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Related articles :

• GS-US-292-0109
• GS-US-311-1089
• Switch to RPV/FTC/TAF
  • GS-US-366-1216
  • GS-US-366-1160

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Table of contents

Switch from TDF to TAF
GS-US-311-1089 Study
Original article : Gallant J, CROI 2016, Abs. 29, Gallant J. Lancet HIV. 2016;3:e158-65,
Raffi F. J Acquir Immune Defic Syndr. 2017;75:226-31
Dernière mise à jour : 01/06/2017

Dr Anton Pozniak
Chelsea and Westminster Hospital
London, UK

• In this randomised double-blind study, switch of patients on F/TDF
  + 3^rd agent with suppressed viral load for F/TAF + continuation
  of 3^rd agent
  • Is non-inferior at W48 and W96 for maintaining virologic suppression (HIV-1 RNA < 50 c/mL)
  • in rare cases of virologic failure, the risk of resistance emergence is low (1 case of M184V on F/TAF), none after W48
  • Is associated with a similar clinical and biological tolerance
  • Leads to improvement of renal parameters: increase in eGFR and decrease in proteinuria, n o renal discontinuations or renal tubulopathy
    in F/TAF group
  • Improves bone mineral density: increase on F/TAF with significant difference of changes at W48 vs F/TDF and c ontinuing increase in hip and spine BMD after W48
  • Increases lipid parameters, with no change in the total cholesterol total: HDL-cholesterol ratio
  • Similar safety findings by 3^rd agent

Design

Randomisation stratified on 3^rd agent (boosted PI or other)
* F/TAF: 200/10 mg if boosted PI, 200/25 mg if other

Endpoints

• Primary: proportion of patients maintaining HIV RNA < 50 c/mL at W48 (ITT, snapshot) ; non-inferiority if lower margin of a two-sided 95% CI for the difference = -10%, > 95% power
• Secondary with multiple adjustments: percentage change in hip and spine bone mineral density

Baseline characteristics and outcome

Virologic outcome at W48 (ITT, snapshot)

Difference (95% CI) = 1.3% (-2.5 to 5.1)

HIV-1 RNA < 50 c/mL at W48 according to 3^rd agent, %

• Virologic success was similar between treatment groups for the subgroups of age, sex, race, and study drug adherence
• Mean changes in CD4 at W48 ‒
  • + 20/mm³ F/TAF
  • + 21/mm³ F/TDF

Adverse events, N (%)

Discontinuation for adverse event, laboratory abnormalities grade 3-4 (D0-W96)

Mean change in bone mineral density through W96 (%, 95% CI)

Bone mineral density status changes through W48

• The distribution of the bone mineral density status (normal, osteopenia, osteoporosis) adjusted for baseline status was significantly different between treatment groups at W48
  • at the hip (p = 0.012)
  • and at the spine (p = 0.037)
• Driven by a higher percentage of subjects in the F/TAF group with an improvement in BMD status (i.e. osteopenia to normal, osteoporosis to normal or osteopenia), and correspondingly, a lower percentage of subjects in the F/TAF with worsening BMD status (i.e. normal to osteopenia or osteoporosis, or osteopenia to osteoporosis)

 

 

Change in renal biomarkers at W96

• Discontinuation for renal adverse event:
  • F/TAF = 0
  • F/TDF = 2 (creatinine increase = 1, renal tubular disorder = 1)

Safety by 3^rd Agent

Median fasting lipids W48 versus baseline (mg/dL)

 

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