Indications And Dose
HIV-1 infection (specialist use only) ▶BY MOUTH ▶Adult: 1 tablet once daily
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Drug reference
HIV-1 infection (specialist use only) ▶BY MOUTH ▶Adult: 1 tablet once daily
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Dispense in original container—contains desiccant.
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Scottish Medicines Consortium (SMC) decisions SMC No. 1142/16 The Scottish Medicines Consortium has advised (May 2016) that elvitegravir with cobicistat, emtricitabine and tenofovir alafenamide (Genvoya ®) is accepted for use within NHS Scotland for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus- 1 (HIV-1), without known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir. This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower. All Wales Medicines Strategy Group (AWMSG) decisions AWMSG No. 2248 The All Wales Medicines Strategy Group has advised (July 2016) that elvitegravir with cobicistat, emtricitabine and tenofovir alafenamide (Genvoya ®) is recommended as an option for use within NHS Wales for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus-1 (HIV-1), without known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir. The recommendation applies only if the approved Wales Patient Access Scheme (WPAS) is used or where the list price is equivalent or lower.
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MHRA/CHM ADVICE: ELVITEGRAVIR BOOSTED WITH COBICISTAT: AVOID USE IN PREGNANCY DUE TO RISK OF TREATMENT FAILURE AND MATERNAL-TO-CHILD TRANSMISSION OF HIV-1 (APRIL 2019) Pharmacokinetic data show mean exposure of elvitegravir boosted with cobicistat (available in combination in Genvoya ® and Stribild ®) to be lower during the second and third trimesters of pregnancy than postpartum. Low elvitegravir exposure may be associated with an increased risk of treatment failure and an increased risk of HIV-1 transmission to the unborn child. For further information, see Pregnancy.
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→Appendix 1: cobicistat. elvitegravir. tenofovir alafenamide
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▶Common or very common Abnormal dreams. diarrhoea. dizziness. fatigue. flatulence. gastrointestinal discomfort . headache. nausea. skin reactions. vomiting ▶Uncommon Anaemia. angioedema. depression ▶Frequency not known Nephrotoxicity. osteonecrosis. weight increased
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Manufacturer advises effective contraception in women of childbearing potential; if using a hormonal contraceptive, it must contain drospirenone or norgestimate as the progestogen and at least 30 micrograms ethinylestradiol.
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Manufacturer advises not to be initiated during pregnancy due to low elvitegravir exposure; women who become pregnant during therapy should be switched to an alternative regimen.
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Manufacturer advises caution (increased risk of hepatic side-effects); avoid in severe impairment (no information available).
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Manufacturer advises avoid if creatinine clearance less than 30 mL/minute—limited information available.
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There can be variation in the licensing of different medicines containing the same drug. Tablet CAUTIONARY AND ADVISORY LABELS 21 ▶Genvoya (Gilead Sciences International Ltd) A Tenofovir alafenamide 10 mg, Cobicistat 150 mg, Elvitegravir 150 mg, Emtricitabine 200 mg Genvoya 150mg/150mg/200mg/10mg tablets | 30 tablet P £879.51
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Missed doses Manufacturer advises if a dose is more than 18 hours late, the missed dose should not be taken and the next dose should be taken at the normal time. Driving and skilled tasks Manufacturer advises patients and carers should be counselled on the effects on driving and performance of skilled tasks—increased risk of dizziness.
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1 tablet once daily
First-line fragment. Read the complete Indications and Dose section above.
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