Advancing Care in Treatment-Naïve HIV-1 Patients1,2

Study Design/Efficacy

AMBER STUDY

Phase 3, randomized, double-blind, active-controlled, international, multicenter, noninferiority study1,2

Key endpoint: Proportion of patients with VL <50 copies/mL at 48 weeks (noninferiority margin 10% by FDA Snapshot)

*Randomization was stratified by VL and CD4+ cell count.

Study Demographics2

Patient Characteristics2

6% of patients with CD4+ count <200 cells/mm2

17% of patients with VLs above 100,000 copies/mL

High Virologic Response Rates Achieved with SYMTUZA® at Week 48 (FDA Snapshot)

91%

of Patients Treated With SYMTUZA® Had Undetectable VLs* (<50 copies/mL)1,2

  • 4% virologic failure (50 copies/mL) rate in the SYMTUZA® arm vs 3% in the control arm1,2
  • 4% of patients in the SYMTUZA® arm had no virologic data vs 8% in the control arm1,2

*Based on a stratum adjusted MH test where stratification factors are HIV-1 RNA level (≤100,000 or >100,000 copies/mL) and CD4+ cell count (<200 or ≥200 cells/µL).1

Included subjects who had VL ≥50 copies/mL in the Week 48 window (Days 295-378); subjects who discontinued early due to lack or loss of efficacy; subjects who discontinued for reasons other than an adverse event, death, or lack or loss of efficacy and at the time of discontinuation had a viral load of ≥50 copies/mL.1,2

Safety & Tolerability Profile

 

SYMTUZA®: Formulated for improved tolerability

Discontinuations due to Adverse Events in AMBER1

Among patients treated with SYMTUZA® over 48 weeks1

2% Discontinuation Rate Due to Adverse Events

Through 48 weeks, only 2 patients (0.6%) discontinued SYMTUZA® due to diarrhea3

*Control: DRV/c + FTC/TDF.

Adverse reactions in patients over 48 weeks1

ADVERSE REACTIONS > 2% GRADES>2 ALL GRADES
  SYMTUZA® (n=362) Control (n=363) SYMTUZA® (n=362) Control (n=363)
Diarrhea (%) 2 2 9 11
Rash (%) 4 5 8 7
Nausea  (%) 1 3 6 10
Fatigue  (%) 1 1 4 4
Headache (%) 1 1 3 2
Abdominal Discomfort - <1 2 4
Flatulence (%) <1 - 2 1

Grades of adverse reactions: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening or disabling.

  • Most adverse reactions during treatment with SYMTUZA® were mild to moderate in severity
    • One Grade 3 reaction was reported and no Grade 4 adverse reactions were reported during treatment with SYMTUZA®
  • Few treatment-naïve patients started a lipid-lowering medication:
    • 1.7% (n=6) of patients in the SYMTUZA® arm and 0.6% (n=2) in the control arm started a lipid-lowering drug during treatment1
  • This is not a complete list of all adverse drug reactions reported with the use of SYMTUZA®. Please refer to the full Prescribing Information for a complete list of adverse drug reactions.

TAF

 

Bone Mineral Density

The BMD Advantages of TAF Were Confirmed With SYMTUZA®1,2

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

Mean Changes in Spine and Hip BMD from Baseline to Week 48 in Treatment-Naïve Patients

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

*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.

†Control: DRV/c + FTC/TDF

Renal Health

The Renal Advantages of TAF Were Confirmed With SYMTUZA®2

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

Mean Changes in eGFRcyst in Treatment-Naïve Patients
  • The mean increase in eGFRcyst was significantly higher in the SYMTUZA® arm vs control arm2
  • The SYMTUZA® arm also showed more favorable eGFRcr and proteinuria results vs the control arm2

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

BMD=bone mineral density; CD4+=cluster of differentiation 4; DRV/c=darunavir/cobicistat; eGFRcyst=estimated glomerular filtration rate based on serum cystatin C; FTC=emtricitabine; MH=Mantel-Haenszel; TAF=tenofovir alafenamide; TDF=tenofovir disoproxil fumarate; VL=viral load

References: 1. SYMTUZA® [package insert]. Titusville, NJ: Janssen Therapeutics, Division of Janssen Products, LP. 2. Eron JJ, Orkin C, Gallant J, et al. 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. Data on file. Janssen Therapeutics, Division of Janssen Products, LP.