Imagine HIV patients needed to take their antiretroviral therapies not every day, not even every month, but every two months. A GlaxoSmithKline two-drug injectable regimen that’s already under review by the FDA for monthly use could soon turn it into reality, thanks to a phase 3 win.
GSK’s ViiV Healthcare said a phase 3 study showed an injection of its cabotegravir and Johnson & Johnson’s Edurant (rilpivirine), when given every two months, could work just as well as it does as a monthly therapy.
An application for the two-drug combo as a once-monthly injection has already been put under the FDA priority review with a decision expected by Dec. 29.
Previously, in two separate phase 3 trials dubbed Atlas and Flair, the long-acting therapy matched up to an oral three-drug regimen of two nucleoside reverse transcriptase inhibitors plus a third agent, and to ViiV’s very own triple-drug therapy Triumeq, in terms of controlling patients’ viral load after 48 weeks.
Now showing a comparable profile between the two-month delivery and the once-monthly approach “is further progress in our efforts to reduce the number of medicines a person living with HIV must take while also reducing the frequency of treatments,” Kimberly Smith, ViiV’s head of R&D, said in a statement.
ViiV has not unveiled detailed data from the Atlas-2M study. But when it does at an upcoming scientific meeting, doubters of the two-drug theory will likely look for signs of weakness in the therapy’s viral suppression ability. But for patients, being able to reduce the frequency of dosing will definitely be welcome news.
Currently, ViiV is charting new territory with its oral two-drug HIV therapies, with eyes on Gilead’s leading position.
Dovato, which combines ViiV’s star integrase inhibitor Tivicay (dolutegravir) and just one nucleoside inhibitor, Epivir (lamivudine), was approved by the FDA in April to treat treatment-naïve patients after showing comparable antiviral activity against a three-drug regimen at week 48. And ViiV recently padded its case—and hopefully extinguished some suspicions—by showing Dovato’s efficacy was maintained after 96 weeks.
Meanwhile, Juluca, which pairs Tivicay with Edurant, is approved in patients already virally suppressed who switch from other drugs. As the first complete two-drug HIV regimen, Juluca has shown it can suppress patients’ viral load through 100 weeks.
In the second quarter, Juluca and Dovato together delivered sales of £89 million ($109 million), not enough to make up for the declines posted by Tivicay and Triumeq.
During the same period, Gilead’s fast-growing triple cocktail Biktarvy racked up $1.12 billion in global sales, up more than 40% over the previous quarter, though some of that jump came from cannibalization of Gilead’s own older therapies.