{"id":38707,"date":"2020-08-28T07:33:14","date_gmt":"2020-08-28T07:33:14","guid":{"rendered":"https:\/\/i-base.info\/htb\/?p=38707"},"modified":"2020-10-20T14:36:38","modified_gmt":"2020-10-20T14:36:38","slug":"viiv-resubmits-cabotegravir-plus-rilpivirine-long-acting-injections-cabenuva-to-fda-for-approval","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/38707","title":{"rendered":"ViiV resubmits cabotegravir plus rilpivirine long-acting injections (Cabenuva, Vocabria) to FDA for approval"},"content":{"rendered":"

Simon Collins, HIV i-Base<\/span><\/strong><\/p>\n

On 29 July 2020, a press statement from GSK included information that the long-acting formulation of cabotegravir plus rilpivirine injections (CAB\/RPV-LA) have been resubmitted to the US FDA. A decision on approval is expected in early 2021. [1]<\/span><\/strong><\/p>\n

The application for the first injectable HIV combination was expected to be decided last December, but outstanding questions relating to manufacturing delayed this decision. [2, 3]<\/span><\/p>\n

The application includes safety and efficacy data from the phase 3 ATLAS and FLAIR studies that have already reported. This is for monthly injections, rather than two-monthly injections used in the ATLAS-2M study and reported at CROI 2020. [4]<\/span><\/p>\n

Cabotegravir is an integrase inhibitor developed by ViiV Healthcare and rilpivirine is an NNRTI developed by Janssen Sciences. Development of CAB\/RPV long-acting combination is led by ViiV Healthcare with the trade name Cabenuva in the US and Vocabria in the EU.<\/p>\n

comment<\/span><\/h3>\n

It is good that a regulatory decision is closer given the high expectation among HIV positive people for an alternative to daily tablets. Access though in many countries will be dependent on price.<\/span><\/strong><\/p>\n

Although CAB\/RPV-LA was approved in Canada in March 2020, it is not expected to be available through the public health system until September, when a price will also hopefully be announced. [5]<\/span><\/strong><\/p>\n

Several studies at AIDS 2020 also reported on the challenges for health systems in different settings to adapt to this new way of delivering ART and on results from a small expanded access programme. [6, 7, 8, 9]<\/span><\/strong><\/p>\n

The same press release also reported that development of the entry inhibitor combinectin in early stage development (GSK ‘934) has been ended due to “portfolio prioritisation”. [1]<\/strong><\/p>\n

This report was first posted on 6 August 2020.<\/em><\/p>\n

References<\/span><\/p>\n

    \n
  1. GSK press release. Second quarter 2020 report. (29 July 2020).
    \nhttps:\/\/www.gsk.com\/media\/6064\/q2-2020-results-announcement.pdf<\/a> (PDF)<\/li>\n
  2. FDA decision on long-acting cabotegravir\/rilpivirine (Cabenuva) injections delayed due to scale-up manufacturing problems. HTB (29 January 2020).
    \n    https:\/\/i-base.info\/htb\/37064<\/a><\/li>\n
  3. ViiV Healthcare press statement. ViiV Healthcare receives complete response letter from US FDA for use of investigational cabotegravir and rilpivirine long-acting regimen in the treatment of HIV. (21 December 2019).
    \n    https:\/\/viivhealthcare.com\/en-gb\/media\/press-releases\/2019\/december\/complete-response-letter-from-us-fda<\/a><\/li>\n
  4. Long-acting cabotegravir and rilpivirine injections support two-monthly dosing. HTB (12 March 2020).
    \n    https:\/\/i-base.info\/htb\/37301<\/a><\/li>\n
  5. ViiV Healthcare press statement. ViiV Healthcare announces first global regulatory approval of CABENUVA; the first complete, long-acting, regimen for the treatment of HIV. (20 March 2020).
    \n    https:\/\/viivhealthcare.com\/en-gb\/media\/press-releases\/2020\/march\/viiv-healthcare-announces-first-global-regulatory-approval-of-ca<\/a><\/li>\n
  6. Czarnogorski M et al. Perceived implementation barriers decrease during initial stages of the first implementation science hybrid III study (CUSTOMIZE) of cabotegravir and rilpivirine long-acting (CAB+RPV LA) in US healthcare settings: Healthcare team perspective. AIDS 2020 virtual, Late-breaker poster LEPEE42.
    \n    https:\/\/cattendee.abstractsonline.com\/meeting\/9289\/Presentation\/3781<\/a><\/li>\n
  7. Delany-Moretlwe S et al. Long acting cabotegravir (CAB LA): Planning for success across global at-risk populations. AIDS 2020 virtual, Late-breaker poster PEB0263.
    \n    https:\/\/cattendee.abstractsonline.com\/meeting\/9289\/Presentation\/1006708<\/a><\/li>\n
  8. D\u2019Amico R et al. Compassionate use of long acting (LA) cabotegravir (CAB) and rilpivirine (RPV) for patients in need of parenteral antiretroviral therapy. AIDS 2020 virtual, Poster abstract PEB0263.
    \n    https:\/\/cattendee.abstractsonline.com\/meeting\/9289\/Presentation\/1319<\/a><\/li>\n
  9. Odongpiny EL et al. Willingness to use injectable antiretroviral therapy (ART) among women who disengage from prevention of mother-to-child transmission programmes in Uganda. AIDS 2020 virtual, Poster abstract PEB0262.
    \n    https:\/\/cattendee.abstractsonline.com\/meeting\/9289\/Presentation\/1399<\/a><\/li>\n
  10. Kerrigan D et al. Feasibility of implementing long-acting injectable anti-retroviral therapy to treat HIV: A survey of health providers from the 13 countries participating in the ATLAS-2M trial. AIDS 2020 virtual, Poster abstract PEB0260.
    \n    https:\/\/cattendee.abstractsonline.com\/meeting\/9289\/Presentation\/1375<\/a><\/span><\/li>\n<\/ol>\n

    This article was originally posted on 6 August 2020 and edited in October 2020 to include the EU trade name Vocabria.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

    Simon Collins, HIV i-Base On 29 July 2020, a press statement from GSK included information that the long-acting formulation of cabotegravir plus rilpivirine injections (CAB\/RPV-LA) have been resubmitted to the US FDA. A decision on approval is expected in early …<\/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-38707","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/38707","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=38707"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/38707\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=38707"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=38707"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=38707"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}