Following non-submission
AWMSG advice |
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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. |
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Medicine details |
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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. |
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Company | Gilead Sciences Ltd | |
BNF chapter | Infections | |
Assessment type | Non-submission | |
Status | Not endorsed (Statement of Advice) | |
Date of issue | 06/02/2018 |