VIENNA, July 22 /PRNewswire/ -- Tibotec Pharmaceuticals
announced today results from two pivotal Phase 3, double-blind,
randomized clinical trials comparing the efficacy, safety and
tolerability of its investigational non-nucleoside reverse
transcriptase inhibitor (NNRTI) TMC278 (rilpivirine) versus
efavirenz (EFV), each administered once daily with a
nucleoside/nucleotide background regimen in treatment-naive,
HIV-1-infected adults. These global trials, known as ECHO and
THRIVE, reached their primary objective, which was to demonstrate
non-inferiority of TMC278 vs. EFV in the proportion of patients
achieving an undetectable viral load (less than 50 copies/mL) at
week 48 (with a maximum allowable difference of 12 percent).
A pooled analysis of ECHO and THRIVE was presented today at
the XVIII International AIDS Conference in Vienna, Austria.
ECHO and THRIVE pooled results showed that 84.3 percent of
patients (n=686) in the TMC278 group reached an undetectable viral
load, compared with 82.3 percent of patients (n=682) in the EFV
group. The difference between the treatment groups was not
significant. Patients received TMC278 (25 mg) or EFV (600 mg), each
administered once daily in combination with a nucleoside/nucleotide
background regimen. The virologic failure rate was 9 percent in the
TMC278 group and 4.8 percent in the EFV group.
TMC278 is an investigational product, and the safety and
efficacy has not yet been established. Tibotec plans to submit
these results to the U.S. Food and Drug Administration (FDA) to
support approval of TMC278 for use in treatment-naive adult
patients.
"I'm very excited by the findings of these Phase 3 results for
TMC278," said Calvin J. Cohen, M.D.,
M.Sc., lead clinical investigator and Research Director at
Community Research Initiative of New England and Harvard Vanguard
Medical Associates. "These studies provide valuable information on
the safety and tolerability of TMC278 and, specifically, its
metabolic and CNS side effect profiles."
Adverse events (AEs) leading to discontinuation in the TMC278
group were 3.4 percent compared to 7.6 percent in the EFV group,
and Grade 2–4 AEs at least possibly related to treatment were 15.9
percent in the TMC278 group versus 31.1 percent in the EFV
group. Grade 2-4 AEs of interest by organ class reported among
patients in the TMC278 group versus the EFV group were psychiatric
(14.9 percent vs. 22.7 percent), neurological (17.1 percent vs.
37.8 percent) and rash-all types (3.1 percent vs. 13.6 percent).
Grade 3/4 lipid abnormalities were also reported among patients in
the TMC278 group versus the EFV group for increases in total
cholesterol (0.1 percent vs. 2.5 percent), LDL-cholesterol (0.7
percent vs. 4.1 percent) and triglycerides (0.3 percent vs. 2.2
percent).
About ECHO and THRIVE
ECHO (TMC278-TiDP6-C209) and THRIVE (TMC278-TiDP6-C215) are
pivotal Phase 3, double-blind, randomized studies that evaluated
the efficacy, safety and tolerability of TMC278 in 1,368
treatment-naive, HIV-1-infected adults. ECHO (Efficacy
Comparison in treatment-naive HIV-infected subjects
Of TMC278 and EFV) evaluated TMC278 (25 mg) once daily,
versus EFV (600 mg) once daily, combined with a fixed
background regimen consisting of emtricitabine + tenofovir
disoproxil fumarate. THRIVE (TMC278 against
HIV, in a once daily RegImen Versus
Efavirenz) evaluated TMC278 (25 mg) once daily versus EFV
(600 mg) once daily, combined with an investigator-selected
background regimen consisting of two N[t]RTIs (abacavir +
lamivudine or emtricitabine + tenofovir disoproxil fumarate or
zidovudine + lamivudine).
Each study is being conducted at more than 100 sites, in more
than 20 countries. The studies will last for a total of 104
weeks, which includes a four-week screening period, a 96-week
treatment period and a four-week follow-up period.
Tibotec Pharmaceuticals plans to file the 48-week findings from
ECHO and THRIVE with the FDA when seeking marketing authorization
for TMC278. Pending approval, Tibotec Therapeutics will
commercialize TMC278 in the United
States. Tibotec has also entered into a license and
collaboration agreement with Gilead Sciences, Inc. (Nasdaq: GILD)
for the development and commercialization of a once-daily,
fixed-dose combination of TMC278 and Gilead's Truvada®
(emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg).
About Tibotec Pharmaceuticals
Tibotec Pharmaceuticals, based in Cork, Ireland, is a pharmaceutical research
and development company. The Company's main research and
development facilities are in Beerse, Belgium, with offices in Titusville, NJ, USA. Tibotec is dedicated to
the discovery and development of innovative HIV/AIDS drugs and
anti-infectives for diseases of high unmet medical need.
About Tibotec Therapeutics
Tibotec Therapeutics, a division of Centocor Ortho Biotech
Products, L.P., headquartered in Titusville, NJ, is dedicated to delivering
innovative virology therapeutics that help healthcare professionals
address serious unmet needs in people living with HIV.
Tibotec Pharmaceuticals and Centocor Ortho Biotech Products,
L.P. are subsidiaries of Johnson & Johnson.
This press release contains "forward-looking statements" as
defined in the Private Securities Litigation Reform Act of 1995.
These statements are based on current expectations of future
events. If underlying assumptions prove inaccurate or unknown
risks or uncertainties materialize, actual results could vary
materially from Tibotec Pharmaceuticals and/or Johnson &
Johnson's expectations and projections. Risks and
uncertainties include general industry conditions and competition;
economic conditions, such as interest rate and currency exchange
rate fluctuations; technological advances and patents attained by
competitors; challenges inherent in new product development,
including obtaining regulatory approvals; domestic and foreign
health care reforms and governmental laws and regulations; and
trends toward health care cost containment. A further list
and description of these risks, uncertainties and other factors can
be found in Exhibit 99 of Johnson & Johnson's Annual Report on
Form 10-K for the fiscal year ended January
3, 2010. Copies of this Form 10-K, as well as
subsequent filings, are available online at www.sec.gov,
www.jnj.com or on request from Johnson & Johnson. Neither
Tibotec Pharmaceuticals nor Johnson & Johnson undertake to
update any forward-looking statements as a result of new
information or future events or developments.
Truvada is a registered trademark of Gilead Sciences,
Inc.
Contact:
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Hans Vanavermaete
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Mobile: +32 (0) 478 44 72
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Pamela Van Houten
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Mobile: +1 908-295-7367
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SOURCE Tibotec Pharmaceuticals