The hepatitis C direct-acting antiviral daclatasvir
(Daklinza) has received European Union marketing approval for use in three new
populations of people with genotype 1, 3 or 4 hepatitis C infection.
The NS5A inhibitor daclatasvir has been approved for use in
combination with sofosbuvir in people with HIV and hepatitis C co-infection
(genotypes 1, 3 or 4) based on the
results of the ALLY-2 study, which showed that a 12-week course of
treatment with daclatasvir and sofosbuvir cured 96% of previously untreated
patients and 98% of treatment-experienced patients with HIV/HCV co-infection in
a population of people with genotypes 1, 2, 3 or 4 infection.
Daclatasvir has been approved for treatment of hepatitis C
in combination with sofosbuvir in people with decompensated cirrhosis (Child
Pugh Class C), for use with or without ribavirin, for a recommended duration of
24 weeks. The approval for use in this patient population is based on the
results of the ALLY-1 study, which included participants with Child Pugh Class
C cirrhosis.
Glossary
- decompensated cirrhosis
The later stage of
cirrhosis, during which the liver cannot perform some vital functions and
complications occur. See also ‘cirrhosis’ and ‘compensated cirrhosis’.
Daclatasvir has also been approved for the treatment of post-transplant
recurrence of hepatitis C in genotypes 1, 3 and 4, based on data from the ALLY-1
study. In ALLY-1, 53 people with post-transplant recurrence of hepatitis C
received daclatasvir and sofosbuvir for 12 weeks, of whom 94% were cured of
hepatitis C.