TMC278 Demonstrates Long-Term Efficacy And Tolerability In Treatment-Naïve Adults With HIV

Main Category: HIV / AIDS
Also Included In: Clinical Trials / Drug Trials
Article Date: 06 Aug 2008 - 2:00 PDT

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New phase IIb data from Tibotec Pharmaceuticals Ltd. show that TMC278, the company's once-daily, investigational non-nucleoside reverse transcriptase inhibitor (NNRTI), provides long-term efficacy and tolerability in treatment-naïve adults with HIV. Ninety-six-week study results showed that more than 70 percent of patients receiving TMC278, plus a background regimen,

achieved a confirmed and sustained undetectable viral load (defined as < 50 HIV RNA copies/mL). These findings were presented today at the International AIDS Conference (AIDS 2008) in Mexico City.

"The phase IIb data show great potential for TMC278 as a once-daily treatment option for patients who have not previously taken anti-HIV medications," said clinical trial investigator Anton Pozniak, M.D., Chelsea and Westminster NHS Foundation Trust, London, UK. "We are continuing to investigate this promising once-daily therapy in two pivotal phase III trials, which will be conducted in Africa, Asia, Europe, North America and South America."

The phase IIb dose-finding study (TMC278-C204) evaluated the efficacy and tolerability of once-daily TMC278 at three doses (25 mg, 75 mg, and 150 mg once daily) and included an open label efavirenz (EFV) 600 mg once daily arm. A total of 366 patients were randomised to receive TMC278 (N= 277) or EFV (N= 89), and all patients received a background regimen of two nucleoside reverse transcriptase inhibitors (NRTIs), zidovudine + lamivudine (AZT/3TC) or tenofovir + emtricitabine (TDF/FTC).

Efficacy Results

At all three TMC278 doses, more than 70 percent of patients achieved an undetectable viral load at week 96. These findings were comparable to the EFV treatment group. Specifically, 76 percent of patients receiving the 25 mg dose of TMC278, which will be used in phase III studies, reached a confirmed and sustained undetectable viral load (<50 HIV-1 RNA copies/mL) at week 96 compared with 71 percent of patient receiving EFV.

Tolerability Results

Overall, treatment emergent adverse events were comparable in the TMC278 combined group vs. the EFV group with no significant difference in discontinuation rates (12 percent vs. 9 percent). 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) were also similar in the TMC278 combined group vs. the EFV group.

The most common AEs related to TMC278 or EFV were nausea (36 percent vs. 29 percent), headache (20 percent vs. EFV 16 percent) and upper respiratory tract infection (15 percent vs. 8 percent).

The incidences of rash, nervous system disorders, psychiatric disorders, headache and insomnia were 9, 31, 16, 20 and 7 percent for the TMC278 combined group, and 21, 48, 21, 16 and 6 percent for the EFV group.

TMC278 is the third anti-HIV compound to be developed by Tibotec Pharmaceuticals; another NNRTI is under investigation in treatment experienced adults with HIV and a protease inhibitor is currently indicated for treatment-experienced adults with HIV. Tibotec Pharmaceuticals is also developing investigational compounds for the treatment of hepatitis C and tuberculosis.

About Tibotec Pharmaceuticals Ltd.

Tibotec Pharmaceuticals Ltd., based in Cork, Ireland, is a pharmaceutical research and development company. The Company's main research and development facilities are in Mechelen, Belgium with offices in Yardley, Pennsylvania, USA. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS drugs and anti-infectives for diseases of high unmet medical need.

http://www.tibotec.com

Tibotec is a member of the Johnson & Johnson family of companies.

Forward Looking Statement

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'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 December 30, 2007. Copies of this Form 10-K, as well as subsequent filings, are available online at http://www.sec.gov, http://www.jnj.com or on request from Johnson & Johnson. Tibotec does not undertake to update any forward-looking statements as a result of new information or future events or developments.

Tibotec Pharmaceuticals Ltd.