Drugs List

Therapeutic Indications

Uses

HIV infection - combination therapy

Contraindications

Children under 6 years
Weight below 25kg
Breastfeeding
Galactosaemia
Pregnancy
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

Pregnancy

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.

Lactation

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
Anaemia
Angioedema
Autoimmune disorders
Autoimmune hepatitis
Depression
Diarrhoea
Dizziness
Dream abnormalities
Dyspepsia
Fatigue
Flatulence
Graves' disease
Headache
Increase in serum glucose
Inflammatory reactions
Nausea
Osteonecrosis
Pruritus
Rash
Rise in blood lipids
Serum creatinine increased
Vomiting

Presentation

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

Drugs List

Therapeutic Indications

Uses

HIV infection - combination therapy

Dosage

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.

Adults

Children

Additional Dosage Information

Contraindications

Children under 6 years
Weight below 25kg
Breastfeeding
Galactosaemia
Pregnancy
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

Pregnancy

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.

Lactation

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
Anaemia
Angioedema
Autoimmune disorders
Autoimmune hepatitis
Depression
Diarrhoea
Dizziness
Dream abnormalities
Dyspepsia
Fatigue
Flatulence
Graves' disease
Headache
Increase in serum glucose
Inflammatory reactions
Nausea
Osteonecrosis
Pruritus
Rash
Rise in blood lipids
Serum creatinine increased
Vomiting

Overdosage

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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

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: https://www.mhra.gov.uk
Last accessed: 22 May 2019