GSK’s monthly HIV treatment breakthrough

GlaxoSmithKline has seen positive clinical results from the phase 3 study of its once-monthly injectable HIV treatment, stepping closer to potentially changing lives of patients living with the virus.

GSK‘s global specialist HIV subsidiary, ViiV Healthcare, revealed its phase 3 ATLAS (Antiretroviral Therapy as Long-Acting Suppression) study showing a two-drug regimen, cabotegravir and rilpivirine.

The experimental drug combination injected once a month had similar efficacy after 48 weeks of treatment to a currently FDA approved Gilead Sciences’ Biktarvy, daily oral three-drug regimen.

The new treatment met the primary endpoint for non-inferiority (the proportion of participants with plasma HIV-1 RNA ≥50 copies per millilitre) using the FDA Snapshot algorithm at week 48.

On top of the promising results, overall safety, virologic response and drug resistance for the injectable regimen were consistent with earlier trial results, the company revealed.

John Pottage

John Pottage

John Pottage, chief scientific and medical officer of ViiV Healthcare, said: “This novel approach is another step towards potentially reducing the treatment burden for people living with HIV.”

“The data from ATLAS suggest a long-acting, injectable 2DR of cabotegravir and rilpivirine may offer an alternative to daily, oral three-drug therapy for people who have previously achieved viral suppression.”

Detailed results from the study are expected to be presented at an upcoming scientific meeting, while headline data from FLAIR, a second pivotal trial evaluating the same combination in treatment-naïve individuals, are expected later this year.

Currently approved rival treatment produced by Gilead Sciences, received a green light from the US FDA in February this year. The triple-combination of bictegravir, emtricitabine, and tenofovir alafenamide is a one-a-day pill to treat patients with HIV-1.

The drug combination tested by ViiV Healthcare, which is being co-developed as part of a collaboration with Janssen Sciences, is not approved by regulatory authorities anywhere in the world.

“If approved, this 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”, said Pottage.

Don't miss your daily pharmaphorum news.
SUBSCRIBE free here.