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.
AVOIDING STRONGER SIDE EFFECTS
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.
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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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