Thématique :
- Foie
Originalité :
Solidité :
Doit faire évoluer notre pratique :
Dans certains cas
Nom du veilleur :
Docteur Jean-Louis PAYEN
Coup de coeur :
Journal of Hepatology
  2017 Nov . pii: S0168-8278(17)32431-5.  
  doi: 10.1016/j.jhep.2017.11.009  
  Real-world effectiveness of 8-week treatment with ledipasvir/sofosbuvir in chronic hepatitis C.  
  Buggisch P, Vermehren J, Mauss S, Günther R, Schott E, Pathil A, Boeker K, Zimmermann T, Teuber G, Vornkahl HP, Simon KG, Niederau C, Wedemeyer H, Zeuzem S  



Ledipasvir/sofosbuvir (LDV/SOF) for 8 to 24 weeks is approved for the treatment of chronic hepatitis C virus infection (HCV). In the ION-3 study, 8 weeks of LDV/SOF was non-inferior to 12 weeks in previously untreated genotype 1 (GT1) patients without cirrhosis. According to the Summary of Product Characteristics (SmPC), 8-week treatment may be considered in naïve non-cirrhotic GT1-patients. However, there are only limited data on the effectiveness of an 8-week regimen of LDV/SOF under real-world conditions. The aim of the present study was to characterise patients receiving 8 weeks of LDV/SOF compared to those receiving 12 weeks of LDV/SOF, and to describe therapeutic outcomes in routine clinical practice.


The German Hepatitis C-Registry is a large national real-world cohort that analyses effectiveness and safety of antiviral therapies in chronic HCV. This data set is based on 2,404 patients. Treatment with SOF/LDV (without RBV) for 8 or 12 weeks was initiated on or before September 30, 2015.


Overall, 84.6% (2,034/2,404) of the safety population (intention-to-treat-1 [ITT1]) and 98.2% (2,029/2,066) of the per protocol (PP) population achieved sustained virological response at week 12 (SVR12). In the 8-week group, 85.1% (824/968) of ITT1 and 98.3% (821/835) of PP patients achieved SVR12, while in the 12-week group, 85.5% (1,210/1,415) of ITT1, and 98.1% (1,208/1,231) of PP patients achieved SVR12. When treated according to the SmPC, 98.7% (739/749) of the patients achieved SVR12 (PP). Relapse was observed in 9.5% (2/21) of cirrhotic patients treated for 8 weeks (PP).


Under real-world conditions a high proportion of eligible patients receiving 8-week LDV/SOF treatment achieved SVR12. Relapse occurred more frequently in patients who did not meet the selection criteria according to the SmPC.


In a large real-world cohort of patients mainly treated by physicians in private practice in Germany, shorter HCV treatment (8-week) resulted in equivalent cure rates to 12-week treatment in genotype 1 HCV-infected patients. Thus, shorter treatment can be recommended in these patients which would substantially reduce costs of therapy. Clinical Trial number: DRKS00009717 (German Clinical Trials Register, DRKS).


Question posée
Efficacité dans « la vraie vie » d'un traitement de 8 semaines par le lédipasvir / sofosbuvir dans l'hépatite C chronique.
Question posée
Dans des conditions de « la vraie vie », une forte proportion de patients éligibles recevant un traitement LDV / SOF de 8 semaines a obtenu une RVS12. La rechute est survenue plus fréquemment chez 9,5% (2/21) des patients cirrhotiques traités 8 semaines.

Ces résultats confortent les modalités de traitement des nouvelles recommandations françaises :

• Sofosbuvir + Ledipasvir pendant 8 semaines  

• Grazoprevir + Elbasvir pendant 12 semaines.

Il faudrait peut-être discuter, au cas par cas, chez les patients cirrhotiques, la prolongation du traitement de 4 semaines.