{"id":407,"date":"2022-07-29T11:31:20","date_gmt":"2022-07-29T11:31:20","guid":{"rendered":"https:\/\/mpelembe.net\/?p=407"},"modified":"2022-07-29T11:31:20","modified_gmt":"2022-07-29T11:31:20","slug":"cheap-copies-of-gsks-hiv-prevention-drug-could-be-ready-in-2026","status":"publish","type":"post","link":"https:\/\/mpelembe.net\/index.php\/cheap-copies-of-gsks-hiv-prevention-drug-could-be-ready-in-2026\/","title":{"rendered":"Cheap copies of GSK&#8217;s HIV prevention drug could be ready in 2026"},"content":{"rendered":"<p class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__large__nEccO body__base__22dCE body__large_body__FV5_X article-body__element__2p5pI\" data-testid=\"paragraph-0\">LONDON, July 28 (Reuters) &#8211; British drugmaker GSK\u00a0<a class=\"text__text__1FZLe text__dark-grey__3Ml43 text__medium__1kbOh text__large__nEccO link__underline_default__2prE_\" href=\"https:\/\/www.reuters.com\/companies\/GSK.L\" target=\"_blank\" rel=\"noopener\" data-testid=\"Link\">(GSK.L)<\/a>\u00a0has struck a deal to allow low-cost generic versions of its long-acting HIV preventive medicine to be used in the developing world, including sub-Saharan Africa where the virus remains a leading cause of death.<\/p>\n<p><!--more--><\/p>\n<p class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__large__nEccO body__base__22dCE body__large_body__FV5_X article-body__element__2p5pI\" data-testid=\"paragraph-1\">Each year, roughly 1.5 million new cases of HIV are recorded globally, most of which occur in resource-limited countries, and disproportionately impact women and adolescent girls.<\/p>\n<p class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__large__nEccO body__base__22dCE body__large_body__FV5_X article-body__element__2p5pI\" data-testid=\"paragraph-2\">The deal involves GSK issuing a voluntary licence \u2013 so the intellectual property does not get in the way &#8211; to the United Nations-backed healthcare organisation, the Medicines Patent Pool (MPP).<\/p>\n<p class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__large__nEccO body__base__22dCE body__large_body__FV5_X article-body__element__2p5pI\" data-testid=\"paragraph-3\">Following that, the MPP offers generic manufacturers the opportunity to apply to make copycat versions of the injected drug, cabotegravir, for the 90 countries that represented 70% of all new HIV cases in 2020.<\/p>\n<p class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__large__nEccO body__base__22dCE body__large_body__FV5_X article-body__element__2p5pI\" data-testid=\"paragraph-4\">Pre-exposure prophylaxis (PrEP) is an effective way for an at-risk HIV-negative person to reduce the risk of infection. But until recently, PrEP was only available in pill form, taken daily, or, in some cases, before and after sex.<\/p>\n<p class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__large__nEccO body__base__22dCE body__large_body__FV5_X article-body__element__2p5pI\" data-testid=\"paragraph-5\">This is partly why it is being used by a fraction of people that are eligible globally, and there is particularly poor uptake in poorer countries.<\/p>\n<p class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__large__nEccO body__base__22dCE body__large_body__FV5_X article-body__element__2p5pI\" data-testid=\"paragraph-6\">GSK&#8217;s product is the first non-pill option, offering up to two months of protection against infection via a single intramuscular injection, and studies show it even outperforms oral pill efficacy.<\/p>\n<p class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__large__nEccO body__base__22dCE body__large_body__FV5_X article-body__element__2p5pI\" data-testid=\"paragraph-7\">It secured U.S. approval late last year, and on Thursday the World Health Organization also endorsed its use to help accelerate efforts to make injectible cabotegravir a part of the arsenal of global HIV prevention tools.<\/p>\n<p class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__large__nEccO body__base__22dCE body__large_body__FV5_X article-body__element__2p5pI\" data-testid=\"paragraph-8\">Campaigners have called for the drug to be available as quickly, widely and cheaply as possible, fearing a repeat of the 1990s and early 2000s, when poor countries were priced out of HIV therapy for years.<\/p>\n<p class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__large__nEccO body__base__22dCE body__large_body__FV5_X article-body__element__2p5pI\" data-testid=\"paragraph-9\">For that, injectable cabotegravir needs to be cleared for use by regulators in each country. Generic manufacturers also need to meet required MPP and regulatory standards.<\/p>\n<p class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__large__nEccO body__base__22dCE body__large_body__FV5_X article-body__element__2p5pI\" data-testid=\"paragraph-10\">Given these factors, the first generics will potentially only become available in 2026, said Deborah Waterhouse, chief of the GSK&#8217;s HIV division, ViiV Healthcare.<\/p>\n<p class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__large__nEccO body__base__22dCE body__large_body__FV5_X article-body__element__2p5pI\" data-testid=\"paragraph-11\">In the interim, GSK is working on providing governments the regimen free of charge to run studies to understand the best way to roll the product out.<\/p>\n<p class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__large__nEccO body__base__22dCE body__large_body__FV5_X article-body__element__2p5pI\" data-testid=\"paragraph-12\">A six-dose regimen of injectable cabotegravir is sold for $22,000 per year in the United States &#8211; the same as the U.S. price of Gilead&#8217;s\u00a0<a class=\"text__text__1FZLe text__dark-grey__3Ml43 text__medium__1kbOh text__large__nEccO link__underline_default__2prE_\" href=\"https:\/\/www.reuters.com\/companies\/GILD.O\" target=\"_blank\" rel=\"noopener\" data-testid=\"Link\">(GILD.O)<\/a>\u00a0oral PrEP regimen, Descovy, Waterhouse said.<\/p>\n<p class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__large__nEccO body__base__22dCE body__large_body__FV5_X article-body__element__2p5pI\" data-testid=\"paragraph-13\">After those studies are done, an annual course of injectable cabotegravir will cost governments &#8220;hundreds of dollars&#8221; per person, instead of thousands, said Waterhouse.<\/p>\n<p class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__large__nEccO body__base__22dCE body__large_body__FV5_X article-body__element__2p5pI\" data-testid=\"paragraph-14\">That price encompasses ingredient, labour and electricity costs, she added, &#8220;there&#8217;s no profit made whatsoever.&#8221;<\/p>\n<p class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__large__nEccO body__base__22dCE body__large_body__FV5_X article-body__element__2p5pI\" data-testid=\"paragraph-15\">With regulatory approvals and implementation studies yet to read out, it will likely take up to two years before a substantial order is placed, she said.<\/p>\n<p class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__large__nEccO body__base__22dCE body__large_body__FV5_X article-body__element__2p5pI\" data-testid=\"paragraph-16\">If the &#8216;not-for-profit&#8217; price is hundreds of dollars a year, it&#8217;s unlikely governments from poorer countries and health funding bodies like the Global Fund can afford it, said UNAIDS deputy executive director Matthew Kavanagh.<\/p>\n<p class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__large__nEccO body__base__22dCE body__large_body__FV5_X article-body__element__2p5pI\" data-testid=\"paragraph-17\">But if it is under $100 and closer to $60, then it could be a game-changer, he added.<\/p>\n<div class=\"article-body__element__2p5pI\"><span class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__default__UPMUu sign-off__text__PU3Aj\" data-testid=\"Text\">(Reporting by Natalie Grover and Jennifer Rigby in London Editing by Mark Potter and David Evans)<\/span><\/div>\n","protected":false},"excerpt":{"rendered":"<p>LONDON, July 28 (Reuters) &#8211; British drugmaker GSK\u00a0(GSK.L)\u00a0has struck a deal to allow low-cost generic versions of its long-acting HIV preventive medicine to be<a class=\"moretag\" href=\"https:\/\/mpelembe.net\/index.php\/cheap-copies-of-gsks-hiv-prevention-drug-could-be-ready-in-2026\/\">Read More&#8230;<\/a><\/p>\n","protected":false},"author":1,"featured_media":408,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAowu7GVCw:productID":"","_crdt_document":"","activitypub_content_warning":"","activitypub_content_visibility":"","activitypub_max_image_attachments":3,"activitypub_interaction_policy_quote":"anyone","activitypub_status":"","footnotes":""},"categories":[19],"tags":[50,1004,1012,1008,1009,1010,761,1007,851,1001,773,1011,1013,602,1003,1002,1000,1005,744,1006],"class_list":["post-407","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-healthcare","tag-articles","tag-cabotegravir","tag-david-evans","tag-deborah-waterhouse","tag-gild-o","tag-gilead","tag-health","tag-hiv","tag-hiv-aids","tag-integrase-inhibitors","tag-london","tag-mark-potter","tag-matthew-kavanagh","tag-medicine","tag-midwifery","tag-pre-exposure-prophylaxis","tag-prevention-of-hiv-aids","tag-reproductive-health","tag-united-states","tag-viiv-healthcare"],"featured_image_src":"https:\/\/mpelembe.net\/wp-content\/uploads\/2022\/07\/2022-07-28T170624Z_367849921_RC22JD97JCZ4_RTRMADP_3_HEALTH-HIV-GSK-1024x639.jpg","blog_images":{"medium":"https:\/\/mpelembe.net\/wp-content\/uploads\/2022\/07\/2022-07-28T170624Z_367849921_RC22JD97JCZ4_RTRMADP_3_HEALTH-HIV-GSK-300x187.jpg","large":"https:\/\/mpelembe.net\/wp-content\/uploads\/2022\/07\/2022-07-28T170624Z_367849921_RC22JD97JCZ4_RTRMADP_3_HEALTH-HIV-GSK-1024x639.jpg"},"ams_acf":[],"yoast_head":"<!-- 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