WEDNESDAY, Jan. 18 (HealthDay News) -- A new cocktail of two
investigational drugs appears to have successfully cleared the
hepatitis C virus in people who don't respond to standard
treatment.
What's more, the approach seems to work without the need for
injections with interferon alpha, an onerous medication that causes
serious side effects in many patients.
Scientists from seven U.S. medical centers and drug maker
Bristol-Myers Squibb published the small study in the Jan. 19 issue
of the
New England Journal of Medicine that is being heralded as
"landmark" research.
"We saw a sustained virologic response -- the virus was undetectable in the patients -- during treatment and remained undetectable after the drugs were stopped," said study author Dr. Anna Lok, director of clinical hepatology at the University of Michigan Medical School in Ann Arbor.
Hepatitis C virus, spread through contact with contaminated
blood, is the most common form of the virus and affects 180 million
people globally, including 4.1 million Americans. It's the leading
cause of chronic liver disease, and can lead to liver cancer. The
standard treatment includes injections of the antiviral drug
interferon alpha, which isn't tolerated well by everyone, said Dr.
Andrew Muir, director of gastroenterology and hepatology research
at the Duke Clinical Research Institute. Its many side effects
include flu-like symptoms, fatigue, fever and depression.
"Many patients cannot complete treatment or decide not to take treatment because of interferon alpha," Muir said.
The study had two arms, said Lok. A group of 10 patients
received four medications, including the two investigational drugs,
the antivirals daclatasvir and asunaprevir, along with the standard
treatment combination of interferon and ribavirin. The other arm of
the study included 11 patients who received only the two
investigational drugs. Both groups underwent treatment for 24
weeks.
The 10 patients on the four-drug regimen experienced a sustained
virologic response with undetectable virus at the end of treatment
and again at 12 weeks beyond their treatment, the researchers
reported. In the two-drug group, four of the 11 patients also had
undetectable levels of the hepatitis C virus in their blood 12
weeks after treatment ended.
All of the patients were infected with genotype 1, the most
common type of hepatitis C virus in the United States, and had not
responded to previous treatment with interferon and ribavirin, said
Lok.
"The four-drug arm was very impressive. These patients had not shown a response before and now we get a 90 to 100 percent rate of sustained response," said Lok.
She said even though only four patients in the two-drug group
reached a sustained response, this is the first study to show it
can be achieved without interferon or ribavirin.
"Clearly, this is the biggest development in hepatitis C research in a very long time," said Dr. Raymond Chung, director of hepatology at Massachusetts General Hospital in Boston, who wrote an accompanying editorial in the same issue of the journal. "It has enormous implications for our ability to treat many more patients with regimens that are significantly more tolerable."
The most common side effects reported were headache, diarrhea,
nausea and fatigue, the study authors said.
Chung called the study "a watershed moment" because it suggests
that an interferon-free treatment is possible. "The conventional
wisdom for quite some time has been that hepatitis C would likely
not be curable without an interferon backbone."
Duke's Dr. Muir added, "The study is also exceptional because it
included patients we would describe as the most difficult to
treat." Their viral load did not go down very much when they
underwent interferon and ribavirin treatment in the past.
The new drugs are not FDA-approved yet, but a number of trials
are under way, said Chung, who believes an interferon-sparing
regimen is only a few years away. "It is not beyond belief that
we'll have an all-oral therapy available as early as 2015. That's
the pace it's going right now," he said.
"There's certainly hope," said Lok, who noted that the research was funded by drug maker Bristol-Myers Squibb.
More information
The U.S. National Institutes of Health has more on
clinical trials for hepatitis C.