ViiV Two-Drug HIV Pill Juluca Close To Europe Okay
The likely EMA approval of Juluca challenges the traditional HIV treatment paradigm of a three-drug regimen, with the single tablet, two-drug regimen offering the same efficacy as well as reduced toxicity and greater convenience.
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With EU submissions for once-monthly long-acting anti-HIV antivirals in hand, Janssen and ViiV appear to have set their sights on providing patients with more options.
ViiV Healthcare has published results from the first long-term Phase III study for switching from a three-drug combination, to an oral two-drug combination. It disproves resistance and safety fears that have hampered prescriber comfort, however, it may have to dampen its sales ambitions when ViiV’s soon-to-be-approved combo Tivicay/Epivir comes to market.
ViiV Healthcare has positive early pivotal data for its second two-drug regimen for HIV, but more reassurance is needed on the relative rates of virologic suppression in patients with low and high viral loads, as well as on the long-term risk of virologic failure. The combination should help form ViiV's defense against rival Gilead and its new triple combination Biktarvy.