First Investigational All Injectable Long Acting HIV Combination Regimen Study Results at 32 Weeks Announced

PR62416

CORK, Ireland, Nov. 3, 2015 /PRNewswire=KYODO JBN/ --

- Injectable combinations once every 4 or 8 weeks show comparable efficacy

versus daily oral combination therapy

Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of

Johnson & Johnson (Janssen), announced that Phase IIb data studying a

combination 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 show comparable efficacy to a daily oral regimen of

three HIV medicines (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 will be presented at a forthcoming

scientific conference.

Logo: http://photos.prnewswire.com/prnh/20140324/NY88746LOGO

"Despite great progress in HIV treatments, the burden of treating HIV patients

remains high. Long-acting injectable drug formulations may offer another option

for HIV maintenance therapy," says Paul Stoffels, M.D. Chief Scientific Officer

and Worldwide Chairman Pharmaceuticals, Johnson & Johnson. "Our hope in

studying such combinations is to make HIV infection manageable with a

potentially transformational all injectable regimen."

If successfully developed and approved by regulatory authorities, this regimen

could offer people living with HIV who are virologically suppressed an option

to switch from a standard daily regimen of three-drug therapy to a long acting

all-injectable regimen that could potentially maintain viral suppression with

just six or twelve injections of each drug per year.  

Following the results of the proof of concept two-drug oral dose-ranging study

LATTE, LATTE 2 was initiated as a phase IIb, multicentre, open label 96 week

study investigating the safety and efficacy of this first all-injectable long

acting combination regimen of rilpivirine and cabotegravir to maintain

suppression of viral load. LATTE 2 included adults (n=309) who, after reaching

virologic suppression on oral therapy with once-daily investigational oral

cabotegravir 30mg + 2 NRTIs (n=286, 93%), were subsequently randomized to one

of three study arms to receive either CAB LA + RPV LA injections every 4 weeks

(n=115, Q4W), 8 weeks (n=115 Q8W) or continued on oral CAB + NRTIs (n=56).

Viral suppression rates (plasma HIV-1 RNA ＜50 c/ml by FDA snapshot analysis)

for 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 rate 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 who continued on oral CAB + NRTIs (2%, n=1). The most common AE reported by

patients was injection site pain (93% of injection recipients). Two patients in

the Q8W arm (none in the Q4W arm) withdrew for injection intolerance. Two

patients met protocol defined virologic failure criteria, Q8W (n=1), oral

(n=1); neither patient had evidence of resistance at failure.

Since the beginning of the HIV epidemic, almost 75 million people have been

infected with the HIV virus.[1] It is estimated that 35 million people are

currently living with HIV globally, with 2.5 million people becoming newly

infected each year.[1],[ 2],[ 3] Standard three-drug oral therapy contains

three active components taken daily: a backbone of two NRTIs, plus either a

non-nucleoside reverse transcriptase inhibitor, protease inhibitor (PI) or

integrase inhibitor (INI).

About EDURANT(R) (Rilpivirine)

EDURANT(R) (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(R) 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(R)

EDURANT(R) is not recommended for patients less than 12 years of age

EDURANT(R) 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(R) is right for you.

Important Safety Information

Can EDURANT(R) be taken with other medicines?

EDURANT(R) may affect the way other medicines work and other medicines may

affect how EDURANT(R) works and may cause serious side effects. If you take

certain medicines with EDURANT(R), the amount of EDURANT(R) 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(R) or other HIV medicines

that are like it. To help get the right amount of medicine in your body, you

should always take EDURANT(R) with a meal. A protein drink alone does not

replace a meal.

Do not take EDURANT(R) if:

- Your HIV infection has been previously treated with HIV medicines

- You are taking any of the following medicines:

Anti-seizure medicines: carbamazepine (Carbatrol(R), Equetro(R), Tegretol(R),

Tegretol-XR(R), Teril(R), Epitol(R)), oxcarbazepine (Trileptal(R)),

phenobarbital (Luminal(R)), phenytoin (Dilantin(R), Dilantin-125(R),

Phenytek(R)) Anti-tuberculosis (anti-TB) medicines: rifampin (Rifater(R),

Rifamate(R), Rimactane(R), Rifadin(R)), rifapentine (Priftin(R))Proton pump

inhibitor (PPI) medicine for certain stomach or intestinal problems:

esomeprazole (Nexium(R), Vimovo(R)), lansoprazole (Prevacid(R)), omeprazole

(Prilosec(R), Zegerid(R)), pantoprazole sodium (Protonix(R)), rabeprazole

(Aciphex(R)) 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(R)), a medicine to treat some bacterial infections).  Talk

to your doctor or pharmacist about the right amount of EDURANT(R) 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(R)

Medicines to block acid in your stomach, including cimetidine (Tagamet(R)),

famotidine (Pepcid(R)), nizatidine (Axid(R)), or ranitidine hydrochloride

(Zantac(R)). Take these medicines at least 12 hours before or at least 4 hours

after you take EDURANT(R)

Any of these medicines (if taken by mouth or injection): clarithromycin

(Biaxin(R)), erythromycin (E-Mycin(R), Eryc(R), Ery-Tab(R), PCE(R),

Pediazole(R), Ilosone(R)), fluconazole (Diflucan(R)), itraconazole

(Sporanox(R)), ketoconazole (Nizoral(R)), methadone (Dolophine(R)),

posaconazole (Noxafil(R)), telithromycin (Ketek(R)), voriconazole (Vfend(R))

This is not a complete list of medicines. Before starting EDURANT(R), 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(R), 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(R) will harm your unborn baby.

You and your healthcare professional will need to decide if taking EDURANT(R)

is right for you.

Do not breastfeed if you are taking EDURANT(R). 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(R)? EDURANT(R) 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(R) 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(R) 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(R) 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 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 accompanying full Product Information for more details.

About cabotegravir   

Cabotegravir is an investigational integrase strand inhibitor (INSTI) and

analogue of dolutegravir (TIVICAY(R)). 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

At Janssen, we are dedicated to addressing and solving some of the most

important unmet medical needs of our time in infectious diseases and vaccines,

oncology, immunology, neuroscience, 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.

References

1. World Health Organization. Global summary of the AIDS epidemic. Available

at: http://www.who.int/gho/hiv/en/. Last accessed October 2015.  

2. Hui Dy. Effects of HIV protease inhibitor therapy on lipid metabolism. Prog

Lipid Res 2003; 42(2):81-92.  

3. World Health Organization. Global summary of the AIDS epidemic. Available

at: http://www.who.int/hiv/data/2012_epi_core_en.png . Last accessed October

2015.

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the

Private Securities Litigation Reform Act of 1995 regarding product development.

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 Janssen Sciences Ireland UC and/or Johnson & Johnson. Risks and

uncertainties include, but are not limited to: challenges and uncertainties

inherent in new product development, including uncertainty of clinical success

and obtaining regulatory approvals; competition, including technological

advances, new products and patents attained by competitors; challenges to

patents; 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 fiscal year ended

December 28, 2014, including in Exhibit 99 thereto, 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.

Source: Janssen Sciences Ireland UC