Sustained Tolerability Through 48 and 96 Weeks

See study designs

SYMTUZA® demonstrated sustained tolerability with ≤3% of patients discontinuing due to adverse events among 1125 patients across pivotal trials through 48 and 96 weeks1-5*

*Week 96 was an open-label, single-arm extension, not the primary endpoint.2,3

patients discontinued due to weight gain, nausea, vomiting, insomnia or anxiety related to SYMTUZA® across pivotal trials2,3,5

Most Adverse Reactions Were Mild to Moderate and Consistent From Week 48 Through Week 96

Adverse Reactions

*Week 96 was an open-label, single-arm extension, not the primary endpoint.2,3

Includes pooled reported terms: dermatitis, dermatitis allergic, erythema, photosensitivity reaction, rash, rash generalized, rash macular, rash maculopapular, rash morbilliform, rash pruritic, toxic skin eruption, and urticaria.6

  • One Grade 3 and no Grade 4 adverse reactions were reported with SYMTUZA® at 48 weeks6
  • 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 treatment
  • Across pivotal trials, no new cases of type 2 diabetes related to SYMTUZA® or clinically relevant changes in blood pressure over 96 weeks5

In virologically suppressed patients:

  • The safety profile of SYMTUZA® in virologically suppressed and treatment-naïve patients was similar6
  • Through 48 weeks, the most common treatment-related adverse events were diarrhea (2%, n=16/763) and osteopenia (1%, n=5/763)4
  • Most adverse events during treatment with SYMTUZA® were mild to moderate in severity (Grades 1 and 2)4
    • The most common Grade 3 adverse event was pneumonia, which was reported for 3 (<1%) patients. No Grade 4 adverse events were reported in 2 or more patients in either group

This is not a complete list of all adverse reactions reported with the use of SYMTUZA®. Please refer to the full Prescribing Information for a complete list of adverse reactions.

 

SELECT IMPORTANT SAFETY INFORMATION 
Diabetes Mellitus/Hyperglycemia:
New-onset or exacerbations of pre-existing diabetes mellitus and hyperglycemia have been reported in patients receiving protease inhibitors.

Consistent Tolerability Profile Regardless of Baseline Neuropsychiatric Comorbidities

Post hoc subgroup analysis of treatment-naïve patients through 48 weeks7*

added risk of study discontinuation due to adverse events related to SYMTUZA® in patients with baseline NPCs7

*Among 725 patients, 88 (SYMTUZA®) and 99 (control) had baseline NPCs.7

In the SYMTUZA® arm, 43% (38/88) had neurologic comorbidities, such as headache (20%) or migraine (6%). In the control arm, 43% (43/99) had neurologic comorbidities, such as headache (21%) or migraine (8%).7

In the SYMTUZA® arm, 64% (56/88) had psychiatric comorbidities, such as depression (35%), anxiety (18%), or insomnia (7%). In the control arm, 70% (69/99) had psychiatric comorbidities, such as depression (27%), anxiety (14%), or insomnia (13%).7

Compared to those without NPCs at baseline.7

SYMTUZA®: A Tolerability Profile That Patients Need and That You Can Rely on

At 48 weeks, the most common adverse reactions (≥2%) in patients rapidly starting SYMTUZA® (N=109) were8:

Adverse Reactions Grades Mob

*Pooled preferred terms of allergic dermatitis, dermatitis, rash, macular rash, maculopapular rash, papular rash, and pruritic rash.

Most adverse reactions during treatment with SYMTUZA® were mild to moderate in severity (Grade 1 or Grade 2)8

  • Few Grade 3 and 4 clinical laboratory abnormalities occurred in ≥2% of patients (increased bilirubin in 3% of patients, increased ALT in 3% of patients, and increased AST in 5% of patients)

This is not a complete list of all adverse reactions reported with the use of SYMTUZA®. See Important Safety Information section below for the most common adverse reactions in the treatment-naïve pivotal trial. Please refer to the full Prescribing Information for a complete list of adverse reactions.

Incidence of ARV-Related Weight Gain

Median weight change from baseline at Weeks 48 and 96* in patients taking SYMTUZA®

*Week 96 was an open-label, single-arm extension, not the primary endpoint.2,3

of patients experienced ARV-related weight gain across pivotal trials  at Weeks 48 and 962,3,5*

discontinuations due to weight gain across pivotal trials2,3,5

of TAF contained in SYMTUZA®6

ALT=alanine aminotransferase; AST=aspartate aminotransferase; BL=baseline; NPC=neurologic/psychiatric comorbidity; TAF=tenofovir alafenamide.

References: 1. 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. 2. 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. 3. 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. 4. 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. 5. Data on file. Janssen Therapeutics, Division of Janssen Products, LP. 6. SYMTUZA® [package insert]. Titusville, NJ: Janssen Therapeutics, Division of Janssen Products, LP. 7. Dunn K, Simonson RB, Luo D, et al. Use of D/C/F/TAF with neurologic/psychiatric comorbidities: AMBER subgroup analysis. Poster presented at: Conference on Retroviruses and Opportunistic Infections; March 8-11, 2020; Boston, MA. 8. Huhn GD, Crofoot G, Ramgopal M, et al. Darunavir/cobicistat/emtricitabine/tenofovir alafenamide in a rapid initiation model of care for HIV-1 infection: primary analysis of the DIAMOND study. Clin Infect Dis. Published online December 27, 2019. doi:10.1093/cid/ciz1213