Gilead's HIV combination treatment Biktarvy approved by FDA

Gilead Sciences on Wednesday announced that the FDA approved its once-daily single-tablet therapy Biktarvy, which combines Descovy (emtricitabine/tenofovir alafenamide) with the integrase strand transfer inhibitor bictegravir, for the treatment of HIV-1 infection. The therapy is specifically indicated for use in adults with no known history of antiretroviral treatment or to replace current antiretroviral regimen in virologically suppressed patients on a stable antiretroviral regimen for at least three months with no history of treatment failure and no known mutations linked to resistance to the individual therapies. 

According to the drugmaker, approval of Biktarvy was supported by safety and efficacy data from four currently ongoing late-stage studies, namely Study 1489 and Study 1490 in treatment-naïve adults and Study 1844 and Study1878 in virologically suppressed adults. Gilead previously unveiled data from all four studies showing that the treatment met the primary endpoint of non-inferiority. 

Commenting on the news, RBC Capital Markets analyst Brian Abrahams said the approval of Biktarvy helps "set the stage for long-term growth and sustainability of Gilead's core HIV franchise." The analyst also predicted that the drug could become a "gold standard" therapy for treatment-naïve patients based on its high barrier to resistance and safety profile. 

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Meanwhile, Mizuho analyst Salim Syed noted that the list price of the drug of $35 859 is in line with that of other single-tablet HIV therapies. Analysts expect Biktarvy to generate about $1 billion in revenue this year, rising to about $5 billion annually by 2024.

Descovy was previously approved in the US and EU for use in children and adults aged 12 and older with HIV-1 infection. 

Separately on Wednesday, ViiV Healthcare, which is majority-owned by GlaxoSmithKline, with Pfizer and Shionogi as shareholders, disclosed that it has filed patent infringement litigation against Gilead over bictegravir in the US and Canada. ViiV said that it will aim to prove that Gilead triple combination HIV drug containing bictegravir infringes ViiV’s patent covering Tivicay (dolutegravir) "and many other compounds that include dolutegravir’s unique chemical scaffold".

For related analysis, see ViewPoints: Gilead plays up its downside. See also The drugs that will shape 2018.

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