On Wednesday, Gilead Sciences, Inc. (NASDAQ: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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