FOSTER CITY, Calif. – Gilead Sciences, Inc. (NASDAQ: NASDAQ:) has announced new clinical data from its HIV treatment research, which includes investigational regimens with varying dosing strategies. The data presented at the 31st Conference on Retroviruses and Opportunistic Infections (CROI) highlights the potential of Gilead’s HIV treatment pipeline to simplify and enhance therapeutic options for individuals living with HIV.
The ARTISTRY-1 study, a Phase 2/3 trial, is evaluating the efficacy and safety of a once-daily oral combination of bictegravir and lenacapavir compared to current complex therapies in virologically suppressed individuals. The study showed that participants maintained low viral loads, and the combination regimens were well tolerated, with the most common treatment-emergent adverse events being diarrhea, COVID-19, and constipation.
A Phase 1b study published in The Lancet HIV examined the twice-yearly dosing of lenacapavir combined with the broadly neutralizing antibodies teropavimab and zinlirvimab. The study found that this investigational long-acting regimen was effective in maintaining virologic suppression over six months. The regimen is now progressing to a Phase 2 study to evaluate its safety and efficacy in a larger cohort.
Additionally, Gilead presented the first proof-of-concept data for GS-1720, a once-weekly integrase strand transfer inhibitor (INSTI). The ongoing Phase 1b trial indicated that GS-1720 has a pharmacokinetic profile suitable for weekly dosing and was generally well tolerated, with no serious adverse events or treatment-related discontinuations reported.
Gilead’s research aims to provide more flexible treatment options that could improve adherence and outcomes for people with HIV. The investigational compounds discussed, including bictegravir, lenacapavir, teropavimab, zinlirvimab, and GS-1720, have not been approved by regulatory authorities for any use, and their safety and efficacy are still being established.
Lenacapavir, under the brand name Sunlenca®, has been approved in several countries for the treatment of multi-drug resistant HIV in combination with other antiretrovirals. It is the only HIV treatment option administered twice-yearly.
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