ViiV Healthcare Announces Phase II Study Results for First Two Drug, Long-acting Injectable Regimen for HIV-1 Treatment

PR63544

LONDON, Feb. 24, 2016 /PRNewswire=KYODO JBN/ --

     32 week maintenance data presented at CROI showed comparable viral

suppression rates between injectable regimen and three drug oral regimen

    ViiV Healthcare, the global specialist HIV company majority owned by GSK,

with Pfizer Inc. and Shionogi Limited as shareholders, today presented positive

results from the LATTE-2 study at the Conference on Retroviruses and

Opportunistic Infections (CROI) in Boston. Headline results were announced in

November 2015.

(Logo: http://photos.prnewswire.com/prnh/20160223/336449LOGO )

    LATTE-2 is a phase IIb, open label study investigating the long-acting,

injectable formulations of cabotegravir (ViiV Healthcare) and rilpivirine

(Janssen Sciences Ireland UC) as a two-drug treatment for patients with HIV-1

infection who had already achieved HIV viral suppression with a three drug oral

regimen of cabotegravir plus two nucleoside reverse transcriptase inhibitors

(NRTIs). The primary endpoint evaluated antiviral activity and safety through

32 weeks of maintenance treatment.

    Following 32 weeks of maintenance treatment, viral suppression rates (%)

for the two drug regimen dosed every eight weeks (95%) or every four weeks

(94%) were comparable to the rate observed in patients continuing with a three

drug oral regimen (91%). One patient in the eight week dosing group and one

patient in the oral regimen group met protocol defined virologic failure

criteria; neither patient had evidence of resistance at failure.  The most

common drug-related adverse event reported by patients receiving injectable

study medication was injection site pain (92%), most of which were mild (82%)

or moderate (17%) in severity.

    John C Pottage, Jr., MD, Chief Scientific and Medical Officer, ViiV

Healthcare commented "There continues to be a need for new HIV medicines,

including those that could offer more flexible dosing regimens for people

living with HIV. The LATTE-2 study results provide the first evidence that a

long-acting two-drug injectable regimen may offer an alternative to daily oral

three-drug therapy for people who have achieved viral suppression.  We are

aiming to commence Phase III studies this year."

    Adverse Events in LATTE-2

    During the maintenance period, the most commonly reported adverse events

not related to injection site reactions for the injectable treatment groups

were nasopharyngitis (20%),  headache (14%) and diarrhoea (12%). For patients

randomised to oral treatment, the most common adverse events during the

maintenance period were nasopharyngitis (25%), headache (7%), and diarrhoea

(5%). Serious adverse events occurred in 6% of patients receiving injectable

treatment (one drug-related) and 5% of patients receiving oral cabotegravir

(none drug-related).  One patient in the eight week injectable treatment group

died due to an event unrelated to study drug (seizure).  Nine patients withdrew

from the study due to adverse events. Lab abnormalities that emerged during the

maintenance phase (greater than or equal to Grade 3 severity) occurred in 16%

of injectable treatment patients and 14% of oral treatment patients through

week 32.

    LATTE-2 (NCT02120352) is an ongoing international multicentre, parallel

group, open-label study that included 309 HIV infected adults who had not

received prior anti-retroviral treatment. Enrolled patients were suppressed

virologically (HIV-1 RNA ＜50 c/mL) during a 20-week induction period with daily

oral cabotegravir (30mg) + 2 NRTIs and subsequently randomised to one of three

study arms in the maintenance period: intramuscular cabotegravir long acting

formulation (400mg) + rilpivirine long acting formulation (600 mg) every four

weeks; intramuscular cabotegravir long acting formulation (600mg) + rilpivirine

long acting formulation (900mg) every eight weeks;  or oral cabotegravir (30mg)

+ 2 NRTIs. The primary endpoint evaluated antiviral activity and safety through

32 weeks of maintenance treatment and the study will continue up to 104 weeks

of treatment.

    About HIV

    HIV has largely become a chronic treatable disease, with improved access to

antiretroviral treatment leading to a 22% drop in global HIV mortality between

2009 and 2013[1] but more can be done for the estimated 37 million people

living with HIV and 2 million individuals newly infected each year worldwide[2].

    About cabotegravir

    Cabotegravir is an investigational integrase strand transfer inhibitor and

analogue of dolutegravir. 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 long-acting nanosuspension

formulation for intramuscular injection.

    About ViiV Healthcare

    ViiV Healthcare is a global specialist HIV company established in November

2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to

delivering advances in treatment and care for people living with HIV. Shionogi

(TYO: 4507) joined in October 2012. The company's aim is to take a deeper and

broader interest in HIV/AIDS than any company has done before and take a new

approach to deliver effective and new HIV medicines,  as well as support

communities affected by HIV. For more information on the company, its

management, portfolio, pipeline, and commitment, please visit

http://www.viivhealthcare.com

    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, [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

[http://www.edurant.com/shared/product/Edurant/EDURANT-PI.pdf ] for more

details.

    [1]

http://apps.who.int/iris/bitstream/10665/128494/1/9789241507585_eng.pdf?ua=1

    [2] http://www.who.int/mediacentre/factsheets/fs360/en

Source: ViiV Healthcare