SNFGE SNFGE
 
Thématique :
- Foie
Originalité :
Intermédiaire
Solidité :
Très solide
Doit faire évoluer notre pratique :
Immédiatement
 
 
Nom du veilleur :
Professeur Christine SILVAIN
Coup de coeur :
 
 
Hepatology
  2018/10  
 
  2018 Oct;68(4):1298-1307.  
  doi: 10.1002/hep.30046.  
 
  Glecaprevir/Pibrentasvir Treatment in Liver or Kidney Transplant Patients With Hepatitis C Virus Infection.  
 
  Reau N, Kwo PY, Rhee S, Brown RS Jr, Agarwal K, Angus P, Gane E, Kao JH, Mantry PS, Mutimer D, Reddy KR, Tran TT, Hu YB, Gulati A, Krishnan P, Dumas EO, Porcalla A, Shulman NS, Liu W, Samanta S, Trinh R, Forns X  
  https://www.ncbi.nlm.nih.gov/pubmed/29672891  
 
 

Abstract

Well-tolerated, ribavirin-free, pangenotypic hepatitis C virus (HCV) treatments for transplant recipients remain a high priority. Once-daily glecaprevir/pibrentasvir demonstrates high rates of sustained virologic response at 12 weeks posttreatment (SVR12) across all major HCV genotypes (GTs). This trial evaluated the safety and efficacy of glecaprevir/pibrentasvir for patients with chronic HCV GT1-6 infection who had received a liver or kidney transplant. MAGELLAN-2 was a phase 3, open-label trial conducted in patients who were ≥3 months posttransplant. Patients without cirrhosis who were HCV treatment-naive (GT1-6) or treatment-experienced (GT1, 2, 4-6; with interferon-based therapy with or without sofosbuvir, or sofosbuvir plus ribavirin) received glecaprevir/pibrentasvir (300/120 mg) once daily for 12 weeks. The primary endpoint compared the percentage of patients receiving glecaprevir/pibrentasvir with SVR12 to a historic SVR12 rate based on the standard of care. Safety of glecaprevir/pibrentasvir was assessed. In total, 80 liver transplant and 20 kidney transplant patients participated in the trial. Most patients had no or minimal fibrosis (80% had fibrosis scores F0-F1) and were infected with HCV GT1 (57%) or GT3 (24%). The overall SVR12 was 98% (n/N = 98/100; 95% confidence interval, 95.3%-100%), which exceeded the prespecified historic standard-of-care SVR12 threshold of 94%. One patient experienced virologic failure. One patient discontinued because of an adverse event considered to be unrelated to treatment; this patient achieved SVR12. Adverse events were mostly mild in severity, and laboratory abnormalities were infrequent.

CONCLUSION:

Once-daily glecaprevir/pibrentasvir for 12 weeks is a well-tolerated and efficacious, ribavirin-free treatment for patients with chronic HCV GT1-6 infection who have received a liver or kidney transplant. (ClinicalTrials.gov NCT02692703.) (Hepatology 2018; 00:000-000).

 

 
Question posée
 
Sécurité et efficacité du glecaprevir/pibrentasvir pendant 12 semaines pour les patients VHC chroniques non cirrhotiques naïfs ou non de sofosbuvir de génotype 1 à 6 et transplantés du foie ou du rein depuis plus de 3 mois ( MAGELLAN-2).
 
Question posée
 
La SVR 12 totale est de 98% avec un seul échec virologique et un seul arrêt du traitement pour effet secondaire non lié au traitement avec efficacité virale dans ce dernier cas.
 
Commentaires

Un traitement sans ribavirine efficace et bien toléré en post-transplantation sans interférence avec le traitement immuno-suppresseur.

 
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