SILVER SPRING, Md., May 23, 2011 /PRNewswire-USNewswire/ — The
U.S. Food and Drug Administration today approved Incivek
(telaprevir) to treat certain adults with chronic hepatitis C
infection. Incivek is used for patients who have either not
received interferon-based drug therapy for their infection or who
have not responded adequately to prior therapies. Incivek is
approved for use with interferon therapy made up of peginterferon
alfa and ribavirin.
The current standard of care for patients with chronic hepatitis
C infection is peginterferon alfa and ribavirin taken for 48 weeks.
Less than 50 percent of patients respond to this therapy.
The safety and effectiveness of Incivek was evaluated in three
phase 3 clinical trials with about 2,250 adult patients who were
previously untreated, or who had received prior therapy. In all
studies patients also received the drug with standard of care. In
previously untreated patients, 79 percent of those receiving
Incivek experienced a sustained virologic response (i.e. the
infection was no longer detected in the blood 24 weeks after
stopping treatment) compared to standard treatment alone.
The sustained virologic response for patients treated with
Incivek across all studies, and across all patient groups, was
between 20 and 45 percent higher than current standard of care.
The studies indicate that treatment with Incivek can be
shortened from 48 weeks to 24 weeks in most patients. Sixty percent
of previously untreated patients achieved an early response and
received only 24 weeks of treatment (compared to the standard of
care of 48 weeks). The sustained virologic response for these
patients was 90 percent.
When a person achieves a sustained virologic response after
completing treatment, this suggests that the hepatitis C infection
has been cured.