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Elvitegravir with cobicistat, emtricitabine and tenofovir alafenamide oral


Oral formulations of elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide (as tenofovir alafenamide fumarate).

Drugs List

  • elvitegravir 150mg and cobicistat 150mg and emtricitabine 200mg and tenofovir alafenamide 10mg film coated tablets
  • GENVOYA 150mg+150mg+200mg+10mg film coated tablets
  • Therapeutic Indications


    HIV infection - combination therapy


    If patients are unable to swallow the tablet whole, it may be split in half and both halves taken one after the other, thus ensuring full dose is taken.


    1 tablet once daily taken with food.


    Children 12 to 18 years, weighing at least 35kg
    1 tablet once daily taken with food.

    Children 6 to 12 years, weighing at least 25kg
    1 tablet once daily taken with food.

    Additional Dosage Information

    Advise patient if a dose is missed within 18 hours of the time it is usually taken, the patient should take the missed dose with food as soon as possible and resume the normal dosing schedule. If the dose is missed by more than 18 hours and it is time for the next dose, the patient should not take the missed dose and resume the usual dosing schedule.


    Children under 6 years
    Weight below 25kg
    Renal impairment - creatinine clearance below 30 ml/minute
    Severe hepatic impairment

    Precautions and Warnings

    Females of childbearing potential
    Glucose-galactose malabsorption syndrome
    Hepatitis B
    Hepatitis C
    Lactose intolerance

    Switch to more suitable alternative before planned pregnancy
    Treatment does not prevent risk of transmission of HIV
    Advise ability to drive/operate machinery may be affected by side effects
    Treatment should be initiated by doctor experienced in HIV management
    Contains lactose
    Advise patient to take with or after food
    Autoimmune disorders can occur many months after initiation of treatment
    Blood lipid and glucose levels may increase requiring treatment
    On discontinuation, may cause recurrence of hepatitis B
    Advise patient to seek medical advice if joint aches or pain occur
    Advise patient to seek medical advice if movement becomes difficult
    Inflammatory symptoms should be evaluated and treated appropriately
    Neonate exposed in utero: Risk of mitochondrial dysfunction
    Risk of developing opportunistic infections
    Advise patient to seek advice at first indications of pregnancy
    Discontinue if hepatic function deteriorates in pts with hepatic impairment
    Advise patient not to take St John's wort concurrently
    Avoid antacids and mineral supplements within 4 hours of dose
    Female: Non-hormonal contraception or minimum 30mcg oestrogen advised
    Take another dose if vomiting occurs within one hour

    Patients co-infected with hepatitis B or C treated with antiretroviral therapy are at an increased risk of severe and potentially fatal adverse reactions. Discontinuation of therapy in patients co-infected with hepatitis B may be associated with severe acute exacerbations of hepatitis. Closely monitor these patients with both clinical and laboratory follow-up for several months after stopping treatment if therapy with elvitegravir with cobicistat, emtricitabine and tenofovir alafenamide is discontinued.

    Blood lipid and glucose levels may increase during antiretroviral therapy. This may be linked to disease control and lifestyle. Refer to established HIV treatment guidelines for monitoring and manage lipid and glucose level disorders as appropriate.

    Treatment regimens containing nucleoside or nucleotide analogues have been reported to cause mitochondrial dysfunction in HIV-negative infants exposed in utero and/or post-natally. Adverse reactions such as haematological (anaemia, neutropenia), metabolic (hyperlactataemia, hyperlipasaemia) and neurological (hypertonia, convulsions, abnormal behaviour) have been reported. Consider in children exposed to nucleoside or nucleotide analogues in utero (including HIV-negative infants) and who present with neurological symptoms or severe clinical findings of unknown cause.

    Pregnancy and Lactation


    Elvitegravir with cobicistat, emtricitabine and tenofovir alafenamide tablets are contraindicated during pregnancy.

    The manufacturer does not recommend elvitegravir with cobicistat, emtricitabine and tenofovir alafenamide treatment to be initiated during pregnancy and women who become pregnant during therapy with this product should be switched to an alternative regimen.

    Treatment with cobicistat and elvitegravir during second and third trimester of pregnancy has shown to substantially lower elvitegravir exposure, which may result in virological failure and increase the risk of transmission of HIV from the mother to infant.

    Animal studies do not indicate direct or indirect harmful effects of elvitegravir, cobicistat or emtricitabine with respect to pregnancy, foetal development, fertility parameters, parturition or postnatal development. Studies with tenofovir alafenamide in animals have shown no harmful effects on pregnancy, fertility parameters or foetal development.


    Elvitegravir with cobicistat, emtricitabine and tenofovir alafenamide is contraindicated in breastfeeding.

    The manufacturer does not recommend the use of elvitegravir with cobicistat, emtricitabine and tenofovir alafenamide during breastfeeding.

    HIV is known to be transmitted in milk. HIV infected mothers should avoid breastfeeding in order to prevent transmission of the disease.

    It is not known if elvitegravir, cobicistat or tenofovir alafenamide are excreted in human milk. Emtricitabine has been shown to be excreted in human milk. Animal studies have shown that elvitegravir, cobicistat and tenofovir are excreted in milk.

    Side Effects

    Abdominal pain
    Autoimmune disorders
    Autoimmune hepatitis
    Dream abnormalities
    Graves' disease
    Increase in serum glucose
    Inflammatory reactions
    Rise in blood lipids
    Serum creatinine increased


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: March 2019

    Reference Sources

    Summary of Product Characteristics: Genvoya 150mg/150mg/200mg/10mg film coated tablets. Gilead Sciences Ireland UC. Revised March 2019.

    MHRA Drug Safety Update April 2019
    Available at:
    Last accessed: 22 May 2019

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