TIDMGSK
RNS Number : 2967S
GlaxoSmithKline PLC
19 December 2016
ViiV Healthcare announces positive results from first phase III
studies of two-drug HIV treatment regimen
First phase III studies to show efficacy of two-drug regimen as
maintenance therapy
London, UK 19 December 2016 - ViiV Healthcare, the global
specialist HIV company majority owned by GSK, with Pfizer Inc. and
Shionogi Limited as shareholders, today announced that both of its
Phase III studies to evaluate the safety and efficacy of switching
virologically suppressed patients from a three or four-drug
(integrase inhibitor-, non-nucleoside reverse transcriptase
inhibitor-, or boosted protease inhibitor-based) antiretroviral
regimen to a two-drug regimen of dolutegravir (ViiV Healthcare) and
rilpivirine (Janssen Sciences Ireland UC) met the primary endpoint
of non inferiority at Week 48.
The primary endpoint, based on FDA's snapshot analysis, was
evaluated as the proportion of patients with plasma HIV-1 RNA
<50 copies per milliliter (c/mL) at Week 48.
The safety profiles for dolutegravir and rilpivirine in these
studies were consistent with the product labelling for each
medicine. Detailed results from the studies will be presented at an
upcoming scientific meeting.
Dominique Limet, CEO ViiV Healthcare, said "These are important
results for the HIV scientific community and represent an important
milestone in our understanding of how HIV can be treated. The
results support our strategy of investigating two-drug regimens as
innovative treatment options for people living with HIV and we are
planning regulatory submissions for this two-drug regimen as a
single tablet in 2017."
The use of dolutegravir and rilpivirine as HIV maintenance
treatment is investigational and not approved anywhere in the
world.
- Ends -
Notes to editors
In June 2014, ViiV Healthcare and Janssen Sciences Ireland UC,
one of the Janssen Pharmaceutical Companies of Johnson &
Johnson announced a partnership to investigate the potential of
combining dolutegravir and rilpivirine in a single tablet in order
to expand the treatment options available to people living with
HIV.
About the SWORD phase III programme for dolutegravir
(Tivicay(R)) and rilpivirine (Edurant(R))
The phase III programme evaluates the efficacy, safety, and
tolerability of switching to dolutegravir and rilpivirine from
current integrase inhibitor-, non-nucleoside reverse transcriptase
inhibitor-, or boosted protease inhibitor-based antiretroviral
regimen in HIV-1-infected adults who are virologically suppressed
with a three or four-drug regimen. In the clinical trials,
dolutegravir and rilpivirine are provided as individual tablets.
SWORD-1 (NCT02429791) and SWORD-2 (NCT02422797) are replicate
148-week, randomised, open-label, non-inferiority studies to assess
the antiviral activity and safety of a two-drug, daily oral regimen
of dolutegravir plus rilpivirine compared with current
antiretroviral therapy.
The primary endpoint is the proportion of patients with plasma
HIV-1 RNA <50 copies per milliliter (c/mL) at Week 48. Key
secondary endpoints include evaluation of the development of viral
resistance, measurements of safety and tolerability, and changes in
renal, bone and cardiovascular biomarkers. The studies also include
exploratory measures to assess change in health-related quality of
life, willingness to switch and adherence to treatment
regimens.
Tivicay(R) is a registered trademark of the ViiV Healthcare
group of companies
Edurant(R) is a registered trademark of Janssen Sciences Ireland
UC
For more information on the trials please visit:
www.clinicaltrials.gov
TIVICAY(R) (dolutegravir) tablets
Professional Indication(s) and Important Safety Information
Indications and Usage
TIVICAY is a human immunodeficiency virus type 1 (HIV-1)
integrase strand transfer inhibitor (INSTI) indicated in
combination with other antiretroviral agents for the treatment of
HIV-1 infection in adults and pediatric patients weighing at least
30 kg
Limitations of Use:
-- Use of TIVICAY in INSTI-experienced patients should be guided
by the number and type of baseline INSTI substitutions. The
efficacy of TIVICAY 50 mg twice daily is reduced in patients with
an INSTI-resistance Q148 substitution plus 2 or more additional
INSTI-resistance substitutions including T66A, L74I/M, E138A/K/T,
G140S/A/C, Y143R/C/H, E157Q, G163S/E/K/Q, or G193E/R
Important Safety Information
Contraindications:
TIVICAY is contraindicated in patients:
-- with previous hypersensitivity reaction to dolutegravir
-- receiving dofetilide (antiarrhythmic)
Hypersensitivity Reactions:
-- Hypersensitivity reactions have been reported and were
characterized by rash, constitutional findings, and sometimes organ
dysfunction, including liver injury. The events were reported in
<1% of subjects receiving TIVICAY in Phase 3 clinical trials
-- Discontinue TIVICAY and other suspect agents immediately if
signs or symptoms of hypersensitivity reactions develop, as a delay
in stopping treatment may result in a life-threatening reaction.
Monitor clinical status, including liver aminotransferases, and
initiate appropriate therapy if hypersensitivity reaction is
suspected
Effects on Serum Liver Biochemistries in Patients with Hepatitis
B or C Co-infection:
-- Patients with underlying hepatitis B or C may be at increased
risk for worsening or development of transaminase elevations with
use of TIVICAY. In some cases the elevations in transaminases were
consistent with immune reconstitution syndrome or hepatitis B
reactivation, particularly in the setting where anti-hepatitis
therapy was withdrawn
-- Appropriate laboratory testing prior to initiating therapy
and monitoring for hepatotoxicity during therapy with TIVICAY are
recommended in patients with underlying hepatic disease such as
hepatitis B or C
Fat Redistribution or accumulation has been observed in patients
receiving antiretroviral therapy.
Immune Reconstitution Syndrome, including the occurrence of
autoimmune disorders with variable time to onset, has been
reported.
Adverse Reactions: The most commonly reported (>=2%) adverse
reactions of moderate to severe intensity in treatment-naïve adult
subjects in any one trial receiving TIVICAY in a combination
regimen were insomnia (3%), fatigue (2%), and headache (2%).
Drug Interactions:
-- Coadministration of TIVICAY with certain inducers of UGT1A
and/or CYP3A may reduce plasma concentrations of dolutegravir and
require dose adjustments of TIVICAY
-- Administer TIVICAY 2 hours before or 6 hours after taking
polyvalent cation-containing antacids or laxatives, sucralfate,
oral supplements containing iron or calcium, or buffered
medications. Alternatively, TIVICAY and supplements containing
calcium or iron can be taken with food
-- Consult the full Prescribing Information for TIVICAY for more
information on potentially significant drug interactions, including
clinical comments
Pregnancy: TIVICAY should be used during pregnancy only if the
potential benefit justifies the potential risk. An Antiretroviral
Pregnancy Registry has been established.
Nursing Mothers: Breastfeeding is not recommended due to the
potential for HIV transmission and the potential for adverse
reactions in nursing infants.
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.
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
overall safety and efficacy profile of rilpivirine is based on
phase III clinical studies. The most common side effects of Edurant
include: depression, headache, trouble sleeping (insomnia) and
rash.
EDURANT(R) Consumer Indication and Important Safety Information
(ISI)
About EDURANT(R)
-- EDURANT(R) (rilpivirine) is a prescription HIV medicine that
is used with other antiretroviral medicines to treat Human
Immunodeficiency Virus-1 (HIV-1)
in adults:
- 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 18 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 negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088.
Please see full Product Information for more details.
Inside information
The information contained in this announcement is inside
information. If you have any queries on this, then please contact
Victoria Whyte GSK Company Secretary (responsible for arranging the
release of this announcement) at GSK House Brentford, Middlesex,
TW8 9GS on +44 208 047 5000.
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 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.
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: Sébastien Desprez +44 (0) 20 8380 6275
Marc Meachem +1 919 483 8756
GSK Global Media enquiries: Simon Steel +44 (0) 20 8047 3763
David Daley +44 (0) 20 8047 2615
Kathleen Cuca +1 215 859 1922
Analyst/Investor enquiries: Tom Curry + 1 215 751 5419
Gary Davies +44 (0) 20 8047 5503
James Dodwell +44 (0) 20 8047 2406
Jeff McLaughlin +1 215 751 7002
This information is provided by RNS
The company news service from the London Stock Exchange
END
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