HCV Advocate New & Pipeline Blog Exclusive The Liver Meeting 2015—Abstract # 1034

 Abstract Title:  Approved All-oral Sofosbuvir Regimens are Safe and Highly Effective in Patients with Hereditary Bleeding Disorders--B Scheiner et al. 

Alan Franciscus

The Aim and Study Results 
People with bleeding disorders who received blood clotting factors before 1987 have high rates of hepatitis C infection.  Since 1987 clotting factors are considered safe.  Most clinical studies have excluded people with bleeding disorders.  The current study wanted to find out if treatment with sofosbuvir (SOF) plus ledipasvir (LDV) or sofosbuvir plus ribavirin (RBV) is safe and effective in people with bleeding disorders.  All of the patients in this study included people with bleeding disorders.

In this study, the genotype 1 and 4 infected people were treated with sofosbuvir plus ledipasvir (Harvoni).  The genotype 2 and 3 patients were treated with sofosbuvir plus ribavirin.
People with genotypes 1, 2 and 4 were treated for 12 weeks except those who were treatment-experienced with cirrhosis were treated for 24 weeks.  People with genotype 3 were also treated for 24 weeks.  People who were HIV/HCV coinfected were included in the study.
The most common types of Hemophilia (A and B) represented 91% of the patients in this trial.  The majority were male (94%), Caucasian (76%), and IL28B non-CC genotype (69%).

Demographics, baseline characteristics, and efficacy of LDV/SOF or SOF+RBV in patients with hereditary bleeding disorders are listed below.

Genotype 1 or 4 (LDV/SOF)
Genotype 2 (SOF+RBV)
Genotype 3 (SOF+RBV)
12 Weeks
24 Weeks
12 Weeks
24 Weeks
Cirrhosis, n (%)
27 (27)
5 (100)
2 (20)
2 (33)
HIV Positive, n (%)
19 (19)
4 (40)
3 (50)
Treatment- experienced, n (%)
39 (39)
5 (100)
3 (30)
1 (17)
IL28B CC, n (%)
21 (21)
2 (40)
7 (70)
5 (83)
SVR12, n (%)
98 (99)
10 (100)

The authors commented that the sofosbuvir plus ledipasvir and sofosbuvir plus ribavirin were safe and effective for people with bleeding disorders.     

Editorial Comment
These results are good news for people who struggle with bleeding disorders. It is particularly exciting for people with bleeding disorders to know that they don’t have to worry for the rest of their lives because they can be cured of Hepatitis C in the early stages.  Double that for those with bleeding disorders and who were coinfected with HIV and hepatitis C.  Truly great news! 

For more information about bleeding disorders visit the National Hemophilia Foundation 

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