Euro UPDATE: Merck’s All Oral, Ribavirin-Free Combo Pill — For Type 1 Hep C Patients, With Advanced Kidney Disease Hits A Home Run!

MRK-C-SURFER-2015 Well, I think it is finally time to say that Merck is serving notice — on Gilead’s Sovaldi® run-away lead in the Hep C market. This will, in time lead to solid head to head competition, for all genotypes of Hep C patients, I’ll brashly predict.

Just a few minutes ago, in Vienna, Austria at EASL — in the middle of the night here in the US — Kenilworth announced that 99 per cent of these studied patients achieved SVR (or sustained viral response) at 12 weeks. A few weeks ago, I had guessed it would be over 90 percent — but I didn’t see the cure rate hitting the 99th percentile. [The Abbott spin-off has an solid entrant here, as well — so prices are destined to come down, for certain.]

C-SURFER is the name of the late breaker EASL presented study, and since Merck has re-won breakthrough status at FDA (on a subset of genotype 1, and genotype 4), this could lead to an approval, in these subsets, in just a few weeks’ time. No promises, but it could — sporting a nearly-perfect cure rate.

. . . .Merck today announced the first presentation of data from C-SURFER, the company’s Phase 2/3 clinical trial evaluating the investigational once-daily treatment regimen of grazoprevir (100mg) and elbasvir (50mg) in patients with advanced chronic kidney disease (CKD) infected with chronic hepatitis C virus (HCV) genotype 1. . . .

Of the 122 patients who received grazoprevir plus elbasvir, 83 percent were treatment-naïve, 36 percent had diabetes, 18 percent had stage 4 CKD, 82 percent had stage 5 CKD, 75 percent were receiving haemodialysis and 45 percent were African-American. Among those patients who received at least one dose of grazoprevir plus elbasvir, five percent (6/122) were excluded from the pre-specified primary efficacy analysis population, or modified full analysis set, due to missing data caused by death or early discontinuation for reasons unrelated to study drug. In the modified full analysis set, 99 percent (115/116) of patients receiving grazoprevir plus elbasvir achieved SVR12. One GT1b infected, non-cirrhotic, interferon-intolerant patient showed a viral relapse at follow-up week 12. Within the modified full analysis set, efficacy was consistent across the patient sub-populations assessed. In a supportive analysis of all 122 patients who received at least one dose of grazoprevir plus elbasvir in the ITG arms, including patients who did not complete the study for reasons not related to study drug, 94 percent (115/122) of patients achieved SVR12. . . .

Onward — it is truly a new day (well. . . almost). Yeah, this news roused me from a sound sleep. It was entirely worthy of the ungodly early wake-up call!


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