April 30, 2026
1 min read
The FDA has accepted Gilead Sciences’ new drug application for a single-tablet, once-daily HIV treatment combination and granted the application priority review, according to the drug-maker.
The investigational combination includes two existing Gilead medications: bictegravir (BIC), a guideline-recommended integrase strand transfer inhibitor; and lenacapavir (LEN), a first-in-class capsid inhibitor approved for the treatment of drug-resistant HIV, and also as a long-acting injection for HIV prevention.
Data derived from Meissner, et al, and Orkin, et al.
Gilead developed the single-tablet regimen for adults who are virologically suppressed on other medication.
“If approved, BIC/LEN has the potential to be a single-tablet regimen designed to provide sustained virologic suppression with a high barrier to resistance for people living with HIV who are virologically suppressed, including those who are aging, with comorbidities, seeking to streamline a complex regimen, with prior [antiretroviral] resistance, and those seeking novel treatment options,” Dietmar Berger, MD, PhD, Gilead chief medical officer, said in a press release.
Gilead’s application was supported by results from two phase 3 trials — ARTISTRY-1 and ARTISTRY-2 — which evaluated BIC/LEN among people with HIV who were already virologically suppressed, including those switching from complex multi-tablet regimens, and found that participants remained virally suppressed on the single-tablet combo.
Results from the trials were presented at the Conference on Retroviruses and Opportunistic Infections in February and covered here. ARTISTRY-1 results were also published in The Lancet. A link to that article can be found below.
Sources/Disclosures
Source:
Press Release
References:
- Meissner EG, et al. Abstract 513. Presented at: Conference on Retroviruses and Opportunistic Infections; Feb. 22-25, 2026; Denver.
- Orkin C, et al. Abstract 181. Presented at: Conference on Retroviruses and Opportunistic Infections; Feb. 22-25, 2026; Denver.
- Orkin C, et al. Lancet. 2026;doi:10.1016/S0140-6736(26)00307-7.
Disclosures:
Berger reports being employed by Gilead.
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