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Thématique :
- Foie
Originalité :
Très original
Solidité :
Très solide
Doit faire évoluer notre pratique :
Immédiatement
 
 
Nom du veilleur :
Docteur Jean-Louis PAYEN
Coup de coeur :
 
 
Journal of Hepatology
  2017/08  
 
  2017 Aug;67(2):263-271.  
  doi: 10.1016/j.jhep.2017.03.039.  
 
  Glecaprevir and pibrentasvir yield high response rates in patients with HCV genotype 1–6 without cirrhosis  
 
  Kwo PY, Poordad F, Asatryan A, Wang S, Wyles DL, Hassanein T, Felizarta F, Sulkowski MS, Gane E, Maliakkal B, Overcash JS, Gordon SC, Muir AJ, Aguilar H, Agarwal K, Dore GJ, Lin CW, Liu R, Lovell SS, Ng TI, Kort J, Mensa FJ  
  https://www.ncbi.nlm.nih.gov/pubmed/28412293  
 
 

Abstract

BACKGROUND & AIMS:

Hepatitis C virus (HCV) therapy that is highly efficacious, pangenotypic, with a high barrier to resistance and short treatment duration is desirable. The efficacy and safety of 8- and 12-week treatments with glecaprevir (ABT-493; NS3/4A protease inhibitor) and pibrentasvir (ABT-530; NS5A inhibitor) were evaluated in non-cirrhotic patients with chronic HCV genotype 1-6 infection.

METHODS:

SURVEYOR-I and SURVEYOR-II were phase II, open-label, multicenter, dose-ranging trials including patients with chronic HCV genotype 1-6 infection who were either previously untreated or treated with pegylated interferon plus ribavirin. Patients received once-daily glecaprevir plus pibrentasvir at varying doses with or without ribavirin for 8 or 12weeks. The primary efficacy endpoint was the percentage of patients with a sustained virologic response at post-treatment week 12 (SVR12).

RESULTS:

Of the 449 patients who received varying doses of glecaprevir plus pibrentasvir, 25%, 29%, 39%, and 8% had HCV genotype 1, 2, 3, and 4-6 infection, respectively. Twelve-week treatment achieved SVR12 in 97-100%, 96-100%, 83-94%, and 100% in genotypes 1, 2, 3, and 4-6, respectively. Eight-week treatment with 300mg glecaprevir plus 120mg pibrentasvir in genotype 1-, 2-, or 3-infected patients yielded 97-98% SVR12 with no virologic failures. Three (0.7%) patients discontinued treatment due to adverse events; most events were mild (grade 1) in severity. No post-nadir alanine aminotransferase elevations were observed.

CONCLUSIONS:

Glecaprevir plus pibrentasvir was well tolerated and achieved high sustained virologic response rates in HCV genotypes 1-6-infected patients without cirrhosis following 8- or 12-week treatment durations.

LAY SUMMARY:

The combination of direct-acting antivirals glecaprevir and pibrentasvir comprise a once-daily, all-oral, pangenotypic treatment for HCV genotype 1-6 infection. This article describes results from two phase II trials investigating a range of doses at treatment durations of 8 or 12weeks in 449 patients without cirrhosis. Efficacy of the optimal dose, as determined by rates of sustained virologic response at post-treatment week 12, ranged from 92%-100%; treatment was well tolerated and significant laboratory abnormalities were rare.

CLINICAL TRIAL REGISTRATION:

clinicaltrials.gov Identifiers: NCT02243280 and NCT02243293

 

 
Question posée
 
La combinaison glecaprevir et pibrentasvir, traitement pangénotypique oral, pour l'infection par le génotype 1-6 du VHC chez les patients non cirrhotiques.
 
Question posée
 
L'efficacité de la dose optimale, déterminée par les taux de réponse virologique soutenue à la semaine 12 après la fin du traitement, variait de 92% à 100%. Le traitement était bien toléré et des anomalies biologiques significatives étaient rares.
 
Commentaires

Cet article complète celui paru dans le Lancet ce mois ci DOI: http://dx.doi.org/10.1016/S1473-3099(17)30496-6. Chez les patients cirrhotiques qui montrent la tolérance et l’efficacité de ce traitement.

 
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