{"id":8427,"date":"2017-08-06T07:28:12","date_gmt":"2017-08-06T11:28:12","guid":{"rendered":"http:\/\/blogs.nejm.org\/hiv-id-observations\/?p=8427"},"modified":"2017-08-30T06:41:29","modified_gmt":"2017-08-30T10:41:29","slug":"reached-end-hcv-drug-development","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/reached-end-hcv-drug-development\/2017\/08\/06\/","title":{"rendered":"Have We Reached the End of HCV Drug Development?"},"content":{"rendered":"
\"\"<\/a>

Rabbit or duck?<\/p><\/div>\n

Two new HCV regimens\u00a0gained\u00a0FDA approval recently, bringing us closer to the end of this\u00a0extraordinary phase of drug development.<\/p>\n

Think about it —\u00a0has there ever been a more spectacularly rapid improvement in treatment of anything<\/em>? If so, please let me know what that is. Remember, as recently as\u00a0early 2013, highly toxic interferon-based therapy (with ribavirin and telaprevir or boceprevir) was still standard-of-care.<\/p>\n

The recent approvals: \u00a0Sofosbuvir-velpatasvir-voxilaprevir (Vosevi) on July 18<\/a>, indicated for patients who have\u00a0failed prior treatment with either sofosbuvir or an NS5A inhibitor.\u00a0Twelve weeks of treatment (one pill daily)\u00a0will cure 95\u201396% of patients<\/a>,\u00a0and pretreatment presence of NS5A, NS3, or NS5B resistance mutations does\u00a0not reduce response. A month of sof-vel-vox — which will only be used as a salvage therapy — is priced at $24,900.<\/p>\n

Then,\u00a0glecaprevir-pibrentasvir (Mavyret) was approved on August 3rd<\/a>. A pan-genotypic regimen that includes\u00a0both an HCV protease inhibitor and an NS5A inhibitor, “G\/P”\u00a0is 3 pills daily, requiring only\u00a08 weeks of therapy in treatment-naive individuals without cirrhosis. Clinical trial results\u00a0show cure rates in the high 90s<\/a>, with a low incidence\u00a0of treatment-related adverse events requiring drug cessation.<\/p>\n

Glecaprevir-pibrentasvir\u00a0can also be used in patients with renal \"\"<\/a>impairment (including dialysis), prior treatment failure of\u00a0genotype 1 with either an NS5A inhibitor or PI (but not both), and in compensated cirrhosis. Treatment duration should be increased to 12 weeks in those with prior treatment or cirrhosis.<\/p>\n

So where does that leave us in terms of “unmet needs” in HCV therapy?<\/p>\n

Let’s review\u00a0what we currently have:<\/p>\n