Gilead Sciences’ human immunodeficiency virus (HIV) single-tablet combination antiretroviral therapy (ART) has proven non-inferior to standard of care (SoC) in a second Phase III trial.
In the double-blind ARTISTRY-2 trial (NCT06333808), patients were switched from Biktarvy (bictegravir 50mg, emtricitabine 200mg, tenofovir alafenamide 25mg) tablets (B/F/TAF) to a single-tablet combination of bictegravir 75mg and lenacapavir 50mg (BIC/LEN).
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In the study, the primary endpoint of non-inferiority was met in patients who switched to the investigating regimen. The primary efficacy endpoint was the percentage of participants with HIV-1 RNA levels ≥50 copies/mL after 48 weeks of treatment.
Key secondary endpoints at Week 48 included the proportion of participants with virologic suppression (HIV viral load <50 copies/mL per FDA Snapshot), change from baseline in CD4 cell count and the proportion of participants with treatment-emergent adverse events (TEAEs).
Gilead confirmed the regimen was well tolerated with no significant or new safety concerns identified, but it did not disclose the status of other key secondary endpoints; however, more data is set to be presented at a future scientific congress.
Dr Eric Meissner, associate professor and director of HIV and hepatitis patient care and research at the Medical University of South Carolina, said: “The findings from ARTISTRY-2 provide evidence that the investigational combination of bictegravir—a standard-of-care integrase strand transfer inhibitor—and lenacapavir—a novel capsid inhibitor—has a comparable efficacy profile to a global guideline-recommended treatment regimen, demonstrating potential to expand current HIV treatment options.”
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By GlobalDataThe ARTISTRY-2 data comes just a month after Gilead announced the success of the ARTISTRY-1 trial (NCT05502341), which also found the single tablet regimen to be non-inferior to SoC ART.
Armed with data from both studies, Gilead plans to speak with regulatory authorities about the candidate.
Gilead shows dominance in HIV market
Gilead has made a real mark on the HIV landscape in recent years, most notably with its twice-yearly pre-exposure prophylaxis (PrEP) version of lenacapavir, branded as Yeztugo in the US.
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, GlobalData’s infectious disease analyst 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.”
As well as this, the company is investigating a once-weekly HIV treatment as part of a partnership with MSD. In a 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).
MSD has also had success with a once daily single-tablet regimen of Pifeltro (doravirine) and islatravir (DOR/ISL). In a Phase III trial, the candidate was proven to be non-inferior to Biktarvy. Pifeltro is already approved in the US for HIV infection treatment.
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.
GlobalData is the parent company of Clinical Trials Arena.
