PMID- 35174470
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220418
IS  - 2193-8229 (Print)
IS  - 2193-6382 (Electronic)
IS  - 2193-6382 (Linking)
VI  - 11
IP  - 2
DP  - 2022 Apr
TI  - Efficacy and Safety of 8- or 12 Weeks of Glecaprevir/Pibrentasvir in Patients 
      with Evidence of Portal Hypertension.
PG  - 913-924
LID - 10.1007/s40121-022-00599-8 [doi]
AB  - INTRODUCTION: High efficacy and safety of 8-week glecaprevir/pibrentasvir (G/P) 
      therapy was seen in hepatitis C (HCV)-infected, treatment-naive (TN), compensated 
      cirrhosis (CC) patients in EXPEDITION-8. To provide further understanding of the 
      efficacy of G/P treatment in HCV-infected TN patients with CC and clinical 
      evidence of portal hypertension (PHT), this analysis focused on differences in 
      sustained virologic response at post-treatment week 12 (SVR12) between 8-week and 
      12-week G/P treatment groups in patients with PHT, and on differences in safety 
      outcomes between PHT and non-PHT groups. METHODS: Data were derived from an ad 
      hoc subgroup analysis of the EXPEDITION-8 study for patients receiving 8 weeks of 
      G/P therapy, and pooled patient-level data from nine clinical studies for 
      patients receiving 12 weeks of therapy. Evidence of PHT included at least one of 
      the following at baseline: FibroScan >/= 20 kPa, platelets < 100 x 10(9)/L, or 
      medical history consistent with PHT. The primary efficacy endpoint was SVR12; 
      adverse events (AEs) consistent with hepatic decompensation were assessed. 
      RESULTS: PHT was identified in 60.6% (208/343) and 57.1% (224/392) of the 8- and 
      12-week groups, respectively. For those with PHT, SVR12 was 97.6% (203/208) and 
      98.7% (221/224) with 8- and 12-week treatment, respectively (intention-to-treat 
      population). For those without PHT, 97.8% (132/135) in the 8-week group and 97.6% 
      (164/168) in the 12-week group achieved SVR12. Eight patients with PHT, and seven 
      without, did not achieve SVR12. Similar rates of AEs were observed in the PHT and 
      non-PHT groups. Three cases of hepatic decompensation in the PHT group, unrelated 
      to G/P according to the investigators, were reported. CONCLUSION: G/P treatment 
      for 8 or 12 weeks was equally efficacious in HCV patients with features of PHT. 
      Safety outcomes were similar between PHT and non-PHT groups, with G/P treatment 
      well tolerated across groups. NCTS: NCT03089944, NCT02642432, NCT02738138, 
      NCT02243293, NCT02651194, NCT03235349, NCT02707952, NCT02966795, NCT03069365, 
      NCT03219216.
CI  - (c) 2022. The Author(s).
FAU - Brown, Robert S Jr
AU  - Brown RS Jr
AUID- ORCID: 0000-0002-8220-065X
AD  - Center for Liver Disease and Transplantation, Weill Cornell Medical College, 1305 
      York Avenue, New York, NY, 10021, USA. rsb2005@med.cornell.edu.
FAU - Collins, Michelle A
AU  - Collins MA
AD  - AbbVie Inc., North Chicago, IL, USA.
FAU - Strasser, Simone I
AU  - Strasser SI
AD  - AW Morrow Gastroenterology and Liver Centre, Royal Prince Alfred Hospital, 
      Sydney, NSW, Australia.
FAU - Emmett, Amanda
AU  - Emmett A
AD  - AbbVie Inc., North Chicago, IL, USA.
FAU - Topp, Andrew S
AU  - Topp AS
AD  - AbbVie Inc., North Chicago, IL, USA.
FAU - Burroughs, Margaret
AU  - Burroughs M
AD  - AbbVie Inc., North Chicago, IL, USA.
FAU - Ferreira, Rosa
AU  - Ferreira R
AD  - AbbVie Inc., North Chicago, IL, USA.
FAU - Feld, Jordan J
AU  - Feld JJ
AD  - Toronto Centre for Liver Disease, University Health Network, University of 
      Toronto, Toronto, ON, Canada.
LA  - eng
SI  - ClinicalTrials.gov/NCT03069365
SI  - ClinicalTrials.gov/NCT02966795
SI  - ClinicalTrials.gov/NCT02707952
SI  - ClinicalTrials.gov/NCT03219216
PT  - Journal Article
DEP - 20220217
PL  - New Zealand
TA  - Infect Dis Ther
JT  - Infectious diseases and therapy
JID - 101634499
PMC - PMC8960502
OTO - NOTNLM
OT  - Glecaprevir
OT  - Hepatitis C
OT  - Pibrentasvir
OT  - Portal Hypertension
OT  - Sustained Virologic Response
EDAT- 2022/02/18 06:00
MHDA- 2022/02/18 06:01
PMCR- 2022/02/17
CRDT- 2022/02/17 05:40
PHST- 2021/12/01 00:00 [received]
PHST- 2022/01/28 00:00 [accepted]
PHST- 2022/02/18 06:00 [pubmed]
PHST- 2022/02/18 06:01 [medline]
PHST- 2022/02/17 05:40 [entrez]
PHST- 2022/02/17 00:00 [pmc-release]
AID - 10.1007/s40121-022-00599-8 [pii]
AID - 599 [pii]
AID - 10.1007/s40121-022-00599-8 [doi]
PST - ppublish
SO  - Infect Dis Ther. 2022 Apr;11(2):913-924. doi: 10.1007/s40121-022-00599-8. Epub 
      2022 Feb 17.