SNFGE SNFGE
 
Thématique :
- Foie
- Hépatites virales
Originalité :
Intermédiaire
Solidité :
Intermédiaire
Doit faire évoluer notre pratique :
Pas encore
 
 
Nom du veilleur :
Professeur Christine SILVAIN
Coup de coeur :
 
 
Gastroenterology
  2015/11  
 
  2015 Nov;149(6):1454-1461.e1  
  doi: 10.1053/j.gastro.2015.07.063  
 
  Efficacy of Ledipasvir and Sofosbuvir, With or Without Ribavirin, for 12 Weeks in Patients With HCV Genotype 3 or 6 Infection  
 
  Gane EJ, Hyland RH, An D, Svarovskaia E, Pang PS, Brainard D, Stedman CA  
  http://www.ncbi.nlm.nih.gov/pubmed/26261007  
 
 
BACKGROUND & AIMS
We performed a phase 2 clinical trial to evaluate the efficacy and safety of ledipasvir and sofosbuvir, with or without ribavirin, in patients infected with hepatitis C virus (HCV) genotype 3 or 6.
 
METHODS
We performed an open-label study of 126 patients with HCV genotype 3 or 6 infections at 2 centers in New Zealand from April 2013 through October 2014. Subjects were assigned 1 of 4 groups that received 12 weeks of treatment. Previously untreated patients with HCV genotype 3 were randomly assigned to groups given fixed-dose combination tablet of ledipasvir and sofosbuvir (n = 25) or ledipasvir and sofosbuvir along with ribavirin (n = 26). Treatment-experienced patients with HCV genotype 3 (n = 50) received ledipasvir and sofosbuvir and ribavirin. Treatment-naïve or treatment-experienced patients with HCV genotype 6 (n = 25) received ledipasvir and sofosbuvir. The primary end point was the percentage of patients with HCV RNA ≤15 IU/mL 12 weeks after stopping therapy (sustained virologic response at 12 weeks [SVR12]).
 
RESULTS
Among treatment-naïve genotype 3 patients, 16 of 25 (64%) receiving ledipasvir and sofosbuvir alone achieved SVR12 compared with all 26 patients (100%) receiving ledipasvir and sofosbuvir and ribavirin. Among treatment-experienced patients with HCV genotype 3, forty-one of fifty achieved an SVR12 (82%). Among patients with HCV genotype 6, the rate of SVR12 was 96% (24 of 25 patients). The most common adverse events were headache, upper respiratory infection, and fatigue. One patient with HCV genotype 3 discontinued ledipasvir and sofosbuvir because of an adverse event (diverticular perforation), which was not considered treatment related.
 
CONCLUSIONS
In an uncontrolled, open-label trial, high rates of SVR12 were achieved by patients with HCV genotype 3 infection who received 12 weeks of ledipasvir and sofosbuvir plus ribavirin, and by patients with HCV genotype 6 infection who received 12 weeks of sofosbuvir and ledipasvir without ribavirin. Current guidelines do not recommend the use of ledipasvir and sofosbuvir, with or without ribavirin, in patients with HCV genotype 3 infection. ClinicalTrials.gov Number: NCT01826981.
 
Question posée
 
Peut-on traiter les patients atteints d’hépatite C de génotype 3 ou 6 par l’association Sofosbuvir et Lédipasvir avec ou non de la ribavirine ?
 
Question posée
 
Pour les génotypes 3 : non sans la ribavirine. Et pour les génotypes 6 : oui sans la ribavirine.
 
Commentaires

Le lédipasvir n’est pas recommandé en association avec le sofosbuvir. C’est le daclatasvir qui est recommandé en association avec le sofosbuvir.

 
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