Tivicay® (dolutegravir) receives positive CHMP opinion in Europe for the
treatment of HIV
LONDON, Nov. 22, 2013
LONDON, Nov. 22, 2013 /PRNewswire/ -- ViiV Healthcare today announced that the
Committee for Medicinal Products for Human Use (CHMP) of the European
Medicines Agency (EMA) has issued a positive opinion recommending marketing
authorisation for Tivicay® (dolutegravir) for use in combination with other
antiretroviral medicinal products for the treatment of HIV-infected adults and
adolescents above 12 years of age.
"We welcome the CHMP's positive opinion on dolutegravir – it puts us a step
closer to offering this new treatment option to people across Europe who are
living with HIV," said Dr John Pottage, Chief Medical Officer, ViiV
Healthcare. "We are committed to research that seeks to make advances in
treatment options for people living with HIV. To make progress, thousands of
patients have supported us through their participation in clinical development
work and we recognise their commitment today with great gratitude."
The CHMP opinion is based on safety and efficacy data for dolutegravir from
four pivotal Phase III studies(1-4). These involved people living with HIV who
were new to treatment and also those with prior experience of treatment, and
included comparators representing antiretroviral treatments commonly used
today in the battle against HIV. More than 2,500 people were treated across
these studies, and the regulatory submission also included data in children
aged 12 years and older.
A CHMP positive opinion is one of the final steps in the regulatory process
leading to the marketing authorisation decision of the European Commission,
which is expected early in 2014.
About Tivicay ® (dolutegravir) Tivicay® was approved by the U.S. FDA in August
2013 and by Health Canada in October 2013 – please refer to local labelling
for more information. It is a human immunodeficiency virus type 1 (HIV-1)
integrase inhibitor. Integrase inhibitors block 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.
Regulatory applications are being evaluated in other countries worldwide.
Regulatory applications for ViiV Healthcare's developmental single-tablet
regimen (STR) combining Tivicay with Kivexa®/Epzicom® (abacavir/lamivudine)
were submitted to regulatory authorities in Europe, Canada and the U.S. in
Important Safety Information for Tivicay® ^ (dolutegravir) 50 mg Tablets:
Dolutegravir is not approved for any indication in the European Union. The
following information is based on the Highlights section of the U.S.
Prescribing Information for Tivicay. Please refer to the full Prescribing
Information for more details.
Indication and Usage: Tivicay is indicated in combination with other
antiretroviral agents for the treatment of HIV-1 infection in adults and
children aged 12 years and older and weighing at least 40 kg.
The following should be considered prior to initiating treatment with Tivicay:
poor virologic response was observed in subjects treated with Tivicay 50 mg
twice daily with an integrase strand transfer inhibitor (INSTI)-resistance
Q148 substitution plus 2 or more additional INSTI-resistance substitutions,
including L74I/M, E138A/D/K/T, G140A/S, Y143H/R, E157Q, G163E/K/Q/R/S, or
Contraindication: Co-administration of TIVICAY with dofetilide
(anti-arrhythmic) is contraindicated due to the potential for increased
dofetilide plasma concentrations and the risk for serious and/or
Hypersensitivity Reactions: Hypersensitivity reactions have been reported and
were characterised by rash, constitutional findings, and sometimes organ
dysfunction, including liver injury. The events were reported in 1% or fewer
subjects receiving TIVICAY in Phase 3 clinical trials. Immediately discontinue
TIVICAY and other suspect agents if signs or symptoms of hypersensitivity
reaction develop, (including but not limited to, severe rash or rash
accompanied by fever, general malaise, fatigue, muscle or joint aches,
blisters or peeling of the skin, oral blisters or lesions, conjunctivitis,
facial edema, hepatitis, eosinophilia, angioedema, difficulty breathing.)
Monitor clinical status, including liver aminotransferases, and initiate
appropriate therapy. Delay in stopping treatment with TIVICAY or other suspect
agents after the onset of hypersensitivity may result in a life-threatening
reaction. TIVICAY should not be used in patients who have experienced a
hypersensitivity reaction to TIVICAY.
Effects on Serum Liver Biochemistries in Patients with Hepatitis B or C
Coinfection: 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: Redistribution/accumulation of body fat has been observed
in patients receiving antiretroviral therapy.
Immune Reconstitution Syndrome: During the initial phase of treatment, immune
reconstitution syndrome can occur, which may necessitate further evaluation
and treatment. Autoimmune disorders have been reported to occur in the setting
of immune reconstitution; the time to onset is more variable and can occur
many months after initiation of treatment.
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%) and
Drug Interactions: Co-administration of TIVICAY with drugs that are strong
inducers of UGT1A1 and/or CYP3A4 may result in reduced plasma concentrations
of dolutegravir and require dose adjustments of TIVICAY.
- TIVICAY should be taken 2 hours before or 6 hours after taking
cation-containing antacids or laxatives, sucralfate, oral iron supplements,
oral calcium supplements, or buffered medications.
- Consult the full Prescribing Information for TIVICAY for more information on
potentially significant drug interactions, including clinical comments.
Pregnancy: Pregnancy category B. TIVICAY should be used during pregnancy only
if the potential benefit justifies the potential risk. An Antiretroviral
Pregnancy Registry has been established.
Breastfeeding: Breastfeeding is NOT recommended due to the potential for HIV
transmission and the potential for adverse reactions in nursing infants.
Paediatric Patients: Safety and efficacy of TIVICAY has not been established
in children younger than 12 years old, or weighing
1.SINGLE (Study ING114467). A Trial Comparing GSK1349572 (dolutegravir) 50mg
Plus Abacavir/Lamivudine Once Daily to Atripla. National Institutes of
Health Study Identifier NCT01263015. More information available at:
2.SPRING-2 (Study ING113086). A Trial Comparing GSK1349572 (dolutegravir)
50mg Once Daily to Raltegravir 400mg Twice Daily. National Institutes of
Health Study Identifier NCT01227824. More information available at:
3.VIKING-3 (Study ING112574). A Study to Assess Dolutegravir in HIV-infected
Subjects With Treatment Failure on an Integrase Inhibitor Containing
Regimen. National Institutes of Health Study Identifier NCT01328041. More
information available at: http://clinicaltrials.gov/show/NCT01328041
4.SAILING (Study ING111762). A Study of GSK1349572 (dolutegravir) Versus
Raltegravir (RAL) With Investigator Selected Background Regimen in
Antiretroviral-Experienced, Integrase Inhibitor-Naive Adults. National
Institutes of Health Study Identifier NCT01231516. More information
available at: http://clinicaltrials.gov/show/NCT01231516
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
joined as a 10% 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 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
ViiV UK/U.S. Media enquiries: Rebecca Hunt +44 (0) 20 8380
Marc Meachem +1 919 483 8756
GSK Global Media enquiries: David Daley +44 (0) 20 8047
Melinda Stubbee +1 919 483 2510
GSK Analyst/Investor enquiries: Sally Jackson +44 20 8047 5543
Kirsty Collins (SRI & CG) +44 20 8047 5534
Tom Curry + 1 215 751 5419
Gary Davies + 44 (0) 20 8047
James Dodwell + 44 (0) 20 8047
Jeff McLaughlin + 1 215 751 7002
Ziba Shamsi + 44 (0) 20 8047
Lucy Singah +44 (0) 20 8047
GlaxoSmithKline 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. Factors that may affect GSK' s operations are described under Item
3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2012.
Press spacebar to pause and continue. Press esc to stop.