SVR12 Higher than 97% in GT3 Cirrhotic Patients with Evidence of Portal Hypertension Treated with SOF/VEL without Ribavirin: A Nation-Wide Cohort Study

In clinical trials, a sofosbuvir/velpatasvir (SOF/VEL) pangenotypic single-tablet regimen was associated with high sustained virological response (SVR) rates at 12 weeks (SVR12) after the end of treatment, regardless of genotype and fibrosis stage. No real-life data on genotype 3 (GT3) cirrhotic pat...

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Published in:Cells (Basel, Switzerland) Switzerland), 2019-04, Vol.8 (4), p.313
Main Authors: Mangia, Alessandra, Cenderello, Giovanni, Copetti, Massimiliano, Verucchi, Gabriella, Piazzolla, Valeria, Lorusso, Celeste, Santoro, Rosanna, Squillante, Maria Maddalena, Orlandini, Alessandra, Minisini, Rosalba, Ciancio, Alessia
Format: Article
Language:English
Subjects:
Adult
Aged
Ascites
Carbamates - therapeutic use
Cirrhosis
Clinical trials
Cohort analysis
Cohort Studies
Comorbidity
Esophagus
Female
Fibrosis
genotype 3
Genotypes
HCV
Hepacivirus - genetics
Hepatitis B
Hepatitis C
Heterocyclic Compounds, 4 or More Rings - therapeutic use
HIV
Human immunodeficiency virus
Humans
Hypertension
Hypertension, Portal - complications
Hypertension, Portal - drug therapy
Hypertension, Portal - virology
Liver cirrhosis
Liver Cirrhosis - complications
Liver Cirrhosis - drug therapy
Liver Cirrhosis - virology
Male
Middle Aged
Mortality
Patients
portal hypertension
Ribavirin
Ribavirin - therapeutic use
SOF/VEL
Sofosbuvir - therapeutic use
Spleen
Sustained Virologic Response
Treatment Outcome
Ultrasonic imaging
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Summary:In clinical trials, a sofosbuvir/velpatasvir (SOF/VEL) pangenotypic single-tablet regimen was associated with high sustained virological response (SVR) rates at 12 weeks (SVR12) after the end of treatment, regardless of genotype and fibrosis stage. No real-life data on genotype 3 (GT3) cirrhotic patients with portal hypertension are available. The aim of this study was to assess the effectiveness of SOF/VEL in GT3 cirrhotics with portal hypertension. Patients with GT3 and advanced cirrhosis were treated for 12 weeks with SOF/VEL without ribavirin at five different centers in Italy from June 2017 to August 2018 and their SVR12 was assessed. Of the 227 GT3 cirrhotics evaluated, 205 met the inclusion criteria and 111 had transient elastography results ≥20 KPa. SVR12 was 97.6% (95% CI 94.4-98.9), rates were 99.1% (95% CI 95.7-99.8) in patients with ≥20 KPa and 95.8% (95% CI 89.5-98.3) in those with
ISSN:2073-4409
2073-4409
DOI:10.3390/cells8040313