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