Gilead Sciences is preparing to file for approval of its single-tablet anti-retroviral therapy (ART) combination in human immunodeficiency virus (HIV) after a Phase II/III trial met its primary endpoint.
The open-label ARTISTRY-1 trial (NCT05502341) evaluated the treatment responses of adults with HIV who are virologically suppressed switching from a multi-tablet regimen to a daily, single-tablet regimen of bictegravir 75mg, an integrase strand transfer inhibitor (INSTI), and lenacapavir 50mg, an HIV capsid inhibitor, (BIC/LEN).
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The trial found the single-tablet regimen to be non-inferior to multi-tablet ART.
The primary endpoint was the percentage of patients with HIV-1 RNA levels ≥50 copies/mL after 48 weeks. Key secondary endpoints were the proportion of participants with virologic suppression (HIV viral load <50 copies/mL), change in baseline in CD4 cell count and the proportion of participants with treatment-emergent adverse events (TEAEs).
Gilead added that the single tablet regimen was generally well tolerated, with no significant or new safety concerns identified, suggesting success in this endpoint.
Currently, patients living with HIV have to take multiple medications daily which complicated adherence and reduces quality of life. Treatment is also impacted by pre-existing resistance, tolerability and drug-drug interactions.
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By GlobalDataAt baseline, patients enrolled in ARTISTRY-1 were taking between two and 11 pills per day for their HIV treatment, with ~40% taking their antiretrovirals more than once a day.
A single-tablet regimen therefore would be a meaningful development for HIV patients, touting a much more convenient dosing schedule.
Clinical professor of infection and inequities at Queen Mary University of London, Chloe Orkin, said: “These ARTISTRY-1 trial results demonstrate that a combination regimen of BIC/LEN maintains viral suppression in people living with HIV who would otherwise have to take a complex multi-tablet regimen. The findings are significant for those people, many of whom have lived with HIV for decades and who have medical comorbidities of aging and thus take many other medications as well.”
The single-tablet regimen is also being investigated in the double-blind, ARTISTRY-2 trial (NCT06333808). ARTISTRY 2 is evaluating the safety and efficacy of switching from Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets) to the single-tablet BIC/LEN. Topline data is expected before the end of 2025.
Gilead plans to approach regulatory authorities with data from the ARTISTRY programme and submit the detailed findings for presentation at a future scientific congress.
If approved, GlobalData predicts a patient-based forecast for the single-tablet regimen of $1.48bn in 2033.
GlobalData is the parent company of Clinical Trials Arena.
Gilead cements name in HIV
Despite the success in the daily combination tablet, Gilead is already trying to outdo itself, with the company also developing a once-weekly HIV treatment with MSD. In the ongoing, open-label Phase II study (NCT05052996), 88.5% and 100% of adults treated with the once-weekly treatment of MSD’s islatravir and Gilead’s lenacapavir maintained undetectable viral load (HIV-1 RNA <50 copies/mL) at week 96. The combination is already being evaluated in Phase III trials (NCT06630286 and NCT06630299).
Gilead has also cemented its name in the prevention space with its twice-yearly pre-exposure prophylaxis (PrEP) version of lenacapavir, Yeztugo. Data show that 99.9% of participants who received Yeztugo in the Phase III PURPOSE 1 and PURPOSE 2 trials remained HIV negative. The PrEP treatment gained approval from the US Food and Drug Administration (FDA) in June 2025.
Following the FDA approval, infectious disease analyst for GlobalData, Anaelle Tannen, said: “The approval of Yeztugo is a momentous step in improving PrEP options available for people vulnerable to contracting HIV.
“The majority of PrEP therapies require daily oral administration. Key opinion leaders previously interviewed by GlobalData noted that there is often a psychosocial burden when taking daily PrEP due to stigma, and patients have concerns about others discovering their medication or adherence challenges. Yeztugo could address these key issues.”
While there have been concerns about price being a barrier to entry for patients, Gilead has allowed generic development of the therapy in third-world countries to try and reduce this barrier.
Gilead is also investigating a once-yearly version of the PrEP therapy.
Lenecapavir is also approved for use as an HIV treatment, under the brand name Sunlenca. The drug is used as part of a combination with other ARTs.
GlobalData predicts a combined patient-based sales forecast for Yeztugo and Sulenca of $4.98bn in 2033.
The HIV market across the seven major markets (7MM: US, France, Germany, Italy, Spain, the UK, and Japan) is forecast to grow at a compound annual growth rate (CAGR) of 1.9% from $26.5bn in 2023 to $32.1bn in 2033, forecasts GlobalData.
