Fresh off its Juluca approval, GlaxoSmithKline beefs up trials of long-acting HIV duo

GSK building
GlaxoSmithKline now has three trials underway of its cabotegravir-rilpivirine combo.

GlaxoSmithKline’s ViiV only just won its first two-drug HIV approval, but it's already bolstering its trial program to see just how convenient it can make a two-drug regimen. 

The British drugmaker is kicking off a phase 3 study that’ll assess every-other-month injections of candidate cabotegravir alongside rilpivirine, marketed by Johnson & Johnson’s Janssen as Edurant. The trial will compare the every-two-month regimen with once-monthly dosing of the same tandem, ViiV said.

If GSK can show that the duo works well with just six treatments per year, it’ll mark a big selling point for the British drugmaker. But it’s still early days, with initial results not expected until 2019. Glaxo only just launched a pair of phase 3 studies last November evaluating once-a-month administration of the cocktail.  

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RELATED: Can Merck knock Glaxo off its HIV perch? Maybe so, one analyst says

As both GlaxoSmithKline and chief HIV nemesis Gilead know, long-acting competition from Merck is on the horizon, albeit far off. As Citi analyst Andrew Baum highlighted in a July note to clients, the New Jersey pharma giant is developing a prospect known as EFdA that has potential as both a daily pill and a twice-yearly injection. That product could reach the market in 2021 at the earliest, Baum said.

RELATED: GlaxoSmithKline turns up the heat on Gilead with landmark 2-drug HIV win

For now, though, Glaxo is reveling in its first two-drug victory, which came in the form of last week’s FDA approval for Juluca. That medication, which pairs rilpivirine with hot-selling Tivicay, should help the company get a leg up on Gilead thanks to a lighter side-effect burden and a lower price. GSK put a sticker of $2,579 on the product, a price it says is “in the lower range of single tablet regimens used to treat HIV in the U.S.”