Glaxo's ViiV touts more 2-drug HIV success with monthly injectable win

GlaxoSmithKline’s ViiV Healthcare has already shown that a two-drug HIV regimen can hang with its three-drug competitors. But now it has data showing it can do the same with administration just once per month.

Thursday, ViiV rolled out results from two studies showing an injection pairing its own cabotegravir with Johnson & Johnson’s rilpivirine (Edurant), given once every four weeks, can maintain viral suppression in HIV-positive adults as well as a standard-of-care three-drug regimen taken daily. The data will be part of the approval application ViiV submits to regulatory authorities later this year.

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“If approved, this two-drug regimen would give people living with HIV one month between each dose of antiretroviral therapy, changing HIV treatment from 365 dosing days per year to just 12,” John Pottage, Jr., M.D., ViiV’s chief scientific and medical officer, said in a statement.

The studies, dubbed Atlas and Flair, revealed similar efficacy, safety and tolerability between the two regimens. But ViiV also touted patient preference data, which showed “nearly all participants who switched to the long-acting injectable regimen preferred it over their prior oral therapy,” Pottage noted.

ViiV already has one two-drug combo on the market in Juluca, a therapy approved for patients who are virally suppressed already. But it’s looking to expand that lineup to grab a larger piece of the pie. Rival Gilead, meanwhile, is tearing up the market with three-drug cocktail Biktarvy, which racked up $1.18 billion in 2018 after its February approval.

ViiV, which has been chipping in important sales for Glaxo as its respiratory drugs have struggled, is also testing a combination of  dolutegravir (Tivicay) and lamivudine (Epivir) in new patients. In June, two phase 3 studies showed that the tandem was noninferior at controlling HIV viral load compared with a standard triplet marrying dolutegravir with Gilead’s Truvada (tenofovir and emtricitabine).