First Regimen Combining Long Acting Injectable Antiretrovirals; 32-Week LATTE 2 Study Results Presented at CROI

CORK, Ireland, – February 24, 2016 – Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, (Janssen) announced 32-week data from an ongoing phase IIb study. A regimen of two investigational long acting, intramuscular (IM) formulations of HIV medicines—Janssen’s rilpivirine and ViiV Healthcare’s cabotegravir—given together every 4 or 8 weeks—show comparable antiviral activity to 3-drug oral antiretroviral therapy (ART) (investigational cabotegravir and two nucleoside reverse transcriptase inhibitors (NRTIs)). The full results of the study, named LATTE-2, co-funded by Janssen and ViiV Healthcare were presented at this year’s Conference on Retroviruses and Opportunistic Infections (CROI) in Boston, Massachusetts today.

The LATTE-2 study is investigating the safety and efficacy of 2-drug IM ART, relative to 3-drug oral ART when used to maintain viral suppression in HIV-1 infected adults.¹

Virologic responses (plasma HIV-1 RNA <50 c/ml by FDA snapshot analysis) for 309 patients at 32 weeks receiving two drug maintenance therapy with investigational long acting cabotegravir (CAB LA) and long acting rilpivirine (RPV LA) whether dosed every 8 weeks (Q8W, 95%) or every 4 weeks (Q4W, 94%) were comparable to the response observed in patients continuing with a three-drug oral regimen of investigational CAB + NRTIs (91%). Patients switching to CAB LA and RPV LA administered Q4W reported more adverse events (AEs) leading to withdrawal (5%; n=6) compared with those receiving an injection Q8W (2%; n=2) or those who continued on oral CAB + NRTIs (2%, n=1). The most common AE reported by patients was injection site pain (92% of injection recipients).¹

LATTE-2 (31LB) is a phase IIb, multicentre, 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 CAB 30 mg + ABC/3TC were randomised 2:2:1 to IM CAB LA + RPV LA every 4 weeks, every 8 weeks, or remained on oral CAB + ABC/3TC (PO) 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 MP.¹

If successfully developed and approved by regulatory authorities, this regimen could offer adult patients living with and treated for HIV an option to maintain viral suppression with six or twelve long acting injections of each drug per year.

“Through scientific advances, over the past two decades, HIV has moved from a death sentence to a manageable chronic disease,” says Wim Parys, M.D., Vice President and Head of Research and Development Global Public Health, Janssen. “Results of the LATTE-2 study show that long acting injectable drug formulations may offer an important option for HIV maintenance therapy and we remain committed to developing such combinations as we enter phase 3 studies.”

Driven by a purpose of caring, and remaining committed to the prevention, detection, education and treatment of HIV, Janssen has a long history in the global battle against HIV/AIDS. It is estimated that around 37 million people are currently living with HIV globally, with 2 million people becoming newly infected each year2. As a company, Janssen has a deep commitment to HIV and the company’s ultimate goal is to help all those living with the virus to achieve an undetectable viral load and have an improved quality of life with the aim of making HIV history.

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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, headache, and trouble sleeping (insomnia).

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 accompanying full Product Information for more details.

About cabotegravir

Cabotegravir is an investigational integrase strand inhibitor (INSTI) and analogue of dolutegravir (TIVICAY®). Cabotegravir is being developed by ViiV Healthcare for the treatment and prevention of HIV and is currently being evaluated as a once-daily oral tablet formulation and as a LA nanosuspension formulation for intramuscular (IM) injection.

About the Janssen Pharmaceutical Companies of Johnson & Johnson

Janssen Sciences Ireland UC is one of the Janssen Pharmaceutical Companies of Johnson & Johnson. At Janssen, we are dedicated to addressing some of the most important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. More information about Janssen can be found at: www.janssen.com.

Delivering Sustainable Impact in Global Public Health

Combatting HIV is an important component of Johnson & Johnson’s long-standing legacy of commitment and partnership to improve global public health for individuals, families and communities worldwide. Janssen supports this commitment with groundbreaking science and innovative strategies to improve access to medicines, foster collaborations, and support public health solutions to sustainably advance health care worldwide. Through Johnson & Johnson’s global public health organization, the company aims to deliver integrated evidence-based solutions to address comprehensive health needs and deliver meaningful and enduring impact in three core focus areas: HIV, maternal and child health, and extensively drug-resistant (XDR)- and Multidrug-resistant (MDR)- tuberculosis (TB).

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