SAN FRANCISCO, Oct. 3, 2018 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson unveils new 96-week data for SYMTUZA™ (darunavir
Results from the pivotal Phase 3 EMERALD study demonstrate that in adults with HIV-1 who are virologically suppressed, switching to SYMTUZA™ resulted in maintained high virologic suppression (91%, 692/763) and low virologic failure (1%, 9/763) at week 96 (per FDA-Snapshot); low cumulative virologic rebound (3.1%, 24/763); and no resistance development, up to 96-weeks.1
"The 96-week results from the EMERALD study demonstrate that SYMTUZA™ can offer clinically appropriate people living with HIV a single-tablet option that may help them maintain high rates of virologic suppression over time," said Joseph Eron, M.D., Professor of Medicine and Director, Clinical Core, University of North Carolina Center for AIDS Research, Chapel Hill, NC.
This 96-week extension study, which follows on from the earlier 24- and 48-week results,2,3,4 reinforced the long-term efficacy, resistance and safety profile of SYMTUZA™ as a treatment for virologically suppressed adults with HIV-1. The patient population studied in EMERALD included patients who may have experienced prior virologic failure and/or who may have resistance to emtricitabine.1 SYMTUZA™ was well-tolerated with 2% (14/763) of people experiencing a study drug related grade 3 or 4 adverse event (AE) and 2% (17/763) AE-related discontinuations over 96 weeks.
The most common AEs (all grades, ?10% of adults) in the extension period were upper respiratory tract infection, viral upper respiratory tract infection, diarrhea, headache and back pain. After initial increases between baseline through to week 48, the lipid profile among D/C/F/TAF patients remained stable thereafter. Improvements in renal and bone parameters were maintained in the SYMTUZA™ group over 96 weeks and consistent with known tenofovir alafenamide and cobicistat profiles.1
In a separate analysis, switching treatment to SYMTUZA™ from the multi-tablet control regimen after 52 weeks achieved comparable efficacy and safety to the 48-week results in the group that switched immediately.1 In this late-switch group, after 44 weeks of SYMTUZA™ exposure, the virologic suppression and virologic failure rates were 94% (330/352) and 2% (6/352) respectively at week 96 (per FDA-Snapshot), and the cumulative rebound rate was 2.3% (8/352) from switch at week-52 through week 96. Over 44 weeks, in this late-switch group, serious adverse events and adverse event-related discontinuations occurred in 6% (21/352) and 2% (7/352) of adults respectively while on SYMTUZA™.
"These new data are extremely important, as they further demonstrate that through 96-weeks SYMTUZA™ offers sustained efficacy, a long-term safety profile and the protective barrier to resistance of darunavir in a single-tablet option for clinically appropriate adults. These are all important factors for people who require long-term HIV-1 therapy," said Richard Nettles M.D., Vice President, US Medical Affairs, Janssen Scientific Affairs, LLC.
On September 25, 2017, SYMTUZA™ was approved for the treatment of HIV-1 infection by the European Commission based on results from a bioequivalence study that compared SYMTUZA™ with the combined administration of the separate agents darunavir [D] 800mg, cobicistat [C] 150mg, and emtricitabine/tenofovir alafenamide [FTC/TAF] 200mg/10mg fixed-dose combination.5,6 FDA approval was granted on July 17, 2018 based on the results from the two pivotal Phase 3 studies, EMERALD and AMBER.5,7
AMBER is a double-blind, non-inferiority study evaluating the efficacy and safety of SYMTUZA™ in antiretroviral therapy (ART) treatment-naïve patients.7 Long-term 96-week data from AMBER will be presented at the upcoming HIV Glasgow Congress, taking place October 28-31, 2018 in Glasgow, UK.
Additionally, interim results from DIAMOND, an ongoing, Phase 3 study assessing the efficacy/safety of SYMTUZA™ 800/150/200/10 mg in a Test-and?Treat model over 48 weeks, were presented at the 2018 International AIDS conference (AIDS 2018). Several studies examining Test?and?Treat models in newly diagnosed, adults with HIV-1 have previously led to improved virologic outcomes, retention in care, and decreased mortality.
SYMTUZA™ does not cure or prevent HIV-1 or AIDS. Please see Important Safety Information below, including Boxed Warning for SYMTUZA™.
To learn more about Janssen's commitment to the prevention and treatment of HIV, please visit jnj.com/HIV.
About the EMERALD clinical trial1-4The Phase 3 EMERALD study is a randomized (2:1), open-label, international, multi-center, parallel-group, non-inferiority study evaluating the efficacy and safety of switching to SYMTUZA™ versus continuing with a boosted protease inhibitor (lopinavir/ritonavir, atazanavir or darunavir boosted by either ritonavir or cobicistat) plus emtricitabine/tenofovir disoproxil fumarate in adult HIV-1 infected patients who are virologically suppressed (viral load <50 c/mL for ?2 months and had no more than one viral load ?50 c/mL and <200 c/mL allowed within 12 months before screening). The primary endpoint of the trial is the proportion of patients with virologic rebound (confirmed viral load ?50 c/mL or premature discontinuations with last viral load ?50 c/mL) cumulative through week 48 (non-inferiority margin=4%).3 Secondary efficacy endpoints were protocol-defined virologic rebound from baseline through week 96 in the SYMTUZA™ group and from switch through week 96 in the late-switch group. FDA snapshot efficacy outcomes were also reported.1
24- and 48-week data have been previously reported.2-4 Of 1,141 randomized and treated patients in the 48-week analysis, 1,080 continued in the 96-week extension phase. In this phase, patients in the SYMTUZA™ arm continued on the same treatment while patients in the bPI plus F/TDF arm were switched over to SYMTUZA™ at week 52 (leading to 44 weeks of SYMTUZA™ exposure) until week 96, with study visits every 12 weeks.
Through 96 weeks, 3.1% (24/763) patients had cumulative virologic rebound in the SYMTUZA™ group. Virologic suppression and virologic failure rates were 91% (692/763) and 1% (9/763) respectively at week 96 (viral load <50 c/mL and virologic failure ?50 c/mL; FDA-Snapshot). Virologic responses were consistent and high with the per-protocol FDA-snapshot analysis (viral load <50 c/mL) and the ITT FDA-snapshot analysis using viral load <20 c/mL and VL <200 c/mL cut offs. No darunavir, primary protease inhibitor, tenofovir or emtricitabine resistance-associated mutations were seen post-baseline.1 SYMTUZA™ was well tolerated with 9% (66/763) and 2% (17/763) serious adverse events and adverse event-related discontinuations respectively over 96 weeks in the SYMTUZA™ group. The most common adverse events (all grades, ?10% of patients) in the extension period were upper respiratory tract infection (16%, 122/763); viral upper respiratory tract infection (13%, 98/763); diarrhea (11%, 80/763); headache (10%, 79/763); and back pain (10%, 76/763). Improvements in renal and bone parameters were maintained in the SYMTUZA™ group over 96 weeks.1
In the late-switch group, after 44 weeks of SYMTUZA™ exposure, the virologic rebound rate was 2.3% (8/352). In this group, the virologic suppression and virologic failure rates were 94% (330/352) and 2% (6/352) respectively at week 96 (per FDA-Snapshot). Over 44 weeks, in the late-switch group, 6% (21/352) and 2% (7/352) serious adverse events and adverse event-related discontinuations respectively occurred while on SYMTUZA™. Improvements in renal and bone parameters were seen in the late-switch group over 44 weeks, with a small change in TC/HDL-C ratio, consistent with the known effect of switching from tenofovir disoproxil fumarate to tenofovir alafenamide based regimens.1
WHAT IS SYMTUZA™?
SYMTUZA™ is a prescription medicine that is used without other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) infection in adults who:
HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).
IMPORTANT SAFETY INFORMATION
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT SYMTUZA™?
SYMTUZA™ can cause serious side effects including:
Who should not take SYMTUZA™?
Before taking SYMTUZA™, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with SYMTUZA™. Keep a list of your medicines to show your healthcare provider and pharmacist.?Do not start taking a new medicine without telling your healthcare provider.
HOW SHOULD I TAKE SYMTUZA™?
WHAT ARE THE POSSIBLE SIDE EFFECTS OF SYMTUZA™?
SYMTUZA™ may cause serious side effects including:
The most common side effects of SYMTUZA™ are:?Diarrhea, rash, nausea, fatigue, headache, stomach problems, and gas.
These are not all of the possible side effects of SYMTUZA™.?
Call your doctor for medical advice about side effects.?You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch??or call 1-800-FDA-1088.?You may also report side effects to Janssen Products, LP at 1-800-JANSSEN (1-800-526-7736).
Please see full Product Information, including Boxed Warning for SYMTUZA™.
Notes to editors
Cobicistat, emtricitabine and tenofovir alafenamide are from Gilead Sciences, Inc. On December 23, 2014, Janssen and Gilead Sciences Inc. amended a licensing agreement for the development and commercialization of a once-daily single-tablet regimen combination of darunavir and Gilead's TAF, emtricitabine and cobicistat. Under the terms of the agreement, Janssen and its affiliates are responsible for the manufacturing, registration, distribution and commercialization of this single-tablet regimen worldwide.
About JanssenAt the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Janssen Pharmaceutica NV is one of the Janssen Pharmaceutical Companies of Johnson & Johnson. Learn more at www.janssen.com and follow us at @JanssenGlobal.
MEDIA CONTACT:Katie BuckleyKBuckle8@its.jnj.com+ 44790 0655 261
INVESTOR RELATIONS:Lesley Fishman+1 732 524 3922
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SOURCE Janssen Pharmaceutical Companies of Johnson & Johnson
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