Project Inform Welcomes Approval and Pricing of Intelence, Calls for Further Research
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.
This article was provided by Project Inform. Visit Project Inform's website to find out more about their activities, publications and services.