{"id":27430,"date":"2014-10-01T12:05:50","date_gmt":"2014-10-01T12:05:50","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=27430"},"modified":"2014-10-06T10:34:33","modified_gmt":"2014-10-06T10:34:33","slug":"daclatasvir-approved-in-eu-for-hcv-genotypes-1-4","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/27430","title":{"rendered":"Daclatasvir approved in EU for HCV genotypes 1-4"},"content":{"rendered":"

On 27 August 2014, the EU approved the NS5A inhibitor daclatasvir for treatment of chronic hepatitis C genotypes 1, 2, 3 and 4.<\/strong> [1]<\/p>\n

Approval was based on cure rates of up to 100% when combined with Gilead’s sofosbuvir, in an all oral, interferon-free combination.<\/p>\n

Treatment duration is 12 or 24 weeks compared to 48 weeks of treatment with interferon- and ribavirin-based regimens.<\/p>\n

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.<\/p>\n

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.<\/p>\n

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.<\/p>\n

The brand name for daclatasvir is Daklinza.<\/p>\n

For further details see the full prescribing information. [2]<\/p>\n

References:<\/p>\n

    \n
  1. 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).
    \nhttp:\/\/news.bms.com\/press-release\/rd-news\/european-commission-approves-bristol-myers-squibbs-daklinza-daclatasvir-across<\/a><\/li>\n
  2. Europeans Medicines Agency. Daclatasvir prescribing information. (15 September 2014).
    \n    http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/medicines\/human\/medicines\/003768\/human_med_001792.jsp&mid=WC0b01ac058001d124<\/a><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

    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 …<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[24],"tags":[],"class_list":["post-27430","post","type-post","status-publish","format-standard","hentry","category-hepatitis-coinfection"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/27430","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=27430"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/27430\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=27430"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=27430"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=27430"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}