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