The Advantages of TAF Were Confirmed With SYMTUZA1-3

Bone Mineral Density

Lowered BMD risk
at 48 weeks

  • In treatment-naïve patients, mean loss of hip and spine BMD was significantly less from baseline to Week 48 vs the control arm2
  • In virologically suppressed patients, mean hip and spine BMD significantly increased from baseline to Week 48 vs the control arm3

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The long-term clinical significance of these BMD changes is not known.

Renal Health

Reduced impact on renal health at 48 weeks

  • In treatment-naïve patients, the SYMTUZA™ arm showed more favorable eGFRcr, eGFRcyst, and proteinuria results vs the control arm2
  • In virologically suppressed patients, the SYMTUZA™ arm showed stable eGFRcyst and improved proteinuria results vs the control arm3

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The BMD Advantages of TAF Were Confirmed With SYMTUZA™1-3

With SYMTUZA™, mean loss of BMD was significantly less from baseline to Week 48 vs
the control arm*

Hip and Spine Bone Mineral Density Levels for SYMTUZA in Treatment Naive Patients

*Bone mineral density was assessed in subgroup analyses. The analysis of treatment-naïve patients consisted of 113 patients on SYMTUZA™ and 99 patients on control HIV medications.

With SYMTUZA™, mean BMD significantly increased from baseline to Week 48 vs the
control arm

The long-term clinical significance of these BMD changes is not known.

Bone mineral density was assessed in subgroup analyses. The analysis of virologically suppressed patients consisted of 209 patients on SYMTUZA™ and 108 on control HIV medications.

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The Renal Advantages of TAF Were Confirmed With SYMTUZA™2,3

The TAF component of SYMTUZA™ may reduce the renal impact on patients vs control through Week 48

  • The mean increase in eGFRcyst was significantly higher in the SYMTUZA™ arm vs control arm2

The control regimen in the treatment-naïve study was DRV/c + FTC/TDF.

  • eGFRcyst was stable in the SYMTUZA™ arm and decreased in the control arm; these findings were statistically significant3

§The control regimen in the virologically suppressed study was bPI + FTC/TDF.

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BMD=bone mineral density; bPI=boosted protease inhibitor; DRV/c=darunavir/cobicistat; eGFR=estimated glomerular filtration rate; eGFRcr=estimated glomerular filtration rate based on serum creatinine; eGFRcyst=estimated glomerular filtration rate based on serum cystatin C; FTC/TDF=emtricitabine/tenofovir disoproxil fumarate; STR=single-tablet regimen.

Reference: 1. SYMTUZA™ [package insert]. Titusville, NJ: Janssen Therapeutics, Division of Janssen Products, LP. 2. Eron JJ, Orkin C, Gallant J, et al; for the AMBER study group. A week 48 randomized phase 3 trial of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naïve HIV-1 patients. AIDS. 2018;32:1431-1442. 3. Orkin C, Molina JM, Negredo E, et al. Efficacy and safety of switching from boosted protease inhibitors plus emtricitabine and tenofovir disoproxil fumarate regimens to single-tablet darunavir, cobicistat, emtricitabine, and tenofovir alafenamide at 48 weeks in adults with virologically suppressed HIV-1 (EMERALD): a phase 3, randomised, non-inferiority trial. Lancet HIV. 2018;5(1):e23-e34.