| LOS ANGELES/LONDON April 11
LOS ANGELES/LONDON April 11 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
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
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
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.
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
"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
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 Oct. 10.
(Additional reporting by Bill Berkrot; Editing by Michele
Gershberg and Ken Wills)