Nov 2 A combination of two oral hepatitis C
treatments developed by Merck & Co led to high cure
rates in previously untreated patients, indicating the company
is a contender in the race to find new treatments for the liver
The treatments tested with and without the older drug
ribavirin led to cure rates of 96 percent to 100 percent,
according to interim data from a small midstage clinical trial.
The results appear to confirm Merck will be competitive in
the crowded race to develop interferon-free treatments for
hepatitis C, assuming they are repeated in larger studies that
include more difficult to treat patient populations, such as
those not helped by prior therapy.
The 65-patient, 3-arm study tested MK-5172, a protease
inhibitor, combined with MK-8742 from a highly promising new
class of drugs called NS5A inhibitors for 12 weeks of treatment.
Based on data available at the time the interim results were
released, 55 of 56 patients who completed the therapy were
considered to be cured of the virus which is transmitted through
infected blood from sources such as infected hypodermic needles
or blood transfusions.
Patients who have no detectable levels of the virus in their
blood 12 weeks after completing 12 weeks of treatment were
deemed to be cured - a measure known as SVR 12, for sustained
In the arm of the study that did not include the older oral
medicine ribavirin, all 11 patients who completed therapy with
MK-5172 and the higher 50 milligram dose of MK-8742 taken once a
day achieved SVR 12.
All 12 patients who began that arm of the study had Genotype
1b of the liver disease, which is prevalent in Europe and Japan.
It is considered somewhat easier to treat than Genotype 1a, the
most common form of the virus seen in the United States, which
may require a third drug in the regimen to achieve similarly
high cure rates.
The other two arms - one testing 50 mg of MK-8742 and one
using 20 mg - did include ribavirin given twice a day.
With the lower dose of the NS5A inhibitor, all 21 patients
who completed therapy were deemed cured. In the group that
received the higher dose in the three-drug combination, 23 of
24, or 96 percent, reached SVR 12. About three quarters of the
patients in those arms were Genotype 1a.
Of the 65 patients in the study, only one had experienced a
relapse of the virus, according to the data to be presented on
Sunday at the American Association for the Study of Liver
Diseases (AASLD) meeting in Washington.
"We are encouraged by these preliminary data for the
combination of MK-5172 and MK-8742. It's a one-two punch with
both arms equally strong," said Eliav Barr, head of infectious
diseases for Merck.
SHORTER TREATMENT DURATION
Current standard treatment regimens for hepatitis C take 24
or 48 weeks and includes injected interferon, which causes
miserable flu-like symptoms that lead many patients to avoid or
Several companies are developing new all-oral combinations
that in clinical trials have cut treatment duration to 12 weeks
for many patients while significantly increasing cure rates from
about 75 percent with current drugs.
Ultimately, physicians would like to also see regimens that
do not require ribavirin, which has its own side effect issues,
including anemia and rash.
It is believed that tens of thousands of hepatitis C
patients have delayed treatment while awaiting the new drugs
expected to start reaching the market next year.
Gilead Sciences is widely seen as being in the lead
with a safe and effective all-oral combination, with
Bristol-Myers-Squibb and AbbVie close behind.
Gilead last week won an approval recommendation from a U.S.
Food and Drug Administration advisory panel for its highly
Some analysts believe the market for all-oral hepatitis C
treatments could reach $20 billion as many more people get
tested for the virus, given the very high cure rates, shorter
treatment durations and tolerable side effects.
An estimated 170 million people worldwide are infected with
hepatitis C, which if left untreated can lead to cirrhosis, need
for a transplant or liver cancer.
The Merck drugs were well tolerated with no serious adverse
side effects reported. The most common side effects were
fatigue, headache and nausea.
Merck plans to expand the Phase II trial to about 400
additional patients, testing its drugs with and without
ribavirin, and including those also infected with the HIV virus,
those with cirrhosis and patients who have failed to be cured by
prior treatments. It is also looking at a regimen of only 8
weeks in previously untreated patients that would include