Tenofovir disoproxil + emtricitabine

Medicine Compliance Aid Stability · New Medicines ·

30934611000001107

Medicine Compliance Aid Stability

Truvada · Gilead Sciences Ltd

Gilead Sciences Ltd
Truvada
Tablet 245mg/200mg
A1 · Amber 1 · Stability data is available in an alternative container (not CAs) that may be extrapolated to support storage in CAs.
No special precautions for storage
Data shows stability for up to 4 weeks
18th August 2015

New Medicines

Truvada · HIV infection - treatment and pre-exposure prophylaxis in adolescents

Information

Truvada
Licence extension / variation
Gilead Sciences
Gilead Sciences

Development and Regulatory status

Launched
Launched
Launched
March 2017

Feb 18: Licence change approved in EU [6].


Dec 17: EU positive opinion for a licence change to include pre-exposure prophylaxis in adolescents. The new indication is: Truvada is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults, treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, and in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents at high risk [5].


Mar 17: Licence change approved in EU [4].


Feb 17: EU positive opinion for a licence change for treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years [3].

Category

Emtricitabine is a nucleoside analogue of cytidine. Tenofovir disoproxil fumarate is converted in vivo to tenofovir, a nucleoside monophosphate (nucleotide) analogue of adenosine monophosphate.
In 2013, a total of 6,000 persons (4,500 men and 1,500 women) were newly diagnosed with HIV in the UK [1]. In 2015, 23 children were newly diagnosed with HIV – down from 131 in 2005. Of these, 17 were born abroad and arrived in the UK at an older age. Of the 860 children born in 2015 to women living with HIV, just one was known to have acquired the virus [2].
HIV infection - treatment and pre-exposure prophylaxis in adolescents
Oral

Evidence based evaluations