Bictegravir/emtricitabine/tenofovir alafenamide

Bictegravir/emtricitabine/tenofovir alafenamide
Combination of
Bictegravirintegrase inhibitor
Emtricitabinenucleoside reverse transcriptase inhibitor
Tenofovir alafenamidenucleoside reverse transcriptase inhibitor
Clinical data
Trade namesBiktarvy, Taffic[1]
AHFS/Drugs.comMonograph
MedlinePlusa618012
License data
Pregnancy
category
Routes of
administration		By mouth
ATC code
Legal status
Legal status
Identifiers
CAS Number
KEGG

Bictegravir/emtricitabine/tenofovir alafenamide, sold under the brand name Biktarvy, is a fixed-dose combination antiretroviral medication for the treatment of HIV/AIDS[6] and as post-exposure prophylaxis (PEP) to prevent HIV infection following potential exposure.[8][9] It contains bictegravir, a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor; emtricitabine, an HIV-1 nucleoside analog reverse transcriptase inhibitor; and tenofovir alafenamide, an HIV-1 nucleoside analog reverse transcriptase inhibitor.[6]

It was approved for use in 2018 in Australia,[10] the European Union[7] and the United States[11] and in 2019 in New Zealand[12] and the United Kingdom;[13] a generic version was approved by the Drugs Controller General of India in 2019.[1] As of 2024, it is recommended as a first-line choice of antiretroviral therapy in several countries, including the European Union,[14] the United Kingdom[15] and the United States.[16]

  1. ^ a b "Hetero launches TAFFIC, the latest 3-in-1 single pill for HIV treatment" (Press release). Hetero Drugs. 17 December 2019. Retrieved 22 February 2024.
  2. ^ "Bictegravir / emtricitabine / tenofovir alafenamide (Biktarvy) Use During Pregnancy". Drugs.com. 16 September 2019. Retrieved 7 March 2020.
  3. ^ "Regulatory Decision Summary for Biktarvy". 23 October 2014.
  4. ^ "Drug and medical device highlights 2018: Helping you maintain and improve your health". Health Canada. 14 October 2020. Retrieved 17 April 2024.
  5. ^ "Biktarvy 50 mg/200 mg/25 mg film-coated tablets - Summary of Product Characteristics (SmPC)". (emc). 25 August 2020. Retrieved 26 August 2020.
  6. ^ a b c "Biktarvy- bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate tablet". DailyMed. 8 August 2019. Retrieved 7 March 2020.
  7. ^ a b "Biktarvy EPAR". European Medicines Agency. 21 June 2018. Retrieved 22 February 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  8. ^ Tanner MR, O'Shea JG, Byrd KM, Johnston M, Dumitru GG, Le JN, et al. (May 2025). "Antiretroviral Postexposure Prophylaxis After Sexual, Injection Drug Use, or Other Nonoccupational Exposure to HIV - CDC Recommendations, United States, 2025". MMWR. Recommendations and Reports : Morbidity and Mortality Weekly Report. Recommendations and Reports. 74 (1): 1–56. doi:10.15585/mmwr.rr7401a1. PMC 12064164. PMID 40331832.
  9. ^ Highleyman L (7 May 2025). "CDC Updates Post-Exposure Prophylaxis Guidelines". POZ. Retrieved 18 July 2025.
  10. ^ "Australian Public Assessment Report for Bictegravir / Emtricitabine / Tenofovir alafenamide" (PDF). Therapeutic Goods Administration. 1 August 2019. Retrieved 22 February 2024.
  11. ^ "U.S. Food and Drug Administration Approves Gilead's Biktarvy (Bictegravir, Emtricitabine, Tenofovir Alafenamide) for Treatment of HIV-1 Infection" (Press release). Gilead Sciences. 7 February 2018.
  12. ^ "BIKTARVY Data Sheet v 8.0" (PDF). Medsafe. 24 August 2023. Retrieved 22 February 2024.
  13. ^ "Bictegravir-emtricitabine-tenofovir alafenamide for the treatment of HIV-1 in adults". NHS England. 17 July 2019. Retrieved 22 February 2024.
  14. ^ "Initial Regimens: ART-naïve Adults". European AIDS Clinical Society. October 2023. Retrieved 22 February 2024.
  15. ^ "BHIVA guidelines on antiretroviral treatment for adults living with HIV-1 2022 (2023 interim update)" (PDF). British HIV Association. 28 May 2023. p. 16. Retrieved 22 February 2024.
  16. ^ "Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV" (PDF). HIV.gov. 21 September 2022. p. 6. Retrieved 22 February 2024.
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