Johnson & Johnson subsidiary Janseen Pharmaceuticals and ViiV Healthcare have reported positive topline results from their phase III trial of an investigational long-acting injectable two drug regimen for the treatment of human immunodeficiency virus-1 (HIV-1).
The ATLAS study demonstrated that the combination of injecting Janssen’s rilpivirine and ViiV’s cabotegravir, had a similar efficacy to the standard of care, which is a daily, oral three drug regimen composed of two nucleoside reverse transcriptase inhibitors (NRTIs) and a third agent. The third component can be either an integrase inhibitor (INI), non- nucleoside reverse transcriptase inhibitors (NNRTI) or a protease inhibitor (PI).
The trial, which involved 618 patients living with HIV-1 and was conducted at multiple global research centres, met its primary endpoint of non-inferiority to the standard of care. It also recorded safety, virology response and drug resistance results consistent with previous phase II studies.
Janssen global public health head of research and development Wim Parys said: “These results offer new evidence that suggest this investigational, two-drug, once a month dosing regimen may reduce the impact of treatment on people’s lives.
“This novel approach would signify a much-needed treatment evolution for people living with HIV, moving from dosing 365 days a year to just 12 times per year.”
ViiV Healthcare chief scientific and medical officer John C Pottage said: “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.
“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.”
Janssen’s rilpivirine is an NNRTI, which has been approved in tablet from to treat HIV alongside other antiretrovirals. However, as an injectable nanoparticle suspension for intramuscular injection it has not yet been approved.
ViiV Healthcare’s cabotegravir is an INI, which is available as a long-acting nanosuspension formulation for intramuscular injection and as a once daily oral tablet to be taken prior to injection. It has not been approved in either form by any global regulatory authorities.
Janseen and ViiV Healthcare have also collaborated on the two drug combination for Juluca, which was recently recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use.