ViiV Healthcare has applied to the FDA and the European Medicines Agency (EMA) for approval of the first two-drug antiretroviral (ARV) regimen to treat HIV. The dual combination of ViiV’s integrase strand transfer inhibitor Tivicay (dolutegravir) and Janssen’s non-nucleoside reverse transcriptase inhibitor (NNRTI) Edurant (rilpivirine) has shown comparable efficacy to three- and four-drug ARV regimens in advanced trials.
The new-drug application (NDA) is for a daily combination tablet of Tivicay and Edurant for use as a maintenance regimen—for people who already have a fully suppressed viral load thanks to effective HIV treatment.
ViiV has submitted a priority review voucher to the FDA along with its NDA. The federal agency is expected to make a decision in January 2018.
The FDA and EMA submissions are based on findings from the replicate, randomized, open-label, non-inferiority Phase III SWORD-1 and -2 studies, in which more than 1,000 participants were initially virally suppressed and taking a three- or four-drug integrase inhibitor–, NNRTI– or boosted protease inhibitor–based ARV regimen. The participants were randomized to remain on their original regimen or to switch to Tivicay and Edurant, which were given as individual tablets. The ongoing studies are set to run for 148 weeks.
Forty-eight week findings from the SWORD trials were presented at the 2017 Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle. The two arms of the study showed similar rates of full viral suppression.
As the trials progress, researchers will further examine the development of viral resistance, safety and tolerability measures and changes in biomarkers indicating kidney, bone and cardiovascular health. Additionally, the trial investigators will explore any association between the two-drug regimen and health-related quality of life and adherence rates, as well as the willingness to switch to such a regimen among people with HIV.
To read a press release on ViiV’s NDAs, click here.