In the news ... 2008
FOR IMMEDIATE RELEASE:
Project Inform Welcomes Approval and Pricing of Intelence,
Calls for Further Research
Contact: Paul Dalton, Director of Treatment Information and Advocacy,
415-558-8669 x212
January 23, 2008
Today Project Inform, a leading national HIV/AIDS treatment and
public policy advocacy organization, enthusiastically supported
the Food and Drug Administration’s approval of Intelence
(etravirine, TMC-125) for treating multi-drug resistant HIV. Project
Inform also praised the manufacturer’s (Tibotec) decision
to resist the pharmaceutical industry’s trend toward ever
higher drug prices—leadership that will help to ensure widespread
access to this life-saving new drug.
Intelence is an important new option for people with drug resistant
HIV. Unlike other drugs of its type, called non-nucleoside
reverse transcriptase inhibitors (NNRTIs), Intelence is able
to overcome much of the resistance to the other NNRTIs. This class
includes one of the most widely used first line treatment options,
efavirenz, sold as Sustiva and as part of the popular fixed-dose
combination pill Atripla. “Finally, people have a second
chance with this class of drugs,” said Paul Dalton, Project
Inform’s Director of Treatment Information and Advocacy. “It
has been a long time coming.” Before the development of Intelence,
most people effectively had one chance at using this important
class of drugs, as HIV that developed resistance to one NNRTI was
most likely to be resistant to the others.
However, important unanswered questions remain about Intelence
that will require further research. For one, only about 10% of
the people in the pivotal studies of Intelence were women, who
make up nearly 25% of people living with HIV in the US and nearly
50% worldwide. Similarly, about 13% of people in the studies had
liver problems—a group that makes up nearly 40% of the US
epidemic. With the GRACE study—a landmark study looking at
possible gender differences among people taking Prezista, Tibotec
showed a commitment to studying its drug in women. Project Inform
calls on them to follow their own example and conduct further research
on Intelence in women and people with liver disease.
The best use of Intelence also remains an issue. Intelence has
been studied mostly alongside the boosted PI Prezista. It has many
drug interactions with other boosted PIs that are commonly used
after treatment failure with other NNRTIs. Intelence cannot be
taken with Aptivus (tipranavir), Lexiva (fosamprenavir), Reyataz
(atazanavir) or full-dose Norvir (ritonavir). Its use with Kaletra
is recommended only with caution. This leaves only Invirase (saquinavir)
and Prezista as the boosted PIs that can be taken with Intelence
without a dose adjustment. However, it can be used with the recently
approved drugs Isentress (raltegravir) and Selzentry (maraviroc),
as well as Fuzeon (enfuvirtide) and all NRTIs.
Tibotec’s decision to price Intelence at $21.80 per day,
well below other recently approved drugs, is to be applauded. Where
Merck, Pfizer and Boehringer Ingelheim have priced their new drugs
near the top of the scale for HIV drugs, Tibotec has priced Intelence
at the low end of the protease inhibitor class. “This decision
is especially welcome on the heels of Bristol-Myers Squibb’s
recent price hikes,” said Dalton. “Tibotec’s
gutsy choice to price this important new drug reasonably should
ensure its quick addition to the formularies of both public and
private insurance programs, ultimately getting to the people who
most need this new drug.”
Tibotec has worked closely with the activist community throughout
the development of Intelence. From the design of the DUET studies—the
pivotal trials that were the basis for the approval of Intelence—to
allowing the use of other experimental drugs in their expanded access
programs and to their pricing, they have shown industry leadership
by listening and responding to the needs of people living with HIV/AIDS.
Project Inform welcomes this practice and implores the rest of the
pharmaceutical industry to follow suit.
