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DewDiligence

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DewDiligence

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Re: DewDiligence post# 64396

Sunday, 08/10/2008 10:54:29 AM

Sunday, August 10, 2008 10:54:29 AM

Post# of 251852
JNJ Reports 96-Week Phase-2b Data for TMC278

[TMC278, a non-nucleoside reverse transcriptase inhibitor, is a direct competitor of IDIX’s IDX899. It should not be confused with TMC125 (Intelence), another NNRTI for HIV that is already on the market. Tibotec is a wholly-owned subsidiary of JNJ.

The phase-2b study described here tested three doses of TMC278 (25, 75 and 150mg qD) in treatment-naïve patients. All three doses achieved results comparable to Sustiva when added to a Truvada or Epzicom background, and hence only the lowest dose (25mg qD) was advanced into phase-3 (#msg-30789106). Details of the phase-2b study may be found at:
http://clinicaltrials.gov/ct2/show/NCT00110305 .]

http://biz.yahoo.com/prnews/080805/nytu028.html

›August 5, 2008

MEXICO CITY, Aug. 5 /PRNewswire/ -- New phase IIb data from Tibotec Pharmaceuticals Ltd. provides additional information on the safety and efficacy of TMC278, the company's once-daily, investigational non-nucleoside reverse transcriptase inhibitor (NNRTI), as part of HIV combination therapy in treatment-naive adults. These findings were presented today at the International AIDS Conference (AIDS 2008) in Mexico City.

Seventy-six percent of patients receiving the 25 mg dose of TMC278, which is being studied in phase III trials, achieved an undetectable viral load (<50 HIV-1 RNA copies/mL) at week 96 compared with 71 percent of patients receiving efavirenz (EFV). Of patients receiving the 75 mg and 150 mg doses of TMC278, 72 percent and 71 percent achieved an undetectable viral load, respectively.

"NNRTIs have been an integral part of combination antiretroviral therapy for over a decade," said clinical trial investigator Peter Shalit, M.D. Swedish Medical Center, Seattle, WA. "The phase IIb data show potential for TMC278 as a once-daily treatment option for patients who have not previously taken anti-HIV medications."

TMC278 is an investigational product, and the safety and efficacy of it, in combination with other antiretroviral agents, has not been established. Two major phase III trials for TMC278 are being conducted in Africa, Asia, Europe, North America and South America, and are currently recruiting treatment-naive adult patients.

Study Design

The phase IIb dose-finding study (TMC278-C204) evaluated the efficacy, tolerability and safety of once-daily TMC278 at three blinded doses (25 mg, 75 mg, and 150 mg) and included an open label EFV 600 mg arm. A total of 368 patients were randomised to receive one of the three doses of TMC278 or EFV, and all patients received a background regimen of two nucleoside reverse transcriptase inhibitors (NRTIs), zidovudine + lamivudine [Epzicom] (AZT/3TC) or tenofovir + emtricitabine [Truvada] (TDF/FTC).

Safety Results

Of patients in the TMC278 combined group compared with EFV, 9 percent vs. 21 percent experienced rash, 31 percent vs. 48 percent experienced nervous system adverse events and 16 percent vs. 21 percent experienced psychiatric events.

Overall, patients in the TMC278 combined group (all doses) vs. the EFV group experienced similar incidences and types of serious adverse events (SAEs) (12 percent vs. 15 percent), grade 3 or 4 adverse events (AEs), (27 percent vs. 21 percent) and grade 3 or 4 laboratory abnormalities (26 percent vs. 24 percent).‹

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