| April 23
April 23 A combination of five oral drugs being
tested by AbbVie Inc cured at least 88 percent of new
patients with hepatitis C after only eight weeks of treatment,
without raising significant safety issues, researchers said on
The latest findings from an ongoing trial sponsored by
AbbVie, called Aviator, also showed that 96 percent of patients
taking the five medicines for 12 weeks eliminated the virus, as
assessed by blood tests 24 weeks after they stopped treatment.
If the virus is undetectable 24 weeks after completing
treatment, known as SVR 24, a patient is considered cured.
The latest results were deemed little different than the 99
percent sustained virologic response (SVR) rate reported in
October, for patients evaluated 12 weeks after completing 12
weeks of the five-drug treatment regimen.
"We are pleased that the data remain consistent and robust,"
said Dr. Kris Kowdley, who is presenting the data this week at a
meeting of the European Association for the Study of the Liver
(EASL) in Amsterdam.
"The data confirm that the 12-week treatment appears to be
optimal, but certainly we are still very pleased with ... data
for the eight-week treatment," Kowdley said in an interview.
AbbVie is deemed to be in a horse race with Gilead Sciences
Inc to be first to market with an all-oral treatment
for the serious liver disease, as companies work to eliminate
difficult-to-tolerate intravenous interferon from the regimen,
while raising cure rates and shortening treatment duration.
Current hepatitis C treatments take either 24 or 48 weeks.
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.
Gilead has been given an edge by many analysts because its
experimental regimen involves fewer drugs. But Abbvie said it is
also 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 tolerate.
Any oral regimen to treat hepatitis C is expected to garner
billions of dollars in annual sales.
Patients in the Aviator study had the most common, but
hardest to treat, genotype 1 variation of the infectious virus.
The AbbVie 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 generic
antiviral 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. That
compared with a cure rate of 95 percent for patients treated for
24 weeks, and then assessed 24 weeks after treatment stopped.
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