Bictegravir
Clinical data | |
---|---|
Other names | GS-9883 |
ATC code |
|
Identifiers | |
| |
JSmol) | |
| |
|
Bictegravir (
The combination drug bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy) was approved for use in 2018 in Australia,[6] the European Union[7] and the United States[8] and in 2019 in New Zealand[9] and the United Kingdom;[10] a generic version was approved by the Drugs Controller General of India in 2019.[11] As of 2024,[update] it is recommended as a first-line choice of antiretroviral therapy in several countries, including the European Union,[12] the United Kingdom[13] and the United States.[14]
Medical use
Bictegravir is used a in fixed dose combination with tenofovir alafenamide and emtricitabine for the treatment of HIV-1 infection.[4][15]
Contraindication
Bictegravir should not be used with dofetilide and rifampin.[16] Use of dofetilide with bictegravir increases the concentration of dofetilide, which can lead to life-threatening events.[16] Concomitant use of bictegravir and rifampin causes significant interactions because of an effect rifampin has on bictegravir.[16] Bictagravir is metabolized primarily through the liver (CYP3A4), so inducers of CYP3A4 should be avoided.[4]
Adverse effects
The most common side effects seen in bictegravir use include diarrhea, nausea, and headache.[4]
Society and culture
Economics
In February 2022, Gilead agreed to pay ViiV Healthcare over $1 billion to settle patent infringement cases.[17][18]
References
- ^ "Recommended INN: List 75" (PDF). WHO Drug Information. 30 (1): 102. 2016. Archived (PDF) from the original on 4 November 2021. Retrieved 4 October 2020.
- ^ "Bictegravir - Gilead Sciences". Adis Insight. Springer Nature Switzerland AG. Archived from the original on 2 February 2017. Retrieved 22 January 2017.
- ^ Highleyman L (6 July 2016). "New integrase inhibitor bictegravir looks promising in early studies". NAM aidsmap. Archived from the original on 2 February 2017. Retrieved 20 January 2017.
- ^ from the original on 28 August 2023. Retrieved 28 August 2023.
- ^ "Gilead Presents Preliminary Data on Bictegravir, an Investigational Integrase Strand Transfer Inhibitor for the Treatment of HIV" (Press release). Gilead Sciences. 20 June 2016. Archived from the original on 2 February 2017. Retrieved 20 January 2017.
- ^ "Australian Public Assessment Report for Bictegravir / Emtricitabine / Tenofovir alafenamide" (PDF). Therapeutic Goods Administration. 1 August 2019. Retrieved 22 February 2024.
- ^ "Biktarvy". European Medicines Agency. 21 June 2018. Retrieved 22 February 2024.
- ^ "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.
- ^ "BIKTARVY Data Sheet v 8.0" (PDF). Medsafe. 24 August 2023. Retrieved 22 February 2024.
- ^ "Bictegravir-emtricitabine-tenofovir alafenamide for the treatment of HIV-1 in adults". NHS England. 17 July 2019. Retrieved 22 February 2024.
- ^ "Hetero launches TAFFIC, the latest 3-in-1 single pill for HIV treatment" (Press release). Hetero Drugs. 17 December 2019. Retrieved 22 February 2024.
- ^ "Initial Regimens: ART-naïve Adults". European AIDS Clinical Society. October 2023. Retrieved 22 February 2024.
- ^ "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.
- ^ "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.
- from the original on 29 January 2022. Retrieved 29 January 2022.
- ^ a b c "Biktarvy - FDA Prescribing Highlights" (PDF). Archived (PDF) from the original on 26 July 2021. Retrieved 29 January 2022.
- ^ "GSK announces settlement between ViiV Healthcare and Gilead Sciences, Inc. resolving litigation relating to Biktarvy and ViiV's dolutegravir patents and entry into a patent licence agreement". ViiV Healthcare (Press release). ViiV Healthcare. Retrieved 26 August 2023.
- ^ "GSK announces settlement between ViiV Healthcare and Gilead Sciences, Inc. resolving litigation relating to Biktarvy and ViiV's dolutegravir patents and entry into a patent licence agreement". GSK US (Press release). 1 February 2022. Retrieved 28 August 2023.
Further reading
- Tsiang M, Jones GS, Goldsmith J, Mulato A, Hansen D, Kan E, et al. (December 2016). "Antiviral Activity of Bictegravir (GS-9883), a Novel Potent HIV-1 Integrase Strand Transfer Inhibitor with an Improved Resistance Profile". Antimicrobial Agents and Chemotherapy. 60 (12): 7086–7097. PMID 27645238.