Gilead Presents Data Demonstrating Established, Investigational HIV Drugs

Data from the ALLIANCE trial showed bictegravir, emtricitabine, and tenofovir alafenamide (BIC FTC TAF; Biktarvy) maintained high rates of suppression for HIV (95.4%) and hepatitis B virus (HBV) (86.6%) for 89 patients who switched to BIC FTC TAF treatment with dolutegravir, emtricitabine, tenofavir disoproxil fumarate (DTG + F/TDF), according to data presented at the Conference on Retroviruses and Opportunistic Infections 2025.¹

In ALLIANCE (NCT03547908), investigators aimed to evaluate Biktarvy compared with DTG + F/TDF as HIV and HBV treatment for patients that are co-infected. Patients received either Biktarvy or DTG + F/TDF once daily for 96 weeks. In the open-label extension, individuals continued to take their blinded drug until the end of the treatment period for up to 48 weeks. The primary outcomes included percentage of individuals with HIV RNA of less than 50 copies/mL at week 48 and percentage of individuals with plasma HBV DNA less than 20 IU/mL at week 48, according to the clinical trial data. Secondary outcomes included the percentage changes of both primary end points at 96 weeks.²

In previous data, both end points were met for non-inferiority, with 95% of patients receiving Biktarvy and 91% receiving DTG + F/TDF meeting the HIV end point and 63% and 43%, respectively, meeting the HBV end point. As for treatment-related adverse events (AEs) included 29% for Biktarvy and 28% for DTG + F/TDF, according to the study authors. In the Biktarvy group, 1 patient reported a serious AE related to treatment.³

In the new analysis, 19% of individuals reported AEs, which were mild to moderate in severity and led to zero discontinuations. The most commonly reported AE included weight gain (9%) and low-density lipoprotein cholesterol increase (3%).¹

Furthermore, Gilead also presented primary results of a phase 2 study, evaluating investigational lenacapavir, teropavimab, and zinlirvimab (LTZ), which confirmed the previously presented phase 1b results. These results showed that 90% of patients who completed the study regimen maintained virological suppression at week 26, and no serious adverse events were seen, including AEs that lead to discontinuation.^1,4

In the phase 2 (NCT05729568) study, investigators aimed to determine the effectiveness, safety, and tolerability of LTZ for virological suppression in adults with HIV. LTZ was compared with oral antiretroviral therapy (ART), according to the clinical trial information. The primary outcome included the proportion of individuals with HIV RNA of 50 copies/mL or more at week 26. Secondary outcomes included proportion of patients with HIV RNA of 50 copies/mL or more at 52 weeks, proportion of patients with RNA less than 50 copies/mL at weeks 26 and 52, and proportion of individuals experiencing treatment-emergent AEs.⁵

At 26 weeks, 96% of individuals who received LTZ and 96% who received ART remained virologically suppressed. CD4 cell count also increased for both groups at week 26. The most common AEs included injection site reactions related to administration, and there were no serious adverse events related to LTZ.¹

Lastly, the company presented results from a phase 2a trial (NCT05281510) as part of efforts to discover a cure for HIV. Results presented showed that the investigational TLR7 agonist, vesatolimod, was well tolerated with no treatment-related serious AEs. The most common AEs included infusion-related reactions.¹

REFERENCES

1. Gilead presents new HIV treatment and cure research data at CROI 2025, including an investigational long-acting, twice-yearly therapy option. News release. Gilead. March 12, 2025. Accessed March 14, 2025. https://www.gilead.com/news/news-details/2025/gilead-presents-new-hiv-treatment-and-cure-research-data-at-croi-2025-including-an-investigational-long-acting-twice-yearly-therapy-option

2. Safety and Efficacy of Bictegravir/​Emtricitabine/​Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/​Tenofovir Disoproxil Fumarate in Treatment Naive, HIV-1 and Hepatitis B Co-Infected Adults (Alliance). ClinicalTrials.gov identification: NCT03547908. Updated March 19, 2024. Accessed March 14, 2025. https://clinicaltrials.gov/study/NCT03547908

3. Avihingsanon A, Lu H, Leong CL, et al. Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, emtricitabine, and tenofovir disoproxil fumarate for initial treatment of HIV-1 and hepatitis B coinfection (ALLIANCE): a double-blind, multicentre, randomised controlled, phase 3 non-inferiority trial. Lancet HIV. 2023;10(10):e640-e652. doi:10.1016/S2352-3018(23)00151-0

4. Gilead presents positive proof-of-concept data for investigational combination regimen of lenacapavir with broadly neutralizing antibodies as a potential twice-yearly approach for the treatment of HIV. News release. Gilead. February 22, 2023. Accessed March 14, 2025. https://www.gilead.com/news/news-details/2023/gilead-presents-positive-proof-of-concept-data-for-investigational-combination-regimen-of-lenacapavir-with-broadly-neutralizing-antibodies-as-a-potential-twice-yearly-approach-for-the-treatm

5. A Study of GS-5423 and GS-2872 in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection. ClinicalTrials.gov identification: NCT05729568. Updated January 13, 2025. Accessed March 14, 2025. https://clinicaltrials.gov/study/NCT05729568