TIDMGSK
RNS Number : 5072V
GlaxoSmithKline PLC
08 April 2019
Issued: 8 April 2019, London UK - LSE Announcement
US FDA approves ViiV Healthcare's Dovato
(dolutegravir/lamivudine), the first, once-daily, single-tablet,
two-drug regimen for treatment-naïve HIV-1 adults
Approval based on GEMINI pivotal trials in which Dovato achieved
non-inferior efficacy compared to a dolutegravir-based,
traditional, three-drug regimen through 48 weeks, with no cases of
resistance(1)
Dovato strengthens ViiV Healthcare's industry-leading portfolio
of innovative treatment approaches for people living with HIV
London, 8 April 2019 - ViiV Healthcare today announced that the
US Food and Drug Administration (FDA) approved Dovato, a complete,
once-daily, single-tablet regimen of dolutegravir (DTG) 50 mg and
lamivudine (3TC) 300 mg for the treatment of HIV-1 infection in
adults with no antiretroviral (ARV) treatment history and with no
known resistance to either DTG or 3TC. Dovato, a two-drug regimen
(2DR), reduces exposure to the number of ARVs from the start of
treatment, while still maintaining the efficacy and high barrier to
resistance of a traditional DTG-based three-drug regimen.(1)
Deborah Waterhouse, CEO, ViiV Healthcare, said: "Building on our
innovative portfolio of medicines, Dovato is powered by
dolutegravir, an antiretroviral included in multiple combination
therapies and the most prescribed integrase inhibitor in the world,
(2) coupled with the established profile of lamivudine. With
Dovato, the first complete, single-tablet, two-drug regimen for
treatment-naïve adults, ViiV Healthcare is delivering what patients
are requesting-a chance to treat their HIV-1 infection with as few
drugs as possible, marking a significant step in HIV
treatment."
The approval of Dovato is supported by the landmark global
GEMINI 1 and 2 studies that included more than 1,400 HIV-1 infected
adults. In these studies, DTG + 3TC demonstrated non-inferiority
based on plasma HIV-1 RNA <50 copies per milliliter (c/mL), a
standard measure of HIV-1 control, at Week 48 when compared to a
three-drug regimen of DTG and two nucleoside reverse transcriptase
inhibitors (NRTIs), tenofovir disoproxil fumarate/emtricitabine
(TDF/FTC), in treatment-naïve, HIV-1 infected adults. The safety
results for DTG + 3TC seen in GEMINI 1 and 2 were consistent with
the product labelling for DTG and 3TC. No patient who experienced
virologic failure in either treatment arm developed
treatment-emergent resistance.(1)
Pedro Cahn, principal investigator for the GEMINI study program
said: "People are now living longer with HIV and will spend a
lifetime taking drugs to suppress their virus. The approval of the
fixed dose combination of dolutegravir and lamivudine, a complete,
single-tablet, two-drug regimen, marks a pivotal moment in the
treatment of HIV-1. Treatment-naïve people living with the virus
have a powerful option that delivers non-inferior efficacy to a
dolutegravir-based three-drug regimen, allowing them to take fewer
ARVs and get and remain suppressed."
Jeff Berry, Test Positive Aware Network (TPAN), said: "The
approval of Dovato is a welcome paradigm shift, as it brings an
innovative treatment approach to newly diagnosed adults with HIV-1.
By exposing patients to fewer drugs at the start of treatment, the
hope is to help address concerns arising from overall management of
prolonged ARV therapy."
DTG/3TC as a complete, once-daily, single-tablet, two-drug
regimen for HIV-1 therapy is currently under review by the European
Medicines Agency (EMA) and regulatory authorities in Canada,
Australia, Switzerland, and South Africa and several additional
submissions are planned throughout 2019.
Notes to editors
About Dovato (dolutegravir/lamivudine)
Dovato is approved as a complete regimen for the treatment of
HIV-1 infection in adults with no known antiretroviral treatment
history and with no known substitutions associated with resistance
to either dolutegravir or lamivudine. Dovato is a once-daily,
single-tablet, two-drug regimen that combines the integrase strand
transfer inhibitor (INSTI) dolutegravir (Tivicay, 50 mg) with the
nucleoside analogue reverse transcriptase inhibitor (NRTI)
lamivudine (Epivir, 300 mg).
Like a DTG-based three-drug regimen, Dovato uses only two drugs
to inhibit the viral cycle at two different sites. INSTIs, like
dolutegravir, inhibit HIV replication by preventing the viral DNA
from integrating into the genetic material of human immune cells
(T-cells). This step is essential in the HIV replication cycle and
is also responsible for establishing chronic infection. Lamivudine
is an NRTI that works by interfering with the conversion of viral
RNA into DNA which in turn stops the virus from multiplying.
Trademarks are owned by or licensed to the ViiV Healthcare group
of companies.
GEMINI 1 and 2 study design
GEMINI 1 (204861) and GEMINI 2 (205543) are duplicate, Phase
III, randomized, double-blind, multicenter, parallel group,
non-inferiority studies. These studies evaluate a two-drug regimen
of dolutegravir and lamivudine compared with a three-drug,
first-line regimen of DTG + TDF/FTC in HIV-1 infected,
antiretroviral therapy (ART)-naïve adult participants with baseline
HIV-1 viral loads up to 500,000 copies per milliliter. The trials
are designed to study the efficacy and safety of once-daily
dolutegravir and lamivudine compared to once-daily dolutegravir and
the fixed-dose combination of TDF/FTC at 48 weeks in
HIV-1-infected, ART-naïve adult participants. The GEMINI studies
are ongoing for 148 weeks. For more information, please search for
NCT02831673 (GEMINI 1) or NCT02831764 (GEMINI 2) on
www.clinicaltrials.gov.
IMPORTANT SAFETY INFORMATION (ISI)
The following ISI is based on the Highlights section of the
Prescribing Information for Dovato. Please consult the full
Prescribing Information for all the labeled safety information for
Dovato.
WARNING: PATIENTS CO-INFECTED WITH HEPATITIS B VIRUS (HBV) AND
HUMAN IMMUNODEFICIENCY VIRUS (HIV-1): EMERGENCE OF
LAMIVUDINE-RESISTANT HBV AND EXACERBATIONS OF HBV
-- All patients with HIV-1 should be tested for the presence of
HBV prior to or when initiating DOVATO. Emergence of
lamivudine-resistant HBV variants associated with
lamivudine-containing antiretroviral regimens has been reported. If
DOVATO is used in patients co-infected with HIV-1 and HBV,
additional treatment should be considered for appropriate treatment
of chronic HBV; otherwise, consider an alternative regimen.
-- Severe acute exacerbations of HBV have been reported in
patients who are co-infected with HIV-1 and HBV and have
discontinued lamivudine, a component of DOVATO. Closely monitor
hepatic function in these patients and, if appropriate, initiate
anti-HBV treatment
DOSAGE AND ADMINISTRATION
-- Prior to or when initiating DOVATO, test patients for HBV infection.
-- Pregnancy Testing: Perform pregnancy testing before
initiation of DOVATO in individuals of childbearing potential.
-- One tablet taken orally once daily with or without food.
-- The dolutegravir dose (50 mg) in DOVATO is insufficient when
coadministered with carbamazepine or rifampin. If DOVATO is
coadministered with carbamazepine or rifampin, take one tablet of
DOVATO once daily, followed by an additional dolutegravir 50-mg
tablet, approximately 12 hours from the dose of DOVATO.
CONTRAINDICATIONS
-- Prior hypersensitivity reaction to dolutegravir or lamivudine.
-- Coadministration with dofetilide.
WARNINGS AND PRECAUTIONS
-- Hypersensitivity reactions characterized by rash,
constitutional findings, and sometimes organ dysfunction, including
liver injury, have been reported with dolutegravir. Discontinue
DOVATO immediately if signs or symptoms of hypersensitivity
reactions develop, as a delay in stopping treatment may result in a
life-threatening reaction.
-- Hepatotoxicity has been reported in patients receiving a
dolutegravir-containing regimen. Patients with underlying hepatitis
B or C may be at increased risk for worsening or development of
transaminase elevations with DOVATO. Monitoring for hepatotoxicity
is recommended.
-- Embryo-fetal toxicity may occur when used at the time of
conception and in early pregnancy. Avoid use of DOVATO at the time
of conception through the first trimester of pregnancy due to the
risk of neural tube defects. Advise individuals of childbearing
potential to use effective contraception.
-- Lactic acidosis and severe hepatomegaly with steatosis,
including fatal cases, have been reported with the use of
nucleoside analogues.
-- Immune reconstitution syndrome has been reported in patients
treated with combination antiretroviral therapy.
ADVERSE REACTIONS
The most common adverse reactions (all grades) observed in
>=2% (in those receiving DOVATO) were headache, diarrhea,
nausea, insomnia, and fatigue.
DRUG INTERACTIONS
-- DOVATO is a complete regimen for the treatment of HIV-1
infection; therefore, coadministration with other antiretroviral
drugs for the treatment of HIV-1 infection is not recommended.
-- Refer to the full prescribing information for important drug interactions with DOVATO.
USE IN SPECIFIC POPULATIONS
-- Pregnancy: Avoid use of DOVATO at the time of conception
through the first trimester due to the risk of neural tube
defects.
-- Lactation: Breastfeeding is not recommended due to the potential for HIV-1 transmission.
-- Females and males of reproductive potential: Pregnancy
testing and contraception are recommended in individuals of
childbearing potential.
-- Renal Impairment: DOVATO is not recommended in patients with
creatinine clearance less than 50 mL/min.
-- Hepatic Impairment: DOVATO is not recommended in patients
with severe hepatic impairment (Child-Pugh Score C).
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. ViiV'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. This
year marks 10 years of ViiV Healthcare innovating on behalf of
people living with HIV and advancing our efforts to leave no person
living with HIV behind.
For more information on the company, its management, portfolio,
pipeline and commitment, please visit www.viivhealthcare.com.
About ViiV Healthcare's Patient Assistance Program
ViiV Healthcare is committed to providing assistance to eligible
people living with HIV who need our medicines. ViiV Healthcare's
centralized service, ViiV Connect, provides comprehensive
information on access and coverage to help patients get their
prescribed ViiV Healthcare medicines whether they are insured,
underinsured or uninsured. ViiV Connect provides one-on-one support
from dedicated access coordinators, as well as having an integrated
website, one site with many resources, including a portal. For more
information on ViiV Connect, visit www.viivconnect.com.
Cautionary statement regarding forward-looking statements
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 2018.
About GSK
GSK is a science-led global healthcare company with a special
purpose: to help people do more, feel better, live longer. For
further information please visit www.gsk.com.
ViiV Healthcare Media Audrey Abernathy +1 919 605 4521 (US)
enquiries:
Patricia O'Connor +44 20 8047 5982 (UK)
GSK Global Media enquiries: Simon Steel +44 (0) 20 8047 5502
(UK)
Kristen Neese +1 804 217 8147 (US)
Analyst/Investor enquiries: Sarah Elton-Farr +44 (0) 20 8047 5194
(UK)
Danielle Smith +44 (0) 20 8047 0932
James Dodwell (UK)
+44 (0) 20 8047 2406
(UK)
Jeff McLaughlin +1 215 751 7002 (US)
References
1. Dovato (dolutegravir/lamivudine) Prescribing Information. U.S. Approval 2019.
2. Number of Patients on Dolutegravir, Worldwide, IMS data. August 2017.
This information is provided by RNS, the news service of the
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Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
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