Low Incidence of ARV-Related Weight Gain
Across pivotal trials, patients on a SYMTUZA® regimen containing 10 mg of TAF experienced a median weight gain of ≤2 kg over 96 weeks1,2*
- In the AMBER trial, through 48 weeks, patients receiving a control regimen (DRV/c + FTC/TDF; n=330) experienced a median change in weight from baseline of 0 kg, while patients receiving SYMTUZA® (n=340) experienced a median change of 1.5 kg1
- In the EMERALD trial, through 48 weeks, patients receiving a control regimen (bPI + FTC/TDF; n=356) experienced a median change in weight from baseline of 0.5 kg, while patients receiving SYMTUZA® (n=728) experienced a median change of 1.3 kg1,2
- A post hoc analysis of high-risk subgroups (Black/African American, Hispanic, female) showed consistent results3†
discontinuations due to weight gain1,2,4
of patients experienced ARV-related weight gain across pivotal trials at Weeks 48 and 961,2,4*
new cases of type 2 diabetes related to SYMTUZA® or clinically relevant changes in blood pressure over 96 weeks1*
significant difference in the number of patients who required lipid-modifying therapy on SYMTUZA® compared to control at 48 weeks5,6
*Week 96 was an open-label, single-arm extension, not a primary endpoint.3
†Median weight change (kg) of patients receiving SYMTUZA® through Week 48/96* stratified by3:
- Black/African American: 1.5/2.0
- White: 1.2/1.8
- Other: 1.4/1.5
- Male: 1.2/1.8
- Female: 1.7/2.0
- Hispanic: 1.3/2.0
- Non-Hispanic: 1.3/1.8
ARV=antiretroviral; bPI=boosted protease inhibitor; DRV/c=darunavir/cobicistat; FTC=emtricitabine; TAF=tenofovir alafenamide; TDF= tenofovir disoproxil fumarate.
SELECT SAFETY INFORMATION
Diabetes Mellitus/Hyperglycemia: New-onset or exacerbations of pre-existing diabetes mellitus and hyperglycemia have been reported in patients receiving protease inhibitors.
References: 1. Data on file. Janssen Therapeutics, Division of Janssen Products, LP. 2. Eron JJ, Orkin C, Cunningham D, et al; EMERALD Study Group. Week 96 efficacy and safety results of the phase 3, randomized EMERALD trial to evaluate switching from boosted-protease inhibitors plus emtricitabine/tenofovir disoproxil fumarate regimens to the once daily, single-tablet regimen of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in treatment-experienced, virologically-suppressed adults living with HIV-1. Antiviral Res. 2019;170:104543. 3. Dunn K, Van Landuyt E, Sheng S, et al. Consistent weight/body mass index change by race, sex, and ethnicity after switching from tenofovir disoproxil fumarate to tenofovir alafenamide on a protease inhibitor-based regimen. Poster presented at: The American Conference for the Treatment of HIV (ACTHIV); May 20-22, 2021; virtual conference. 4. Orkin C, Eron JJ, Rockstroh J, et al; AMBER Study Group. Week 96 results of a phase 3 trial of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naive HIV-1 patients. AIDS. 2020;34(5):707-718. 5. Eron JJ, Orkin C, Gallant J, et al; AMBER Study Group. A week-48 randomized phase-3 trial of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naive HIV-1 patients. AIDS. 2018;32(11):1431-1442. 6. Orkin C, Molina JM, Negredo E, et al; EMERALD Study Group. 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.
