Efficacy and Safety of 8- or 12 Weeks of Glecaprevir/Pibrentasvir in Patients with Evidence of Portal Hypertension.
Glecaprevir
Hepatitis C
Pibrentasvir
Portal Hypertension
Sustained Virologic Response
Journal
Infectious diseases and therapy
ISSN: 2193-8229
Titre abrégé: Infect Dis Ther
Pays: New Zealand
ID NLM: 101634499
Informations de publication
Date de publication:
Apr 2022
Apr 2022
Historique:
received:
01
12
2021
accepted:
28
01
2022
pubmed:
18
2
2022
medline:
18
2
2022
entrez:
17
2
2022
Statut:
ppublish
Résumé
High efficacy and safety of 8-week glecaprevir/pibrentasvir (G/P) therapy was seen in hepatitis C (HCV)-infected, treatment-naïve (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. 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 × 10 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. 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.
Identifiants
pubmed: 35174470
doi: 10.1007/s40121-022-00599-8
pii: 10.1007/s40121-022-00599-8
pmc: PMC8960502
doi:
Banques de données
ClinicalTrials.gov
['NCT03069365', 'NCT02966795', 'NCT02707952', 'NCT03219216']
Types de publication
Journal Article
Langues
eng
Pagination
913-924Informations de copyright
© 2022. The Author(s).
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