Positive new Phase IIIb/IV results for ViiV Healthcare’s Triumeq

ViiV Healthcare today announced 24-week data from the Phase IIIb/IV STRIIVING study, an open-label study evaluating the efficacy, safety and tolerability of switching from an antiretroviral therapy (ART) to the once-daily, fixed-dose dolutegravir-based regimen, Triumeq (abacavir/dolutegravir/lamivudine) in virologically suppressed adults with HIV-1 (n=274).

The study included (n=277) adults who remained on their existing ART to 24 weeks, said ViiV Healthcare, the HIV/AIDS joint venture majority owned by UK pharma major GlaxoSmithKline (LSE: GSK) and partnered with Pfizer and Shionogi. Triumeq was approved in the USA and Europe during 2015 and gained clearance in Japan earlier this year. GSK reported that HIV sales in the second quarter of this year increased 59% to £559 million ($871 million). The growth was driven by Tivicay (dolutegravir) and Triumeq. GSK’s shares were up 1.7% at 1,268.38 pence in mid-morning trading

The STRIIVING study met its primary endpoint, demonstrating that viral suppression was non-inferior for patients switching to abacavir/dolutegravir/lamivudine (HIV RNA <50 copies/mL in intention to treat efficacy (ITTe, primary endpoint; n=551): 85% (abacavir/dolutegravir/lamivudine) versus 88% (existing ART) [adjusted difference -3.4%; 95% CI: -9.1, 2.3], per protocol (PP; n=435): 93% versus 93% [adjusted difference -0.3%; 95% CI: -4.9, 4.4]). No patients had protocol defined virologic failure (confirmed plasma HIV-1 RNA ≥400 copies/mL) and therefore no patients were evaluated for treatment-emergent resistance in either arm (ITTe).