News from Gilead on TMC278 and GS9450

On April 20, Gilead Sciences announced that the Phase 2 clinical trial of GS 9450, an investigational capsase inhibitor, in patients with chronic hepatitis C, was halted. This decision follows reports of significant laboratory abnormalities and adverse events in a number of clinical study participants.

According to a press release issued by Gilead, “Patient safety is Gilead’s top priority, and the company has therefore made the decision to halt this study
immediately. Gilead will be conducting a thorough review of all available data to assess future clinical development of the compound.”

Better news was reported in an April 27th press release regarding progress on the fixed dose combination of Gilead’s Truvada with Tibotec Pharmaceutical’s TMC278. According to the release, data supports “bioequivalence of a formulation of the fixed dose combination of Truvada (emtricitabine
and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals’ investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC278 (rilpivirine hydrochloride, 25 mg).”

A bioequivalence study is required to demonstrate that a co-formulated product results in the same levels of medication in the blood as achieved when the individual products are dosed simultaneously as separate pills.

Gilead anticipates submitting a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the fixed dose combination following validation of the TMC278 NDA.

Johnson & Johnson, which owns Tibotec Pharmaceuticals, announced last week that the two pivotal Phase 3 studies evaluating TMC278 as a treatment for HIV in treatment-naïve patients met the primary efficacy objective. In addition, the company announced plans to present the data in full at an upcoming HIV
conference, and that submission of TMC278 for regulatory review is on track for the third quarter of this year.

The fixed-dose single-tablet combination of Truvada and TMC278 is an investigational product and the safety and efficacy have not yet been established.

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.


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