Black patients fare well on Vertex hepatitis C drug

* 62 pct black patients cured vs 25 pct on current drugs

* 62 pct with advanced liver disease cured vs 33 pct

By Bill Berkrot

NEW YORK, Oct 30 (BestGrowthStock) – A closer look at data from a
late stage trial of Vertex Pharmaceuticals Inc’s (VRTX.O: )
eagerly anticipated hepatitis C drug telaprevir showed
impressive cure rates for black patients and for patients with
advanced liver disease.

In the Phase III study known as Advance, 62 percent of
black patients who received telaprevir achieved sustained viral
response (SVR), which is considered tantamount to a cure. That
compared with just a 25 percent cure rate from the current
standard drugs of pegylated interferon and ribavirin.

“If you look at that treatment difference and then you look
at the difference in the overall population, in fact the
benefit relatively speaking is even greater,” Robert Kauffman,
Vertex’s chief medical officer, said in a telephone interview.

“Obviously, from an absolute point of view it’s still a
little bit lesser response,” he said.

The study’s overall cure rates — 75 percent for telaprevir
in combination with the current standard drugs versus 44
percent for the standard drugs alone — was previously
released. But full details of the trial were being presented
for the first time at the American Association for the Study of
Liver Diseases meeting in Boston.

Breaking out an analysis of black patients in the trial was
significant because of the greater prevalence of hepatitis C
and historically lower cure rates for that population.

“African Americans bare a large proportion of the burden of
hepatitis C in the United States” compared with Caucasians
and the overall general population, Kauffman said.

According to data compiled from 1999 to 2002, one in seven
African American men between the ages of 50 and 59 in the
United States is living with hepatitis C.

Telaprevir, from a new class of antiviral drugs, is widely
expected to be approved by U.S. regulators next year. Vertex
plans to complete its application seeking approval this year.

Excitement has been high over the drug, and a similar
experimental medicine being developed by Merck & Co (MRK.N: ),
because they have demonstrated significantly higher cure rates
than current drugs and the potential to cut treatment duration
in half for many patients.

Cutting treatment duration from the current 48 weeks is a
huge advantage as the current drugs, which must still be taken
with the new medicines, can cause debilitating flu-like
symptoms that cause many patients to discontinue treatment or
avoid it altogether. It is believed that thousands of patients
with hepatitis C have been putting off treatment to await the
new, more effective medicines.

In the Advance study, 58 percent of patients who received
telaprevir met the criteria for a 24-week treatment duration.
That criteria called for levels of the virus in the blood to
fall to undetectable levels after four and 12 weeks of
treatment.

A separate study demonstrated no additional benefit from
extending telaprevir treatment to the full 48 weeks in patients
who met the criteria for shorter duration treatment.

A further sub-group analysis of the Advance data showed
that telaprevir led to a 62 percent cure rate in hepatitis C
patients with advanced liver fibrosis or cirrhosis compared
with a 33 percent SVR rate on standard drugs. Patients with
those conditions, which can lead to liver cancer or need for a
transplant, are also traditionally more difficult to treat than
the overall hepatitis C population.

“In our Phase III program, starting people with 12 weeks of
telaprevir-based combination therapy resulted in significant
improvements in viral cure rates, regardless of race, extent of
liver damage or experience with prior treatment,” Kauffman
said.
(Reporting by Bill Berkrot; Editing by Bernard Orr)

Black patients fare well on Vertex hepatitis C drug