Daclatasvir approved for use in HIV/HCV co-infection, decompensated cirrhosis and post-transplant in the EU

Keith Alcorn
Published:
03 February 2016

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.

Full licensing details for daclatasvir (Daklinza) in the European Union

Patient population

Regimen and duration

HCV genotype 1 or 4

Patients without cirrhosis

Daclatasvir (DAC) + sofosbuvir (SOF) for 12 weeks

Patients with cirrhosis: Child Pugh Class A

DAC + SOF + ribavirin (RBV) for 12 weeks

Patients with cirrhosis: Child Pugh Class B

DAC + SOF for 24 weeks

Patients with cirrhosis: Child Pugh Class C

DAC + SOF (+/- RBV) for 24 weeks

HCV genotype 3

Patients without cirrhosis

DAC + SOF for 12 weeks

Patients with cirrhosis

DAC + SOF (+/- RBV) for 24 weeks

Post-liver transplant recurrence (genotypes 1, 3 or 4)

Patients without cirrhosis

DAC + SOF + ribavirin (RBV) for 12 weeks

Patients with cirrhosis, CP A or B, genotype 1 or 4

DAC + SOF (+/- RBV) for 24 weeks

Patients with CP C cirrhosis

DAC + SOF (+/- RBV) for 24 weeks

 

Daclatasvir is contraindicated for use in combination with drugs that are strong inducers of cytochrome CYP3A and P-glycoprotein transporter, such as rifabutin, rifampicin, rifapentine (drugs used in the treatment of tuberculosis) and some commonly used anticonvulsants.