VIKING-3 study

VIKING-3 is a single-arm, open-label, multicentre study in treatment-experienced adults (N=183).

The study consisted of a 7-day functional monotherapy period where DTG replaced RAL or EVG in the previously failing ART regimen. A second, optimised phase started from Day 8, when the background ART regimen was optimised according to baseline resistance data with ≥1 fully active drug. Study visits were at screening (Day ~42 to Day ~35), Days 1 and 8, every 4 weeks through Week 48 and every 12 weeks thereafter.1

Study design:1
Viking-3 study design illustration
Primary endpoint:1

Mean change from baseline in plasma HIV-1 RNA with DTG 50 mg BID at Day 8 and the proportion of patients with HIV-1 RNA <50 copies/mL at Week 24.

Results/outcomes:1,2
  • In treatment-experienced patients, a strong antiviral response was demonstrated with DTG at both 24 and 48 weeks
    • Mean change from baselines was 1.43 log10 HIV-1 RNA c/mL with 8 days of functional monotherapy
    • 69% (126/183) at Week 24 and 63% (116/183) at Week 48 achieved HIV-1 RNA <50 c/mL with DTG + OBR
    • Difference in response rates between Week 24 and Week 48 was primarily for non-virological reasons
       
  • Response rates to DTG were significantly reduced with increasing baseline integrase resistance

  • DTG 50 mg BID was generally well tolerated despite advanced disease status

  • Withdrawals due to AEs were infrequent (5/183 [3%])

  • For individuals with protocol-defined virologic failure:
    • Few new cases of PDVF from Week 24 to Week 48

References:

  1. Castagna A, et al. J Infect Dis. 2014;210:354–362.
  2. Vavro CL, et al. EUDRW. 2014. Oral 10.
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.