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elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide (Genvoya®)

 

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 alafenamide (Genvoya®) cannot be endorsed for use within NHS Wales for the treatment of human immunodeficiency virus-1 (HIV-1) infection without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir, in children aged from 6 years to 12 years and with body weight at least 25 kg for whom alternative regimens are unsuitable due to resistance or toxicities.

 Statement of Advice (SOA): elvitegravir combination (Genvoya) 3628 (PDF, 98Kb)

Medicine details

Medicine name elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide (Genvoya®)
Formulation 150 mg/150 mg/200 mg/10 mg film-coated tablet
Reference number 3628
Indication

Treatment of human immunodeficiency virus-1 (HIV-1) infection without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir, in children aged from 6 years to 12 years and with body weight at least 25 kg for whom alternative regimens are unsuitable due to resistance or toxicities.

Company Gilead Sciences Ltd
BNF chapter Infections
Assessment type Non-submission
Status Not endorsed (Statement of Advice)
Date of issue 22/03/2018
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