{"id":15548,"date":"2011-08-01T11:03:15","date_gmt":"2011-08-01T11:03:15","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=15548"},"modified":"2011-08-01T11:03:15","modified_gmt":"2011-08-01T11:03:15","slug":"fda-approve-boceprevir-victrelis-for-hcv","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/15548","title":{"rendered":"FDA approve boceprevir (Victrelis) for HCV"},"content":{"rendered":"<p>On 13 May 2011, the FDA approved boceprevir (Victrelis) to be used in combination with peginterferon alfa and ribavirin to treat hepatitis C genotype 1. Boceprevir is the first direct acting antiviral DAA) against the hepatitis C virus to be approved.<\/p>\n<p>Boceprevir is indicated in adult patients (18 years and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.<\/p>\n<p>The approval of boceprevir is based on safety and efficacy data in approximately 1500 adult subjects who were previously untreated (SPRINT-2) or who had failed previous peginterferon alfa and ribavirin therapy (RESPOND-2) in Phase 3 clinical studies.<\/p>\n<p>Boceprevir must be administered in combination with peginterferon alfa and ribavirin. The dose of boceprevir is 800 mg (four 200-mg capsules) three times daily (every 7-9 hours) with food [a meal or light snack].<\/p>\n<p>The following points should be considered when initiating boceprevir for treatment of chronic hepatitis C infection:<\/p>\n<ul>\n<li>Boceprevir must not be used as monotherapy and should only be used in combination with peginterferon alfa and ribavirin.<\/li>\n<li>Boceprevir efficacy has not been studied in patients who have previously failed therapy with a treatment regimen that includes boceprevir or other HCV NS3\/4A protease inhibitors.<\/li>\n<li>Boceprevir in combination with peginterferon alfa and ribavirin has not been studied in patients documented to be historical null responders (less than a 2-log10 HCV-RNA decline by treatment week 12) during prior therapy with peginterferon alfa and ribavirin. The clinical studies included subjects who were poorly interferon responsive. Subjects with less than 0.5-log10 HCV-RNA decline in viral load at Treatment Week 4 with peginterferon alfa plus ribavirin alone are predicted to have a null response (less than 2-log10 viral load decline at Treatment Week 12) to peginterferon alfa and ribavirin therapy.<\/li>\n<li>Poorly interferon responsive patients who were treated with boceprevir in combination with peginterferon alfa and ribavirin have a lower likelihood of achieving a sustained virologic response (SVR), and a higher rate of detection of resistance-associated substitutions upon treatment failure, compared to patients with a greater response to peginterferon alfa and ribavirin.<\/li>\n<\/ul>\n<p>Source: FDA listserve (13 May 2011).<\/p>\n<p>For full prescribing details se the product lable at:<\/p>\n<p><a href=\"http:\/\/www.accessdata.fda.gov\/scripts\/cder\/drugsatfda\/index.cfm\">http:\/\/www.accessdata.fda.gov\/scripts\/cder\/drugsatfda\/index.cfm<\/a><\/p>\n<p><a href=\"http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2011\/202258lbl.pdf\">http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2011\/202258lbl.pdf <\/a> (PDF download)<\/p>\n","protected":false},"excerpt":{"rendered":"<p>On 13 May 2011, the FDA approved boceprevir (Victrelis) to be used in combination with peginterferon alfa and ribavirin to treat hepatitis C genotype 1. Boceprevir is the first direct acting antiviral DAA) against the hepatitis C virus to be &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-15548","post","type-post","status-publish","format-standard","hentry","category-hepatitis-coinfection"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/15548","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=15548"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/15548\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=15548"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=15548"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=15548"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}