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Triple therapy 'might cure hep C in six weeks'

Phase II trials shows promise for Merck and Gilead drugs


A three-drug regimen based on two Merck & Co drugs and Gilead's Sovaldi could potentially cure some patients with hepatitis C virus (HCV) in as little as six weeks, according to a phase II trial.

The results of the C-SWIFT study - reported at the ongoing American Association for the Study of Liver Diseases (AASLD) in Boston - showed that the combination was remarkably effective in patients with genotype 1 HCV, the most common form of the virus in the US, Europe and Latin America.

The regimen consists of a fixed-dose combination of Merck's NS3/4A protease inhibitor grazoprevir (MK-5172) and NS5A inhibitor elbasvir (MK8742) with Gilead's big-selling NS5B inhibitor Sovaldi (sofosbuvir).

The study involved treatment-naïve genotype 1 patients, including non-cirrhotic patients who were treated for either four or six weeks and patients with cirrhotic disease who received a six or eight week course.

Lead investigator Eric Lawitz of the Texas Liver Institute in San Antonio reported mid-stage results showing that 87% of non-cirrhotic patients and 80% of patients with cirrhosis had a sustained virological response (SVR) after six weeks.

With eight weeks of therapy the SVR rose to nearly 95% among the cirrhotic group, although the four-week regimen was not sufficiently effective with an SVR of 40%.

"These interim data provide a compelling proof-of-concept for the potential of an eight- or six-week triple therapy course in treatment-naive patients with genotype 1 disease," said Lawitz, who added that larger-scale studies of the combination are already being planned.

Merck has been seen as a later entrant in the HCV sector behind Gilead and AbbVie, but made its long-term commitment to the sector clear after buying Idenix for nearly $4bn earlier this year in order to get hold of a pipeline headed by IDX21437 (now called MK-3682), an NS5B inhibitor that at first glance seems like it could be at least as effective as Sovaldi.

The latest data will encourage Merck as it moves towards testing a three-drug combination based on grazoprevir/elbasvir and the Idenix compound that could provide reliable six-week treatment and be on the market in 2017.

Merck said it plans to start two phase II trials of MK-3682; one as a combination with grazoprevir/elbasvir and another in combination with grazoprevir and Merck's early-stage NS5A inhibitor MK-8408. The two trials will initially examine an eight week course and then see if the duration can be cut down.

Competition in the HCV looks likely to become increasingly intense as more and more drug cocktails become available, with Gilead already securing US approval for Harvoni - its fixed-dose combination of sofosbuvir and NS5A inhibitor ledipasvir - and AbbVie which could get a green light for its four-drug combination before the end of the year. The FDA has just recently approved a combination of Sovaldi with Janssen's NS3/4A protease inhibitor Olysio (simeprevir).

Also presenting new data at the AASLD over the weekend was Bristol-Myers Squibb, which has achieved strong results in a trial of NS5A inhibitor daclatasvir, NS3/4A protease inhibitor asunaprevir and non-nucleoside NS5B polymerase inhibitor beclabuvir (formerly BMS-791325) in patients with genotype 1 HCV and cirrhosis.

Article by
Phil Taylor

10th November 2014

From: Research



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