ViiV Healthcare Ltd. is seeking U.S. approval to expand the use of its two-drug HIV treatment Dovato to patients who are already on a three-drug regimen.
If approved, Dovato will be available as a "switch treatment" for adults with HIV-1 who are already seeing benefits from an existing treatment regimen, usually a three-drug combo containing tenofovir, alafenamide and fumarate. ViiV's Dovato is only available in the US for HIV patients who have never received treatment for their disease.
It is also approved in Europe for patients with no known or suspected resistance to lamivudine, one of two medicines that make up Dovato, which also contains dolutegravir.
ViiV is majority owned by GlaxoSmithKline PLC and also counts Pfizer Inc. and Shionogi & Co. Ltd. as its shareholders.
The company's filing is based on data from a phase 3 trial called Tango, which showed Dovato worked as well as a three-drug treatment regimen in patients who switched to ViiV's medicine. In July, the London-based company announced results from two post-approval studies that reached the same conclusion in patients who had not previously been treated.
"Today's submission takes us a step closer toward offering this option for virologically suppressed adults living with HIV who are looking to treat HIV with fewer drugs," Kimberly Smith, head of research and development at ViiV Healthcare, said in a statement.
Approximately 1.1 million people in the U.S. are affected by HIV, of which 15% do not know they have the infection, according to a U.S. Food and Drug Administration estimate.