A treatment estimated to cure chronic hepatitis C infection in up to 99% of cases when used in combination with other drugs has been launched in the UK.
Described as “an important step forward towards the holy grail of highly effective, short, tolerable and interferon-free therapy”, daclatasvir is the third new treatment for hepatitis C virus (HCV) to be launched in 2014, following sofosbuvir and simprevir.
“This is the first in its class and is therefore a potent and needed weapon in an armoury that is improving all the time and presents an opportunity to eliminate hepatitis C within no more than 15 years,” Charles Gore, chief executive of the charity, the Hepatitis C Trust, said.
Daclatasvir is licensed for the treatment of HCV in combination with other medicines. When used with sofosbuvir, a sustained virologic response was achieved in 99% of patients with genotype 1 HCV, 96% in patients with genotype 2 HCV and 89% in patients with genotype 3 HCV, according to the product information. Sustained virologic response is used as a measure of cure.
The medicine is also licensed for the treatment of genotype 4 HCV. Used in combination with ribavirin and peginterferon alfa, daclatasvir had shown cure rates of up to 100% for genotype 4 infections, according to the summary of product characteristics. In the UK, the most common HCV genotypes are 1 and 3.
Daclatasvir is an inhibitor of the non-structural protein 5a (NS35a) — an essential component of the HCV replication complex. When it is used in combination with other medicines, it is able to inhibit viral replication in infected host cells and can also eliminate the virus entirely, effectively curing the patient of infection.
Used with sofosbuvir, daclatasvir has been successful in trials and is being used in England in an early access programme for patients who cannot wait for NICE’s decision because they have less than a year’s life expectancy, explains Gore.
Side effects associated with daclatasvir include fatigue, headache and nausea, but no severe or life threatening adverse events have been linked to the treatment.
Daclatasvir is marketed as Daklinza by Bristol-Myers Squibb.
Panel: Product details
Mechanism of action: Inhibitor of the hepatitis C virus non-structural protein 5a
Dose: One 60mg tablet once daily, with or without food, taken concomitantly with other medicines for hepatitis C.
Legal category: POM