What is it and what is it used for?
Biktarvy is an antiviral medicine used to treat adults infected with human immunodeficiency virus 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Biktarvy contains the active substances bictegravir, emtricitabine and tenofovir alafenamide. It is only used in patients where the virus has not developed resistance to a class of HIV medicines called integrase inhibitors, or to tenofovir or emtricitabine.
How Biktarvy works
Biktarvy contains three active substances which work in different ways against HIV:
- Bictegravir is a type of antiviral agent called an ‘integrase inhibitor’. It blocks an enzyme called integrase that is needed by the HIV virus to make new copies of itself in the body.
- Tenofovir alafenamide is a ‘prodrug’ of tenofovir, meaning that it is converted into the active substance tenofovir in the body. Tenofovir is a nucleotide reverse transcriptase inhibitor (NRTI), which means that it blocks the activity of reverse transcriptase, another enzyme of the virus that allows it to reproduce itself.
- Emtricitabine is another type of NRTI (a nucleoside reverse transcriptase inhibitor) and it works in the same way as tenofovir.
Biktarvy does not cure HIV-1 infection or AIDS, but it can hold off damage to the immune system and the development of infections and diseases associated with AIDS.
How Biktarvy is used
Biktarvy can only be obtained with a prescription and treatment should be started by a doctor who has experience in the management of HIV infection.
Biktarvy is available as tablets, each containing 50 mg bictegravir, 200 mg emtricitabine, and 25 mg tenofovir alafenamide. The recommended dose is one tablet a day.
For more information about using Biktarvy, see the package leaflet or contact your doctor or pharmacist.
What are the benefits?
Biktarvy was shown to be as effective as comparator antiviral medicines. Side effects were similar to those of medicines of the same class. The European Medicines Agency therefore decided that Biktarvy’s benefits are greater than its risks and it can be authorised for use in the EU.
What are main side effects?
The most common side effects with Biktarvy (which may affect around 1 in 20 people) are headache, diarrhoea and nausea (feeling sick).
For the full list of side effects of Biktarvy, see the package leaflet.
Product information changes
Angioedema and urticaria have been added as potential side effects from treatment with a frequency of uncommon
Angioedema is swelling underneath the skin. It's usually a reaction to a trigger, such as a medication or something you're allergic to.
It isn't normally serious, but it can be a recurring problem for some people and can very occasionally be life-threatening if it affects breathing.
Symptoms of angioedema
The swelling most often affects the:
- area around the eyes
- lips and tongue
Many people also have a raised, itchy rash called urticaria (hives).
In more serious cases, angioedema can also cause breathing difficulties, tummy (abdominal) pain and dizziness.
Who should avoid taking it?
Biktarvy must not be used together with rifampicin (an antibiotic) or with St. John’s wort (a herbal medicine used for treating depression).
For the full list of restrictions, see the package leaflet.
What studies have been done?
The benefits of Biktarvy in the treatment of HIV infection were investigated in four main studies.
Two studies involved adults infected with HIV-1 who had not been treated previously, and looked at the numbers whose viral load (the amount of HIV-1 in the blood) was reduced to less than 50 copies per ml after 48 weeks of treatment.
In the first study, Biktarvy was compared with another antiviral medicine containing abacavir, dolutegravir and lamivudine in 629 patients. Overall, 92% of patients taking Biktarvy (290 out of 314) achieved viral load reduction, compared with 93% (293 out of 315) of patients who achieved it with the comparator.
The second study compared Biktarvy with dolutegravir plus emtricitabine/tenofovir alafenamide in 645 patients: 89% (286 out of 320) of patients taking Biktarvy achieved satisfactory viral load reduction, compared with 93% (302 out of 325) of patients on the comparator.
Two other studies involved previously treated patients in whom the viral load was already lower than 50 copies per ml, and looked at whether it increased above this level 48 weeks after patients were switched from their previous HIV treatment to Biktarvy.
In one study, the percentage of patients with viral load greater than or equal to 50 copies/ml was 1% (3 out of 282) of patients who switched to Biktarvy, compared with 0.5% (1 out of 281) of patients who stayed on their previous treatment (dolutegravir, abacavir, lamivudine).
In the second study, the viral load went above the threshold in 2% (5 out of 290) of patients switched to Biktarvy, and in 2% (5 out of 287) of patients who stayed on their previous treatment (‘boosted’ atazanavir or darunavir plus either emtricitabine/tenofovir or abacavir/lamivudine).
Biktarvy was first approved for use in the EU in 2018. It is manufactured by Gilead.
European Medicines Agency website page for Biktarvy (accessed 21/06/18)
Links available in External Resources