- Gilead Sciences' triplet therapy Biktarvy proved as effective as GlaxoSmithKline's well-established triplet Triumeq in treating HIV-1 infection for infected adults who hadn't received previous therapy, according to data from a Phase 3 study disclosed by Gilead Wednesday.
- Gilead provided an update for top-line results 96 weeks into a 144-week trial, showing Biktarvy to be non-inferior to Triumeq in maintaining virological suppression. No study participants randomized to Biktarvy developed treatment-emergent resistance.
- The results will be presented as a late-breaking abstract this week at IDWeek 2018 in San Francisco.
Gilead and GSK are fighting in the same busy marketplace, and growth here is crucial for Gilead, as its hepatitis C portfolio has fallen fast — revenues dropped by about 40% in 2017.
Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) has the benefit of a broad label, and since its approval earlier this year, Gilead has pushed it as an alternative to other treatments on the market. For example, data from a different Phase 3 study supported Biktarvy as an effective switch option for HIV-positive women, a group the company said has been underrepresented in traditional HIV clinical trials.
Results from this Phase 3 study help to further build the profile for Biktarvy.
"This study underscores the role of Biktarvy as a first-line treatment option for appropriate adults living with HIV who are new to therapy," said David Wohl, a professor of medicine at the University of North Carolina and lead study author, in a statement issued by Gilead.
In this study, dubbed Study 1489, 629 treatment-naive adults were randomized to either triplet. After 96 weeks, the data showed 88% of patients on Biktarvy and 90% of patients on Triumeq (abacavir/dolutegravir/lamivudine) achieved HIV-1 RNA levels of less than 50 copies/mL. The trial will continue through 144 weeks and remain randomized and blinded.
Biktarvy's approval ruffled GSK's feathers, prompting the pharma to file patent infringement lawsuits against Gilead in the U.S. and Canada, claiming that Gilead's bictegravir infringed the intellectual property for GSK's dolutegravir.
GSK, meanwhile, aims to grow its business with a two-drug regimen developed through its subsidiary ViiV Healthcare. A combination of lamivudine and Tivicay (dolutegravir), the doublet did well against Tivicay plus Gilead Sciences' Truvada (tenofovir disoproxil fumarate and emtricitabine) in the GEMINI 1 and 2 Phase 3 trials.
ViiV Healthcare plans to file for approval before the end of 2018.