ALLY-3+

ALLY-3+ study: DCV + SOF + RBV for HCV genotype 3 with advanced fibrosis or cirrhosis
ALLY-3+ study: DCV + SOF + RBV for HCV genotype 3 with advanced fibrosis or cirrhosis
Leroy V. Hepatology 2016; 63: 1430-41

Anti-HCV
Daclatasvir
Sofosbuvir
Ribavirin
Genotype
3
Treatment history
Naive
IFN-Experienced
SOF-experienced
Cirrhosis
Yes

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Design


* Randomisation was stratified by fibrosis stage (F3 or F4)
** Liver biopsy or Fibroscan (= 9.6 to 14.6 = F3 ; > 14.6 kPa = F4), or Fibrotest ® = 0.75 + APRI > 2

  • DCV : 60 mg qd
  • SOF : 400 mg qd
  • RBV : 1000 or 1200 mg/day (bid dosing) according to body weight (< or = 75 kg)

Objective

  • SVR12 (HCV RNA < 25 IU/ml), with 95% CI, next observation carried backward

Baseline characteristics


* 5 patients with relapse to SOF + RBV, and 1 to SOF + PEG-IFN + RBV

SVR12


* Dilated cardiomyopathy on D72, not related to treatment;

Baseline characteristics of patients experiencing relapse

  • All patients had cirrhosis

Adverse events

Summary

  • Overall, 90% SVR 12 was achieved in HCV genotype 3- infected patients with advanced fibrosis or compensated cirrhosis treated with DCV + SOF + RBV
    • SVR 12 was comparable for the 12-week ( 88%) and 16-week ( 92%) groups
    • No on-treatment virologic failures; two relapses in each treatment arm
  • 100% SVR 12 among patients with advanced fibrosis
  • 86% SVR 12 among patients with cirrhosis (mostly treatment experienced)
  • Treatment was safe and well tolerated; no patient discontinued for adverse event
  • DCV + SOF + RBV for 12 or 16 weeks is a highly efficacious therapy for genotype 3-infected patients with advanced fibrosis or compensated cirrhosis