AAHIVM Encouraged by TMC125 Approval

Washington, D.C. -- The American Academy of HIV Medicine (AAHIVM), a national organization of HIV-treating physicians, nurse practitioners and physician assistants, praised the accelerated U.S. Food and Drug Administration (FDA) approval of the anti-HIV medication TMC125 (etravirine), the first non-nucleoside reverse transcriptase inhibitor (NNRTI) to be introduced in nearly 10 years, and the first to show antiviral activity in treatment-experienced adult patients with NNRTI-resistant virus. NNRTI drug resistance occurs when HIV develops mutations that partially or completely stop the NNRTI from binding to the reverse transcriptase enzyme, causing the drug to lose effectiveness.

"With the FDA's accelerated approval of TMC125, we are encouraged by the increased treatment options that are now available for our patients," said AAHIVM Board Chair Jeffrey Schouten, MD, AAHIVS. "With antiretroviral therapy now in its third decade, HIV care providers have increasing concern over the cross-resistance of the NNRTI class. A patient resistant to one NNRTI is generally resistant to the other NNRTIs available, which significantly limits our options with our longtime and treatment-experienced patients. This drug may also be very useful for people who are infected with an NNRTI-resistant strain of HIV which is not uncommon. TMC125 offers HIV care providers another treatment option that could dramatically increase the capacity for continued success in their patients' long-term HIV care."

FDA-accelerated approval procedures allow for earlier approval of drugs that provide a meaningful therapeutic advantage over existing treatment for serious or life-threatening diseases. Longer-term data will be required before the FDA can consider traditional approval of TMC125. Dr. Schouten emphasized the importance of closely monitoring changes to any treatment regimen to recognize possible barriers to treatment adherence and to maximize potential for treatment success.

The American Academy of HIV Medicine is an independent organization of AAHIVM HIV Specialists^TM and other health care professionals dedicated to advancing excellence in HIV/AIDS care. Through advocacy and education, AAHIVM is committed to supporting HIV clinicians and to ensuring better care for those living with HIV disease. AAHIVM is the only U.S. medical organization serving a membership of MDs, DOs, NPs and PAs, and providing all members the opportunity to credential as HIV Specialists^TM.