LONDON, November 22, 2017 /PRNewswire/ --
ViiV Healthcare, the global specialist HIV company, majority
owned by GlaxoSmithKline, with Pfizer Inc. and Shionogi Limited as
shareholders, today announced that the US Food and Drug
Administration (FDA) has approved Juluca®, indicated as a complete
regimen for the maintenance treatment of HIV-1 infection in adults
who are virologically suppressed (HIV-1 RNA less than 50 copies per
mL) on a stable antiretroviral (ART) regimen for at least six
months with no history of treatment failure and no known
substitutions associated with resistance to the individual
components of Juluca.[1]
(Logo:
http://photos.prnewswire.com/prnh/20160223/336449LOGO )
Juluca is the first 2-drug regimen (2DR) comprising dolutegravir
50mg (ViiV Healthcare), an integrase strand transfer inhibitor and
rilpivirine 25mg (Janssen Therapeutics, Division of Janssen
Products LP), a non-nucleoside reverse transcriptase inhibitor.
Deborah Waterhouse, CEO ViiV
Healthcare said, "The FDA approval of Juluca marks an important
milestone in our commitment to deliver innovative advances in HIV
care by providing new treatment options that challenge the
traditional approach to care. This is the start of a new era
in HIV treatment. We are delighted to be able to provide the first
2-drug regimen to physicians and people living with HIV in the US,
to support the reduction of long-term ART exposure as they receive
life-long treatment for their chronic condition."
This FDA approval is based primarily upon data from two pivotal
phase III clinical trials,
SWORD-1[2] and
SWORD-2,[2] which showed the
2-drug regimen achieved non-inferior viral suppression (HIV-1 RNA
less than 50 copies per mL) at 48 weeks compared with a three- or
four-drug regimen in both pooled and individual analyses of the
SWORD-1 and SWORD-2 studies (CAR 485/511 [95%], dolutegravir +
rilpivirine 486/513 [95%] [adjusted difference -0.2% (95%
confidence interval CI: 3.0%, 2.5%), pooled
analysis]).[2] Virologic
suppression rates were similar between treatment
arms.[2]
Drug related adverse events and adverse events leading to
withdrawal occurred in low frequencies in both arms of the study,
but more frequently in the investigational arm.
John C Pottage, Jr, MD, Chief Scientific and Medical Officer,
ViiV Healthcare, commented, "Based on the fundamental principle
that no one should have to take more medicines than necessary, ViiV
Healthcare has put in place a comprehensive 2-drug regimen research
and development programme built around the characteristics of
dolutegravir. Juluca, our new 2-drug regimen, once-daily, single
pill, now provides people living with HIV who are virologically
suppressed, the option to reduce the number of antiretrovirals they
take, while maintaining the efficacy of a traditional three-drug
regimen."
Juluca is the first medicine in our 2-drug regimen pipeline,
which looks to help lessen the lifetime burden of treatment for
people living with HIV. Our R&D efforts are exploring the
potential of two further 2-drug regimens both in phase III
development, a once-daily, single pill containing
dolutegravir/lamivudine for treatment naïve patients, as well as
cabotegravir/rilpivirine long-acting injectable for
treatment-experienced and naïve patients.
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 HIV
HIV stands for the Human Immunodeficiency Virus. Unlike some
other viruses, the human body cannot get rid of HIV, so once
someone has HIV they have it for life. There is no cure for HIV,
but effective treatment can control the virus so that people with
HIV can enjoy healthy and productive lives.
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,[3] but more can be done for
the estimated 36.7 million people living with HIV and 1.8 million
individuals newly infected each year
worldwide.[4]
About Juluca
Juluca is a 2-drug regimen, once-daily, single pill that
combines the INSTI dolutegravir (50mg), with the NNRTI rilpivirine
(25mg) taken once-daily as a complete HIV regimen for people living
with HIV who are virologically suppressed.
Two essential steps in the HIV life cycle include reverse
transcription - when the virus turns its RNA (ribonucleic acid)
copy into DNA (deoxyribonucleic acid) - and integration - the
moment when viral DNA becomes part of the host cell's DNA. These
processes require two enzymes called nucleoside reverse
transcriptase and integrase. NNRTIs and INSTIs interfere with the
action of these two enzymes to prevent the virus from replicating.
This decrease in replication can lead to less virus being available
to cause subsequent infection of uninfected cells.
Juluca was approved by the US Food and Drug Administration (FDA)
on 21st November 2017, as
a complete regimen for the treatment of HIV-1 infection in adults
who are virologically suppressed (HIV-1 RNA less than 50 copies per
mL) on a stable antiretroviral regimen for at least 6 months with
no history of treatment failure and no known substitutions
associated with resistance to the individual components of Juluca.
Juluca is expected to be available in pharmacies in the US from
11th December 2017.
ViiV Healthcare has also submitted regulatory marketing
applications in Europe,
Canada, Australia and Switzerland.
About the SWORD phase III program for dolutegravir
(Tivicay®) and rilpivirine
(Edurant®)
The SWORD phase III program evaluates the efficacy, safety, and
tolerability of switching to dolutegravir plus 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. 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 (full 148-week data will be shared in 2018). In the SWORD
clinical trials, dolutegravir and rilpivirine are provided as
individual tablets.
The primary endpoint is the proportion of patients with plasma
HIV-1 RNA <50 copies per millilitre (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.
For more information on the trials please visit:
http://www.clinicaltrials.gov
Juluca and Tivicay are registered trademarks of the ViiV
Healthcare group of companies.
*Edurant is a registered trademark of Janssen Sciences Ireland
UC.
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to
use JULUCA safely and effectively. See full prescribing
information for JULUCA.
JULUCA (dolutegravir and rilpivirine) tablets, for
oral use Initial U.S. Approval: 2017
INDICATIONS AND USAGE
JULUCA, a two-drug combination of dolutegravir, a human
immunodeficiency virus type 1 (HIV-1) integrase strand transfer
inhibitor (INSTI), and rilpivirine, a HIV-1 non-nucleoside reverse
transcriptase inhibitor (NNRTI), is indicated as a complete regimen
for the treatment of HIV-1 infection in adults to replace the
current antiretroviral regimen in those who are virologically
suppressed (HIV-1 RNA less than 50 copies per mL) on a stable
antiretroviral regimen for at least 6 months with no history of
treatment failure and no known substitutions associated with
resistance to the individual components of JULUCA.
DOSAGE AND ADMINISTRATION
- One tablet taken orally once daily with a meal.
- Rifabutin coadministration: Take an additional 25-mg tablet of
rilpivirine with JULUCA once daily with a meal for the duration of
the rifabutin coadministration.
DOSAGE FORMS AND STRENGTHS
Each tablet contains: 50 mg of dolutegravir (equivalent to 52.6
mg dolutegravir sodium) and 25 mg of rilpivirine (equivalent to
27.5 mg rilpivirine hydrochloride).
CONTRAINDICATIONS
- Previous hypersensitivity reaction to dolutegravir or
rilpivirine.
- Coadministration with dofetilide.
- Coadministration with drugs where significant decreases in
rilpivirine plasma concentrations may occur, which may result in
loss of virologic response.
WARNINGS AND PRECAUTIONS
- Severe skin and hypersensitivity reactions characterised by
rash, constitutional findings, and sometimes organ dysfunction,
including liver injury, have been reported with the individual
components. Discontinue JULUCA immediately if signs or symptoms of
severe skin or 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- or rilpivirine-containing regimen. Monitoring for
hepatotoxicity is recommended.
- Depressive disorders have been reported with the use of
rilpivirine- or dolutegravir-containing regimens. Immediate medical
evaluation is recommended for severe depressive symptoms.
ADVERSE REACTIONS
The most common adverse reactions (all Grades) observed in at
least 2% of subjects were diarrhoea and headache.
To report SUSPECTED ADVERSE REACTIONS, contact ViiV
Healthcare at 1-888-844-8872 or FDA at 1-800-FDA-1088 or
http://www.fda.gov/medwatch.
DRUG INTERACTIONS
- Because JULUCA is a complete regimen, coadministration with
other antiretroviral medications for the treatment of HIV-1
infection is not recommended.
- Refer to the full prescribing information for important drug
interactions with JULUCA.
- Drugs that induce or inhibit CYP3A4 or UGT1A1 may affect the
plasma concentrations of the components of JULUCA.
- Drugs that increase gastric pH or containing polyvalent cations
may decrease plasma concentrations of the components of JULUCA
- Consider alternatives to prescribing JULUCA with drugs with a
known risk of Torsade de Pointes.
USE IN SPECIFIC POPULATIONS
- Lactation: Breastfeeding is not recommended due to the
potential for HIV transmission.
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
http://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
http://www.gsk.com.
References
- Juluca US label information
- Llibre JM, Hung C-C, Brinson C, et al. SWORD 1 & 2: Switch
to DTG + RPV maintains virologic suppression through 48 weeks, a
Phase III study. Presented at: Conference on Retroviruses and
Opportunistic Infections; February 13-16,
2017; Seattle, WA,
USA.
- World Health Organization. Global Update on the health sector
response to HIV, 2014. July 2014.
Available at:
http://apps.who.int/iris/bitstream/10665/128494/1/9789241507585_eng.pdf?ua=1.
Last accessed November 2017.
- World Health Organization. HIV/AIDS Fact Sheet. Available at:
http://www.who.int/mediacentre/factsheets/fs360/en/. Last accessed
November 2017.
ViiV Healthcare Media enquiries:
Patricia O'Connor,
+44-208-047-5982
Marc Meachem, +1-919-483-8756
GSK Global Media enquiries:
Simon Steel,
+44(0)20-8047-3763
David Daley, +44(0)20-8047-2615
Analyst/Investor enquiries:
Sarah Elton-Farr,
+44(0)20-8047-5194
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