Gilead Presents New HIV Treatment And Cure Research Data

On Wednesday, Gilead Sciences, Inc. GILD presented data from its HIV treatment portfolio and pipeline at the Conference on Retroviruses and Opportunistic Infections (CROI 2025).

ALLIANCE is an ongoing Phase 3 study evaluating Biktarvy versus dolutegravir 50 mg (DTG) + emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg, F/TDF, DTG+F/TDF, in adults with HIV-1/HBV coinfection initiating treatment.

• Previously reported results demonstrated the efficacy of both antiretroviral regimens.
• The newly presented data shows that Biktarvy maintained high rates of HIV-1 (95.4%) and HBV (86.6%) virologic suppression, defined as HIV RNA <50 copies/ mL and HBV DNA <29 IU/ mL, respectively, in participants (n=89) following a switch to Biktarvy after 96 weeks of treatment with DTG+ F/TDF.
• Study drug-related treatment-emergent adverse events were reported in 19% of participants and most were mild to moderate, with zero discontinuations due to TEAEs.

Also Read: Gilead Ups 2025 Outlook, Eyes Lenacapavir Launch For HIV Prevention

At CROI 2025, the primary results of a Phase 2 study evaluating lenacapavir (LEN) with teropavimab (TAB) and zinlirvimab (ZAB) (LTZ) were presented.

• The study met its primary endpoint: the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 26.
• The Week 26 data demonstrated the high efficacy of the LTZ regimen, with 96% of participants who received LTZ and 96% (n=26 of 27) who received SBR, remained virologically suppressed.
• CD4 cell counts also increased from baseline to week 26 in both groups.
• The most common AEs with LTZ were injection site reactions related to subcutaneous LEN administration.

The Phase 2a GS-US-382-5445 trial enrolled 20 South African cisgender women who had received antiretroviral therapy (ART) soon after acquiring HIV and were virologically suppressed for at least 12 months.

• Participants received up to 10 oral doses of Gilead’s vesatolimod, every 2 weeks starting on day 0, plus IV infusions of broadly neutralizing antibodies (bNAbs) VRC07-523LS and CAP256V2LS, provided by the National Institutes of Health.
• Results presented at CROI showed the treatment combination was generally well-tolerated with no treatment-related serious adverse events (TEAEs) reported.

Price Action: GILD stock is up 0.04% at $114.47 at the last check Wednesday.

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