TIDMGSK
RNS Number : 8543X
GlaxoSmithKline PLC
15 August 2018
PRESS RELEASE
ViiV Healthcare reports positive 48-week results for first
pivotal, phase III study for novel, long-acting, injectable
HIV-treatment regimen
ATLAS study meets primary endpoint, showing similar efficacy of
a once-a-month, investigational, injectable two-drug regimen of
cabotegravir and rilpivirine compared to a standard of care, daily,
oral three-drug regimen
Full results from the study will be presented at an upcoming
scientific meeting
London, 15 August 2018 - ViiV Healthcare today announced
positive headline results from its global, phase III ATLAS study of
a long-acting, injectable two-drug regimen (2DR) for the treatment
of HIV. ATLAS (Antiretroviral Therapy as Long-Acting Suppression)
was designed to establish if HIV-1-infected adult participants who
had maintained viral suppression for at least six months, on a
daily oral regimen comprised of two nucleoside reverse
transcriptase inhibitors (NRTIs) plus a third agent, maintained
similar rates of viral suppression upon switching to the
investigational, two-drug, long-acting, injectable regimen of
cabotegravir and rilpivirine, compared with continuing the
three-drug oral regimen.
The study showed long-acting cabotegravir and rilpivirine,
injected once a month, had similar efficacy to a standard of care,
daily, oral three-drug regimen at Week 48. The injectable treatment
regimen met the primary endpoint for non-inferiority (the
proportion of participants with plasma HIV-1 RNA >=50 copies per
milliliter [c/mL] using the FDA Snapshot algorithm at Week 48).
Overall safety, virologic response and drug resistance results for
the injectable regimen were consistent with results from the phase
II LATTE and LATTE-2 studies.[1](, [2])
John C. Pottage, Jr., MD, Chief Scientific and Medical Officer
of ViiV Healthcare, said: "This novel approach is another step
towards potentially reducing the treatment burden for people living
with HIV. The data from ATLAS suggest a long-acting, injectable 2DR
of cabotegravir and rilpivirine may offer an alternative to daily,
oral three-drug therapy for people who have previously achieved
viral suppression. If approved, this regimen would give people
living with HIV one month between each dose of antiretroviral
therapy, changing HIV treatment from 365 dosing days per year, to
just 12."
Detailed results from the study will be presented at an upcoming
scientific meeting. Headline results from FLAIR, a second pivotal
trial designed to evaluate a long-acting, injectable regimen of
cabotegravir and rilpivirine in treatment-naïve individuals, are
expected later this year.[3]
This investigational, long-acting, injectable regimen is being
co-developed as part of a collaboration with Janssen Sciences
Ireland UC, and is not approved by regulatory authorities anywhere
in the world.
Notes to editors
About ATLAS (NCT02951052)
The ATLAS study is part of ViiV Healthcare's innovative clinical
trial programme for two-drug regimens. The study includes 618 men
and women living with HIV and is being conducted at research
centres in Argentina, Australia, Canada, France, Germany, Italy,
Mexico, Russia, South Africa, South Korea, Spain, Sweden, and the
United States.
ATLAS is a phase III, open-label, active-controlled,
multicentre, parallel-group, non-inferiority study designed to
assess the antiviral activity and safety of a two-drug regimen of
long-acting, injectable cabotegravir and rilpivirine dosed every
four weeks compared to continuation of current oral anti-retroviral
therapy (ART) of two nucleoside reverse transcriptase inhibitors
(NRTIs) plus an integrase strand transfer inhibitor (INI),
non-nucleoside reverse transcriptase inhibitor (NNRTI), or protease
inhibitor (PI) among virally-suppressed individuals. The primary
endpoint for ATLAS is the proportion of participants with plasma
HIV-1 RNA >=50 c/mL per the FDA Snapshot algorithm at Week 48
(Missing, Switch, or Discontinuation = Failure, Intent-to-Treat
Exposed [ITT-E] population). Subjects were required to be
virally-suppressed for six months or greater, on first or second
regimen, with no prior failure.
For further information please see
https://clinicaltrials.gov/ct2/show/NCT02951052.
About cabotegravir
Cabotegravir is an investigational integrase inhibitor (INI) and
is not approved by regulatory authorities anywhere in the world.
Cabotegravir is being developed by ViiV Healthcare for the
treatment and prevention of HIV and is currently being evaluated as
a long-acting formulation for intramuscular injection and also as a
once-daily oral tablet for use as a lead-in, to establish the
tolerability of cabotegravir prior to long-acting injection.
About rilpivirine
Edurant(R) (rilpivirine) is a once daily non-nucleoside reverse
transcriptase inhibitor (NNRTI) used for the treatment of human
immunodeficiency virus (HIV-1) infection in combination with other
antiretroviral agents in antiretroviral treatment-naïve adult
patients with a viral load <= 100,000 HIV RNA copies/mL.
Long-acting rilpivirine is not approved by regulatory authorities
anywhere in the world.
Rilpivirine was developed by Janssen Sciences Ireland UC, one of
the Janssen Pharmaceutical Companies of Johnson & Johnson.
Rilpivirine is approved in the U.S. and E.U. as Edurant(R) as a
25mg tablet taken once-a-day and is always taken with a meal. The
most common side effects of Edurant include: depression, headache,
trouble sleeping (insomnia) and rash.
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:
o 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))
o 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))
o More than 1 dose of the steroid medicine dexamethasone or
dexamethasone sodium phosphate
o 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 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).
Click here for full US prescribing information.
Click here for the EU Summary of Product Characteristics.
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 and for people who are at risk of becoming
infected with HIV. Shionogi joined as a shareholder 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 innovative medicines for HIV treatment and
prevention, as well as support communities affected by HIV.
For more information on the company, its management, portfolio,
pipeline, and commitment, please visit www.viivhealthcare.com.
Cautionary statement regarding forward-looking statements
ViiV Healthcare Limited, the global specialist HIV company, is
majority owned by GlaxoSmithKline plc, with Pfizer Inc. and
Shionogi Limited. GSK cautions investors that any forward-looking
statements or projections made by GSK, including those made in this
announcement, are subject to risks and uncertainties that may cause
actual results to differ materially from those projected. Such
factors include, but are not limited to, those described under Item
3.D 'Principal risks and uncertainties' in the company's Annual
Report on Form 20-F for 2017.
About GSK
GSK - one of the world's leading research-based pharmaceutical
and healthcare companies - is committed to improving the quality of
human life by enabling people to do more, feel better and live
longer. For further information please visit www.gsk.com.
ViiV Healthcare Media
enquiries: Melinda Stubbee +1 919 491 0831
Cara Vivarelli-O'Neill +1 919 614 6521
GSK Global Media enquiries: Simon Steel +44 (0) 20 8047 5502
Sarah Spencer +1 215 751 7002
Analyst/Investor enquiries: Sarah Elton-Farr +44 (0) 20 8047 5194
Danielle Smith +44 (0) 20 8047 0932
James Dodwell +44 (0) 20 8047 2406
Jeff McLaughlin +1 215 751 7002
[1] Margolis D A et al. Cabotegravir plus rilpivirine, once a
day, after induction with cabotegravir plus nucleoside reverse
transcriptase inhibitors in antiretroviral-naive adults with HIV-1
infection (LATTE): a randomised phase 2b dose-ranging trial. The
Lancet Infectious Diseases. Published online July 2015. Available
at:
http://www.thelancet.com/journals/laninf/article/PIIS1473-3099(15)00152-8/abstract
[2] Margolis, D. et al. Long-acting intramuscular cabotegravir
and rilpivirine in adults with HIV-1 infection (LATTE-2):96-week
results of a randomised, open-label, phase 2b, non-inferiority
trial. The Lancet. July 2017. Published online:
http://dx.doi.org/10.1016/S0140-6736(17)31917-7 Last accessed
August 2018
[3] Study to evaluate the efficacy, safety, and tolerability of
long-acting intramuscular cabotegravir and rilpivirine for
maintenance of virologic suppression following switch from an
integrase inhibitor in HIV-1 infected therapy naïve participants.
Available at:
https://clinicaltrials.gov/ct2/show/NCT02938520?term=FLAIR+Cabotegravir&rank=1.
Last accessed August 2018
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END
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