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Johnson & Johnson to Present New Data for Investigational Preventive Vaccine and Single-Tablet Treatment Regimens for HIV-1 at AIDS 2018
Johnson & Johnson to Present New Data for Investigational Preventive Vaccine and Single-Tablet Treatment Regimens for HIV-1 at AIDS 2018
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Presentations will include first long term immunological data for preventive mosaic-based vaccine, new Phase 3 findings for SYMTUZATM (D/C/F/TAF) and studies highlighting impact of novel interventions for HIV-affected populations.

New Brunswick, July 20, 2018 As part of its commitment to make HIV history, the Janssen Pharmaceutical Companies of Johnson & Johnson today announced that over ten company-sponsored and partnered presentations will be presented at the 22nd International AIDS Conference (AIDS 2018) in Amsterdam, The Netherlands (23-27 July). Johnson & Johnson will also be hosting a major satellite symposium, Biomedical Research Innovations in the

Prevention, Remission and Cure of HIV/AIDS, which will take place immediately prior to the opening ceremony of the conference on July 23.

Notable Janssen presentations at AIDS 2018 will include the first long-term immunological data for the company’s investigational preventive vaccine regimen against HIV-1. Janssen’s mosaic-based regimen is designed as a “global vaccine” with the goal of preventing HIV infections due to a wide variety of HIV-1 subtypes responsible for the worldwide pandemic. Findings up to one year after last vaccination on safety and immunogenicity (ability to elicit an immune response) will be presented from the Phase 1/2a APPROACH study. Initial data from APPROACH were published in The Lancet on July 6, 2018, and showed a robust HIV immune response among a high percentage of healthy volunteers.

“The progress made in the last thirty years in the fight against HIV is remarkable, yet there is still much more to be done to achieve the UN’s target of ending the epidemic by 2030,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. “In our quest towards a world without HIV, we are partnering with others to achieve the very best science. From our clinical trials of an investigational vaccine to exploring ways to transform the efficacy and tolerability of therapy, we aim to change the trajectory of health for humanity.”

Janssen will also present new data for SYMTUZATM, the darunavir-based single-tablet regimen for the treatment of HIV-1 infection, for which FDA approval is pending. These data include Week 48 results from the pivotal EMERALD trial, providing evidence on the efficacy and safety of switching from a boosted protease inhibitor-based regimen to a single-tablet regimen of SYMTUZATM in the treatment of HIV-1. Results from subgroups according to baseline regimen will be presented.

Johnson & Johnson is also proud to support its partners at AIDS 2018, harnessing extensive resources, pushing boundaries and exploring solutions to tackle some of the today’s most pressing public health challenges. Johnson & Johnson is committed to reducing the burden of HIV among the world’s most underserved populations through collaborations exploring multiple solutions, from investigating the role of a dapivirine-coated vaginal ring and its potential to reduce HIV transmission, to how cellphones may be used to support adherence to antiretroviral therapy.

A selected list of company and partnered data is listed below:

New data for our investigational vaccine regimen

APPROACH: This Phase 1/2a study will describe long-term safety and immunogenicity data in humans for investigational “mosaic”-based, prime-boost regimens that are designed to elicit an immune response against a variety of HIV subtypes prevalent worldwide.

  • Oral presentation from 11:45 CEST (05:45 EDT) on Tuesday 24 July (Abstract #10764); Venue E105-108

HPX1002/IPCAVD010: This Phase 1 study explores the immunologic responses of shorter mosaic-based vaccine regimens.

  • Oral presentation by Janssen’s partner Beth Israel Deaconess Medical Center (BIDMC) from 12:00 CEST (06:00 EDT) on Tuesday 24 July (Abstract #11441); Venue E105-108

New data for SYMTUZATM, the darunavir-based single-tablet regimen
EMERALD: Week 48 data in the pivotal EMERALD trial of HIV-1, providing evidence on the efficacy and safety of switching from a boosted protease inhibitor-based regimen to a single-tablet regimen of SYMTUZATM. Results from subgroups according to baseline regimen with be presented.

  • Poster presentation from 12:30-14:30 CEST (06:30-08:30 EDT) on Thursday 26 July (Abstract #5718); Poster Exhibition area, Hall 1, next to the Global Village (ground floor, by the Main Entrance)

DIAMOND: Interim findings from the Phase 3 DIAMOND trial will provide evidence on the use of SYMTUZATM for the treatment of HIV-1 within community programs that use a Test-to-Treat model.

  • Poster presentation from 12:30-14:30 CEST (06:30-08:30 EDT) on Wednesday 25 July (Abstract #5095); Poster Exhibition area, Hall 1, next to the Global Village (ground floor, by the Main Entrance)

Final results of pilot study with darunavir/cobicistat/rilpivirine
PREZENT: Data will provide a first look at the final 96-week results of a pilot study into darunavir with cobicistat and ripilvirine in HIV-positive treatment-naïve participants.

  • Poster presentation in partnership with IIS from 12:30-14:30 CEST (06:30-08:30 EDT) on Thursday 26 July (Abstract #4347); Poster Exhibition area, Hall 1, next to the Global Village (ground floor, by the Main Entrance)

Longer-term data for JULUCA®, the first licensed two-drug maintenance treatment for HIV
SWORD 1 and 2: Data presented will show the evidence for durable maintenance of HIV-1 suppression to 100 weeks with a two-drug, single-tablet regimen combining ViiV Healthcare’s dolutegravir and Janssen’s rilpivirine, highlighting how it is possible to reduce cumulative ARV exposure while maintaining virological suppression.

  • Poster presentation by ViiV Healthcare from 12:30-14:30 CEST (06:30-08:30 EDT) on Thursday 26 July (Abstract #11730); Poster Exhibition area, Hall 1, next to the Global Village (ground floor, by the Main Entrance)

Results from Phase 2b study of an investigational two-drug long-acting injectable regimen comprising of ViiV’s cabotegravir and Janssen’s rilpivirine
LATTE-2: Data will explore patient satisfaction with the long-acting injectable regimen.

  • Poster presentation by ViiV Healthcare from 12:30-14:30 CEST (06:30-08:30 EDT) on Thursday 26 July (Abstract #6001); Poster Exhibition area, Hall 1, next to the Global Village (ground floor, by the Main Entrance)

LATTE-2: Data will explore patient adherence to long-acting cabotegravir and rilpivirine injections through 96-weeks of maintenance therapy

  • Poster presentation by ViiV Healthcare from 12:30-14:30 CEST (06:30-08:30 EDT) on Thursday 26 July (Abstract #10659); Poster Exhibition area, Hall 1, next to the Global Village (ground floor, by the Main Entrance)

Cellphone intervention to promote adherence to antiretroviral therapy and improve standard of care

Multi-Octave: Data presented will show the effectiveness of using 2-way cellphone intervention (CPI) to boost 3rd line adherence in ART-experienced individuals.

  • Poster presentation by AIDS Clinical Trials Group from 12:30-14:30 CEST (06:30-08:30 EDT) on Thursday 26 July (Abstract #5097); Poster Exhibition area, Hall 1, next to the Global Village (ground floor, by the Main Entrance)

New data on dapivirine vaginal ring, including variation on packaging and branding to improve product appeal to women, and social and behavioral data around male experiences of ring

Testing potential names and branding of packaging to ensure product is culturally appropriate, acceptable and appealing to women at risk of HIV in high HIV burden countries.

  • Poster presentation by International Partnership for Microbicides from 12:30-14:30 CEST (06:30-08:30 EDT) on Wednesday 25 July (Abstract #8590); Poster Exhibition area, Hall 1, next to the Global Village (ground floor, by the Main Entrance)

An exploration of the perceptions and experiences of male sex partners of women participating in the 104-week Phase 3 study using the dapivirine ring, and how these could affect ring use.

  • Poster presentation by International Partnership for Microbicides from 12:30-14:30 CEST (06:30-08:30 EDT) on Thursday 26 July (Abstract #10591); Poster Exhibition area, Hall 1, next to the Global Village (ground floor, by the Main Entrance)

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.

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Notes to editors

About Janssen’s Investigational HIV Vaccine Regimen

Since 2005, Janssen Vaccines & Prevention B.V. has been participating in the NIH-supported Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) program under grants AI066305, AI078526 and AI096040, in collaboration with Professor Dan Barouch at Beth Israel Deaconess Medical Center (BIDMC), Harvard Medical School. Janssen’s partners on the APPROACH study included BIDMC; the United States Military HIV Research Program (MHRP) at the Walter Reed Army Institute of Research (WRAIR), with the Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF); the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH); the Ragon Institute of Massachusetts General Hospital, MIT and Harvard; the International AIDS Vaccine Initiative (IAVI); and the HIV Vaccine Trials Network (HVTN). Janssen’s partners on HPX1002/IPCAVD010 included BIDMC and the Ragon Institute.

About SYMTUZATM

SYMTUZATM is approved by the US Food and Drug Administration (FDA) for the treatment of human immunodeficiency virus type 1 (HIV-1) in treatment-naïve and certain virologically suppressed adults.

SYMTUZATM is a fixed-dose combination of four active substances (darunavir, cobicistat, emtricitabine and tenofovir alafenamide), available as 800 mg/150 mg/200 mg/10 mg film-coated tablets. Darunavir inhibits the HIV protease and prevents the formation of mature infectious virus particles. Emtricitabine and tenofovir alafenamide are substrates and competitive inhibitors of HIV reverse transcriptase. After phosphorylation, they are incorporated into the viral DNA chain, resulting in chain termination. Cobicistat enhances the systemic exposure of darunavir and has no direct antiviral effect.

In the European Union, SYMTUZATM is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents (aged 12 years and older with body weight at least 40 kg). Genotypic testing should guide the use of SYMTUZATM.

Cobicistat, emtricitabine and TAF 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, darunavir-based STR including 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 SYMTUZATM worldwide.

Notes to editors

About SYMTUZATM

SYMTUZATM is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) in treatment-naïve and certain virologically suppressed adults.

SYMTUZATM is a fixed-dose combination of four active substances (darunavir, cobicistat, emtricitabine and tenofovir alafenamide), available as 800 mg/150 mg/200 mg/10 mg film-coated tablets. Darunavir inhibits the HIV protease and prevents the formation of mature infectious virus particles. Emtricitabine and tenofovir alafenamide are substrates and competitive inhibitors of HIV reverse transcriptase. After phosphorylation, they are incorporated into the viral DNA chain, resulting in chain termination. Cobicistat enhances the systemic exposure of darunavir and has no direct antiviral effect.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about SYMTUZA™?

SYMTUZA™ can cause serious side effects including:

  • Worsening of hepatitis B virus infection. Your healthcare provider will test you for hepatitis B virus (HBV) before starting treatment with SYMTUZA™. If you have HBV infection and take SYMTUZA™, your HBV may get worse (flare-up) if you stop taking SYMTUZA™.
  • Do not stop taking SYMTUZA™ without first talking to your healthcare provider.
  • Do not run out of SYMTUZA™. Refill your prescription or talk to your healthcare provider before your SYMTUZA™ is all gone.
  • If you stop taking SYMTUZA™, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your HBV infection or give you a medicine to treat your HBV infection. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking SYMTUZA™.
  • Change in liver enzymes. People with a history of hepatitis B or C virus infection or who have certain liver enzyme changes may have an increased risk of developing new or worsening liver problems during treatment with SYMTUZA™. Liver problems can also happen during treatment with SYMTUZA™ in people without a history of liver disease. Your healthcare provider may need to do tests to check your liver enzymes before and during treatment with SYMTUZA™.
  • Severe liver problems. In rare cases, severe liver problems can happen that can lead to death. Tell your healthcare provider right away if you get these symptoms:
  • Skin or the white part of your eyes turn yellow
  • Dark "tea-colored" urine
  • Light-colored stools
  • Loss of appetite for several days or longer
  • Nausea
  • Vomiting
  • Stomach area pain

SYMTUZA™ may cause severe or life-threatening skin reactions or rashes which may sometime require treatment in a hospital. Call your healthcare provider right away if you develop a rash. Stop taking SYMTUZA™ and call your healthcare provider right away if you develop any skin changes with symptoms below:

  • Fever
  • Tiredness
  • Muscle or joint pain
  • Blisters or skin lesions
  • Mouth sores or ulcers
  • Red or inflamed eyes, like "pink eye" (conjunctivitis)

Who should not take SYMTUZA™?

  • Do not take SYMTUZA™ with any of the following medicines: alfuzosin, carbamazepine, cisapride, colchicine (if you have liver or kidney problems), dronedarone, elbasvir and grazoprevir, ergot-containing medicines (such as: dihydroergotamine, ergotamine tartrate, methylergonovine), lovastatin or a product that contains lovastatin, lurasidone, oral midazolam (when taken by mouth), phenobarbital, phenytoin, pimozide, ranolazine, rifampin, St. John's wort (Hypericum perforatum) or a product that contains St. John's wort, sildenafil when used for pulmonary arterial hypertension (PAH), simvastatin or a product that contains simvastatin, or triazolam.
  • Serious problems can happen if you take any of these medicines with SYMTUZA™.

Before taking SYMTUZA™, tell your healthcare provider about all of your medical conditions, including if you:

  • have liver problems (including hepatitis B or hepatitis C), have kidney problems, are allergic to sulfa (sulfonamide), have diabetes, have hemophilia, or have any other medical condition.
  • are pregnant (if you become pregnant while taking SYMTUZA™), or plan to become pregnant. It is unknown if SYMTUZA™ will harm your unborn baby.
  • SYMTUZA™ should not be used during pregnancy.
  • are breastfeeding or plan to breastfeed. Do not breastfeed if you take SYMTUZA™.

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™?

  • Take SYMTUZA™ 1 time a day with food.

What are the possible side effects of SYMTUZA™?

SYMTUZA™ may cause serious side effects including:

  • See "What is the most important information I should know about SYMTUZA™?"
  • Immune system changes can happen in people who start HIV medications.
  • New or worse kidney problems, including kidney failure.
  • Your healthcare provider should do blood and urine tests to check your kidneys before you start and while you are taking SYMTUZA™.
  • Too much lactic acid in your blood (lactic acidosis).
  • Too much lactic acid is a serious but rare medical emergency that can lead to death. Tell your healthcare provider right away if you get these symptoms: weakness or being more tired than usual, unusual muscle pain, being short of breath or fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, feel dizzy or lightheaded, or a fast or abnormal heartbeat.
  • Diabetes and high blood sugar (hyperglycemia). Some people who take protease inhibitors including SYMTUZA™ can get high blood sugar, develop diabetes, or your diabetes can get worse. Tell your healthcare provider if you notice an increase in thirst or if you start urinating more often while taking SYMTUZA™.
  • Changes in body fat can happen in people taking HIV-1 medications.
  • Increased bleeding can occur in people with hemophilia who are taking SYMTUZA™.

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™.

About JULUCA®

JULUCA® was approved by the FDA on 21 November 2017, Health Canada on 18 May 2018 and the European Commission (EC) on 21 May 2018, as a complete regimen for the treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of dolutegravir/rilpivirine.

JULUCA® is a two-drug regimen, single-pill that combines the INI dolutegravir from ViiV Healthcare (50mg), with the NNRTI rilpivirine (25mg) taken once-daily with food as a complete regimen for people living with HIV-1 who are virologically suppressed.

HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use JULUCA® safely and effectively. See full prescribing information for JULUCA®.

JULUCA® (dolutegravir and rilpivirine) tablets, for oral use Initial U.S. Approval: 2017

INDICATIONS AND USAGE
JULUCA®, a two-drug combination of dolutegravir, a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI), and rilpivirine, a HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI), is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of JULUCA®.

DOSAGE AND ADMINISTRATION

  • One tablet taken orally once daily with a meal.
  • Rifabutin coadministration: Take an additional 25-mg tablet of rilpivirine with JULUCA® once daily with a meal for the duration of the rifabutin coadministration.

DOSAGE FORMS AND STRENGTHS
Each tablet contains: 50 mg of dolutegravir (equivalent to 52.6 mg dolutegravir sodium) and 25 mg of rilpivirine (equivalent to 27.5 mg rilpivirine hydrochloride).

CONTRAINDICATIONS

  • Previous hypersensitivity reaction to dolutegravir or rilpivirine.
  • Coadministration with dofetilide.
  • Coadministration with drugs where significant decreases in rilpivirine plasma concentrations may occur, which may result in loss of virologic response.

WARNINGS AND PRECAUTIONS

  • Severe skin and hypersensitivity reactions characterised by rash, constitutional findings, and sometimes organ dysfunction, including liver injury, have been reported with the individual components. Discontinue JULUCA® immediately if signs or symptoms of severe skin or hypersensitivity reactions develop, as a delay in stopping treatment may result in a life-threatening reaction.
  • Hepatotoxicity has been reported in patients receiving a dolutegravir- or rilpivirine-containing regimen. Monitoring for hepatotoxicity is recommended.
  • Depressive disorders have been reported with the use of rilpivirine- or dolutegravir-containing regimens. Immediate medical evaluation is recommended for severe depressive symptoms.

ADVERSE REACTIONS
The most common adverse reactions (all Grades) observed in at least 2% of subjects were diarrhoea and headache.

To report SUSPECTED ADVERSE REACTIONS, contact ViiV Healthcare at 1-888-844-8872 or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.

DRUG INTERACTIONS

  • Because JULUCA® is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended.
  • Refer to the full prescribing information for important drug interactions with JULUCA®.
  • Drugs that induce or inhibit CYP3A4 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.

USE IN SPECIFIC POPULATIONS
Lactation: Breastfeeding is not recommended due to the potential for HIV transmission.

About the Janssen Pharmaceutical Companies
At Janssen, 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. Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenUS and www.twitter.com/JanssenGlobal.

Tivicay® is a registered trademark of the ViiV Healthcare group of companies.

EDURANT® is a registered trademark of Janssen Sciences Ireland UC.

EDURANT® (rilpivirine)

EDURANT® (rilpivirine), in combination with other antiretroviral agents, is a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve patients with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy.

The following points should be considered when initiating therapy with EDURANT®:

  • More EDURANT®-treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure (HIV-1 RNA ≥50 copies/mL) compared to EDURANT®-treated subjects with HIV-1 RNA less than or equal to 100,000 copies/mL
  • Regardless of HIV-1 RNA at the start of therapy, more EDURANT®-treated subjects with CD4+ cell count less than 200 cells/mm3experienced virologic failure compared to EDURANT®-treated subjects with CD4+ cell count greater than or equal to 200 cells/mm3
  • The observed virologic failure rate in EDURANT®-treated subjects conferred a higher rate of overall treatment resistance and cross-resistance to the NNRTI class compared to efavirenz
  • More subjects treated with EDURANT®developed tenofovir and lamivudine/emtricitabine-associated resistance compared to efavirenz

EDURANT® is not recommended for patients less than 12 years of age.

Important Safety Information

Contraindications

  • Coadministration of EDURANT® with the following drugs is contraindicated because significant decreases in rilpivirine plasma concentrations may occur due to CYP3A enzyme induction or gastric pH increase, which may result in loss of virologic response and possible resistance and cross-resistance: carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifapentine, proton pump inhibitors such as esomeprazole, lansoprazole, omeprazole, pantoprazole, and rabeprazole, systemic dexamethasone (more than a single dose), and products containing St. John’s wort (Hypericum perforatum)

Warnings and Precautions

  • Skin and Hypersensitivity Reactions: Severe skin and hypersensitivity reactions have been reported during the postmarketing experience, including cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), with rilpivirine-containing regimens. While some skin reactions were accompanied by constitutional symptoms such as fever, other skin reactions were associated with organ dysfunctions, including elevations in hepatic serum biochemistries. EDURANT® should be discontinued immediately if signs or symptoms of severe skin or hypersensitivity reactions develop, including but not limited to, severe rash or rash accompanied by fever, blisters, mucosal involvement, conjunctivitis, facial edema, angioedema, hepatitis or eosinophilia. Clinical status including laboratory parameters should be monitored and appropriate therapy should be initiated
  • Depressive Disorders: Severe depressive disorders, defined as depressed mood, depression, dysphoria, major depression, mood altered, negative thoughts, suicide attempt, and suicidal ideation, have been reported with EDURANT®. Immediate medical evaluation is recommended for severe depressive symptoms
  • Hepatotoxicity: Hepatic adverse events were reported. Patients with underlying hepatic disease, including hepatitis B or C, or marked elevations in transaminases before treatment may be at increased risk for worsening or development of transaminase elevations. Monitor liver function tests (LFTs) before and during treatment. A few hepatotoxicity cases occurred in patients with no pre-existing hepatic disease or other identifiable risk factors; therefore, monitoring of LFTs should be considered in all patients
  • Fat Redistribution: Redistribution and/or accumulation of body fat have been observed in patients receiving ARV therapy. The causal relationship, mechanism, and long-term consequences of these events have not been established
  • Immune Reconstitution Syndrome has been reported in patients treated with combination ARV therapy, including EDURANT®. Autoimmune disorders (such as Graves disease, polymyositis, and Guillain-Barré syndrome) have also been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable and can occur many months after initiation of treatment

Drug Interactions

  • EDURANT® should be used with caution when coadministered with drugs that may reduce the exposure of rilpivirine, such as antacids and H2-receptor antagonists
  • Concomitant use of EDURANT® with rifabutin may cause a decrease in the plasma concentrations of rilpivirine. Please read the Dosage and Administration Section of the Prescribing Information for more details regarding the concomitant use of EDURANT® and rifabutin
  • EDURANT® should be used with caution when coadministered with a drug with a known risk of Torsade de Pointes
  • EDURANT® should not be used in combination with NNRTIs

This is not a complete list of potential drug interactions.

Please see full Prescribing Information for more details.

Use in Specific Populations

  • Hepatic Impairment: EDURANT® should be used with caution in patients with severe hepatic impairment (Child-Pugh Class C) as pharmacokinetics of EDURANT® have not been evaluated in these patients
  • Pregnancy Category B: EDURANT® should be used during pregnancy only if the potential benefit justifies the potential risk. No adequate and well-controlled studies have been conducted in pregnant women

Adverse Reactions

  • The most common adverse drug reactions reported (incidence >2%) of at least moderate intensity (≥ Grade 2) in patients taking EDURANT®through 96 weeks were depressive disorders (5%), headache (3%), insomnia (3%), and rash (3%)

034144-151202

Please see full Prescribing Information for more details.

TIVICAY® (dolutegravir) tablets

Important Safety Information for TIVICAY® (dolutegravir) 10-, 25-, and 50-mg tablets, for oral use

The following Important Safety Information (ISI) is based on the Highlights section of the US Prescribing Information for TIVICAY® and local variations apply. Please consult the full Prescribing Information for all the labeled safety information for TIVICAY® or please refer to applicable local labelling.

FDA INDICATIONS AND USAGE

TIVICAY® is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 30 kg.

Limitations of Use:

  • Use of TIVICAY® in integrase strand transfer inhibitor (INSTI)-experienced patients should be guided by the number and type of baseline INSTI substitutions. The efficacy of TIVICAY 50 mg twice daily is reduced in patients with an INSTI-resistance Q148 substitution plus 2 or more additional INSTI-resistance substitutions including T66A, L74I/M, E138A/K/T, G140S/A/C, Y143R/C/H, E157Q, G163S/E/K/Q, or G193E/R.

CONTRAINDICATIONS

  • Previous hypersensitivity reaction to dolutegravir.
  • Coadministration with dofetilide.

WARNINGS AND PRECAUTIONS

  • Hypersensitivity reactions characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury, have been reported. Discontinue TIVICAY® and other suspect agents immediately if signs or symptoms of hypersensitivity reactions develop, as a delay in stopping treatment may result in a life-threatening reaction.
  • Patients with underlying hepatitis B or C may be at increased risk for worsening or development of transaminase elevations with use of TIVICAY®. Appropriate laboratory testing prior to initiating therapy and monitoring for hepatotoxicity during therapy with TIVICAY® is recommended in patients with underlying hepatic disease such as hepatitis B or C.
  • Redistribution/accumulation of body fat and immune reconstitution syndrome have been reported in patients treated with combination antiretroviral therapy.

ADVERSE REACTIONS
The most common adverse reactions of moderate to severe intensity and incidence at least 2% (in those receiving TIVICAY® in any one adult trial) are insomnia, fatigue, and headache.

DRUG INTERACTIONS

  • Drugs that are metabolic inducers may decrease the plasma concentrations of dolutegravir.
  • TIVICAY® should be taken 2 hours before or 6 hours after taking cation-containing antacids or laxatives, sucralfate, oral supplements containing iron or calcium, or buffered medications. Alternatively, TIVICAY® and supplements containing calcium or iron can be taken together with food.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: TIVICAY® should be used during pregnancy only if the potential benefit justifies the potential risk.
  • Lactation: Breastfeeding is not recommended.

Please visit the following link for the full US prescribing and patient information: https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Tivicay/pdf/TIVICAY-PI-PIL.PDF#page=1

About Johnson & Johnson

At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly-based health care company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity.

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. Learn more at www.janssen.com and follow us at @JanssenGlobal.

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 www.sec.gov, 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.

  • MEDIA CONTACTS:
    Ronan Collins
    +47 488 42500

    Katie Buckley
    + 44 790 0655 261

    Corina Ramers-Verhoeven
    CRamersV@its.jnj.com
    +31 6 1530 0086

    INVESTOR RELATIONS:
    Lesley Fishman
    +1 732 524 3922
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