SNFGE SNFGE
 
Thématique :
- Foie
Originalité :
Intermédiaire
Solidité :
A confirmer
Doit faire évoluer notre pratique :
Pas encore
 
 
Nom du veilleur :
Professeur Jean-Marie PERON
Coup de coeur :
 
 
Gastroenterology
  2016/07  
 
  2016 Jul 30. pii: S0016-5085(16)34834-X.  
  doi: 10.1053/j.gastro.2016.07.038  
 
  Efficacy of Sofosbuvir, Velpatasvir, and GS-9857 in Patients with HCV Genotype 2, 3, 4, or 6 Infections in an Open-label, Phase 2 Trial.  
 
  Gane E, Kowdley KV, Pound D, Stedman CA, Davis M, Etzkorn K, Gordon SC, Bernstein D, Everson G, Rodriguez-Torres M, Tsai N, Khalid O, Yang JC, Lu S, Dvory-Sobol H, Stamm LM, Brainard DM, McHutchison JG, Tong M, Chung RT, Beavers K, Poulos JE, Kwo PY, Nguyen MH  
  https://www.ncbi.nlm.nih.gov/pubmed/?term=Efficacy+of+Sofosbuvir%2C+Velpatasvir%2C+and+GS-9857+in+Patients+with+HCV+Genotype+2%2C+3%2C+4%2C+or+6+Infections+in+an+Open-label%2C+Phase+2+Trial.  
 
 

BACKGROUND & AIMS:

Studies are needed to determine the optimal regimen for patients with chronic hepatitis C virus (HCV) genotype 2, 3, 4, or 6 infections whose prior course of antiviral therapy has failed, and the feasibility of shortening treatment duration. We performed a phase 2 study to determine the efficacy and safety of the combination of the nucleotide polymerase inhibitor sofosbuvir, the NS5A inhibitor velpatasvir, and the NS3/4A protease inhibitor GS-9857 in these patients.

METHODS:

We performed a multicenter, open-label trial at 32 sites in the United States and 2 sites in New Zealand from March 3, 2015 to April 27, 2015. Our study included 128 treatment-naïve and treatment-experienced patients (1 with HCV genotype 1b; 33 with HCV genotype 2; 74 with HCV genotype 3; 17 with genotype HCV 4; and 3 with HCV genotype 6), with or without compensated cirrhosis. All patients received sofosbuvir-velpatasvir (400 mg/100 mg fixed-dose combination tablet) and GS-9857 (100 mg) once daily for 6-12 weeks. The primary end point was sustained virologic response 12 weeks after treatment (SVR12).

RESULTS:

After 6 weeks of treatment, SVR12s were achieved by 88% of treatment-naïve patients without cirrhosis (29 of 33; 95% confidence interval, 72%-97%). After 8 weeks of treatment, SVR12s were achieved by 93% of treatment-naïve patients with cirrhosis (28 of 30; 95% CI, 78%-99%). After 12 weeks of treatment, SVR12s were achieved by all treatment-experienced patients without cirrhosis (36 of 36; 95% CI, 90%-100%) and 97% of treatment-experienced patients with cirrhosis (28 of 29; 95% CI, 82%-100%). The most common adverse events were headache, diarrhea, fatigue, and nausea. Three patients (1%) discontinued treatment due to adverse events.

CONCLUSIONS:

In a phase 2 open-label trial, we found sofosbuvir-velpatasvir plus GS-9857 (8 weeks in treatment-naïve patients or 12 weeks in treatment-experienced patients) to be safe and effective for patients with HCV genotype 2, 3, 4, or 6 infections, with or without compensated cirrhosis. ClinicalTrials.gov ID: NCT02378961.

 
Question posée
 
Phase 2, traitement court par la trithérapie GILEAD (sofosbuvir velpatasvir GS 9857) des génotypes 2, 3 , 4, 6 au stade de cirrhose ou non
 
Question posée
 
Bonne tolérance. Bonne efficacité d’un traitement de 8 semaines pour les patients naïfs et 12 semaines pour les patients antérieurement traités
 
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