Idenix believes that the Hepatitis C virus (HCV) treatment paradigm will evolve rapidly over the next three to five years with continued development of direct-acting antivirals (DAAs) from different drug classes. These treatments could potentially increase sustained virologic response (SVR) rates, reduce the duration of treatment, and improve tolerability and convenience for patients.
The most significant step in the paradigm shift will occur when pegylated interferon and/or ribavirin (PegIFN/RBV) is eliminated from treatment and patients receive an all-oral DAA combination regimen. This approach would expand the treated HCV population by including those patients who are intolerant to pegylated interferon-based therapies or those for whom existing treatment regimens have been ineffective. The combination of three or more direct-acting HCV antiviral agents, particularly agents directed against different HCV targets, could potentially lead to a potent inhibition of HCV replication and the suppression of the emergence of drug resistance, resulting in a higher cure rate. Nucleosides/nucleotides and protease inhibitors could be the preferred backbone in a combination regimen due to distinct modes of action, complementary resistance profiles and broad genotypic activity. Potent NS5A inhibitors and non-nucleosides could be the third or fourth component of a DAA combination regimen.
Idenix is building a pipeline of HCV drug candidates with a research and development program focused on nucleotide prodrugs and NS5A inhibitors. With clinical candidates in these two classes, the Company believes that they will be able to play a role in future combination regimens to treat hepatitis C—not only within Idenix but also with other companies. Idenix believes that the successful DAA combinations will be those that can significantly increase cure rates with good safety profiles and convenience. Most importantly, patients with hepatitis C will benefit if our goal is realized.