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Janssen announces JULUCA (dolutegravir/rilpivirine) maintains viral suppression with two drugs in a once-daily, single-pill

Jul 24, 2018
The Netherlands

100-Week Results for JULUCA®, the First Licensed Two-Drug, Once-Daily Single-Pill for the Treatment of HIV-1 Presented at AIDS 2018

Amsterdam, The Netherlands, July 24, 2018 The Janssen Pharmaceutical Companies of Johnson & Johnson today announced 100-week results from the Phase 3 program for JULUCA® (dolutegravir 50mg [ViiV Healthcare]/rilpivirine 25mg [Janssen Sciences Ireland UC]), the first licensed two-drug regimen, once-daily, single-pill for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in virologically suppressed adults. The data from the SWORD 1 and SWORD 2 studies highlight the durable efficacy and safety of JULUCA®, with most patients achieving virological suppression (HIV-1 RNA <50 copies/mL) through Week 100. Data is being presented by ViiV Healthcare at the 22nd International AIDS Conference taking place 23-27 July 2018 in Amsterdam, The Netherlands.

The SWORD studies evaluate the efficacy, safety and tolerability of switching to dolutegravir and rilpivirine from a current three- or four-drug antiretroviral regimen (integrase inhibitor, non-nucleoside reverse transcriptase inhibitor or boosted protease inhibitor-based) in HIV-1-infected adults who are virologically suppressed. In the pooled data from the SWORD 1 and SWORD 2 studies, 89% (456/513) of participants on the two-drug regimen of dolutegravir and rilpivirine maintained viral suppression (HIV-1 RNA <50 copies/mL) through Week 100.

“The 100-week SWORD results represent a crucial step forward in our efforts to deliver a two-drug regimen that maintains durable efficacy while being well-tolerated,” says Brian Woodfall, M.D., Vice President, Global Head Late Development, Infectious Diseases & Vaccines, Janssen Pharmaceutica NV. “As HIV is increasingly treated as a life-long rather than life-limiting condition, we remain committed to ensuring that optimized and simplified treatment options are available for people living with HIV.”

In the ‘early switch’ arm (n=513), patients switched to a dolutegravir and rilpivirine regimen at Day 1. Ninety-five percent of patients maintained a high level of virologic suppression through Week 48. The drug continued to be efficacious through Week 100. Findings were shown to be reproducible in the ‘late switch’ arm (n=477) in which participants continued with their current ARV regimen until Week 52, then switched to the dolutegravir and rilpivirine regimen. In this arm, 93% (n=444) of participants maintained viral suppression through Week 100.

The safety profile of the late-switch group was similar to that of the early-switch group 48 weeks post-switch. In the ‘early-switch’ arm, snapshot virologic non-response was observed in 3% (n=13) of participants and six participants (1.2%) met the confirmed virologic withdrawal criterion. The cohort on the two-drug regimen of dolutegravir and rilpivirine demonstrated a safety profile consistent with the respective label of each individual component. Fifty-eight participants (11%) experienced serious adverse events and 34 participants (7%) experienced adverse events that led to withdrawal. Three participants failed with NNRTI mutations, and of these, one had pre-existing NNRTI mutations at baseline, developed resistance to rilpivirine and was withdrawn. No participants developed INI resistance.

In the ‘late-switch’ arm, three participants (<1%) met the confirmed virologic withdrawal criterion, and the safety profile of the late switch group was comparable to the early switch group (dolutegravir and rilpivirine from day 1 to Week 100). Thirty participants (6%) experienced serious adverse events and 15 participants (3%) experienced adverse events that led to withdrawal.

The 48-week results from the SWORD studies were presented at CROI 2017 and later published in The Lancet. Data from the SWORD studies as well as a pivotal bioequivalence study have led to successful regulatory approval of the two-drug regimen in the United States, European Union, Canada and Australia, marketed by ViiV Healthcare under the trade name JULUCA®.

Notes to editors 
About the SWORD Phase 3 Program for dolutegravir (Tivicay®) and rilpivirine (EDURANT®)

The Phase 3 program evaluates the efficacy, safety, and tolerability of switching to dolutegravir plus rilpivirine from a current integrase inhibitor-, non-nucleoside reverse transcriptase inhibitor-, or boosted protease inhibitor-based antiretroviral regimen in HIV-1-infected adults who are virologically suppressed with a three- or four- drug regimen. In the clinical trials, dolutegravir and rilpivirine were provided as individual tablets. SWORD-1 (NCT02429791) and SWORD-2 (NCT02422797) are replicate 148-week, randomized, open-label, non-inferiority studies conducted to assess the antiviral activity and safety of a two-drug, daily oral regimen of dolutegravir plus rilpivirine compared with current antiretroviral therapy. 

The primary endpoint is the proportion of patients with plasma HIV-1 RNA <50 copies per milliliter (c/mL) at Week 48. Key secondary endpoints include evaluation of the development of viral resistance, measurements of safety and tolerability, and changes in renal, bone and cardiovascular biomarkers. The study also includes exploratory measures to assess changes in health-related quality of life, willingness to switch and adherence to treatment regimens.

For more information on the trials, please visit: www.clinicaltrials.gov.

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

About JULUCA®
In June 2014, Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and ViiV Healthcare announced a collaboration to investigate the potential of combining dolutegravir and rilpivirine in a single pill in order to expand the treatment options available to people living with HIV.

JULUCA® is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically-suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen for at least six months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor or integrase inhibitor.

U.S. IMPORTANT SAFETY INFORMATION: JULUCA (dolutegravir and rilpivirine) tablets

Professional Indication(s) and Important Safety Information

Indication and Usage for JULUCA®

JULUCA® is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen for ≥6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of JULUCA®.

Important Safety Information

CONTRAINDICATIONS

JULUCA® is contraindicated in patients:

  • with previous hypersensitivity reaction to dolutegravir or rilpivirine.
  • receiving dofetilide, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifapentine, systemic dexamethasone (>1 dose), St. John’s wort, and proton pump inhibitors (e.g., esomeprazole, lansoprazole, omeprazole, pantoprazole, and rabeprazole).    

WARNINGS AND PRECAUTIONS

Skin and Hypersensitivity Reactions:

  • Hypersensitivity reactions have been reported with dolutegravir and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury. These events were reported in <1% of subjects receiving dolutegravir in Phase 3 clinical trials.
  • Severe skin and hypersensitivity reactions have been reported during postmarketing experience, including cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), with rilpivirine-containing regimens and have been accompanied by fever and/or organ dysfunctions including elevations in hepatic serum biochemistries.
  • Discontinue JULUCA® immediately if signs or symptoms of severe skin or hypersensitivity reactions develop (such as severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters or peeling of the skin, mucosal involvement, conjunctivitis, facial edema, hepatitis, eosinophilia, angioedema, and difficulty breathing), as a delay in stopping treatment may result in a life-threatening reaction. Clinical status, including laboratory parameters with liver aminotransferases, should be monitored and appropriate therapy initiated.

Hepatotoxicity:

  • Hepatic adverse events have been reported, including cases of hepatic toxicity, in patients without pre-existing hepatic disease or other identifiable risk factors.
  • Patients with underlying hepatitis B or C or marked elevations in transaminases prior to treatment may be at increased risk for worsening or development of transaminase elevations. In some cases, the elevations in transaminases were consistent with immune reconstitution syndrome or hepatitis B reactivation, particularly in the setting where anti-hepatitis therapy was withdrawn.
  • Monitoring for hepatotoxicity is recommended.

Depressive Disorders:

  • Depressive disorders (including depressed mood, depression, dysphoria, major depression, mood altered, negative thoughts, suicide attempt, and suicidal ideation) have been reported.
  • Promptly evaluate patients with severe depressive symptoms.

Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions:

  • The concomitant use of JULUCA® and other drugs may result in known or potentially significant drug interactions, see Contraindications and Drug Interactions sections. Rilpivirine doses 3 and 12 times higher than the recommended dose can prolong the QTc interval. Consider alternatives to JULUCA® when coadministered with a drug with a known risk of Torsade de Pointes. Consider the potential for drug interactions prior to and during therapy with JULUCA® and monitor for adverse reactions.

ADVERSE REACTIONS: Most common adverse reactions with JULUCA® (incidence ≥2%, all Grades) were diarrhea (2%) and headache (2%).

DRUG INTERACTIONS

  • Because JULUCA® is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended.
  • Drugs that induce or inhibit CYP3A or UGT1A1 may affect the plasma concentrations of the components of JULUCA®.
  • Drugs that increase gastric pH or containing polyvalent cations may decrease plasma concentrations of the components of JULUCA®.
  • Consider alternatives to prescribing JULUCA® with drugs with a known risk of Torsade de Pointes.
  • Consult the full Prescribing Information for JULUCA® for more information on potentially significant drug interactions, including clinical comments.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: There are insufficient prospective pregnancy data to adequately assess the risk of birth defects and miscarriage. An Antiretroviral Pregnancy Registry has been established.
  • Lactation: Breastfeeding is not recommended due to the potential for HIV-1 transmission and the potential for adverse reactions in nursing infants.

DOSAGE AND ADMINISTRATION

  • Dosage: 1 tablet taken orally once daily with a meal for adult patients.
  • Recommended Dosage of JULUCA® with Rifabutin Coadministration: Take an additional 25-mg tablet of rilpivirine with JULUCA® once daily with a meal for the duration of the rifabutin coadministration.

Full US prescribing information including is available at:

https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Juluca/pdf/JULUCA-PI-PIL.PDF

 

For the EU Summary of Product Characteristics, please visit:

https://www.medicines.org.uk/emc/product/9246

About Janssen

At 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 Sciences Ireland UC and Janssen Pharmaceutica NV are part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Learn more at www.janssen.com and follow us at @JanssenGlobal.

MEDIA CONTACT:
Katie Buckley
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INVESTOR RELATIONS:
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Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding development of potential preventive and treatment regimens for HIV. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Janssen Pharmaceutical Companies and Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product development, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new indications and therapeutic combinations; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the year ended January 1, 2017, including under "Item 1A Risk Factors," its most recently filed Quarterly Report on Form 10-Q, including in the section captioned "Cautionary Note Regarding Forward-Looking Statements," and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at http://www.sec.gov, http://www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.