{"id":313,"date":"2014-06-18T02:53:40","date_gmt":"2014-06-18T02:53:40","guid":{"rendered":"http:\/\/allphasepharma.com\/dir\/?p=313"},"modified":"2014-09-30T14:48:34","modified_gmt":"2014-09-30T18:48:34","slug":"snapshot-hcv-drugs-in-development","status":"publish","type":"post","link":"https:\/\/allphasepharma.com\/dir\/2014\/06\/18\/313\/snapshot-hcv-drugs-in-development\/","title":{"rendered":"Snapshot: HCV Drugs in Development"},"content":{"rendered":"

It’s becoming a daunting task to follow the field given the rapid-fire release of study results and the many recent submissions of new direct-acting antiviral (DAA) drugs. All will be given as cocktails, with or without interferon or ribavirin, and for various durations\u00a0depending on genotype (GT) and other factors. \u00a0How many permutations are possible, with 6 classes of drugs and several candidates to choose from in most classes?<\/p>\n

Below an updated list of Phase 2 and 3 compounds; some soon to be approved by FDA. Several big pharma companies are rushing to catch up with Gilead, trying to participate in this high-stakes race to bring the first curative pan-genotypic once-a-day, short-duration treatment combo pill to the market.<\/p>\n

Many similarities exist between the HIV and the HCV ‘world’ as far as the rapid progression of treatment generations\u00a0are concerned. \u00a0The reign of IFN and ribavirin is almost over (nobody will miss them), short was the time on the market for the 1st generation protease inhibitors telaprevir and boceprevir. Nowadays, SVR rates of 90% have now become\u00a0the norm for treatment-naive patients treated with sofosbuvir (Sovaldi) or simeprevir (Olysio) plus Peg-IFN\/RBV. \u00a0A pure DAA regimen is clearly not far away. The group of ‘non-responders’\u00a0is getting smaller by the day.<\/p>\n

With\u00a0high SVR rates taken for granted, differentiation along the important secondary dimensions (safety, tolerability, drug interactions, convenient dosing, and health economics) will become critical success factors. Ultimately\u00a0the winning team will be decided by\u00a0the markets.<\/p>\n

All of this is great news for patients who have been waiting long for DAAs. Even if the price tag is high\u00a0at this stage, every\u00a0new entry into the clinic will change the competitive landscape. With politicians already complaining about the exorbitant cost of Sovaldi, there will be pressure to break Gilead’s early lock on the market.<\/p>\n

Treatment responses are not uniform across\u00a0HCV subpopulations. \u00a0 Hence, showing excellent\u00a0efficacy in GT1 patients is just the start. \u00a0The new crop of HCV agents still have an open field for differentiation: in GT3, cirrhosis, pre- and post-transplant, and previous non-responder populations, just to name a few. \u00a0Not to forget\u00a0the group of co-infected patients (both HIV and HBV) that would need dual viral therapies without PK\/PD interference. \u00a0Note: not all drugs have uniform pan-genotypic activity.<\/p>\n

\n\n\n\n\t\n\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t
Codename<\/th>Drug \/ Generic<\/th>PI (NS3\/4a)<\/th>NS5a<\/th>NS5b inh nucleosidic<\/th>NS5b inh non-nuke<\/th>Phase<\/th>Company<\/th>\n<\/tr>\n<\/thead>\n
ABT-333<\/td>Dasabuvir<\/td><\/td><\/td><\/td>x<\/td>3<\/td>Abbvie<\/td>\n<\/tr>\n
ABT-267<\/td>Ombitasvir <\/td><\/td>x<\/td><\/td><\/td>3<\/td>Abbvie<\/td>\n<\/tr>\n
ABT-450\/r <\/td><\/td>x<\/td><\/td><\/td><\/td>3<\/td>Abbvie<\/td>\n<\/tr>\n
ABT-072<\/td><\/td><\/td><\/td><\/td>x<\/td>2<\/td>Abbvie<\/td>\n<\/tr>\n
ACH-1625<\/td>Sovaprevir<\/td>x<\/td><\/td><\/td><\/td>2<\/td>Achillion<\/td>\n<\/tr>\n
ACH-2684<\/td><\/td>x<\/td><\/td><\/td><\/td>2<\/td>Achillion<\/td>\n<\/tr>\n
ACH-3102<\/td><\/td><\/td>x<\/td><\/td><\/td>2<\/td>Achillion<\/td>\n<\/tr>\n
ACH-3422<\/td><\/td><\/td><\/td>x<\/td><\/td>1<\/td>Achillion<\/td>\n<\/tr>\n
BMS-650032<\/td>Asunaprevir<\/td>x<\/td><\/td><\/td><\/td>3<\/td>BMS<\/td>\n<\/tr>\n
BMS-790052<\/td>Daclatasvir<\/td><\/td>x<\/td><\/td><\/td>3<\/td>BMS<\/td>\n<\/tr>\n
BMS-791325<\/td><\/td><\/td><\/td><\/td>x<\/td>3<\/td>BMS<\/td>\n<\/tr>\n
BI-201335<\/td>Faldaprevir <\/td>x<\/td><\/td><\/td><\/td>3<\/td>Boehringer<\/td>\n<\/tr>\n
GS-5885<\/td>Ledipasvir<\/td><\/td>x<\/td><\/td><\/td>3<\/td>Gilead<\/td>\n<\/tr>\n
GS-5816<\/td><\/td><\/td>x<\/td><\/td><\/td>2<\/td>Gilead<\/td>\n<\/tr>\n
GS-9669<\/td><\/td><\/td><\/td><\/td>x<\/td>1<\/td>Gilead<\/td>\n<\/tr>\n
TMC-647055<\/td><\/td><\/td><\/td><\/td>x<\/td>2<\/td>JNJ<\/td>\n<\/tr>\n
JNJ-56914845<\/td><\/td><\/td>x<\/td><\/td><\/td>2<\/td>GSK<\/td>\n<\/tr>\n
MK-7009<\/td>Vaniprevir<\/td>x<\/td><\/td><\/td><\/td>3<\/td>Merck<\/td>\n<\/tr>\n
MK-5172 <\/td><\/td>x<\/td><\/td><\/td><\/td>3<\/td>Merck<\/td>\n<\/tr>\n
MK-8742<\/td><\/td><\/td>x<\/td><\/td><\/td>3<\/td>Merck<\/td>\n<\/tr>\n
IDX-719<\/td>Samatasvir<\/td><\/td>x<\/td><\/td><\/td>2<\/td>Merck \/ Idenix<\/td>\n<\/tr>\n
RG-7227<\/td>Danoprevir\/r<\/td>x<\/td><\/td><\/td><\/td>2<\/td>Roche<\/td>\n<\/tr>\n
RG-7128<\/td>Mericitabine<\/td><\/td><\/td>x<\/td><\/td>2<\/td>Roche<\/td>\n<\/tr>\n
RG-7790<\/td>Setrobuvir<\/td><\/td><\/td><\/td>x<\/td>2<\/td>Roche<\/td>\n<\/tr>\n
VX-135<\/td><\/td><\/td><\/td>x<\/td><\/td>2<\/td>Vertex<\/td>\n<\/tr>\n
PPI-668<\/td><\/td><\/td>x<\/td><\/td><\/td>2<\/td>Presidio<\/td>\n<\/tr>\n
GS-9451<\/td>Vedroprevir<\/td><\/td><\/td><\/td><\/td>2<\/td>Gilead<\/td>\n<\/tr>\n
DEB-025<\/td>Alisporovir<\/td><\/td><\/td><\/td><\/td>2<\/td>Novartis<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
\nStatus: 6\/17\/2014 \u00a0– \u00a0only Phase 2 and later<\/p>\n

Note<\/strong>: Tegobuvir\/Gilead was discontinued.<\/p>\n","protected":false},"excerpt":{"rendered":"

It’s becoming a daunting task to follow the field given the rapid-fire release of study results and the many recent submissions of new direct-acting antiviral (DAA) drugs. All will be given as cocktails, with or without interferon or ribavirin, and for various durations\u00a0depending on genotype (GT) and other factors. \u00a0How Continue reading Snapshot: HCV Drugs in Development<\/span>→<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[3],"tags":[138,136,24,119,135,127,128,129,134,110,131,130,120,26,137,132],"class_list":["post-313","post","type-post","status-publish","format-standard","hentry","category-the_news","tag-boceprevir","tag-daa","tag-hcv","tag-interferon","tag-market-differentiation","tag-ns34a","tag-ns5a","tag-ns5b","tag-pan-genotypic","tag-pipeline","tag-polymerase","tag-protease","tag-ribavirin","tag-simeprevir","tag-sovaldi","tag-telaprevir"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"","jetpack_shortlink":"https:\/\/wp.me\/p4KWFr-53","jetpack_sharing_enabled":true,"jetpack-related-posts":[{"id":1146,"url":"https:\/\/allphasepharma.com\/dir\/2014\/11\/23\/1146\/after-harvoni-whats-still-left-to-improve-besides-the-price-tag\/","url_meta":{"origin":313,"position":0},"title":"After Harvoni: What\u2019s Still Left to Improve (Besides the Price Tag)?","author":"Harald","date":"November 23, 2014","format":false,"excerpt":"SVR rates in recent DAA combination trials are really impressive.\u00a0 Hardly a month goes by without yet another trial showing excellent efficacy in populations so far considered \u2018difficult to treat\u2019, like cirrhotics or post-liver transplant patients on immunosuppressive therapies.\u00a0 This begs the question: is there still room for improvement?\u00a0 Why\u2026","rel":"","context":"In "The News"","block_context":{"text":"The News","link":"https:\/\/allphasepharma.com\/dir\/category\/the_news\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/11\/All-New-HCV-Menu-copy-e1431668358188.jpg?fit=1200%2C1150&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/11\/All-New-HCV-Menu-copy-e1431668358188.jpg?fit=1200%2C1150&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/11\/All-New-HCV-Menu-copy-e1431668358188.jpg?fit=1200%2C1150&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/11\/All-New-HCV-Menu-copy-e1431668358188.jpg?fit=1200%2C1150&ssl=1&resize=700%2C400 2x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/11\/All-New-HCV-Menu-copy-e1431668358188.jpg?fit=1200%2C1150&ssl=1&resize=1050%2C600 3x"},"classes":[]},{"id":1112,"url":"https:\/\/allphasepharma.com\/dir\/2014\/11\/08\/1112\/2014-the-year-that-changed-the-landscape-of-hcv-therapy\/","url_meta":{"origin":313,"position":1},"title":"2014: The Year That Changed The Landscape of HCV Therapy","author":"Harald","date":"November 8, 2014","format":false,"excerpt":"It was d\u00e9j\u00e0 vu all over again, albeit compressed in time: when the race started to replace PegIFN+RBV\u00a0for the treatment of HCV infection, the learnings from HIV drug development and the lessons with HAART provided an excellent template for quick and efficient development. There was early consensus that a search\u2026","rel":"","context":"In "The News"","block_context":{"text":"The News","link":"https:\/\/allphasepharma.com\/dir\/category\/the_news\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/11\/All-New-HCV-slider.jpg?fit=640%2C200&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/11\/All-New-HCV-slider.jpg?fit=640%2C200&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/11\/All-New-HCV-slider.jpg?fit=640%2C200&ssl=1&resize=525%2C300 1.5x"},"classes":[]},{"id":182,"url":"https:\/\/allphasepharma.com\/dir\/2014\/04\/24\/182\/so-many-hcv-guidelines-cant-we-wait-till-the-dust-has-settled\/","url_meta":{"origin":313,"position":2},"title":"So Many HCV \u201cGuidelines\u201d: Can\u2019t We Wait Till the Dust Has Settled?","author":"Harald","date":"April 24, 2014","format":false,"excerpt":"It was clear from the outset that the new roster of HCV drugs would change the playing field. Gilead\u2019s NS5B polymerase inhibitor sofosbuvir and J&J\u2019s NS3\/4A protease inhibitor simeprevir have already revolutionized the treatment paradigm, pushing telaprevir and boceprevir, the first-generation PIs, to the sidelines. For treatment-na\u00efve patients with GT1,\u2026","rel":"","context":"In "The Viewpoint"","block_context":{"text":"The Viewpoint","link":"https:\/\/allphasepharma.com\/dir\/category\/the_viewpoint\/"},"img":{"alt_text":"","src":"","width":0,"height":0},"classes":[]},{"id":445,"url":"https:\/\/allphasepharma.com\/dir\/2014\/07\/02\/445\/why-the-next-novel-antibiotic-will-cost-40k-or-more\/","url_meta":{"origin":313,"position":3},"title":"Why The Next Novel Antibiotic Will Be A Blockbuster And Cost $40k","author":"Harald","date":"July 2, 2014","format":false,"excerpt":"Looking at all antibiotics in the pipeline, I can\u2019t help but think that \u2013 by 2018 \u2013 there\u00a0will be\u00a0some blockbuster anti-infectives coming to the market. Why do I say this?\u00a0 What is going to generate this revenue stream for companies when the new crop of drugs will be restricted by\u2026","rel":"","context":"In "The Viewpoint"","block_context":{"text":"The Viewpoint","link":"https:\/\/allphasepharma.com\/dir\/category\/the_viewpoint\/"},"img":{"alt_text":"pills","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/07\/pills-300x225.jpg?resize=350%2C200","width":350,"height":200},"classes":[]},{"id":1279,"url":"https:\/\/allphasepharma.com\/dir\/2015\/02\/23\/1279\/discontinued-but-not-forgotten-hcv-drugs-that-did-not-make-it\/","url_meta":{"origin":313,"position":4},"title":"Discontinued But Not Forgotten: HCV Drugs That Did Not Make It","author":"Harald","date":"February 23, 2015","format":false,"excerpt":"I find it useful to look back and review drug candidates that were stopped in development.\u00a0 In case of insufficient efficacy, i.e., not enough of a VL reduction or early viral rebound, everyone can sympathize with the decision to discontinue a drug. 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