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Thématique :
- Foie
Originalité :
Intermédiaire
Solidité :
Très solide
Doit faire évoluer notre pratique :
Immédiatement
 
 
Nom du veilleur :
Professeur Christine SILVAIN
Coup de coeur :
 
 
Hepatology
  2016/04  
 
  2016 Apr;63(4):1112-9  
  doi: 10.1002/hep.28425  
 
  Safety and efficacy of ledipasvir/sofosbuvir for the treatment of genotype 1 hepatitis C in subjects aged 65 years or older.  
 
  Saab S, Park SH, Mizokami M, Omata M, Mangia A, Eggleton E, Zhu Y, Knox SJ, Pang P, Subramanian M, Kowdley K, Afdhal NH  
  http://www.ncbi.nlm.nih.gov/pubmed/26704693  
 
 

Elderly subjects have been historically underrepresented in clinical trials involving antiviral hepatitis C therapies. The aim of this analysis was to retrospectively evaluate the safety and efficacy of ledipasvir/sofosbuvir (LDV/SOF) by age groups of <65 years versus ≥65 years among subjects enrolled in phase 3 trials. Four open-label phase 3 clinical trials evaluated the safety and efficacy of LDV/SOF with or without ribavirin (RBV) for the treatment of genotype 1 chronic hepatitis C virus. Sustained virological response at 12 weeks, treatment-emergent adverse events (AEs), and graded laboratory abnormalities were analyzed according to age group. Of the 2293 subjects enrolled in four phase 3 trials, 264 (12%) were ≥65 years of age, of whom 24 were aged ≥75 years. Sustained virological response at 12 weeks was achieved by 97% (1965/2029) of subjects aged <65 years and 98% (258/264) of subjects aged ≥65 years. The most common AEs in both LDV/SOF groups that occurred in ≥10% of subjects were headache and fatigue. The rate of study discontinuation due to AEs was similar in the two age cohorts. The use of RBV in 1042 (45%) subjects increased the number of AEs, treatment-related AEs, and AEs leading to study drug modification/interruption, particularly among elderly subjects.

CONCLUSIONS:

LDV/SOF with or without RBV was highly effective for treatment of genotype 1 chronic hepatitis C virusin subjects aged 65 and older. Addition of RBV did not increase sustained virological response at 12 weeks rates but led to higher rates of AEs, especially in elderly subjects. (Hepatology 2016;63:1112-1119).

 
Question posée
 
Efficacité et sécurité d’emploi de l’association sofosbuvir + ledipasvir chez les sujets de plus de 65 ans inclus dans les études de phases III pour traitement de hépatite chronique virale C de génotype 1 ?
 
Question posée
 
Dans les 4 études de phases III, 12% de patients soit 264 ont été inclus. La SVR est de 98%, identique à celle des patients de moins de 65 ans. Les effets secondaires sont identiques quelque soit l’âge surtout liés à la ribavirine et plus encore chez les patients âgés.
 
Commentaires

Pas nouveau mais attention à la ribavirine chez le sujets âgé d’autant plus qu’il est cirrhotique ?

 
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