Advancing Care in Treatment-Naïve Patients1,2
Phase 3, randomized, double-blind, active-controlled, international, multicenter, noninferiority study1,2
- After week 48 database lock and unblinding, patients could continue on or switch to D/C/F/TAF in an open-label, single-arm extension phase until Week 96.
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.
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)
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 arm†1,2
- 4% of patients in the SYMTUZA® arm had no virologic data vs 8% in the control arm1,2
†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
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.
Median Weight Change From Baseline at 48 weeks in Treatment-Naïve Patients
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)|
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.
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
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
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