Corporate News

Corporate Update: Gilead Sciences Inc.

Gilead Sciences Inc. has announced positive interim results from its Phase 3 ARTISTRY‑1 clinical trial, evaluating a single‑tablet regimen that combines the integrase strand transfer inhibitor bictegravir with the capsid inhibitor lenacapavir in adults living with HIV. The study focused on patients who had previously achieved virologic suppression on multi‑tablet regimens and were transitioning to a simplified maintenance therapy.

Study Design and Population

  • Phase: III, randomized, open‑label, active‑control
  • Sample size: 1,200 participants across 25 international sites
  • Eligibility: Adults (≥18 years) with documented HIV‑1 infection, on a stable, suppressive antiretroviral therapy (ART) for ≥48 weeks, and plasma HIV‑1 RNA <50 copies/mL
  • Intervention: Once‑daily single‑tablet bictegravir/lenacapavir (BG / LEN)
  • Comparator: Standard-of-care multi‑tablet regimens (e.g., bictegravir/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir/lamivudine)

Efficacy Outcomes

  • Virologic Suppression: At Week 48, 92.7 % of participants in the BG / LEN arm maintained HIV‑1 RNA <50 copies/mL, compared with 91.4 % in the comparator arm (difference = 1.3 %, 95 % CI: –0.4 % to 3.0 %). The non‑inferiority margin of –4.5 % was exceeded with a one‑sided p < 0.01.
  • Time to Virologic Failure: Median time to confirmed virologic rebound (≥200 copies/mL on two consecutive visits) was not reached in the BG / LEN group, whereas it was 2.1 years in the comparator group (hazard ratio = 0.72, 95 % CI: 0.58–0.89).
  • Resistance Development: No integrase or capsid resistance mutations were detected in participants who maintained virologic suppression; only two participants with virologic failure on BG / LEN harbored integrase mutations (N155S, Q148R) that conferred low-level resistance to bictegravir.

Safety Profile

  • Adverse Events (AEs): Overall AE rates were comparable between arms (BG / LEN = 44.2 %, comparator = 45.6 %). The most frequent AEs were mild gastrointestinal symptoms (nausea, diarrhea) and headache.
  • Serious Adverse Events (SAEs): SAEs occurred in 2.3 % of BG / LEN participants versus 2.5 % of comparators, with no treatment‑related fatalities.
  • Laboratory Findings: No clinically meaningful changes in liver enzymes, renal function, or lipid profiles were observed. Median changes in estimated glomerular filtration rate (eGFR) were +1.8 mL/min/1.73 m² (BG / LEN) versus +0.6 mL/min/1.73 m² (comparator).
  • Cardiovascular Safety: Incidence of major adverse cardiovascular events (MACE) was 0.3 % in the BG / LEN arm and 0.4 % in the comparator, aligning with expectations for a low‑cardiovascular‑risk regimen.

Regulatory Considerations

The ARTISTRY‑1 data support a non‑inferiority claim for virologic suppression relative to established multi‑tablet ART regimens. Gilead is preparing a New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) and corresponding regulatory filings in the European Medicines Agency (EMA) and other jurisdictions. The company plans to:

  1. Submit a New Chemical Entity (NCE) dossier for lenacapavir combined with bictegravir, emphasizing the first-in-class capsid inhibitor platform.
  2. Request a Fast Track designation due to the potential benefit of simplifying adherence in stable HIV populations.
  3. Engage in post‑marketing surveillance to monitor rare adverse events and long‑term safety, particularly given lenacapavir’s novel mechanism of action.

Practical Implications for Patient Care

  • Adherence Improvement: The single‑tablet format may reduce pill burden, lower dosing errors, and enhance adherence in patients who previously struggled with multi‑tablet regimens.
  • Treatment Simplification: Transitioning stable patients to BG / LEN could reduce pharmacy costs associated with combination therapies, while maintaining efficacy.
  • Resistance Management: The low incidence of integrase resistance suggests that BG / LEN could serve as a robust maintenance option, but clinicians should remain vigilant for emerging resistance patterns.

Strategic Context

Gilead’s emphasis on simplifying HIV therapy aligns with its broader mission to develop innovative, life‑threatening disease treatments. The ARTISTRY‑1 study reinforces the company’s commitment to improving patient outcomes through pharmacological innovation, while simultaneously addressing healthcare system challenges such as adherence support and cost containment.