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Press Release

Janssen Presents Switch Data for New HIV-1 Treatment SYMTUZA™ (D/C/F/TAF) and Second Study Supporting its Use in a Rapid Initiation Scenario

Janssen
Posted on: 25 Jul 18

AMSTERDAM, July 24, 2018 /PRNewswire/ --

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data reinforcing the safety and efficacy of switching to SYMTUZA™ (D/C/F/TAF) for the treatment of HIV-1 regardless of prior treatment regimen among treatment-experienced patients. Data presented from another Phase 3 study also provide evidence to support a darunavir-based regimen when rapidly initiating treatment in people who are newly diagnosed with HIV-1.

Analyses from the pivotal Phase 3 EMERALD trial further support the efficacy and safety of switching from boosted protease inhibitor-based (bPI) regimens to D/C/F/TAF for the treatment of HIV-1 regardless of prior treatment regimen in virologically suppressed, treatment-experienced adults as previously published in The Lancet. Results from EMERALD showed similar virologic response rates at Week 48 (HIV-1 RNA <50 copies/mL: 95% vs 94%; HIV-1 RNA ≥50 copies/mL: 1% vs 1%) and rates of virologic rebound (2.5% vs 2.1%) were demonstrated with D/C/F/TAF compared to continuation of previous treatment in the overall population.

In the new analyses, data is presented in subgroups according to baseline regimen. Results were consistent across subgroups based on bPI regimens used at screening. The EMERALD trial investigates the proportion of patients with virologic rebound cumulative through Week 48.

"Forty-eight-week data from the pivotal EMERALD trial demonstrate continued virologic control following a switch to treatment with SYMTUZA™ regardless of the individual's previous boosted protease inhibitor-based regimen," said Gregory Huhn, M.D., Infectious Disease Specialist, Cook County Health System, Chicago, Illinois. "These data add to the growing body of evidence that supports healthcare professionals to navigate treatment options."

Additionally, interim results from the Phase 3 DIAMOND study provide evidence to support the use of a darunavir-based regimen when rapidly initiating treatment in newly diagnosed HIV-1 patients, as recommended by the U.S. Department of Health and Human Services guidelines.

DIAMOND is the first Phase 3 trial for a single-tablet regimen conducted in a rapid initiation scenario. In this study, no patients met predefined resistance stopping rules and 81% of patients achieved virologic suppression <50 copies/mL at Week 24 in an intent-to-treat (ITT) analysis. 90% of patients achieved virologic suppression <50 copies/ML at Week 24 based on as-observed analysis. Analysis at 24 Weeks is interim, and the primary endpoint will be at 48 Weeks. No patients stopped due to protocol-defined virologic failure, or lack of efficacy, and only one patient discontinued due to an adverse event.

DIAMOND is a single-arm pilot ongoing study to assess the efficacy and safety of D/C/F/TAF in a Test-and-Treat model over 48 weeks. In this study, adults diagnosed with HIV-1 infection within 14 days were immediately enrolled and started on D/C/F/TAF without screening/baseline laboratory or HIV genotypic resistance information. Screening/baseline laboratory and resistance findings were reviewed by investigators as results became available and patients not meeting predefined safety or resistance stopping rules continued treatment.

"HIV drug resistance and rapid initiation of treatment are key issues in today's HIV care landscape," said Brian Woodfall, M.D. Vice President, Global Head, Late Development, Infectious Diseases & Vaccines, Janssen Pharmaceutica NV. "We are committed to developing treatments for HIV that address key real-world challenges such as these. SYMTUZA™ provides an important new option for people living with HIV."

SYMTUZA™ was approved by the U.S. FDA on July 17, 2018. It received European Commission approval in September 2017.

About EMERALD 

EMERALD (NCT02269917) is a Phase 3, randomized (2:1), non-inferiority trial among treatment-experienced, virologically suppressed HIV-1-infected adults with viral load (VL) <50 copies/mL for ≥2 months (one 50≤VL<200 copies/mL allowed in prior 12 months). Previous non-darunavir virologic failure is allowed. The primary endpoint is the proportion of patients with virologic rebound (confirmed VL ≥50 copies/mL or premature discontinuation with last VL ≥50 copies/mL) cumulative through Week 48. Virologic response at Week 48 was VL <50 copies/mL (FDA snapshot). Safety was assessed by adverse events (AEs). Results were evaluated in subgroups based on bPI (darunavir [with ritonavir or cobicistat] vs atazanavir [with ritonavir or cobicistat] or lopinavir [with ritonavir]) and boosting agent (ritonavir vs cobicistat) used at baseline. A total of 1141 patients were randomized and treated. At screening, use of darunavir (70% of patients) was more common than atazanavir or lopinavir (30% combined), and boosting with ritonavir (85%) was more common than cobicistat (15%). Fifty eight percent had prior exposure to ≥5 ARVs and 15% had experienced prior VF. Results showed that virologically suppressed, treatment-experienced HIV-1-infected adults who switched to D/C/F/TAF had low, non-inferior cumulative virologic rebound rates versus continuation of prior therapy. In the overall population, similar rates of virologic rebound and virologic response were seen with D/C/F/TAF regardless of previous regimen. No patients developed resistance to study drugs.

For more information on this clinical trial, please visit: http://www.clinicaltrials.gov

About DIAMOND 

DIAMOND (NCT03227861) is an ongoing, Phase 3, single‐arm, open‐label, prospective, multicenter study assessing the efficacy/safety of D/C/F/TAF 800/150/200/10 mg in a rapid initiation scenario over 48 weeks. Adults diagnosed with HIV‐1 infection within 14 days were immediately enrolled and started on D/C/F/TAF without screening/baseline laboratory or HIV genotypic resistance information available. Investigators reviewed screening/baseline laboratory and resistance findings as results became available; patients not meeting predefined safety or resistance stopping rules continued treatment. At the Week 24 interim analysis, 91% (99/109) of patients continued on D/C/F/TAF and only 10/109 discontinued (3 due to safety stopping rules, 3 lost to follow up, 2 withdrew consent, 1 protocol violation, 1 adverse event [AE]). No patients were required to discontinue treatment due to resistance stopping rules. At Week 24, in an Intent-to-Treat analysis, 88 of 109 (81%) patients had achieved HIV-1 RNA <50 copies/mL (FDA snapshot), no participants experienced protocol-defined virologic failure, or discontinued due to lack of efficacy. Most adverse events were Grade 1 or Grade 2 and only one participant discontinued treatment due to an adverse event. No serious adverse events related to study drug were reported.

The DIAMOND study was not included in the data submission package for U.S. FDA approval.

For more information on this clinical trial, please visit: http://www.clinicaltrials.gov

Further details on our work in HIV and the breadth of science being driven by Johnson & Johnson companies and their partners is available at jnj.com/HIV.

For more information:
www.prnewswire.com/news-releases/janssen-presents-switch-data-for-new-hiv-1-treatment-symtuza-d-c-f-taf-and-second-study-supporting-its-use-in-a-rapid-initiation-scenario-821253418.html

Editor's Details

Mike Wood
PharmiWeb.com
www.pharmiweb.com
editor@pharmiweb.com

Last updated on: 25/07/2018

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