Business Wire

Data Published in The Lancet Shows High Efficacy at 96 Weeks for First Investigational Two-Drug, Long-Acting Injectable HIV Regimen

Jaa

Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) today announced that a regimen of two investigational long-acting, injectable formulations of HIV medicines —Janssen’s rilpivirine and ViiV Healthcare’s cabotegravir — given together every 4 or 8 weeks was as effective as 3-drug oral antiretroviral therapy (ART) at maintaining HIV-1 viral suppression through 96 weeks (HIV-1 RNA <50 copies per mL). Results published in The Lancet show that if approved, this first two-drug, long-acting regimen could offer a highly effective suppressive maintenance therapy for people living with HIV.

Viral suppression was achieved in 94 percent of those (n=108) receiving injections every eight weeks, warranting further investigation. Virologic response was also achieved by 87 percent (n=100) of those receiving injections every four weeks versus 84 percent (n=47) receiving oral ART therapy. In an unprecedented outcome, no virologic non-responders to the long-acting regimen were observed in the four-week group, as determined by the stringent FDA snapshot algorithm. Few virologic non-responders were seen in the eight-weekly group (n=5 [4%]). These results highlighted that the two-drug, long-acting regimen offered durability of virologic response throughout almost 2 years of treatment.

“Results published in The Lancet strengthen the evidence that a two-drug, long-acting regimen may offer an effective and acceptable alternative for people who have achieved viral suppression but struggle with daily, oral regimens to control their HIV,” said Paul Stoffels M.D., Chief Scientific Officer, Johnson & Johnson. “Non-adherence to treatment remains a challenge for many people living with HIV and one of the main drivers of resistance to HIV medicines. Our hope is to make HIV treatment manageable for all by developing innovative solutions like long-acting regimens.”

In LATTE-2, patients with HIV-1 viral suppression on oral medication (cabotegravir plus abacavir/lamivudine) were randomized 2:2:1 to long-acting injections every four or eight weeks, or to daily oral cabotegravir taken with abacavir and lamivudine.

High satisfaction was reported in the study by those receiving the two-drug, long-acting regimen, which suggests it may provide a preferred alternative for many people living with HIV who may not wish to consider taking life-long oral therapy. The data are based on the observed case data set of subjects who completed questionnaires at week 48 and week 96.

The two-drug, long-acting regimen was generally well tolerated, with no drug-related serious adverse events and few adverse event-related withdrawals. While injection-site reactions (ISRs) were common (four-weekly group, 97% of patients; eight-weekly group, 96% of patients), they were transient in nature, and mild or moderate in severity. The long-term acceptability of administering chronic intramuscular injections to patients was also demonstrated in LATTE-2, with very few withdrawals resulting from ISRs (two patients [<1%]), through 96 weeks.

The most commonly reported non-ISR adverse events were nasopharyngitis (four-weekly group, 34%; eight-weekly group, 30%; oral cabotegravir plus abacavir/lamivudine groups, 39%), diarrhea (four-weekly group, 28%; eight-weekly group, 23%; oral cabotegravir plus abacavir/lamivudine group, 20%), and headache (four-weekly group, 23%; eight-weekly group, 25%; oral cabotegravir plus abacavir/lamivudine group, 25%).

Two global Phase 3 switch studies, FLAIR (First Long-Acting Injectable Regimen) and ATLAS (Antiretroviral Therapy as Long-Acting Suppression), are currently examining the safety and efficacy of four weekly dosing with the two-drug, injectable regimen. For more information on the clinical trials, please visit: www.clinicaltrials.gov.

These results will be presented in an oral abstract session at the 9th International AIDS Society Conference on HIV Science (IAS 2017) at 12:00 on Monday 24 July 2017. Please visit jnj.com/HIV for additional details on the breadth of science being presented by Johnson & Johnson companies and its partners.

###

About the LATTE 2 clinical trial (NCT02120352)

LATTE-2 is an ongoing Phase 2b, multicenter, parallel group, and open-label study which recruited ART-naïve HIV-infected adults. Enrolled patients who had a plasma HIV-1 RNA, <50 c/mL during 20-week Induction Period (IP) with daily oral cabotegravir (CAB) 30 mg plus abacavir/lamivudine 600 mg/300 mg were randomized 2:2:1 to intramuscular injections every 4 weeks (long-acting cabotegravir 400 mg plus rilpivirine 600 mg; two 2-mL injections) or every 8 weeks (long-acting cabotegravir 600 mg plus rilpivirine 900 mg; two 3-mL injections), or to continue receiving three-drug, oral ART in the Maintenance Period (MP). The primary endpoints evaluated antiviral activity by FDA snapshot algorithm, protocol defined virologic failure, and safety at 32 weeks in the maintenance period. Antiviral activity, protocol-defined virologic failures and safety events through 96 weeks for the maintenance population were key secondary endpoints.

About cabotegravir

Cabotegravir is an investigational integrase strand transfer inhibitor (INSTI) and is not approved by regulatory authorities anywhere in the world. Cabotegravir is being developed by ViiV Healthcare as a long-acting, nanosuspension formulation for intramuscular injection for the treatment and prevention of HIV.

About EDURANT ®  (Rilpivirine)

EDURANT ® (rilpivirine) is a prescription HIV medicine that is used with other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) in patients:

  • Who have never taken HIV medicines before, and
  • Who have an amount of HIV in their blood (called “viral load”) that is no more than 100,000 copies/mL. Your healthcare professional will measure your viral load.

EDURANT ® should be taken in combination with other HIV medicines. Your healthcare professional will work with you to find the right combination of HIV medicines.

It is important that you remain under the care of your healthcare professional during treatment with EDURANT ® .

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

EDURANT ® does not cure HIV infection or AIDS. You should remain on your HIV medications without stopping to ensure that you control your HIV infection and decrease the risk of HIV-related illnesses. Ask your healthcare professional about how to prevent passing HIV to other people.

Please read Important Safety Information below, and talk to your healthcare professional to learn if EDURANT ® is right for you.

Important Safety Information

Can EDURANT ® be taken with other medicines?

EDURANT ® may affect the way other medicines work and other medicines may affect how EDURANT ® works and may cause serious side effects. If you take certain medicines with EDURANT ® , the amount of EDURANT ® in your body may be too low and it may not work to help control your HIV infection, and the HIV virus in your body may become resistant to EDURANT ® or other HIV medicines that are like it. To help get the right amount of medicine in your body, you should always take EDURANT ® with a meal. A protein drink alone does not replace a meal.

Do not take EDURANT ® if:

  • Your HIV infection has been previously treated with HIV medicines
  • You are taking any of the following medicines:
    • Anti-seizure medicines: carbamazepine (Carbatrol ® , Equetro ® , Tegretol ® , Tegretol-XR ® , Teril ® , Epitol ® ), oxcarbazepine (Trileptal ® ), phenobarbital (Luminal ® ), phenytoin (Dilantin ® , Dilantin-125 ® , Phenytek ® ).
    • Anti-tuberculosis (anti-TB) medicines: rifampin (Rifater ® , Rifamate ® , Rimactane ® , Rifadin ® ), rifapentine (Priftin ® ) Proton pump inhibitor (PPI) medicine for certain stomach or intestinal problems: esomeprazole (Nexium ® , Vimovo ® ), lansoprazole (Prevacid ® ), omeprazole (Prilosec ® , Zegerid ® ), pantoprazole sodium (Protonix ® ), rabeprazole (Aciphex ® ).
    • More than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium phosphate.
    • St. John’s wort (Hypericum perforatum).
  • Especially tell your doctor if you take:
    • Rifabutin (Mycobutin ® ), a medicine to treat some bacterial infections). Talk to your doctor or pharmacist about the right amount of EDURANT ® you should take if you also take rifabutin.
    • Medicines used to treat HIV.
    • An antacid medicine that contains aluminum, magnesium hydroxide, or calcium carbonate. Take antacids at least 2 hours before or at least 4 hours after you take EDURANT ® .
    • Medicines to block acid in your stomach, including cimetidine (Tagamet ® ), famotidine (Pepcid ® ), nizatidine (Axid ® ), or ranitidine hydrochloride (Zantac ® ). Take these medicines at least 12 hours before or at least 4 hours after you take EDURANT ® .
    • Any of these medicines (if taken by mouth or injection): clarithromycin (Biaxin ® ), erythromycin (E-Mycin ® , Eryc ® , Ery-Tab ® , PCE ® , Pediazole ® , Ilosone ® ), fluconazole (Diflucan ® ), itraconazole (Sporanox ® ), ketoconazole (Nizoral ® ), methadone (Dolophine ® ), posaconazole (Noxafil ® ), telithromycin (Ketek ® ), voriconazole (Vfend ® ).

This is not a complete list of medicines. Before starting EDURANT®, be sure to tell your healthcare professional about all the medicines you are taking or plan to take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Before taking EDURANT ® , also tell your healthcare professional if you have had or currently have liver problems (including hepatitis B or C), have ever had a mental health problem, are pregnant or planning to become pregnant, or breastfeeding. It is not known if EDURANT ® will harm your unborn baby.

You and your healthcare professional will need to decide if taking EDURANT ® is right for you.

Do not breastfeed if you are taking EDURANT ® . You should not breastfeed if you have HIV because of the chance of passing HIV to your baby.

What are the possible side effects of EDURANT ® ? EDURANT ® can cause serious side effects including:

  • Severe skin rash and allergic reactions. Call your doctor right away if you get a rash. Stop taking EDURANT ® and seek medical help right away if you get a rash with any of the following symptoms: severe allergic reaction causing swelling of the face, eyes, lips, mouth, tongue, or throat (which may lead to difficulty swallowing or breathing); mouth sores or blisters on your body; inflamed eye (conjunctivitis); fever; dark urine; or pain on the right side of the stomach area (abdominal pain).
  • Depression or mood changes. Tell your doctor right away if you have any of the following symptoms: feeling sad or hopeless, feeling anxious or restless, have thoughts of hurting yourself (suicide), or have tried to hurt yourself.
  • Liver problems. People with a history of hepatitis B or C virus infection or who have certain liver function test changes may have an increased risk of developing new or worsening liver problems during treatment. Liver problems were also reported during treatment in some people without a history of liver disease. Your healthcare professional may need to do tests to check liver function before and during treatment.
  • Changes in body shape or body fat have been seen in some patients taking HIV medicines. The exact cause and long-term health effects of these conditions are not known.
  • Changes in your immune system (immune reconstitution syndrome).
  • Your immune system may get stronger and begin to fight infections. Tell your healthcare professional right away if you start having any new symptoms of infection.
  • Other common side effects of EDURANT ® include depression, headache, trouble sleeping (insomnia), and rash.

This is not a complete list of all side effects. If you experience these or other symptoms, contact your healthcare professional right away. Do not stop taking EDURANT ® or any other medications without first talking to your healthcare professional.

You are encouraged to report side effects of prescription drugs to the FDA. Visit 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 for more details.

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.

Contact information

Janssen
MEDIA CONTACTS:
Ronan Collins
+47 488 425 00
rcollin5@its.jnj.com
or
Katie Buckley
+44 7971 956 179
kbuckle8@its.jnj.com
or
Gavin Hart
+1 917 686 9221
Ghart9@its.jnj.com
or
INVESTOR RELATIONS:
Lesley Fishman
+1 732-524-3922
or
Joseph J. Wolk
+1 732-524-1142

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme tältä julkaisijalta, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Knopp Biosciences Announces Renewal of NIH Blueprint Grant Award for Advancing KCNQ2 Modulators in Epilepsy23.10.2017 18:11Tiedote

Knopp Biosciences LLC today announced the renewal and expansion of its grant award from the National Institutes of Health Blueprint Neurotherapeutics Network to advance novel treatments for epilepsy. The Phase 2 award under the NIH Small Business Innovation Research (SBIR) program anticipates NIH support of up to $2 million over the next three years of the project, subject to satisfactory completion of milestones. The renewal follows the successful completion of all milestones under a previously awarded Phase 1 grant of $400,000. Knopp is directing its potassium channel activator program to preclinical and clinical development of small-molecule drug candidates against a validated, anti-seizure pharmaceutical target encoded by the KCNQ2 gene. Knopp intends to advance novel, small-molecule KCNQ2 activators in neonatal epileptic encephalopathy, a rare disorder caused by inherit

HCL Technologies Powers Volvo Ocean Race 2017-1823.10.2017 16:02Tiedote

The 2017-18 edition of the Volvo Ocean Race was flagged off at Alicante, Spain, with HCL Technologies as the strategic IT services provider. The leading global IT services company has provided end-to-end infrastructure support as well as connectivity between the Race Village and the Command Centre in Alicante further connecting them to 12 Host Cities on the race route globally. The world's longest and toughest professional sporting event began at Alicante and will finish eight months later at The Hague. At the flag-off, Jordi Neves, Chief Digital Officer, Volvo Ocean Race, said: “Over four decades, Volvo Ocean Race has drawn some of the greatest ever sailors. This edition of the race will be more digitally focused than before, with HCL as the strategic IT services provider. This edition is also special for us as we embark on a major Sustainability Program in partnership wi

CES Unveiled Paris Returns Tomorrow for Fifth Year with 70+ Exhibitors23.10.2017 16:00Tiedote

Consumer Technology Association (CTA):   WHAT:             CES Unveiled Paris returns to Paris tomorrow, for its fifth consecutive year, hosting more than 70 exhibitors. More than 600 attendees are expected at the event which will unite French tech startups, top media, buyers and industry influencers around the latest tech innovation and provide a preview of CES® 2018. Schedule as follows:  

Wipro Cited as a Leader in Everest Group PEAK Matrix™ for IT Security Services23.10.2017 15:59Tiedote

Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO), a leading global information technology, consulting and business process services company, today announced that it has been recognized as a ‘Leader’ by Everest Group, a global independent consulting and research firm, in its report titled “IT Security Services- Market Trends and PEAK MatrixTM Assessment 2017: Security- the Biggest Digital Insecurity”. The report analyzed the capabilities of 17 leading global IT service providers on Everest Group’s PEAK Matrix. Wipro has been named as a Leader for its strong global delivery network with a transformational mind-set, and its ability to deliver high quality of services across regions and service segments, in terms of both execution and responsiveness. The report highlights the trends influencing the IT security services market, focusing on the increasing complexities, size and

ZeroStack Delivers Unified Multi-Cloud Application Development Platform Leveraging Existing Hardware Assets23.10.2017 15:00Tiedote

ZeroStack, Inc., creators of the self-driving on-premises cloud, today announced that its cloud platform now runs on Nutanix HCI hardware, expanding choices for IT departments that want to empower their DevOps groups with a software-defined infrastructure that offers SaaS-delivered, multi-cloud operations. Developers can have a consistent platform no matter where they are located while reducing operational complexity and costs. Developers need a common platform to reduce costs and ensure efficient processes for software development, and budget-constrained IT departments want to gain maximum leverage out of existing hardware. ZeroStack’s Intelligent Cloud Platform is hardware independent, so it enables consistent processes regardless of the hardware used or where the developers access the infrastructure. As a result, developers can create secure private workspaces and build a per

Biogen and Eisai Expand Existing Collaboration Agreement to Develop and Commercialize Investigational Alzheimer’s Disease Treatments Including Phase 3 Aducanumab23.10.2017 14:15Tiedote

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (NASDAQ: BIIB) (Headquarters: Cambridge, Massachusetts, United States, CEO: Michel Vounatsos, “Biogen”) announced today that the companies have expanded their existing agreement to jointly develop and commercialize investigational Alzheimer’s disease treatments. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171023005462/en/ Under the terms of the agreement Eisai has exercised its option to co-develop and co-promote aducanumab, Biogen’s investigational anti-amyloid beta (Aβ) antibody for patients with Alzheimer’s disease (“AD”). The expanded agreement leverages each company’s respective geographic strengths for commercialization and adjusts the respective share of profits from potential sales of aducanumab. Biogen will receive 55

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme