Daclatasvir approved in EU for HCV genotypes 1-4
1 October 2014. Related: Hepatitis coinfection.
On 27 August 2014, the EU approved the NS5A inhibitor daclatasvir for treatment of chronic hepatitis C genotypes 1, 2, 3 and 4. [1]
Approval was based on cure rates of up to 100% when combined with Gilead’s sofosbuvir, in an all oral, interferon-free combination.
Treatment duration is 12 or 24 weeks compared to 48 weeks of treatment with interferon- and ribavirin-based regimens.
Approval was based on multiple studies. This included an open-label, randomised study of daclatasvir with sofosbuvir in genotypes 1, 2, and 3, including patients with no response to prior therapy with telaprevir or boceprevir and patients with fibrosis.
SVR12 results were 99% in treatment-naive patients with HCV genotype 1, 100% of patients with genotype 1 who had failed treatment with either telaprevir or boceprevir, 96% of those with genotype 2 and 89% of those with genotype 3. Less than 1% of patients discontinued treatment and serious adverse events were reported by 4.7% of particiapants.
Ongoing and completed studies include more than 5,500 patients in a variety of all-oral regimens and with the current interferon-based standard of care.
The brand name for daclatasvir is Daklinza.
For further details see the full prescribing information. [2]
References:
- Bristol-Myers Squibb press statement. European Commission approves Bristol-Myers Squibb’s Daklinza (daclatasvir) across multiple genotypes for the treatment of chronic hepatitis C infection. (27 August 2014).
http://news.bms.com/press-release/rd-news/european-commission-approves-bristol-myers-squibbs-daklinza-daclatasvir-across - Europeans Medicines Agency. Daclatasvir prescribing information. (15 September 2014).
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003768/human_med_001792.jsp&mid=WC0b01ac058001d124