WASHINGTON, Jan. 31 /PRNewswire/ -- The FDA approved Tibotec Pharmaceutical's novel non-nucleoside reverse transcriptase inhibitor (NNRTI) INTELENCE(R). The company also announced introductory pricing for the eagerly anticipated new compound at $21.80 per day, substantially lower than other recently introduced antiretrovirals.
"The efficacy that INTELENCE (TMC125/etravirine) has shown in the DUET studies is impressive. INTELENCE is an important new HIV medication that, for the first time, re-opens the NNRTI class to patients with NNRTI-resistant virus," stated Donna Christian-Chistensen, MD, Chair of the Congressional Black Caucus Health Brain Trust and TIICANN board member. "We applaud Tibotec for its efforts to make this innovative new medication available and accessible to people living with HIV."
In the Duet study, 612 patients were randomized and treated (304 in the TMC125 group, 308 in the placebo group). At week 24, 170 (56%) patients in the TMC125 group and 119 (39%) patients in the placebo group achieved a confirmed viral load of less than 50 copies per mL (difference in response rates 17%; 95% CI 9-25; p=0 005). Most adverse events were mild or moderate in severity. The type and incidence of adverse events, including neuropsychiatric events, seen with TMC125 were generally comparable with placebo, with the exception of rash (61 [20%] patients on TMC125 vs 30 [10%] on placebo) and diarrhea (36 [12%] patients on TMC125 vs 63 [20%] on placebo).
"As a long time member of the Fair Price Coalition, I must recognize the transparency, understanding and respect exhibited by Tibotec in its relations with the HIV/AIDS community," said Bill Arnold, Executive Director of TIICANN. "It is remarkable that Tibotec remains collegial in the broadest sense of that word in the face of the challenges being faced by its parent company, Johnson & Johnson."
"As a patient with a remarkably low tolerance for most antiretrovirals, I have always depended on NNRTIs as the base of my regimens," admitted Gary Rose, TIICANN's Chair. "It is a major relief for me to have a new option as my present regimen combining an NNRTI and a protease inhibitor which is both toxic and weakening. I think this is quite a common phenomena among patients with long-term exposure to antiretrovirals and so Tibotec's determination to develop new, non-cross resistant drugs for HIV, and just as importantly, oral compounds for hepatitis C - the company's dedication to virology is notable - is a cause for quiet celebration among infectious disease doctors and my fellow patients."
Congressman Maurice Hinchey, a TII CANN Board member stated: "Representing New York, which continues to bear the largest portion of the many burdens of the American AIDS epidemic, I'm very sensitive to any efforts to make new treatments affordable and accessible to all regardless of their financial circumstances or health insurance coverage. No HIV+ or AIDS patient should be denied access to critical drugs that can help them live longer and more productive lives."
Contact: Bill Arnold (202) 588-1775
|SOURCE The AIDS Institute|
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