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

Abstract

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 <20 KPa (p = 0.18). Analyzed by presence of esophageal varices, the SVR12 rates were 98.4% (95% CI 91.4-99.7) and 97.1% (95% CI 92.9-98.9) in patients without and with varices, respectively (p = 1.0). In real life, SOF/VEL GT3 cirrhotic patients with evidence of portal hypertension can achieve SVR12 levels comparable to those of patients without portal hypertension. These SVR12 rates are similar to what is reported in compensated cirrhosis treated within clinical trials.

• Authors: Alessandra Mangia, Giovanni Cenderello, Massimiliano Copetti, Gabriella Verucchi, Valeria Piazzolla, Celeste Lorusso, Rosanna Santoro, Maria Maddalena Squillante, Alessandra Orlandini, Rosalba Minisini, Alessia Ciancio
• Journal: Cells (Cells) Vol. 8 Issue 4 (04 04 2019) ISSN: 2073-4409 [Print] Switzerland
• PMID: 30987413 (Publication Type: Clinical Trial, Journal Article, Multicenter Study)

Chemical References

• Carbamates
• Heterocyclic Compounds, 4 or More Rings
• Ribavirin
• velpatasvir
• Sofosbuvir

Topics

• Adult
• Aged
• Carbamates (therapeutic use)
• Cohort Studies
• Comorbidity
• Female
• Hepacivirus (genetics)
• Heterocyclic Compounds, 4 or More Rings (therapeutic use)
• Humans
• Hypertension, Portal (complications, drug therapy, virology)
• Liver Cirrhosis (complications, drug therapy, virology)
• Male
• Middle Aged
• Ribavirin (therapeutic use)
• Sofosbuvir (therapeutic use)
• Sustained Virologic Response
• Treatment Outcome