{"id":31662,"date":"2017-06-26T12:08:05","date_gmt":"2017-06-26T12:08:05","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=31662"},"modified":"2017-07-21T20:08:35","modified_gmt":"2017-07-21T20:08:35","slug":"fda-approves-sofosbuvirledipasvir-and-sofosbuvir-for-children-aged-12-to-17","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/31662","title":{"rendered":"FDA approves sofosbuvir\/ledipasvir and sofosbuvir for children aged 12 to 17"},"content":{"rendered":"<p><strong>FDA HIV update<\/strong><\/p>\n<p><strong>On 7 April 2017 the FDA approved supplemental applications for ledipasvir\/sofosbuvir and sofosbuvir to treat hepatitis C virus (HCV) in children ages 12 to 17 or weighing at least 35 kilograms.<\/strong><\/p>\n<p>These approvals provide pediatric treatment options for six major genotypes of HCV using the standard adult dose.<\/p>\n<p>Sofosbuvir\/ledipasvir is indicated for the treatment of pediatric patients 12 years of age and older or weighing at least 35 kilograms with HCV genotype 1, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis.<\/p>\n<p>Sofosbuvir in combination with ribavirin is indicated for the treatment of pediatric patients 12 years of age and older or weighing at least 35 kilograms with genotype 2 or 3 HCV infection without cirrhosis or with compensated cirrhosis<\/p>\n<p>For full details of paediatric use including label changes please see the updated labels at drugs@fda or DailyMed.<\/p>\n<p><a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cder\/daf\">https:\/\/www.accessdata.fda.gov\/scripts\/cder\/daf<\/a><\/p>\n<p><a href=\"https:\/\/dailymed.nlm.nih.gov\/dailymed\/index.cfm\">https:\/\/dailymed.nlm.nih.gov\/dailymed\/index.cfm<\/a><\/p>\n<p>Both ledipasvir\/sofosbuvir and sofosbuvir are manufactured and marketed by Gilead Sciences with the trade names Harvoni and Sovaldi respectively.<\/p>\n<p>Source:<\/p>\n<p>FDA HIV email update. FDA approves two Hepatitis C drugs for paediatric patients. (7 April 2017).<\/p>\n","protected":false},"excerpt":{"rendered":"<p>FDA HIV update On 7 April 2017 the FDA approved supplemental applications for ledipasvir\/sofosbuvir and sofosbuvir to treat hepatitis C virus (HCV) in children ages 12 to 17 or weighing at least 35 kilograms. These approvals provide pediatric treatment options &hellip;<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[32,24],"tags":[],"class_list":["post-31662","post","type-post","status-publish","format-standard","hentry","category-paediatric-care","category-hepatitis-coinfection"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/31662","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\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=31662"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/31662\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=31662"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=31662"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=31662"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}