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

London (ots/PRNewswire) -

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
(>= 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® (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 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/10665/128494/1/978924150758
5_eng.pdf?ua=1

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

ots Originaltext: ViiV Healthcare
Im Internet recherchierbar: http://www.presseportal.de

Contact:
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+44 7920 567 707
Global Communications
ViiV Healthcare

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(US)
+1 919 483 8756
US Communications
ViiV Healthcare
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