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 Results of the study called C-Worthy were presented
on Thursday at the annual meeting of the European Association for
the Study of the Liver (EASL) in London. Researchers are due on
Friday to present results of how the Merck pills fared in more
difficult to treat patients, such as those who failed to be helped
by prior treatments and those with more advanced liver disease.
In the arm of the Phase II study presented on Thursday, 43 of 44
patients treated with 100 milligrams of MK-5172 and 50 mg of MK-8742
once a day for 12 weeks achieved sustained virologic response (SVR),
which is considered cured. One patient relapsed, researchers said.
Those who have no detectable levels of the hepatitis C virus in
their blood 12 weeks after completing the 12 weeks of treatment are
deemed to have achieved SVR.
Current standard treatments take 24 or 48 weeks, cure about 75
percent of patients and involve miserable side effects that have led
thousands of patients to put off treatment and wait for highly
touted new drugs to become available.
The study also included results of patients treated with the two
Merck drugs plus the older drug ribavirin for both 12 weeks and
eight weeks. But all eyes will be on the ribavirin-free results as
several companies race to produce all-oral treatment regimens that
include neither ribavirin nor interferon, which are both used in
current treatments and cause flu-like symptoms, anemia and other
side effects.
Gilead Sciences Inc, AbbVie and Bristol-Myers Squibb Co are also
developing a new generation of all-oral hepatitis C treatments that
in previous trials have demonstrated cure rates in excess of 90
percent, while cutting treatment duration to 12 weeks with few side
effects.
Gilead, which later this year could have a one pill, once a day
two-drug regimen approved in the United States, is widely perceived
by Wall Street to be the best of the bunch with some analysts
forecasting annual sales of $9 billion or more.\
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Merck is a bit behind the other three companies in its
development timeline, but could prove to be the one that gives
Gilead a run for its money as it aims to also produce a one pill,
once a day regimen. The AbbVie and Bristol-Myers programs involve
more pills and more drugs, but equally impressive cure rates so far
in clinical testing.
"Merck has begun a Phase III trial in (previously untreated
patients) using one pill, once per day. This should increase
everyone's confidence that Merck really has a regimen competitive
with Gilead's," ISI Group analyst Mark Schoenebaum said in a
research note.
The Merck anti-viral medicines, which hamper the virus' ability to
replicate in different ways, were tested in patients who had the
genotype 1 form of the virus — the most prevalent and considered the
most difficult to treat.
The most common side effects seen with the Merck drugs were fatigue,
headache and nausea.
An estimated 170 million people are believed to be infected with
hepatitis C worldwide. If left untreated, the progressive disease
can lead to cirrhosis, liver cancer or the need for a liver
transplant.
(Reporting by Bill Berkrot; editing by Bernard Orr)
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