US FDA approves once-daily oral bictegravir/lenacapavir as simplified HIV combination (Bixlenvo)

28 August 2026. Related: Antiretrovirals, Treatment access.

Simon Collins, HIV i-Base

BIC/LEN – Biktarvy – Triumeq (cms)

On 27 August 2026 the US FDA approved a once-daily single tablet regimen (STR) of bictegravir 75 mg/lenacapavir 50 mg as a simplification option for people currently on complex combinations.

Approval was based on results from the phase 3 ARTISTRY-1 and -2 studies presented at CROI earlier this year and previously reported in HTB. [2]

BIC/LEN was developed by Gilead Sciences and is marketed under the trade name Bixlenvo.

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This important new STR will safely and effectively offer a new option for people on complex multi-tablet combinations.

Access in Europe though will depend on price.

Although lenacapavir was approved as a treatment for multi-drug resistance, in 2022 in the UK, NHS England took four years to make the drug available. [3]

References

1. US FDA Approves Gilead’s Bixlenvo a New Once-Daily Single Tablet Option for Virologically Suppressed Adults With HIV Including Those on Complex Regimens. (27 August 2026).
   https://www.gilead.com/news/news-details/2026/u-s–fda-approves-gileads-bixlenvo-a-new-once-daily-single-tablet-option-for-virologically-suppressed-adults-with-hiv-including-those-on-complex-regimens
2. CROI 2026: Once-daily oral BIC/LEN simplifies ART for those on complex combinations. HTB (25 February 2026).
   https://i-base.info/htb/53317
3. NHS England finally approves lenacapavir for ART. HTB (28 August 2026),.
   https://i-base.info/htb/54565