Switch studies in virologically suppressed patients

Switch ABC/3TC to TDF/FTC
GS-US-1717 Study : Switch ABC/3TC to TAF/FTC
Original article : Winston A, Lancet HIV.2018 ; 5:e162-71
Last update : 07/05/2018

Dr Anton Pozniak
Chelsea and Westminster Hospital
London, UK

  • Switch from ABC/3TC to TAF/FTC was non inferior to ABC/3TC in maintaining virologic suppression in combination with a variety of third agents
  • No differences of TAF/FTC vs ABC/3TC in
    • Renal biomarkers
    • Bone mineral density
    • Fasting lipids
  • In virologically suppressed patients with creatinine clearance > 50 mL/min, TAF/FTC provides an alternative backbone to ABC/3TC with similar effects on kidney and bone

Design


* TAF/FTC : 100/200 mg when coadministered with ATV boosted , DRV boosted or LPV/r ; 25/200 mg when co-administered with NNRTI, RAL, DTG or MVC

Objective

  • Primary endpoint: non-inferiority of TAF/FTC at W48: % HIV-1 RNA < 50 c/mL by ITT, snapshot analysis ; lower limit of the 95% CI for the difference = - 10%, 90% power

Baseline characteristics and patient disposition

Efficacy at W48 (ITT, snapshot)

Per protocol analysis

  • HIV RNA < 50 c/mL at W48
    • TAF/FTC : 99.1%
    • ABC/3TC : 99.1%
    • Difference : 0.0% (95% CI: -2.5 to 2.3)

Emergence of resistance, N


* Confirmed HIV RNA > 50 c/ mL or unconfirmed > 400 c/ mL at last visit

Adverse events


* Considered related to study drug (n = 8) : abdominal distension + myalgia , nausea + vomiting + dehydration , nausea + feeling jittery + decrease appetite , anxiety , Brugada syndrome, increased creatinine , burning sensation + headache + paresthesia , vision blurred + visual field defect + eye pain ; not related to study drug : cough , tuberculosis , sudden cardiac death , neutropenia
** Considered related to study drug (n = 8) : affective disorder , panic attack , depression + bone pain + arthralgia , dermatitis + pruritus , rash + pruritus , diarrhea , myalgia + dysesthesia , tinnitus + dry mouth + dyspnea ; not related to study drug : depression + suicide attempt

Median changes in creatinine clearance (Q1, Q3), mL/min

No difference between groups in changes at W48

  • ̶In renal biomarkers (urine RBP:creatinine and B2M:creatinine ratios)
  • In bone mineral density (hip and lumbar spine)

Median changes in fasting lipids at W48, mg/dL

   

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