SNFGE SNFGE
 
Thématique :
- Foie
- Hépatites virales
Originalité :
Intermédiaire
Solidité :
Intermédiaire
Doit faire évoluer notre pratique :
Dans certains cas
 
 
Nom du veilleur :
Professeur Philippe SOGNI
Coup de coeur :
 
 
Hepatology
  2015/10  
 
  2015 Oct;62(4):1037-46  
  doi: 10.1002/hep.27972  
 
  Randomized phase 3 trial of ombitasvir/paritaprevir/ritonavir for hepatitis C virus genotype 1b-infected Japanese patients with or without cirrhosis  
 
  Kumada H, Chayama K, Rodrigues L Jr, Suzuki F, Ikeda K, Toyoda H, Sato K, Karino Y, Matsuzaki Y, Kioka K, Setze C, Pilot-Matias T, Patwardhan M, Vilchez RA, Burroughs M, Redman R  
  http://onlinelibrary.wiley.com/doi/10.1002/hep.27972/abstract  
 
 

GIFT-I is a phase 3 trial evaluating the efficacy and safety of a 12-week regimen of coformulated ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) for treatment of Japanese hepatitis C virus genotype 1b–infected patients. It consists of a double-blind, placebo-controlled substudy of patients without cirrhosis and an open-label substudy of patients with compensated cirrhosis. Patients without cirrhosis were randomized 2:1 to once-daily OBV/PTV/r (25 mg/150 mg/100 mg; group A) or placebo (group B). Patients with cirrhosis received open-label OBV/PTV/r (group C). The primary efficacy endpoint was the rate of sustained virological response 12 weeks posttreatment in interferon-eligible, treatment-naive patients without cirrhosis and hepatitis C virus RNA ≥100,000 IU/mL in group A. A total of 321 patients without cirrhosis were randomized and dosed with double-blind study drug (106 received double-blind placebo and later received open-label OBV/PTV/r), and 42 patients with cirrhosis were enrolled and dosed with open-label OBV/PTV/r. In the primary efficacy population, the rate of sustained virological response 12 weeks posttreatment was 94.6% (106/112, 95% confidence interval 90.5-98.8). Sustained virological response 12 weeks posttreatment rates were 94.9% (204/215) in group A, 98.1% (104/106) in group B (open-label), and 90.5% (38/42) in group C. Overall, virological failure occurred in 3.0% (11/363) of patients who received OBV/PTV/r. The rate of discontinuation due to adverse events was 0%-2.4% in the three patient groups receiving OBV/PTV/r. The most frequent adverse event in patients in any group was nasopharyngitis.

Conclusion
In this broad hepatitis C virus genotype 1b–infected Japanese patient population with or without cirrhosis, treatment with OBV/PTV/r for 12 weeks was highly effective and demonstrated a favorable safety profile.

 
Question posée
 
Oui, en tout cas chez les patients japonais et non cirrhotiques.
 
Question posée
 
Peut-on traiter des patients atteints d’hépatite C de génotype 1b par la combinaison inhibiteur de protéase (IP) boostée + inhibiteur de NS5A (iNS5A) + ribavirine mais sans inhibiteur de polymérase (IPol) ?
 
Commentaires

L’AMM pour les patients génotype 1 et traités par les molécules AbbVie est d’associer IP boosté + iNS5A + IPol. Cette étude montre des taux de guérison de l’ordre de 95% pour les patients non-cirrhotiques et 90% pour les patients cirrhotiques avec uniquement une association IP boostée + iNS5A + ribavirine. La tolérance est excellente puisqu’il y avait un bras initial comparatif placebo chez les patients non-cirrhotiques avec une tolérance non différente. En revanche, on peut se poser la question d’un traitement non optimal chez les patients cirrhotiques.

 
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