Elvitegravir with cobicistat,
emtricitabine and tenofovir
alafenamide 03-May-2018
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, emtricitabine below, elvitegravir, cobicistat,
tenofovir alafenamide p. 400.lINDICATIONS AND DOSE
HIV- 1 infection (specialist use only)
▶BY MOUTH
▶Child 6–11 years (body-weight 25 kg and above): 1 tablet
once daily
▶Child 12–17 years (body-weight 35 kg and above): 1 tablet
once dailylINTERACTIONS→Appendix 1 : cobicistat.elvitegravir.
tenofovir alafenamide
lSIDE-EFFECTS
▶Common or very commonAbnormal dreams.diarrhoea.
dizziness.fatigue.flatulence.gastrointestinal discomfort
.headache.nausea.skin reactions.vomiting
▶UncommonAnaemia.angioedema.depression
▶Frequency not knownNephrotoxicity.osteonecrosis.
weight increased
lCONCEPTION AND CONTRACEPTIONManufacturer 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.
lHEPATIC IMPAIRMENTManufacturer advises use with
caution in mild-to-moderate impairment (greater risk of
hepatic side-effects); avoid in severe impairment—no
information available.
lRENAL IMPAIRMENTManufacturer advises avoid if
creatinine clearance less than 30 mL/minute—limited
information available. Manufacturer advises caution in
children under 12 years with renal impairment—no
information available.
lPRESCRIBING AND DISPENSING INFORMATIONDispense in
original container—contains desiccant.
lPATIENT AND CARER ADVICE
Missed dosesManufacturer 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 tasksManufacturer advises patients and
carers should be counselled on the effects on driving and
performance of skilled tasks—increased risk of dizziness.
lNATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) Decisions
TheScottish Medicines Consortiumhas 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
type 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
TheAll Wales Medicines Strategy Grouphas 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 type 1 (HIV- 1 ), without knownmutations 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.lMEDICINAL FORMS
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 mgGenvoya
150 mg/ 150 mg/ 200 mg/ 10 mg tablets| 30 tabletP£ 879. 51eiiiiF 415Emtricitabine
(FTC)
lINDICATIONS AND DOSE
HIV infection in combination with other antiretroviral
drugs
▶BY MOUTH USING CAPSULES
▶Child (body-weight 33 kg and above): 200 mg once daily
▶BY MOUTH USING ORAL SOLUTION
▶Child 4 months–17 years (body-weight up to
33 kg): 6 mg/kg once daily
▶Child 4 months–17 years (body-weight 33 kg and
above): 240 mg once daily
DOSE EQUIVALENCE AND CONVERSION
▶ 240 mg oral solution: 200 mg capsule; where
appropriate the capsule may be used instead of the oral
solution.lSIDE-EFFECTS
▶Common or very commonDyspepsia.hyperbilirubinaemia.
hyperglycaemia.hypersensitivity.hypertriglyceridaemia.
neutropenia.pain.rash pustular.skin reactions.sleep
disorders
▶UncommonAngioedema
lHEPATIC IMPAIRMENT
MonitoringOn discontinuation, monitor patients with
hepatitis B (risk of exacerbation of hepatitis).
lRENAL IMPAIRMENT
Dose adjustmentsReduce dose or increase dosage interval
if estimated glomerularfiltration rate less than
50 mL/minute/ 1. 73 m^2 ; consult product literature.
lPRESCRIBING AND DISPENSING INFORMATIONFlavours of
oral liquid formulations may include candy.
lPATIENT AND CARER ADVICE
Missed dosesIf a dose is more than 12 hours late, the
missed dose should not be taken and the next dose should
be taken at the normal time.lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Oral solution
ELECTROLYTES:May contain Sodium
▶Emtriva(Gilead Sciences International Ltd)
Emtricitabine 10 mg per 1 mlEmtriva 10 mg/ml oral solution sugar-
free| 170 mlP£ 39. 53
Capsule
▶Emtriva(Gilead Sciences International Ltd)
Emtricitabine 200 mgEmtriva 200 mg capsules| 30 capsuleP
£ 138. 98
Combinations available:Darunavir with cobicistat,
emtricitabine and tenofovir alafenamide,p. 424418 Viral infection BNFC 2018 – 2019
Infection5