Tenofovir disoproxil + cobicistat + elvitegravir + emtricitabine

Medicine Compliance Aid Stability · New Medicines ·

23167611000001108

Medicine Compliance Aid Stability

Stribild · Gilead Sciences Ltd

Gilead Sciences Ltd
Stribild
Tablets 150 mg/150 mg/200 mg/245 mg
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 6 weeks in an open container.
18th August 2015

New Medicines

Stribild · HIV infection in adolescents aged 12 to < 18 years weighing ≥ 35 kg who are infected with HIV-1 without known mutations associated with resistance

Information

Stribild
Licence extension / variation
Gilead Sciences
Gilead Sciences

Development and Regulatory status

Launched
Launched
Oct 2017
Oct 17: Licence extension approved by EMA [3].
Sep 17: EU positive opinion for a licence change for treatment of HIV-1 infection in adolescents aged 12 to < 18 years weighing ≥ 35 kg who are infected with HIV-1 without known mutations associated with resistance to any of the three antiretroviral agents in Stribild and who have experienced toxicities which preclude the use of other regimens that do not contain tenofovir disoproxil fumarate (TDF) [2]

Category

Elvitegravir is an integrase inhibitor and cobicistat is a potent inhibitor of cytochrome P450 3A. Emtricitabine and tenofovir are Reverse-transcriptase inhibitors.
In 2013, a total of 6,000 persons (4,500 men and 1,500 women) were newly diagnosed with HIV in the UK. The number of newly diagnosed heterosexual men and women has dropped over the years from 4,890 in 2004 to 2,490 in 2013) due to fewer diagnoses among people born in sub-Saharan Africa [1].
HIV infection in adolescents aged 12 to < 18 years weighing ≥ 35 kg who are infected with HIV-1 without known mutations associated with resistance
Oral

Evidence based evaluations