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elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil (Stribild®)

 

Following non-submission

AWMSG advice

Status: Not endorsed (Statement of Advice)

In the absence of a submission from the holder of the marketing authorisation, elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil (Stribild®) cannot be endorsed for use within NHS Wales for the 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.

 Statement of Advice (SOA): elvitegravir combination (Stribild) 3616 (PDF, 140Kb)

Medicine details

Medicine name elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil (Stribild®)
Formulation 150 mg / 150 mg / 200 mg / 245 mg film-coated tablet
Reference number 3616
Indication

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.

Company Gilead Sciences Ltd
BNF chapter Infections
Assessment type Non-submission
Status Not endorsed (Statement of Advice)
Date of issue 06/02/2018
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