ViiV HEALTHCARE WELCOMES EUROPEAN COMMISSION APPROVAL OF DOLUTEGRAVIR PAEDIATRIC TYPE II VARIATION AND EXTENSION APPLICATIONS
ViiV Healthcare has today announced that the European Commission has approved the Type II variation and extension applications to reduce the weight and age limit for the treatment of HIV in children and adolescents with Tivicay (
This approval follows the Committee for Medicinal Products for Human Use (CHMP) positive opinion in December 2016 and the U.S. Food and Drug Administration’s (FDA)
Note to editors
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.
About Tivicay® (
Dolutegravir (Tivicay) is an integrase strand transfer inhibitor (INSTI) for use in combination with other antiretroviral agents for the treatment of HIV. 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. Tivicay is approved in over 100 countries across North America, Europe, Asia, Australia, Africa
Important information about Tivicay® (
EMA indications and usage: Tivicay is indicated in combination with other antiretroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children above 6 years of age.
Use of Tivicay in the presence of documented resistance that includes Q148 + ≥2 secondary mutations from G140A/C/S, E138A/K/T, L74I
Tivicay is contraindicated in patients:
- With previous hypersensitivity reaction to
- Receiving dofetilide (antiarrhythmic)
Integrase class resistance of particular concern: The decision to use
Hypersensitivity reactions: Hypersensitivity reactions have been reported with
Immune Reactivation Syndrome: In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms. Typically, such reactions have been observed within the first few weeks or months of initiation of
Liver biochemistry elevations consistent with immune reconstitution syndrome were observed in some hepatitis B and/or C co-infected patients at the start of
Opportunistic infections: Patients should be advised that
Drug interactions: Factors that decrease
Dolutegravir increased metformin concentrations: a dose adjustment of metformin should be considered when starting and stopping co-administration of
Osteonecrosis: Although the
Adverse reactions: The most severe adverse reaction, seen in an individual patient, was a hypersensitivity reaction that included rash and severe liver effects. The most commonly seen treatment-emergent adverse reactions were nausea (13%),
Pregnancy: Dolutegravir should be used during pregnancy only if the expected benefit justifies the potential risk to the
Breastfeeding: It is recommended that HIV-infected women do not breastfeed their infants under any circumstances in order to avoid transmission of HIV.
The full EU SmPC for Tivicay® (
 ViiV Healthcare - Tivicay® Summary of Product Characteristics, updated February 2017
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