With current regimens resulting in up to 99% cure rates in some subsets of patients, a pan-genotypic, once-a-day single pill regimen is the next far-reaching goal. The HCV therapy landscape has evolved rapidly in the last two years. Gilead's Sovaldi was the first interferon-free nucleotide ('nuc') polymerase inhibitor approved for people infected with HCV GT2 (Nat. Biotechnol. 32, 3–5, 2014) in December 2013. Gilead followed with Harvoni in October 2014, the first noninterferon, nonribavirin, single pill cocktail to treat people infected with HCV GT1, the most frequently isolated variant in the US (Nat. Biotechnol. 32, 1070, 2014). Once-daily Harvoni combines ledipasvir, a nonstructural 5A (NS5A) replication inhibitor, with Sovaldi, and in some patients with low viral loads achieves viral cures in as little as eight weeks.
AbbVie has set out to challenge Sovaldi with its fixed combinations of direct-acting antivirals with distinct mechanisms of action. AbbVie's interferon-free combo regimen Viekirax (ombitasvir—a novel NS5A inhibitor, and protease inhibitors paritaprevir and ritonavir) plus Exviera (dasabuvir), a non-nucleoside polymerase inhibitor, received US Food and Drug Administration (FDA) approval in December 2014 for treating GT1 infections and marketing authorization in January 2015 from the European Commission.
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