{"id":879,"date":"2015-11-04T16:25:32","date_gmt":"2015-11-04T16:25:32","guid":{"rendered":"http:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/?p=879"},"modified":"2017-08-21T11:29:13","modified_gmt":"2017-08-21T11:29:13","slug":"primary-care-corner-with-geoffrey-modest-md-hep-c-1b-treatment-ribavirin-free","status":"publish","type":"post","link":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/2015\/11\/04\/primary-care-corner-with-geoffrey-modest-md-hep-c-1b-treatment-ribavirin-free\/","title":{"rendered":"Primary Care Corner with Geoffrey Modest MD: Hep c 1b treatment, ribavirin-free"},"content":{"rendered":"<p><strong>By Dr. Geoffrey Modest<\/strong><\/p>\n<p>A new study highlights how rapidly the field of Hepatitis C management is progressing, moving from an interferon-free therapy to one that is now\u00a0also ribavirin-free\u00a0(see\u00a0Gastroenterology 2015; 149: 971).<\/p>\n<p>Details:<\/p>\n<ul>\n<li>Open-label international\u00a0study of 82 patients without cirrhosis (42 treatment-naive and 40 prior null\u00a0responders) and 99 with cirrhosis (47 treatment-naive and 52 treatment-experienced with prior relapse, or a null or partial response). The demographics varied some between these different groups, but overall approx 50% male, 85% white, mean age 55, in non-cirrhotic patients &#8211;&gt;\u00a060%\u00a0with fibrosis score F0-F1, 25% F2, 13% F3).\u00a0All with genotype 1b infection. 68-95% had non-CC IL28B genotype (this may not be clinically relevant, but\u00a0this genotype\u00a0did portend a\u00a0less favorable\u00a0response to perinterferon\/ribavirin treatment).<\/li>\n<li>Treated with ombitasvir 25mg (a NS5A replication complex inhibitor), paritaprevir 150mg (an NS3\/4A protease inhibitor),\u00a0and ritonavir 100mg once daily for 12 weeks (if no cirrhosis) or 24 weeks (with cirrhosis). [Note: This is the same combo in the pill Viekira, minus dabasuvir 250mg]<\/li>\n<li>Primary endpoint: sustained viral response at 12 weeks after the end of treatment (SVR12)<\/li>\n<\/ul>\n<p>Results:<\/p>\n<ul>\n<li>Without cirrhosis:\u00a0treatment-naive had\u00a0SVR12 of\u00a095.2%, null responders had SVR12 of 90.0%<\/li>\n<li>\u200bWith\u00a0cirrhosis: treatment-naive had SVR12\u00a0of\u00a097.9%, treatment-experienced had SVR12 of 96.2%<\/li>\n<li>Virologic relapse happened\u00a0in 3 null responders without cirrhosis and 1 with cirrhosis<\/li>\n<li>Virologic breakthrough occurred in 1 null responder without cirrhosis<\/li>\n<li>\u200bAdverse events (varied by assigned group)\u00a0included headache (17-33%), asthenia (5-21%), pruritis (0-17%), and diarrhea (0-15%). Almost all were &#8220;mild&#8221;. Serious adverse effects in 7 patients (1 each): extrusion of penile prosthesis, COPD exacerbation, esophageal variceal hemorrhage, humerus fracture and partial seizures, elevate ALT and AST levels (this patient stopped drugs for days 20-36, but then was able to resume and had an SVR12), peripheral artery aneurysm and hepatic neoplasm.\u00a0Only one patient discontinued meds because of an adverse effect (isolated peripheral edema which resolved after study drug cessation)<\/li>\n<li>One interesting sideline of the study: there\u00a0were detectable RAVs (resistance-associated variants), mostly to NS5A (17.6%) as well as NS3 (1.1%). but there was no association between these baseline RAVs and response to therapy (though all 4\u00a0of those with virologic relapse and the 1 with virologic breakthrough did have RAVs in both NS3 and NS5A at the time of failure)<\/li>\n<\/ul>\n<p>So, what does this all mean? \u00a0There\u00a0are evolving therapies which are working on larger groups of people (treatment-naive or not, cirrhotic or not), which seem to have high barrier to clinical\u00a0resistance, and with fewer meds causing adverse effects (ribavirin in this case). The landscape is changing quickly, and there is increasing hope of developing an interferon and ribavirin-free, pangenotypic, single pill therapy (at least this is much more likely than developing a reasonable-cost\u00a0therapy). And, as with HIV treatment, the newer regimens are simpler, more effective, and have\u00a0many fewer adverse effects. Which means that we in primary care are in increasingly good positions to take care of patients with\u00a0these infections as part of taking care of the whole patient.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Primary Care Corner with Geoffrey Modest MD: Hep c 1b treatment, ribavirin-free [&#8230;]<\/p>\n<p><a class=\"btn btn-secondary understrap-read-more-link\" href=\"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/2015\/11\/04\/primary-care-corner-with-geoffrey-modest-md-hep-c-1b-treatment-ribavirin-free\/\">Read More&#8230;<\/a><\/p>\n","protected":false},"author":148,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[14283],"tags":[],"class_list":["post-879","post","type-post","status-publish","format-standard","hentry","category-archive"],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/posts\/879","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/users\/148"}],"replies":[{"embeddable":true,"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/comments?post=879"}],"version-history":[{"count":0,"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/posts\/879\/revisions"}],"wp:attachment":[{"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/media?parent=879"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/categories?post=879"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/tags?post=879"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}