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.
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.
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.”