Janssen Sciences Ireland announced ViiV Healthcare has made regulatory submissions to both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for a single-tablet, two-drug regimen of dolutegravir (ViiV Healthcare) and rilpivirine (Janssen). If approved, this will be the first two-drug regimen for the maintenance treatment of HIV-1 infection and will offer those living with HIV 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 the Phase III SWORD studies which included more than one thousand patients who previously achieved viral suppression on a three or four drug antiretroviral regimen. The data were presented at the 2017 Conference on Retroviruses and Opportunistic Infections (CROI) in February.
A Priority Review voucher was submitted to the FDA along with the dolutegravir and rilpivirine two-drug regimen New Drug Application (NDA). Under the Prescription Drug User Fee Act, the anticipated target action date is six months after receipt of the application by the FDA.
"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," Lawrence M. Blatt, Global Therapeutic Area Head, Infectious Disease Therapeutics, Janssen said. "If approved, this novel regimen will offer patients who are virally suppressed a safe and effective treatment option."
Use of dolutegravir and rilpivirine as a two-drug regimen for HIV maintenance therapy is investigational and not approved anywhere in the world.