Gilead’s Biktarvy gets European approval, setting up battle with GSK

Gilead has gained European approval for its new HIV combination therapy Biktarvy, hot on the heels of GSK's rival Juluca.

The single tablet regimen (STR) is a combination of integrase inhibitor bictegravir with Gilead’s already blockbuster Descovy, a combination of emtricitabine (FTC) and tenofovir alafenamide (TAF).

Analysts predict big things for Biktarvy, forecasting revenues of around $896mn this year and $3.7bn for 2022, making long-term HIV treatment more convenient for patients, and showing itself to prevent any cases of drug resistance.

“To help support the long-term health of people living with HIV, it is crucial to have regimens that deliver durable viral suppression with a high barrier to resistance,” said Professor Alan Winston, Professor of HIV and Genitourinary Medicine at Imperial College and Consultant Physician at St. Mary’s Hospital, London, UK. “In clinical trials through 48 weeks, BIC/FTC/TAF has shown high efficacy and zero resistance. With convenient dosing and few pre-screening or ongoing monitoring requirements, it has the potential to simplify treatment initiation, and follow-up over time.”

Juluca, marketed by GSK-led ViiV Healthcare is a two-drug combination which received EU approval just last month, putting the companies into direct competition.

The competition is so fierce that GSK sued its rival in February, claiming patent infingement in the US.

Gilead has an upper hand on GSK, as Biktarvy has been approved for treatment naive patients as well as patients who have been virologically suppressed on an antiretroviral regimen for at least three months. By contrast, Juluca's approval is for patients who have been virologically suppressed for six months, with no history of treatment failure—but not for patients new to drug treatment.

Gilead is relying on its HIV franchise to maintain its growth, as its once-flagship hepatitis C franchise continues to see sales decline, dropping by 60% to $1bn earlier this year.