dm+d

23942511000001102

Medicine Compliance Aid Stability

TivicayViiV Healthcare UK Ltd

ViiV Healthcare UK Ltd
Tivicay
Tablets 50mg
A2 · Amber 2No stability data is available, the manufacturer does not, or cannot recommend use in CAs but there are no theoretical concerns with the product.
No special precautions for storage
No special precautions for storage.
7 November 2022

New Medicines

TivicayHIV infection - dispersible tablet formulation for use in children aged ≥4 weeks age and weighing ≥3 kg (in addition to use in adults and adolescents)

Information

Tivicay
New formulation & dosing regimen
ViiV Healthcare
GlaxoSmithKline

Development and Regulatory status

Launched
Approved (Licensed)
Approved (Licensed)
March 2021
Mar 21Tivicay 5mg dispersible tablets available in the UK. Price for 60 tablets =£159.60 [8].
Jan 21Also approved in UK [7].
Jan 21Approved in the EU for paediatric patients aged at least four weeks and weighing at least 3kg [6].
Nov 20Recommended for EU approval by CHMP - the amended indication is "in combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children of at least 4 weeks of age or older and weighing at least 3 kg." A new dose form, 5 mg dispersible tablets, has also been licensed [5].
Jun 20Approved in US for treatment of patients aged at least 4 weeks old and weighing at least 3 kg in combination with other antiretroviral treatments [4].
Apr 20Currently pre-registration in EU [2].

Category

Integrase inhibitor
According to Collaborative HIV Paediatric Study [CHIPS], in 2020 a total of 2,210 of children were reported to be living with HIV in the UK. [6]
HIV infection - dispersible tablet formulation for use in children aged ≥4 weeks age and weighing ≥3 kg (in addition to use in adults and adolescents)
Oral

Trial or other data

Sep 22Results of PII/III ODYSSEY study (NCT02259127) are published in The Lancet HIV [9].
Apr 20PI/II study (NCT01302847) is active but no longer recruiting; due to complete collection of primary outcome data in Jan 21. It has trial sites in the US, Brazil, Thailand and some African countries [3].
Nov 17PII/III study (NCT02259127) is recruiting [3].
May 16PII/III study to assess whether dolutegravir combined with 2 currently used anti-HIV medicines is non-inferior to the standard combination of medicines used in terms of efficacy and better in terms of toxicity starts (NCT02259127). 700 patients will be recruited in South Africa, Uganda and Zimbabwe [3].
Mar 11PI/II study to test the safety of and immune response to DTG in HIV-1 infected infants, children, and adolescents starts (NCT01302847) [3].

Evidence based evaluations