Switch studies in virologically suppressed patients

Switch to DTG/ABC/3TC
STRIIVING Study
Original article : Lake J. AIDS 2016, Durban, THAB0203, Trottier B, ICAAC 2015, Session H2 &
Koteff J. EACS 2015, Abs. LBPS10/1
Dernière mise à jour : 06/09/2016

Dr Anton Pozniak
Chelsea and Westminster Hospital
London, UK

  • Efficacy
    • Similar virologic response for DTG/ABC/3TC and continuation of current ART at W24, with non-inferiority
    • Success rate was maintained through 48 weeks in the early switch group
    • In the late switch group, virologic suppression was observed in 92% of subjects on DTG/ABC/3TC (24 weeks post-switch)
    • There were no protocol-defined virologic failure in the study
  • Tolerability
    • 4% of subjects discontinued due to adverse events by W24 in the DTG/ABC/3TC arm vs 0% in the continuation group
    • There were no further discontinuations due to adverse events in the early switch arm post-week 24
    • Rates of discontinuation for adverse events in the late switch arm was 2%

Design

Endpoints

  • Primary: proportion of patients maintaining HIV RNA < 50 c/mL at W48 (ITT-E, snapshot) ; non-inferiority if lower margin of the two-sided 95% CI for the difference = - 10%, 90% power
  • Secondary: CD4 cell count changes, safety, lipid, renal, bone and cardiovascular changes, development of resistance, treatment satisfaction

Baseline characteristics and patient disposition

HIV RNA < 50 c/ mL (ITT-e)

  • No subjects met protocol-defined virologic failure in either study arm ; 4 subjects with HIV RNA > 50 c/mL at W48 (1 early switch, 3 deferred switch) ; all 4 resuppressed < 50 c/mL

Adverse events at W24, n (%)

Adverse events leading to discontinuation of DTG/ABC/3TC (N = 10)

Fasting Lipids, mean mg/ dL

Mean change from baseline in serum creatinine (mg/dL) through 24 weeks

  • Small, non-progressive changes in serum creatinine were observed in the DTG/ABC/3TC arm due to known inhibition of tubular creatinine secretion by DTG

Treatment Satisfaction (HIVTSQ) Adjusted mean change in total score at W24

  • At baseline, overall treatment satisfaction scores were similar between groups
   

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