This site is intended for UK healthcare professionals
Medscape UK Univadis Logo
Medscape UK Univadis Logo

Elvitegravir with cobicistat, emtricitabine and tenofovir disoproxil oral


Oral formulations of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil.

Drugs List

  • elvitegravir 150mg and cobicistat 150mg and emtricitabine 200mg and tenofovir disoproxil 245mg film coated tablets
  • STRIBILD 150mg+150mg+200mg+245mg film coated tablets
  • Therapeutic Indications


    Antiretroviral combination therapy-HIV infected adults and children over 12



    One tablet to be taken once a day, with food.


    Adolescents aged 12 years and older weighing at least 35kg

    One tablet to be taken once a day, with food.

    Patients with Renal Impairment

    Emtricitabine and tenofovir are primarily excreted by the kidneys by a combination of glomerular filtration and active tubular secretion.

    Patients who have previously discontinued treatment with tenofovir disoproxil fumarate due to renal toxicity should not be treated with this fixed dose combination tablet.


    Children under 12 years
    Children weighing less than 35kg
    Renal impairment - creatinine clearance below 70ml/min

    Precautions and Warnings

    Children under 18 years
    Patients over 65 years
    Glucose-galactose malabsorption syndrome
    Hepatitis B
    Hepatitis C
    Lactose intolerance
    Renal impairment - creatinine clearance 70-90ml/minute
    Severe hepatic impairment

    Switch to more suitable alternative before planned pregnancy
    Therapy cessation not recommended in decompensated liver disease/cirrhosis
    Treatment does not prevent risk of transmission of HIV
    Advise ability to drive/operate machinery may be affected by side effects
    Perform viral resistance testing before initiating therapy
    Treatment should be initiated by doctor experienced in HIV management
    Contains lactose
    Evaluate renal function before and during treatment
    Autoimmune disorders can occur many months after initiation of treatment
    Blood lipid and glucose levels may increase requiring treatment
    Monitor renal function every 4 weeks during first year, then every 3 months
    Monitor renal function in patients with risk factors for renal impairment
    Monitor serum phosphate levels
    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
    May cause loss of bone mineral density
    Neonate exposed in utero: Risk of mitochondrial dysfunction
    Advise patient to seek advice at first indications of pregnancy
    Discontinue if creatinine clearance falls below 50 ml/minute
    Discontinue if hepatic function deteriorates in pts with hepatic impairment
    Interrupt treatment if serum phosphate decreases to below 1 mg/dL
    Suspend therapy if renal function deteriorates; reinstitute when normal
    Advise patient not to take NSAIDs unless advised by clinician
    Advise patient not to take St John's wort concurrently
    Avoid antacids within 4 hours of dose
    Female: Non-hormonal contraception or minimum 30mcg oestrogen advised
    Take another dose if vomiting occurs within one hour

    Female patients of childbearing potential should use either a hormonal contraceptive containing at least 30 micrograms ethinylestradiol and containing norgestimate as the progestogen or should use an alternative reliable method of contraception.

    Creatinine clearance should be calculated and urine glucose and urine protein should be determined in all patients before initiating treatment, then every 4 weeks during the first year of therapy and then every 3 months thereafter.

    Avoid use with concurrent or recent use of nephrotoxic drugs (e.g. cidofovir, aminoglycosides, foscarnet, vancomycin, ganciclovir, etc) and/or NSAIDs. If concomitant use is unavoidable, renal function should be monitored weekly.

    Discontinuation of therapy in patients co-infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis. Patients co-infected with HIV and HBV who discontinue therapy should be closely monitored with both clinical and laboratory follow up for at least several months after stopping treatment. If appropriate, initiation of hepatitis B therapy may be warranted. In patients with advanced liver disease or cirrhosis, treatment discontinuation is not recommended since post-treatment exacerbation of hepatitis may lead to hepatic decompensation.

    Patients who experience a confirmed increase in serum creatinine of greater than 26.5 micromoles/l (0.3mg/dl) from baseline should be closely monitored for renal safety.

    If serum phosphate is less than 0.48mmol/l (1.5mg/dl) or creatinine clearance is decreased to less than 70ml/minute, renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations. The manufacturer suggests to discontinue therapy in these patients unless potential benefit of therapy outweighs the possible risks of continuing.

    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, hyperlipasemia) 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 disoproxil tablets are contraindicated during pregnancy.

    The manufacturer does not recommend elvitegravir with cobicistat, emtricitabine and tenofovir disoproxil 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, emtricitabine and tenofovir disoproxil with respect to pregnancy, foetal development, parturition or postnatal development.


    Elvitegravir with cobicistat, emtricitabine and tenofovir disoproxil tablets are contraindicated in 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 or cobicistat are excreted in human milk. Emtricitabine and tenofovir have been shown to be excreted in human milk. Animal studies have shown that elvitegravir, cobicistat and tenofovir are excreted in milk.

    At the time of writing there is limited published information regarding the use of elvitegravir with cobicistat, emtricitabine and tenofovir disoproxil tablets during breastfeeding.


    Advise patients 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 almost time for the next dose, the patient should not take the missed dose and resume the usual dosing schedule.

    Advise patients if they vomit within 1 hour of taking a dose, another dose should be taken.

    Advise patient not to take NSAIDs unless advised by clinician.

    Advise patient to seek advice at first indications of pregnancy.

    Side Effects

    Abdominal distension
    Abdominal pain
    Acute interstitial nephritis
    Acute tubular necrosis
    Allergic reaction
    Autoimmune hepatitis
    Creatine kinase increased
    Decreased appetite
    Diabetes insipidus
    Dream abnormalities
    Elevated amylase levels
    Elevated serum lipase
    Fanconi syndrome
    Graves' disease
    Hepatic steatosis
    Immune Reactivation/Reconstitution Syndrome
    Increase of liver transaminases
    Inflammatory reactions
    Lactic acidosis
    Maculopapular rash
    Muscle weakness
    Proximal tubulopathy
    Pustular rash
    Renal failure
    Serum creatinine increased
    Skin discolouration
    Suicidal tendencies


    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: January 2018

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Summary of Product Characteristics: Stribild 150 mg/150 mg/200 mg/245 mg film-coated tablets. Gilead Sciences Ltd. Revised April 2019

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

    NICE Evidence Services Available at: Last accessed: 13 July 2018

    Access the full UK drug database with a FREE Medscape UK Account
    It takes just a few minutes, and you’ll get unlimited access to information on over 11,000 UK drugs.
    Register for Free

    Already a member? Log in

    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

    FDB Logo

    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.