STRIIVING STUDY

STRIIVING was a Phase 3b, randomised, open-label, multicentre, active-controlled, non-inferiority study in patients with HIV-1 who had maintained virological suppression on a stable ART regimen for ≥6 months prior to screening (N=553).

This study was designed to investigate the efficacy of DTG/ABC/3TC in stably suppressed ART-experienced adults, to establish whether regimen switching is an option for patients. For the first 24 weeks, patients received either DTG/ABC/3TC once daily or continued on their current therapy. After 24 weeks, both treatment arms were given once daily DTG/ABC/3TC. Primary analysis occurred at Week 24, with secondary analysis occurring until Week 48.1

Study design:1
Striivingstudy design illustration
Primary endpoint:1

Proportion of subjects who maintained plasma HIV-1 RNA levels of <50 copies/mL at 24 weeks, using the FDA snapshot algorithm (-10% non-inferiority margin).
 

Results/outcomes:1
  • Switching to DTG/ABC/3TC was non-inferior to continuing ART
    • 85% vs 88% achieved virological suppression at Week 24 (difference in proportion -3.4%; 95%: CI -9.1 to 2.4)
    • 83% achieved virological suppression at Week 48 in the early-switch group
    • 92% achieved virological suppression at Week 48 in the late-switch group
  • Both groups had very few virological failures (<1%) and no subject in either arm met the virological withdrawal criteria
  • Both treatment arms had similar tolerability
    • 4% in the DTG arm had AEs leading to withdrawal at 24 weeks
    • 2% in the late-switch arm had AEs leading to withdrawal between 24 and 48 weeks
    • Neither arm had any serious drug-related events

References:

  1. Trottier B, et al. Antivir Ther. 2017;22:295­–305.
DOVATO (Dolutegravir/lamivudine)

Dolutegravir (DTG)

Dolutegravir (DTG) has been studied across diverse patient populations as part of both 3-drug and 2-drug regimens, including patients who are virologically suppressed, treatment-experienced or treatment-naïve.

Read more

PM-GB-DLL-WCNT-210002 | April 2021

Adverse event reporting

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GlaxoSmithKline on 0800 221441.

If you are from outside the UK, you can report adverse events to GSK/ViiV by selecting your region and market, here.