ViiV Healthcare announces results from STRIIVING HIV-1 studySeptember 23, 2015
ViiV Healthcare announced on Wednesday 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. According to ViiV Healthcare, Striiving 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) vs. 88% (existing ART) [adjusted difference -3.4%; 95% CI: -9.1, 2.3], per protocol (PP; n=435): 93% vs. 93% [adjusted difference -0.3%; 95% CI: -4.9, 4.4]).
ViiV Healthcare said that 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).1
Furthermore, statistically, the treatment satisfaction score improved significantly more for those patients switching to once-daily abacavir/dolutegravir/lamivudine from their established regimen, as assessed by the HIV Treatment Satisfaction Questionnaire (adjusted difference 2.4, 95% CI: 1.3, 3.5; p<0.001).
“For clinicians, choosing among antiretroviral therapies now involves balancing efficacy with factors such as tolerability, dosing, ability to use with other medications, and resistance profile. These data support the use of once-daily abacavir/dolutegravir/lamivudine as a treatment option in the switch setting for appropriate patients,” said John Pottage, MD, Chief Scientific and Medical Officer, ViiV Healthcare.