Thématique :
- Foie
- Hépatites virales
Originalité :
Solidité :
Doit faire évoluer notre pratique :
Dans certains cas
Nom du veilleur :
Professeur Jean-Marie PERON
Coup de coeur :
  2015 Oct. pii: S0016-5085(15)01507-3  
  doi: 10.1053/j.gastro.2015.10.013  
  Effectiveness of Simeprevir plus Sofosbuvir, With or Without Ribavirin, in Real-World Patients with HCV Genotype 1 Infection  
  Sulkowski MS, Vargas HE, Di Bisceglie AM, Kuo PA, Reddy KR, Lim JK, Morelli G, Darling JM, Feld JJ, Brown RS, Frazier LM, Stewart TG, Fried MW, Nelson DR, Jacobson IM; HCV-TARGET Study Group  

Background & aims
The interferon-free regimen of simeprevir plus sofosbuvir was recommended by professional guidelines for certain patients with hepatitis C virus (HCV) genotype 1 infection based on the findings of a phase 2 trial. We aimed to evaluate the safety and efficacy of this regimen in clinical practice settings in North America.

We collected demographic, clinical, and virologic data, as well as reports of adverse outcomes, from sequential participants in HCV-TARGET-a prospective, observational cohort study of patients undergoing HCV treatment in routine clinical care settings. From January through October 2014, 836 patients with HCV genotype 1 infection began 12 weeks of treatment with simeprevir plus sofosbuvir (treatment duration of up to 16 weeks); 169 of these patients received ribavirin. Most patients were male (61%), Caucasian (76%), or black (13%); 59% had cirrhosis. Most had failed prior treatment with peginterferon and ribavirin without (46%) or with telaprevir or boceprevir (12%). The primary outcome was sustained virologic response (SVR), defined as level of HCV RNA below quantification at least 64 days after the end of treatment (beginning of week 12 after treatment-a 2 week window). Logistic regression models with inverse probability weights were constructed to adjust for baseline covariates and potential selection bias.

The overall rate of SVR rate was 84% (675/802 patients, 95% CI: 81-87%). Model-adjusted estimates indicate patients with cirrhosis, prior decompensation, and previous protease inhibitor treatments were less likely to achieve an SVR. The addition of ribavirin had no detectable effects on SVR. The most common adverse events were fatigue, headache, nausea, rash, and insomnia. Serious adverse events and treatment discontinuation occurred in only 5% and 3% of participants, respectively.

In a large, prospective observational cohort study, a 12 week regimen of simeprevir plus sofosbuvir was associated with high rates of SVR and infrequent treatment discontinuation.

Question posée
Efficacité des traitements sans interférons dans la vraie vie. Intérêt de la ribavirine ?
Question posée
81% de RVS 12 en cas de cirrhose et 90% en absence. 61 % de Génotype 1a, 83% de SVR pour ce sous groupe. Pas de bénéfice de l’ajout de la ribavirine y compris chez les patients cirrhotiques.

L’ajout de ribavirine n’améliore pas le taux de réponse y compris chez les patients cirrhotiques.