Friday, April 11, 2014

Doctors welcome hepatitis C drug rivals, Gilead still leads

Doctors welcome hepatitis C drug rivals, Gilead still leads
LOS ANGELES/LONDON Fri Apr 11, 2014 1:04am EDT

Reuters - Doctors at a key medical conference welcomed the prospect of more new drugs to treat the liver-destroying hepatitis C virus, while agreeing that Gilead Sciences Inc continues to lead the effort.

Gilead, under fire from insurers and legislators for the $1,000-a-pill price of its Sovaldi drug, presented pivotal data on Friday at the European Association for the Study of the Liver conference in London, showing a cure rate of 94 percent after eight weeks of treatment with its experimental two-drug pill.

Midstage trial results from Merck & Co Inc, also presented at the meeting, showed that 12 weeks of therapy with its two-drug combination cured 98 percent of previously-untreated patients.

AbbVie and Bristol-Myers Squibb are also developing new generation all-oral hepatitis C treatments that have demonstrated cure rates in excess of 90 percent.

Citi Research sees Gilead as the clear market leader, but in the long term expects that Merck will be the second largest player, followed by AbbVie.

"We assume Merck will use aggressive pricing to maximize market share," Citi analyst Yaron Werber said in a research note.

Wall Street analysts, on average, forecast Sovaldi sales of $9.1 billion in 2017, according to Thomson Reuters Pharma.

Doctors at the London meeting said the value proposition of the new direct-acting antiviral drugs should stack up for governments and insurers, given the potential huge costs down the line from the disease, which can lead to liver cirrohosis and liver transplants.

"Competition will drive the price down, but probably not far enough," said Markus Peck-Radosavljevic, professor of medicine in the Medical University of Vienna and secretary-general of EASL.

The current U.S. price for a 12-week course of treatment with Sovaldi is $84,000, and Gilead has said the price in the United Kingdom is about $57,000.

"We spend at least this sort of money for cancer drugs, which only prolong patients' lives by a few weeks, and often with much worse side effects," said Dr Mark Thurz, professor of hepatology at Imperial College, London.


The World Health Organization estimates that 150 million people worldwide are infected with hepatitis C, which can be spread through blood, often via contaminated needles.

Before Sovaldi's launch late last year, patients with hepatitis C had to be treated for at least six months with several drugs, including interferon, an injected medicine that can cause severe flu-like symptoms, and ribavirin, which can cause rash, anemia and other side effects.

The combination of Gilead's Sovaldi and ledipasvir, an experimental drug from a class known as NS5A inhibitors, was shown to work better than the same regimen plus ribavirin.

The trial, also published in the New England Journal of Medicine, involved 647 previously untreated patients with genotype 1 hepatitis C - the hardest to treat, but the most common type in the United States - who had not developed liver cirrhosis.

"The key points useful to clinicians here are the very high rates of sustained virologic response and very good safety profile," said Dr Kris Kowdley, director of the liver center at Seattle's Virginia Mason Medical Center and the study's lead author.

More patients in the ribavirin group suffered side effects such as fatigue, headache and nausea.

The U.S. Food and Drug Administration has granted priority review to Gilead's application for the once-daily combination of Sovaldi, or sofosbuvir, and ledipasvir. The agency is slated to decide on the marketing application by October 10.

(Additional reporting by Bill Berkrot; Editing by Michele Gershberg and Ken Wills)

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