{"id":5694,"date":"2014-12-20T07:25:27","date_gmt":"2014-12-20T12:25:27","guid":{"rendered":"http:\/\/blogs.nejm.org\/?p=5694"},"modified":"2015-06-04T14:31:51","modified_gmt":"2015-06-04T18:31:51","slug":"new-hcv-option-effective-safe-well-tolerated-and-use-will-likely-be-driven-by-payors","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/new-hcv-option-effective-safe-well-tolerated-and-use-will-likely-be-driven-by-payors\/2014\/12\/20\/","title":{"rendered":"New HCV Option Effective, Safe, Well-Tolerated — And Use Will Likely Be Driven by Payors"},"content":{"rendered":"

As expected, the FDA approved the next treatment option for HCV<\/a>\u00a0on Friday — “Viekira Pak”, a (sometimes complete) regimen consisting of ritonavir-booted parataprevir and ombitasvir\u00a0given as a two\u00a0pills once a day, plus one pill of of dasabuvir given twice daily. It is indicated for treatment of HCV genotype 1.<\/p>\n

For those of you mechanistically inclined, parataprevir is a protease inhibitor, ombitasvir\u00a0an NS5A inhibitor, and dasabuvir the first approved non-nucleoside polymerase inhibitor. Ritonavir is there for PK boosting.<\/p>\n

Cure rates have been outstanding — 90% and higher<\/a>\u00a0— and severe adverse events rare. All good news so far.<\/p>\n

So what’s the issue? The full prescribing information is here<\/a>, but this is the key table:<\/p>\n

\"viekirapak_pi_pdf\"<\/a><\/p>\n

Obviously, many patients will require concomitant administration of ribavirin, which makes this a considerably more complex regimen than the sofosbuvir\/ledipasvir\u00a0combination pill that has been available since October.<\/a> Two\u00a0other disadvantages include\u00a0more drug-drug interactions<\/a> (ID\/HIV doctors are certainly familiar with ritonavir), and the potential for broader antiviral resistance if the treatment fails.<\/p>\n

Whether these make a difference or not in clinical practice is a key unknown. But you can bet good Hanukkah gelt that payors are\u00a0highly motivated<\/a> to find out. Here’s some proof.<\/a><\/p>\n

Hey, Happy 20th Birthday to this classic:<\/p>\n