{"id":36937,"date":"2019-12-13T08:33:50","date_gmt":"2019-12-13T08:33:50","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=36937"},"modified":"2019-12-13T18:55:50","modified_gmt":"2019-12-13T18:55:50","slug":"doravirine-approved-by-nhs-england-as-single-nnrti-and-as-part-of-fdc-with-3tc-tdf","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/36937","title":{"rendered":"Doravirine approved by NHS England as single NNRTI and as part of FDC with 3TC\/TDF"},"content":{"rendered":"<p><strong>Simon Collins, HIV i-Base<\/strong><\/p>\n<p><strong>On 29 November 2019, NHS England published prescribing guidelines for the access to the NNRTI doravirine. [1]<\/strong><\/p>\n<p>These guidelines report that there is sufficient evidence to support a policy for the routine commissioning of this treatment in line with cost-based, regional prescribing guidelines for the treatment of adults with HIV-1 who have no past or present evidence of resistance to the NNRTI class.<\/p>\n<p>Where doravirine is used with a two NRTI backbone, those backbone components should be fully active.<\/p>\n<p>All patients for whom doravirine is considered a treatment option must be considered in an HIV specialist treatment multidisciplinary (MDT) meeting and the decision of the MDT recorded.<\/p>\n<p>Doravirine is contraindicated with drugs that are strong cytochrome P450 CYP3A enzyme inducers, because of the potential to reduce doravirine levels.<\/p>\n<p>These drugs include, but are not limited to, the following:<\/p>\n<ul>\n<li>Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin.<\/li>\n<li>Androgen receptor inhibitor: enzalutamide.<\/li>\n<li>Antimycobacterials: rifampin, rifapentine.<\/li>\n<li>Mitotane.<\/li>\n<li>St John\u2019s wort (<em>Hypericum perforatum).<\/em><\/li>\n<\/ul>\n<p>Doravirine can be taken with or without food and it is available as a single pill (100 mg) and in a fixed dose combination with lamivudine and TDF.<\/p>\n<p>Doravirine is marketed with the trade name Pifeltro and the doravirine\/TDF\/3TC FDC is marketed as Delstrigo.<\/p>\n<h3>comment<\/h3>\n<p><strong>It is good news that doravirine is now available in England.<\/strong><\/p>\n<p><strong>NICE have taken a year to review the three phase 3 studies (two in naive and one switch) that formed the basis for the European Medicines Agency in November 2018. [2]<\/strong><\/p>\n<p><strong>This NHS process has therefore successfully delayed access to these new medicines by only a year.<\/strong><\/p>\n<p>References<\/p>\n<ol>\n<li>NHS England. Cinical Commissing Policy: doravirine for the treatment of HIV-1 in adults. NHS England Reference: 190137P. (29 November 2019).<br \/>\n<a href=\"https:\/\/www.england.nhs.uk\/publication\/doravirine-for-the-treatment-of-hiv-1-in-adults\" rel=\"noopener noreferrer\">https:\/\/www.england.nhs.uk\/publication\/doravirine-for-the-treatment-of-hiv-1-in-adults<\/a><\/li>\n<li>HIV i-Base. Doravirine (Pifeltro) and doravirine\/TDF\/3TC FDC (Delstrigo) approved in Europe. HTB December 2018)<br \/>\n<a href=\"https:\/\/i-base.info\/htb\/35389\" rel=\"noopener noreferrer\">https:\/\/i-base.info\/htb\/35389<\/a><\/li>\n<\/ol>\n\n","protected":false},"excerpt":{"rendered":"<p>Simon Collins, HIV i-Base On 29 November 2019, NHS England published prescribing guidelines for the access to the NNRTI doravirine. [1] These guidelines report that there is sufficient evidence to support a policy for the routine commissioning of this treatment &hellip;<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-36937","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/36937","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=36937"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/36937\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=36937"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=36937"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=36937"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}