Biktarvy

Biktarvy is a fixed-dose combination tablet. It combines 50mg of bictegravir, 200mg of emtricitabine and 25mg of tenofovir alafenamide. Biktarvy is manufactured by Gilead Sciences.

Bictegravir is an HIV integrase inhibitor. Emtricitabine is a nucleoside reverse transcriptase inhibitor. Tenofovir alafenamide is a nucleotide reverse transcriptase inhibitor. Emtricitabine and tenofovir alafenamide are also marketed as the fixed-dose combination product Descovy and included in the fixed-dose products Odefsey, Genvoya and Symtuza.

Biktarvy was approved in the European Union for the treatment of HIV in adults in June 2018. Biktarvy was approved in the United States in February 2018.

Biktarvy was approved on the basis of clinical trials in previously untreated people and people with suppressed viral load who switched from another regimen.

In previously untreated people, a pooled analysis of studies 1489 and 1490 showed that 91% of people who received Biktarvy had a viral load below 50 copies/ml after 48 weeks, compared to 93% receiving either Triumeq (dolutegravir, abacavir and lamivudine) or dolutegravir, emtricitabine and tenofovir alafenamide. Biktarvy showed no significant difference in viral suppression compared to dolutegravir-containing treatment when analysed by baseline CD4 cell count, viral load, age, sex or race. (Gallant) (Sax)

Two studies evaluated switching to bictegravir in virally suppressed people. In study 1844, there was no significant difference in the proportions virally suppressed 48 weeks after switching from dolutegravir, abacavir and lamivudine to Biktarvy or maintaining the existing regimen. (Daar) In study 1878 there was no significant difference in the proportions virally suppressed 48 weeks after switching from an atazanavir or darunavir-containing regimen or continuing the regimen. (Molina)

Biktarvy is not recommended for people with severely impaired kidney function (< 30ml/min). Biktarvy has not been studied in children or adolescents.

Biktarvy is recommended as a preferred option for first-line HIV treatment in US treatment guidelines.

Biktarvy is dosed as one purple-brown tablet once a day, with or without food.

Glossary

virological suppression

Halting of the function or replication of a virus. In HIV, optimal viral suppression is measured as the reduction of viral load (HIV RNA) to undetectable levels and is the goal of antiretroviral therapy.

regimen

A combination of medications and the way it is taken.

viral load

Measurement of the amount of virus in a blood sample, reported as number of HIV RNA copies per milliliter of blood plasma. The VL is an important indicator of HIV progression and of how well treatment is working. 

 

trial

A clinical trial is a research study that evaluates a treatment or intervention with human volunteers, in order to answer specific questions about its safety, efficacy and medical effects.

integrase inhibitors (INI, INSTI)

A class of antiretroviral drugs. Integrase strand transfer inhibitors (INSTIs) block integrase (see ‘integrase’). Blocking integrase prevents HIV from replicating.

Common side-effects of Biktarvy include depression, abnormal dreams, headache, dizziness and tiredness.

You should not take Biktarvy if you are currently taking medicines from the following groups:

  • products that contain St John’s wort (a herbal remedy used for depression and anxiety)
  • rifabutin, rifampicin and rifapentine (used to treat some bacterial infections such as tuberculosis)
  • carbamazepine, oxcarbazepine, phenobarbital and phenytoin (used to treat epilepsy and prevent seizures)
  • ciclosporin (an immunosuppressant)
  • sucralfate (a treatment for stomach ulcers and severe gastric reflux).

There are very limited data on the use of bictegravir or tenofovir alafenamide in pregnant women and Biktarvy should not be used during pregnancy unless the benefits are considered to outweigh the risk.

Activity of bictegravir against HIV already resistant to other integrase inhibitors has not been studied. No resistance to bictegravir has been detected in people who experienced viral rebound in clinical trials of the drug.

References

Gallant J et al. Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial. The Lancet, 390: 2063-72, 2017.

Sax PE, et al. Coformulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection (GS-US-380-1490): a randomised, double-blind, multicentre, phase 3, non-inferiority trial. The Lancet, 390: 2073-82, 2017.

Daar E, DeJesus E, Ruane P, et al. Phase 3 randomized, controlled trial of switching to fixed-dose bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) from boosted protease inhibitor-based regimens in virologically suppressed adults: week 48 results. ID Week 2017, San Diego, abstract LB-4, October 4-8, 2017.

Molina JM et al. Switch to bictegravir/F/TAF from DTG and ABC/3TC. Conference on Retroviruses and Opportunistic Infections, Boston, abstract 22, March 4-7, 2018.

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