{"id":1146,"date":"2014-11-23T15:49:53","date_gmt":"2014-11-23T20:49:53","guid":{"rendered":"http:\/\/allphasepharma.com\/dir\/?p=1146"},"modified":"2015-07-09T02:15:48","modified_gmt":"2015-07-09T06:15:48","slug":"after-harvoni-whats-still-left-to-improve-besides-the-price-tag","status":"publish","type":"post","link":"https:\/\/allphasepharma.com\/dir\/2014\/11\/23\/1146\/after-harvoni-whats-still-left-to-improve-besides-the-price-tag\/","title":{"rendered":"After Harvoni: What\u2019s Still Left to Improve (Besides the Price Tag)?"},"content":{"rendered":"

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<\/p>\n

\"...not<\/a>
…not so long ago…<\/figcaption><\/figure>\n

\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 are there still drugs in early stages of development?\u00a0 Doesn\u2019t Harvoni and Sovaldi + simeprevir (and some other combos) already have it all: efficacy, safety, tolerability and once-daily convenience?<\/p>\n

We are clearly experiencing the end of the pegylated interferon plus ribavirin era, and that is a good thing.\u00a0 But don\u2019t assume that HCV drug development has now come to an end: There are plenty of reasons for companies to develop better HCV drugs.\u00a0

Spending on hepatitis C drugs alone is projected to rise seven-fold from $3 billion a year in 2011 to $21 billion in 2018, according to market research firm Decision Resources Group LLC
\nRef. [1]<\/p>\n<\/div><\/p>\n

Here my – admittedly subjective – list of areas for future opportunities:<\/p>\n

    \n
  1. Need for more combinations from same and from different drug classes\n
      \n
    1. For reasons of tolerability<\/li>\n
    2. For reasons of viral resistance to a combo partner:
      \nthere is a low resistance threshold with NS5A inhibitors and the protease inhibitors<\/li>\n
    3. For faster viral clearance and shorter treatment durations<\/li>\n
    4. For better PK match<\/li>\n
    5. For truly pan-genotypic activity:
      \nnot a given with NS5A combos<\/li>\n
    6. As a fall-back option in case of sofosbuvir issues down the road<\/li>\n<\/ol>\n<\/li>\n
    7. Need for stand-alone drugs\n
        \n
      1. For free partnering of drugs from different companies<\/li>\n
      2. For individualized dosing \/ dose adjustment<\/li>\n<\/ol>\n<\/li>\n
      3. Need for shorter treatment duration\n
          \n
        1. 12-wks is good but 8 wks is better<\/li>\n
        2. For better compliance<\/li>\n<\/ol>\n<\/li>\n
        3. Need for new drugs for special populations like:\n
            \n
          1. \u2018new\u2019 non-responders to first-round DAA therapy<\/li>\n
          2. pre-liver transplant and\u00a0decompensated cirrhotics<\/li>\n
          3. post-liver transplantation patients<\/li>\n
          4. HBV \/ HIV co-infected patients<\/li>\n
          5. Patients with co-morbidities<\/li>\n
          6. Patients unable to take certain DAAs because it would create drug interaction problems<\/li>\n
          7. Immunosuppressed \/ transplant patients<\/li>\n
          8. GT3 patients<\/li>\n<\/ol>\n<\/li>\n<\/ol>\n

            So, there is still room for new drugs for\u00a0special situations and special patient

            By law, insurers cannot deny access to new drugs if they represent a real improvement for patients, leaving drug companies with the upper hand in most price discussions.
            \nRef. [2]<\/span>\u00a0<\/p>\n<\/div>populations for whom neither Harvoni nor the Sovaldi\/Olysio combination is not ideal.<\/p>\n

            Or just too expensive…<\/p>\n

            I would be interested in your comments on areas of need not listed above.<\/p>\n

            \u00a0References:
            \n<\/strong>[1]\u00a0<\/strong>http:\/\/www.bloomberg.com\/news\/2014-01-27\/at-84-000-gilead-hepatitis-c-drug-sets-off-payer-revolt.html<\/a><\/p>\n

            [2]\u00a0http:\/\/www.newsweek.com\/insurers-worry-84000-hepatitis-c-drug-sovaldi-could-break-bank-252539<\/a><\/p>\n

             <\/p>\n

             <\/p>\n","protected":false},"excerpt":{"rendered":"

            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 Continue reading After Harvoni: What\u2019s Still Left to Improve (Besides the Price Tag)?<\/span>→<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":1117,"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":[3,18],"tags":[664,712,136,709,705,661,707,711,704,708,139,134,666,710,120,26,25,137,706],"class_list":["post-1146","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-the_news","category-the_viewpoint","tag-cirrhosis","tag-co-pegus","tag-daa","tag-direct-acting-antiviral-agents","tag-gt3-patients","tag-harvoni","tag-hbvhcv-co-infection","tag-hcv-drug-price","tag-hcv-resistance","tag-hcvhiv-co-infection","tag-olysio","tag-pan-genotypic","tag-peg-interferon","tag-pegasys","tag-ribavirin","tag-simeprevir","tag-sofosbuvir","tag-sovaldi","tag-transplantation"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/11\/All-New-HCV-Menu-copy-e1431668358188.jpg?fit=1250%2C1198&ssl=1","jetpack_shortlink":"https:\/\/wp.me\/p4KWFr-iu","jetpack_sharing_enabled":true,"jetpack-related-posts":[{"id":1112,"url":"https:\/\/allphasepharma.com\/dir\/2014\/11\/08\/1112\/2014-the-year-that-changed-the-landscape-of-hcv-therapy\/","url_meta":{"origin":1146,"position":0},"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":313,"url":"https:\/\/allphasepharma.com\/dir\/2014\/06\/18\/313\/snapshot-hcv-drugs-in-development\/","url_meta":{"origin":1146,"position":1},"title":"Snapshot: HCV Drugs in Development","author":"Harald","date":"June 18, 2014","format":false,"excerpt":"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\u2026","rel":"","context":"In "The News"","block_context":{"text":"The News","link":"https:\/\/allphasepharma.com\/dir\/category\/the_news\/"},"img":{"alt_text":"","src":"","width":0,"height":0},"classes":[]},{"id":2285,"url":"https:\/\/allphasepharma.com\/dir\/2016\/02\/07\/2285\/mister-s-goes-to-washington\/","url_meta":{"origin":1146,"position":2},"title":"Mister S. Goes To Washington","author":"Harald","date":"February 7, 2016","format":false,"excerpt":"Let\u2019s just assume that Mr. Martin Shkrely had provided full testimony at the Congressional\u00a0hearing, this is what it might\u00a0have said: Read my lips: NO MORE REBATES ! It\u2019s time to give Shkrely a break \u2013 he has been maligned too much. The media already made him into the new Gordon\u2026","rel":"","context":"In "The News"","block_context":{"text":"The News","link":"https:\/\/allphasepharma.com\/dir\/category\/the_news\/"},"img":{"alt_text":"Shrely-slider NEW copy","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2016\/02\/Shrely-slider-NEW-copy.jpg?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2016\/02\/Shrely-slider-NEW-copy.jpg?resize=350%2C200 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2016\/02\/Shrely-slider-NEW-copy.jpg?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":1146,"position":3},"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":5814,"url":"https:\/\/allphasepharma.com\/dir\/2025\/11\/27\/5814\/obeldesivir-fails-in-yet-another-study\/","url_meta":{"origin":1146,"position":4},"title":"Obeldesivir Fails in Yet Another Study","author":"Harald","date":"November 27, 2025","format":false,"excerpt":"There are studies that are bound to succeed, and those that are likely to fail.\u00a0 A failed trial is nothing to be proud of \u2013 and in this case, it was a gamble against overwhelming odds.\u00a0 We feel the Gilead marketing department was pushing their luck big time with this\u2026","rel":"","context":"In "Recent Literature"","block_context":{"text":"Recent Literature","link":"https:\/\/allphasepharma.com\/dir\/category\/recent_literature\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2025\/11\/IDSA-Covid-Guideline.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2025\/11\/IDSA-Covid-Guideline.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2025\/11\/IDSA-Covid-Guideline.jpg?resize=525%2C300&ssl=1 1.5x"},"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":1146,"position":5},"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":[]}],"jetpack_likes_enabled":true,"_links":{"self":[{"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/posts\/1146","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/comments?post=1146"}],"version-history":[{"count":9,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/posts\/1146\/revisions"}],"predecessor-version":[{"id":1163,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/posts\/1146\/revisions\/1163"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/media\/1117"}],"wp:attachment":[{"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/media?parent=1146"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/categories?post=1146"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/tags?post=1146"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}