Advancing Care in Virologically Suppressed HIV-1 Patients1,2

Study Design/Efficacy

EMERALD STUDY

Phase 3, randomized, open-label, international, multicenter, noninferiority study of switching virologically suppressed adults to SYMTUZA®1,2

Key endpoints:

  • Proportion of patients with virologic rebound at Week 48 (noninferiority margin 4%)2
  • Proportion of subjects who have VL <50 copies/mL at 48 weeks (FDA Snapshot) 2

*bPI at screening, DRV/COBI or RTV, ATV/COBI or RTV, or LPV/RTV

Except no history of VF on darunavir-based regimens, and if historical genotypes were available, absence of darunavir resistance-associated mutations.

At least one plasma HIV-1 RNA measurement VL <50 copies/mL occurring within 2-12 months prior to the screening visit while on the stable ARV regimen and had HIV-1 RNA <50 copies /mL at the 
screening visit.3

§Randomization was stratified by bPI used at screening.

Study Demographics2

* Received at least one dose of study medication.

Interquartile range: 19-75 years.

‡ Interquartile range: 20-78 years.

§ Exceeds 100% due to rounding.

Patient Characteristics2

The Symtuza® arm of the study included

15%

of patients who had prior virologic failure on at least one ARV2

Across both arms of the study

53
patients

had archived emtricitabine resistance-associated substitutions, mainly at reverse transcriptase position M184.

Patient Characterictics were similar across treatment arms.

  • All patients with emtricitabine resistance-associated substitutions had HIV-1 RNA <50 copies/mL at Week 48 (n=50) or at the last on-treatment viral load (n=3)1
 

High Virologic Response Rates Maintained with SYMTUZA® at Week 481,2

95%

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

  • 1% virologic failure rate in the SYMTUZA® arm vs. 1% in the control arm1,2†
  • 4% of patients in the SYMTUZA® arm had no virologic data vs 6% in the control arm1,2
  • There were no discontinuations for efficacy reasons2

*Based on MH test adjusting for bPI at screening (ATV with RTV or COBI, DRV with RTV or COBI, LPV with RTV).

Included subjects who had ≥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 ≥50 copies/mL.

Safety & Tolerability Profile

 

Discontinuations due to Adverse Events in EMERALD1,2 

Among patients treated with SYMTUZA® over 48 weeks1

1% Discontinuation Rate Due to Adverse Events

Through 48 weeks, only 1 patient (0.1%) discontinued SYMTUZA® due to diarrhea1

  • Overall, the safety profile of SYMTUZA® in virologically suppressed adults was similar to that in subjects with no prior antiretroviral treatment history1

*Control: bPI + FTC/TDF.

TAF

 

Bone Mineral Density

The Bone Mineral Density Advantages of TAF Were Confirmed With SYMTUZA®1,2

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

Mean Changes in Spine and Hip BMD from Baseline to Week 48
in Virologically Suppressed Patients

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.

Control: bPI + 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 Virologically Suppressed Patients
  • eGFRcyst was stable in the SYMTUZA® arm and decreased in the control arm; these findings were statistically significant2
  • The SYMTUZA® arm showed improved proteinuria results vs the control arm2

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

ARV=antiretroviral; ATV=atazanavir; BMD=bone mineral density; bPI=boosted protease inhibitor; COBI=cobicistat; DRV=darunavir; eGFRcyst=estimate glomerular filtration rate based on serum cystatin C; FTC=emtricitabine; LPV=lopinavir; MH=Mantel-Haenszel; RTV=ritonavir; TAF=tenofovir alafenamide; TDF=tenofovir disoproxil fumarate; VF=virologic failure; VL=viral load

References: 1. SYMTUZA® [package insert]. Titusville, NJ: Janssen Therapeutics, Division of Janssen Products, LP. 2. 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. 3. Data on file. Janssen Therapeutics, Division of Janssen Products, LP.