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Oral hepatitis C regimens tackle advanced liver disease

 New data released at the International Liver Congress by AbbVie, Merck & Co and Gilead

Merck & CoInterferon-free treatment regimens for hepatitis C virus (HCV) infection featured prominently at the International Liver Congress (ILC) over the weekend, with new data from AbbVie, Merck & Co and Gilead Sciences.

All three companies reported encouraging new clinical results in HCV patients with advanced liver disease that had progressed to complications such as cirrhosis, who are notoriously difficult to treat effectively.

AbbVie reported data from a pivotal phase III trial of its all-oral regimen, revealing that after 12 weeks around 92 per cent of HCV patients with the hard-to-treat genotype 1 (GT1) strain of the virus as well as established liver disease had a sustained virologic response (SVR), rising to 96 per cent at 12 weeks.

The regimen includes ABT-450/ritonavir co-formulated with NS5A inhibitor ombitasvir (ABT-267) given once-daily, alongside NS5B RNA polymerase inhibitor dasabuvir (ABT-333) 250mg dosed twice-daily. The company now says it intends to press ahead with a regulatory filing for the cocktail within the next few weeks.

Merck announced interim results from an ongoing phase II trial at the ILC that evaluated the efficacy and safety of its two-drug regimen based on NS3/4A protease inhibitor MK-5172 and NS5A replication complex inhibitor MK-8742, given with or without ribavirin, in GT1 HCV patients with cirrhosis.

SVR rates were as high as 97 per cent at 12 weeks among patients who had not been treated for HCV infection before, and above 90 per cent even for patients with HCV and HIV co-infection, a particularly hard-to-treat group. Merck recently started its phase III programme for the combination.

Finally, Gilead reported the results of two phase II trials and data from a compassionate use programme which looked at the effectiveness of its recently-launched NS5B polymerase inhibitor Sovaldi (sofosbuvir) with ribavirin in HCV patients with advanced liver disease.

All three studies showed that the regimen suppressed virus levels in 60 to 95 per cent of patients and was well tolerated, cementing the clinical evidence for a drug that is already set to become a mega blockbuster in its first year on the market despite criticism of its hefty price tag of $84,000 per 12-week course in the US.

Late last week, it was reported that Gilead has reached a deal with Medecins sans Frontieres (MSF) to make the drug available at just $900 per course to countries such as Kenya, Mozambique, Myanmar and India.

Article by
Phil Taylor

14th April 2014

From: Research

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