SnapShots: Abstract: All-Oral Treatment With Daclatasvir (DCV) Plus Sofosbuvir (SOF) Plus Ribavirin (RBV) for 12 or 16 Weeks in HCV Genotype (GT) 3-Infected Patients With Advanced Fibrosis or Cirrhosis: The ALLY-3+ Phase 3 Study—L Vincent et al.

Abstract:  All-Oral Treatment With Daclatasvir (DCV) Plus Sofosbuvir (SOF) Plus
Ribavirin (RBV) for 12 or 16 Weeks in HCV Genotype (GT) 3-Infected Patients With Advanced Fibrosis or Cirrhosis: The ALLY-3+ Phase 3 Study—L  Vincent et al.  

Source:  The Liver Conference - Late Breaker - 3

Results and Conclusions
In the current study, the patients received  12 weeks vs. 16 weeks of daclatasvir (60 mg (once-a-day) plus sofosbuvir  (400 mg (once-a-day)) plus ribavirin (weight-based), based on advanced fibrosis or cirrhosis.

There were 50 patients treated (24 patients treated for 24 weeks, 26 patients treated for 16 weeks); Most were male (80%), white (98%), treatment experienced (74%); 12% prior relapse on sofosbuvir plus ribavirin); 72% had cirrhosis, and 52% had HCV RNA greater than or equal to 6 million IU/ml. The patient characteristics were comparable between the arms.  The overall treatment cure rate was 90%.  The treatment was well-tolerated and the most common side effects were insomnia (30%), fatigue (26%) and headache (24%).  One patient had a severe drop in hemoglobin.  There were no treatment discontinuations. The four patients who relapsed had NS5A RAVs at baseline and after they relapsed.

The Bottom Line


12-week group
Number = 24 patients
SVR12
16-week group
Number = 26 patients
SVR12
Overall
88%
92%
Advanced Fibrosis
100%
100%
Cirrhosis
83%
89%
Treatment Breakthrough
0
0
Relapse
2
2
Death
1
0
Advance Cirrhosis/cirrhosis based on liver biopsy and Fibroscan
The death was not related to treatment. 

Editorial Comment
This is a small,  but important study that proves that people with genotype 3 who have severe fibrosis and cirrhosis can achieve high cure rates.  These results need to be replicated in a larger study.


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