ViiV Healthcare has filed a single-tablet, two-drug regimen of its dolutegravir and Janssen’s rilpivirine with regulators in both the US and EU.
If approved, the therapy will be the first two-drug regimen for the maintenance treatment of HIV-1 infection offering patients who are virally suppressed the option to switch to a regimen which does not include a nucleotide reverse transcriptase inhibitor (NRTI).
The submissions are based on data from the Phase III SWORD studies, which included more than one thousand patients and showed that the two-drug regimen was comparable in efficacy to three- or four-drug antiretroviral regimens in virologically suppressed patients.
“People living with HIV have always faced complex treatment regimens and a high pill burden. We know adherence is critically important for treatment outcomes and these regulatory submissions for dolutegravir plus rilpivirine represent a significant step forward in our efforts to deliver the first single-tablet, two-drug regimen for people living with HIV,” said Lawrence Blatt, global therapeutic area head, Infectious Disease Therapeutics, Janssen.
“If approved, this novel regimen will offer patients who are virally suppressed a safe and effective treatment option.”
In the US the regimen is undergoing a speedy six month review after ViiV submitted a priority review voucher to the FDA alongside the New Drug Application.
ViiV is majority-owned by GSK, with Pfizer and Shionogi as shareholders.