, Illinois.
FAU - Trinh, Roger
AU  - Trinh R
AD  - AbbVie Inc, North Chicago, Illinois.
FAU - Mensa, Federico J
AU  - Mensa FJ
AD  - AbbVie Inc, North Chicago, Illinois.
FAU - Wyles, David L
AU  - Wyles DL
AD  - Denver Health Medical Center, Denver, Colorado.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20181211
PL  - England
TA  - J Viral Hepat
JT  - Journal of viral hepatitis
JID - 9435672
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  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aminoisobutyric Acids
MH  - Antiviral Agents/*therapeutic use
MH  - Benzimidazoles/*therapeutic use
MH  - Cyclopropanes
MH  - Data Interpretation, Statistical
MH  - Drug Therapy, Combination
MH  - Female
MH  - Genotype
MH  - Hepacivirus/drug effects/genetics
MH  - Hepatitis C, Chronic/*drug therapy
MH  - Humans
MH  - Lactams, Macrocyclic
MH  - Leucine/analogs & derivatives
MH  - Male
MH  - Middle Aged
MH  - Proline/analogs & derivatives
MH  - Pyrrolidines
MH  - Quinoxalines/*therapeutic use
MH  - Sulfonamides/*therapeutic use
MH  - Sustained Virologic Response
MH  - Treatment Outcome
MH  - Young Adult
PMC - PMC7379735
OTO - NOTNLM
OT  - G/P
OT  - GT3
OT  - PWID
OT  - cirrhosis
OT  - hepatitis C virus
COIS- AbbVie sponsored the studies (NCT02243293, NCT02640157, NCT02738138, NCT02651194 
      and NCT02692703), contributed to their design, collection, analysis and 
      interpretation of the data and participated in the writing, review and approval 
      of the content of the manuscript. All authors had access to all relevant data. 
      This manuscript contains information on the investigational use of glecaprevir 
      (GLE; formerly ABT-493) and pibrentasvir (PIB; formerly ABT-530). S Flamm: 
      Speaker/Consultant: AbbVie, Gilead and Merck; Grant/Research Support: AbbVie and 
      Gilead. D Mutimer: Consultant: AbbVie, Bristol-Myers Squibb, Gilead, Janssen and 
      Merck. J Rockstroh: Grant/Research support: Gilead; Consultant: Abbott, AbbVie, 
      Bionor, Cipla, Gilead, Janssen, Merck and ViiV; Speaker: Gilead, Janssen and 
      Merck. Y Horsmans: Consultant: AbbVie, Bristol-Myers Squibb, Gilead, Janssen and 
      Merck. PY Kwo: Grant/Research Support/Advisor: AbbVie, Bristol-Myers Squibb, 
      Gilead, Janssen and Merck. O Weiland: Advisor/speaker: Merck, Bristol-Myers 
      Squibb, Janssen, Gilead, AbbVie, Medivir. E Villa: Consultant: MSD, AbbVie, 
      Gilead, Bristol-Myers Squibb and Novartis. J Heo: Grant/Research Support: 
      GlaxoSmithKline, Bristol-Myers Squibb and Hoffmann-La Roche; Advisor: AbbVie, 
      Bristol-Myers Squibb, Gilead, Pharma Essentia, SillaJen and Johnson & Johnson. E 
      Gane: Advisor: AbbVie, Gilead, Achillion, Novartis, Roche, Merck and Janssen. S 
      Ryder: Consultant: AbbVie, Boehringer-Ingelheim, MSD, Conatus and Gilead. TM 
      Welzel: Consultant/Speaker for: Abbvie, Bristol-Myers Squibb, Gilead, Janssen, 
      Boehringer-Ingelheim, Intercept. P Ruane: Grant/Research Support: AbbVie, 
      Bristol-Meyers Squibb, Gilead, Merck, Idenix, ViiV, Janssen; Consultant/Advisor: 
      AbbVie, Merck, Gilead; Speaker: Gilead, ViiV, Merck; Stockholder: Gilead. K 
      Agarwal: Consultant/Advisor: Janssen, Merck, Bristol-Myers Squibb, Gilead, 
      AbbVie, Astellas, Achillion and Novartis. D Wyles: Grant/Research support: 
      AbbVie, Gilead, Merck; Consultant/Advisor: AbbVie, Gilead, Merck. A Asatryan, S 
      Wang, TI Ng, Z Xue, SS Lovell, P Krishnan, S Kopecky-Bromberg, R Trinh and F 
      Mensa: employees of AbbVie and may hold stock or stock options.
EDAT- 2018/11/14 06:00
MHDA- 2020/05/29 06:00
PMCR- 2020/07/24
CRDT- 2018/11/14 06:00
PHST- 2018/05/03 00:00 [received]
PHST- 2018/10/22 00:00 [accepted]
PHST- 2018/11/14 06:00 [pubmed]
PHST- 2020/05/29 06:00 [medline]
PHST- 2018/11/14 06:00 [entrez]
PHST- 2020/07/24 00:00 [pmc-release]
AID - JVH13038 [pii]
AID - 10.1111/jvh.13038 [doi]
PST - ppublish
SO  - J Viral Hepat. 2019 Mar;26(3):337-349. doi: 10.1111/jvh.13038. Epub 2018 Dec 11.