Gilead Sciences presented data at a conference in Denver and published the results in The Lancet on February 25, 2026, showing that its experimental single‑tablet regimen combining bictegravir and lenacapavir produced low discontinuation rates in clinical studies.
The study reported discontinuation rates due to adverse events of 1.6% in one treatment arm and 0.5% in the other, both well below the 2% threshold that typically signals tolerability concerns. Virologic suppression was maintained, with only 0.8% of patients on the combination pill showing detectable virus after 48 weeks compared with 1.1% on multi‑tablet regimens; another trial found 1.3% of participants on the BIC/LEN combo had HIV‑1 RNA levels ≥50 copies/mL versus 1.0% on Biktarvy.
Senior Vice President Jared Baeten said the results "represent the latest example of Gilead’s commitment to advancing HIV treatment through continuous scientific innovation" and that the once‑daily pill "combines the durability of bictegravir with lenacapavir, a first‑in‑class capsid inhibitor, to sustain virologic suppression for patients seeking new options."
Gilead’s HIV business, dominated by Biktarvy and Descovy, grew 6% in 2025 and the company has guided 2026 total product sales to $29.6‑$30.0 billion and non‑GAAP diluted EPS to $8.45‑$8.85, slightly below analyst consensus. The new regimen could add a future revenue stream once regulatory approval is obtained, expected in the second half of 2026.
Investors noted that the guidance for 2026 was below consensus estimates, but the positive clinical data were viewed as a promising step toward expanding Gilead’s HIV portfolio and maintaining its market leadership as patents for existing products approach expiration.
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