AAHIVM Encouraged by TMC125 Approval

New HIV Medication Could Offer More Options for Treatment-Experienced


Feb 04, 2008, 00:00 ET from The AIDS Institute

    WASHINGTON, Feb. 4 /PRNewswire/ -- 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).

SOURCE The AIDS Institute