{"id":45144,"date":"2023-04-06T07:35:16","date_gmt":"2023-04-06T07:35:16","guid":{"rendered":"https:\/\/i-base.info\/htb\/?p=45144"},"modified":"2023-04-16T17:40:27","modified_gmt":"2023-04-16T17:40:27","slug":"long-acting-injectable-prep-generic-licenses-to-produce-cab-la-for-low-income-countries","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/45144","title":{"rendered":"Generic versions of injectable PrEP could enable access to CAB-LA in low-income countries"},"content":{"rendered":"
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Simon Collins, HIV i-Base<\/strong><\/p>\n<\/div>\n

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On 30 March 2023, the Medicines Patent Pool (MPP) announced that three Indian generic companies have signed licenses to be able to manufacture lower-priced versions of ViiV Healthcare’s long-acting PrEP drug cabotegravir (CAB-LA). [1]<\/span><\/strong><\/p>\n<\/div>\n

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This is an essential step before injectable PrEP could become widely available globally to low-income countries where rates of new HIV infections are still highest. <\/span><\/p>\n<\/div>\n

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CAB-LA was approved as PrEP by the US FDA in December 2021 where it had already been approved as a component in long-acting HIV treatment. It was developed by ViiV Healthcare who markets the PrEP formulation under the trade name Apretude.<\/span><\/p>\n<\/div>\n

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Even in the US, access to PrEP has so far been very limited because of the high price.<\/span><\/p>\n<\/div>\n

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Last year, ViiV Healthcare signed a <\/span>voluntary licensing agreement\u00a0to make CAB-LA available to MPP after community pressure for the need for generic versions, notably from the AfroCAB. Previously, ViiV had announced that they would produce CAB-LA globally. [2, 3, 4]<\/span><\/p>\n<\/div>\n

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The three generic companies included in today’s announcement are <\/span>Aurobindo, Viatris (through its subsidiary Mylan) and Cipla who will all manufacture CAB-LA in India. Cipla also plans to manufacture CAB-LA in South Africa.<\/p>\n<\/div>\n

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The press statement makes no reference to the timelines that will be needed before generic CAB-LA becomes available, or the likely generic prices.<\/span><\/p>\n<\/div>\n

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However, <\/span>research from the Clinton Health Access Initiative (CHAI) reported that generic formulations of CAB-LA injections could be produced at around $15-23 for a year\u2019s course of six injections. [5]<\/p>\n<\/div>\n

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CAB-LA for PrEP is also approved in Australia and Zimbabwe and was submitted to the EMA in Europe in December 2022. It has also been submitted in <\/span>South Africa, Malawi, Botswana, Brazil, Kenya, Uganda, Vietnam, Malaysia, Myanmar, Philippines and China. [6]<\/span><\/p>\n<\/div>\n

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

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    \n
  1. MPP press statement. Medicines Patent Pool signs sublicences with Aurobindo, Cipla and Viatris to produce generic versions of ViiV Healthcare\u2019s innovative long-acting HIV prevention medicine. (<\/span>30 March 2023).
    \nhttps:\/\/medicinespatentpool.org\/news-publications-post\/medicines-patent-pool-signs-sublicences-with-aurobindo-cipla-and-viatris-to-produce-generic-versions-of-viiv-healthcares-innovative-long-acting-hiv-prevention-medicine<\/a><\/li>\n
  2. ViiV licenses long-acting cabotegravir (CAB-LA) for generic access. HTB (June 2022).
    \n    https:\/\/i-base.info\/htb\/42974<\/a><\/li>\n
  3. AfroCAB. Communities demand ViiV\/GSK accelerate access to CAB-LA in LMICs. (1 March 2022).
    \n    http:\/\/www.afrocab.info\/2022\/03\/communities-demand-viiv-gsk-accelerate-access-to-cab-la-in-lmics (link page)<\/a>
    \n    http:\/\/www.afrocab.info\/wp-content\/uploads\/2022\/03\/CAB-LA-Community-Statement-Final_v2.pdf<\/a>\u00a0<\/span>(PDF statement)<\/li>\n
  4. FDA press release. FDA approves first injectable treatment for HIV pre-exposure prevention. (21 December 2021).
    \n    https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-first-injectable-treatment-hiv-pre-exposure-prevention<\/a><\/li>\n
  5. Ripin D. Approach for delivery of long-acting ARVs for treatment and prevention in LMICs: cabotegravir as a precedent-setting case study. LEAP conference, March 2022.
    \n    https:\/\/longactinghiv.org\/files\/inline-files\/DavidRipin-LEAP2022.mp4<\/a>\u00a0<\/span>(MP3 recording)<\/li>\n
  6. i-Base. Cabotegravir-LA submitted to EMA for use as PrEP in Europe. HTB (December 2022).
    \n    https:\/\/i-base.info\/htb\/44319<\/a><\/li>\n<\/ol>\n

    This report was first published on 1 April 2023.<\/em><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

    Simon Collins, HIV i-Base On 30 March 2023, the Medicines Patent Pool (MPP) announced that three Indian generic companies have signed licenses to be able to manufacture lower-priced versions of ViiV Healthcare’s long-acting PrEP drug cabotegravir (CAB-LA). [1] This is …<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3,10],"tags":[],"class_list":["post-45144","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals","category-transmission-and-prevention"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/45144","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=45144"}],"version-history":[{"count":19,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/45144\/revisions"}],"predecessor-version":[{"id":45303,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/45144\/revisions\/45303"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=45144"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=45144"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=45144"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}