* 96 pct cured with AbbVie 12-week treatment regimen
* AbbVie shares up 2 percent
* Bristol-Myers shares up 1.2 percent after promising data
By Ransdell Pierson and Bill Berkrot
April 23 AbbVie Inc's experimental
hepatitis C treatment cured up to 96 percent of patients in just
12 weeks, according to data released on Tuesday, shoring up its
position in the race to deliver a potent oral therapy for the
serious liver disease.
AbbVie's treatment, a combination of five oral medications,
is expected to be a close contender to a treatment in
development by Gilead Sciences Inc. Analysts see the
Gilead drug winning regulatory approval as early as 2014, with
AbbVie close behind.
AbbVie said on Tuesday that about 88 percent of new patients
with hepatitis C were deemed cured after only eight weeks of
treatment, while 96 percent of those treated for 12 weeks
eliminated the liver virus, as verified by blood tests 24 weeks
after completion of treatment. No serious safety concerns were
observed by researchers.
If the virus is undetectable 24 weeks after completing
treatment - known as sustained virologic response, or SVR 24 - a
patient is considered cured.
The latest findings from an ongoing trial sponsored by
AbbVie, called Aviator, were unveiled at a meeting of the
European Association for the Study of the Liver (EASL) in
Amsterdam. Shares of AbbVie rose 2 percent in morning trading on
the New York Stock Exchange.
"AbbVie looked good, but I think Gilead is still in the
lead," said Tim Nelson, an analyst with Nuveen Asset Management.
He estimates that the market for oral hepatitis C treatments
would be worth billions of dollars in annual sales.
Hepatitis C affects an estimated 170 million people
worldwide, and if left untreated can lead to cirrhosis, liver
cancer or the need for a new liver.
Existing treatments must be taken by patients for either 24
or 48 weeks and the most effective have a cure rate as high as
80 percent. Several companies are working to eliminate infusions
of difficult-to-tolerate interferon from the regimen, while
raising cure rates and shortening the length of treatment.
MORE ROBUST DATA
The latest results from AbbVie confirmed interim data
presented in October, which showed a 99 percent SVR rate for
patients evaluated 12 weeks after completing a 12-week regimen
of the treatment.
"We are pleased that the data remain consistent and robust,"
lead researcher Dr. Kris Kowdley in said an interview. "The data
confirm that the 12-week treatment appears to be optimal, but
certainly we are still very pleased with ... data for the
AbbVie spokeswoman Tracy Sorrentino said the 8-week data was
impressive. But for larger late-stage trials, she said the
company plans to test the drug combination for 12 weeks, in
order "to help the greatest number of patients achieve virologic
Gilead has been given an edge by many analysts because its
experimental regimen involves fewer drugs and may be closer to
reaching the market. AbbVie said it is testing regimens with
fewer drugs and ones that do not include the older oral drug
ribavirin, which can also be difficult for some patients to
Bristol-Myers Squibb unveiled data on Tuesday at the
meeting from a smaller mid-stage study of its three-drug
combination that does not include ribavirin. Its program is
behind those of Gilead and AbbVie, but cure rates in excess of
90 percent and a relatively clean safety profile are expected to
make it a formidable player in the field.
Bristol-Myers shares were up 1.2 percent.
Patients in the AbbVie Aviator study had the most common,
but hardest to treat, genotype 1 variation of the infectious
The AbbVie regimen included three experimental direct acting
antiviral drugs that each attack a different target necessary
for virus replication. The drugs were the protease inhibitor
ABT-450, whose effect was boosted by a widely used antiviral
called ritonavir; the polymerase inhibitor ABT-333, and ABT-267
from a class known as NS5A inhibitors. Those were given along
with the older medicine ribavirin.
Kowdley, director of the Liver Center of Excellence at
Virginia Mason Medical Center in Seattle, said the trial also
showed impressive results among patients who had failed to
benefit from earlier therapy.
The cure rate after 12 weeks of treatment was 93 percent for
those patients, called null responders, assessed both 12 weeks
and 24 weeks after completion of their drug regimens. In
addition, data showed a cure rate of 95 percent for patients
treated for 24 weeks, and then assessed 24 weeks after treatment
AbbVie said the safety of the tested drugs was similar to
that seen in results presented last year. Of the 247 patients
evaluated, serious side effects were seen in four patients (1.6
percent), while seven patients had elevated levels of liver
enzymes that can be considered a potential sign of toxicity.
Less-serious side effects seen in more than 10 percent of
patients included headache, fatigue, nausea, insomnia and