12:00 AM
Sep 13, 2010
 |  BioCentury  |  Product Development

Combination hesitation

Idenix setback doesn’t change outlook for combining direct antivirals for HCV

Idenix Pharmaceuticals Inc. and competing companies developing combinations of direct antivirals to treat HCV all agreed that the side effects seen in a Phase I trial of two of the biotech's antivirals are compound-specific. The setback thus won't dampen interest in replacing interferon-based regimens with an all-oral cocktail of direct antivirals as the standard of care.

Last week, FDA placed IDX184 and IDX320 on hold after Idenix saw liver abnormalities in a Phase I trial combining the two agents alone.

Despite the setback, direct antiviral agents - small molecules that target viral proteins to block replication - are the future of HCV therapy, according to Raymond Chung, director of hepatology at Harvard Medical School.

"Even with the introduction of telaprevir and boceprevir next year as add-ons to interferon-based therapy, this is not going to move the needle substantially in terms of providing treatment for the vast majority of patients" who failed or could not tolerate IFN, "or who have remained on the sidelines because of concerns about efficacy and tolerability," noted Chung.

Telaprevir and boceprevir, both protease inhibitors, are in Phase III testing to treat HCV genotype 1 infection. Vertex Pharmaceuticals Inc. and Merck & Co. Inc. plan to submit NDAs for their respective compounds this half.

Vertex is developing telaprevir with Johnson & Johnson and Mitsubishi Tanabe Pharma Corp.

"An oral cocktail of direct antivirals involving multiple complementary agents with non-overlapping mechanisms remains the Holy Grail," Chung said, because in addition to offering significantly better tolerability, compliance and success, the strategy presents the possibility of a pan-genotypic cure beyond the genotype 1 infection that is predominant in the U.S. and Europe.

Because no single agent has been sufficiently effective,...

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