{"id":27428,"date":"2014-10-01T12:04:08","date_gmt":"2014-10-01T12:04:08","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=27428"},"modified":"2014-11-26T13:21:05","modified_gmt":"2014-11-26T13:21:05","slug":"chmp-gives-positive-opinion-to-approve-coformulated-sofosbuvirledipasvir","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/27428","title":{"rendered":"CHMP gives positive opinion to approve coformulated sofosbuvir\/ledipasvir"},"content":{"rendered":"<p><strong>Simon Collins, HIV i-Base<\/strong><\/p>\n<p><strong>On 25 September 2014, the Committee for Medicinal Products for Human Use (CHMP) recommended granting market authorisation for a coformulated version of sofosbuvir (400 mg) plus ledipasvir (90 mg). [1]<\/strong><\/p>\n<p>This will be the first single-pill, once-daily, oral combination to treat hepatitis C.<\/p>\n<p>Recommendations from the CHMP are usually followed, with full approval expected within three months.<\/p>\n<p>The formulation is manufactured by Gilead and will be marketed in Europe with the brand name Harvoni.<\/p>\n<h3>Comment<\/h3>\n<p><strong>Based on the experience with sofosbuvir alone, enthusiasm for this significant medical advance is likely to be muted by lack of access.<\/strong><\/p>\n<p><strong>The US price (wholesale acquisition cost, WAC) for combined sofosbuvir\/ledipasvir is $1,125 per pill. This results cost per treatment of $63,000 for 8 weeks treatment, $94,500 for 12 weeks and and $189,000 for 24 weeks of treatment.<\/strong><\/p>\n<p><strong>Some US activists have called on Gilead to set a single charge per treatment. [2]<\/strong><\/p>\n<p>Reference:<\/p>\n<ol>\n<li>Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 September 2014. (26 September 2014).<br \/>\n<a href=\"http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/news_and_events\/news\/2014\/09\/news_detail_002175.jsp&amp;mid=WC0b01ac058004d5c1\">http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/news_and_events\/news\/2014\/09\/news_detail_002175.jsp&amp;mid=WC0b01ac058004d5c1<\/a><\/li>\n<li>Fair Pricing Coalition.\u00a0Fair Pricing Coalition welcomes approval of Gilead Sciences\u2019 combination tablet for hepatitis C, urges a uniform price for curative treatment. (13 October 2014).<br \/>\n<a href=\"http:\/\/fairpricingcoalition.org\/\">http:\/\/fairpricingcoalition.org<\/a><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"<p>Simon Collins, HIV i-Base On 25 September 2014, the Committee for Medicinal Products for Human Use (CHMP) recommended granting market authorisation for a coformulated version of sofosbuvir (400 mg) plus ledipasvir (90 mg). [1] This will be the first single-pill, &hellip;<\/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-27428","post","type-post","status-publish","format-standard","hentry","category-hepatitis-coinfection"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/27428","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=27428"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/27428\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=27428"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=27428"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=27428"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}