Gilead Sciences, Inc. announced the presentation of key data highlighting the breadth of its innovative HIV treatment research pipeline. The latest results explore clinical outcomes from a study evaluating an investigational combination regimen of bictegravir and lenacapavir, new findings from a study evaluating the investigational combination of lenacapavir with broadly neutralizing antibodies (bNAbs), and new proof-of-concept data on GS-1720, a novel once-weekly integrase strand transfer inhibitor (INSTI). The data presented at the 31st Conference on Retroviruses and Opportunistic Infections (CROI) demonstrate Gilead's commitment to advancing the next wave of biomedical innovations in HIV to address the unmet needs of people with the virus and help end the epidemic worldwide.

In new Phase 2 data, 128 participants on a stable baseline regimen for six or more months prior to screening were randomly allocated in a 2:2:1 ratio to receive once-daily oral bictegravir 75 mg + lenacapavir 25 mg (n=51), bictegravir75 mg + lenacapavIR 50 mg (n=52) or continue their current stable baseline regimen (n=25). The primary endpoint was the proportion of patients without virologic suppression (HIV viral load 50 copies/mL per FDA Snapshot) at Week 24. Key secondary endpoints included the proportion of participants with virologic suppression (H IV viral load 50 copies/mL Per FDA Snapshot) and the proportion of participants with treatment-emergent adverse events (TEAEs).

Results showed that all three treatment groups had robust virologic suppression at six months, with consistently low viral loads throughout the study. In approximately 40% of participants, the virus was susceptible to TAB and ZAB, indicating that certain individuals living with multi-drug resistant HIV may be suitable candidates for future trials investigating long-acting regimens containing TAB and ZAB. New clinical data featured in a late-breaker oral presentation at CROI demonstrate the first proof of concept that an integrase strand transfer inhibitor (ININI) has a pharmacokinetic profile suitable for a weekly dosing interval.

GS-1720 is a selective INSTI being evaluated as a novel, investigational once-weekly antiretroviral agent in combination with long-acting agents with a goal to provide people with HIV with new long-acting options. Optionality is critical for those who are not able to adhere to current regimens and for helping people with HIV, regardless of where they find themselves on the continuum of care, to improve their individual outcomes and advance public health. Teropavimab (GS-5423, TAB), zinlirvimab (GS-2872, ZAB), and GS-1720 are investigational compounds and are not approved by the U.S. Food and Drug Administration or any other regulatory authority for any use.

The use of these compounds alone or in combination with lenacapavir are investigational.