New Phase IIIb/IV data show switching to once-daily Triumeq maintains HIV viral suppression

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The FINANCIAL — ViiV Healthcare on September 23 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.  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]).1 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), according to GlaxoSmithKline.

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.  

The STRIIVING study recruited patients switching from a broad range of protease inhibitor (PI; n=234), integrase strand transfer inhibitor (INSTI; n=146) and non-nucleoside reverse transcriptase inhibitor (NNRTI; n=171)-based regimens, with the aim of reflecting a common clinical situation.

Patients switching to abacavir/dolutegravir/lamivudine reported more adverse events (AEs) leading to withdrawal compared with those who continued on their established regimen (ITTe: 4% vs. 0%). The majority of these AEs were Grade I & 2.1 The most common AEs (≥ 5%) reported in patients switched to the abacavir/dolutegravir/lamivudine arm included cough (5%), diarrhoea (7%), fatigue (7%), headache (5%), nausea (10%) and upper respiratory tract infection (7%).1The AE profile observed with abacavir/dolutegravir/lamivudine in the study is in line with previous studies with dolutegravir-based regimens.

 

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