GSK, Pfizer's ViiV Healthcare Shows Strong HIV Viral Suppression In Latest Study

ViiV Healthcare announced Wednesday the latest findings from its EMBRACE phase 2b study.

The study found that N6LS (VH3810109 or VH109), given every four months in combination with monthly cabotegravir long-acting (CAB LA), kept viral levels suppressed in adults living with HIV who were already stable on treatment.

These results were presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2025).

Results from the EMBRACE study at the six-month primary endpoint showed:

• 96% of participants receiving VH109 60mg/kg intravenously (IV) and 88% receiving VH109 3000mg subcutaneously (SC) with rHuPH20 maintained HIV-1 RNA levels below 50 copies/mL, compared to 96% in the standard-of-care group.

• Overall, 4% of the IV group and 6% of the SC group had HIV-1 RNA levels of 50 copies/mL or higher when measured at month six, compared to none in the standard-of-care group.

• VH109 was generally well tolerated, though infusion site reactions were more frequent with SC administration, occurring in 14% compared to none with IV administration.

• ViiV Healthcare will progress a six-month IV formulation of VH109 in combination with CAB LA for further evaluation in an EMBRACE part two trial.

The company also presented data from two phase 2a proof-of-concept studies of investigational antiretroviral therapies, VH4524184 (VH184) and VH4011499 (VH499).

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VH184 demonstrated potency at all doses. After 10 days of monotherapy, the average decreases were -1.17, -2.15, and -2.31 log10 copies/mL for the 10mg, 50mg, and 300mg doses, respectively.

• The maximum viral load decline (-2.69 log10) was observed in the 300mg dose. Additionally, no drug-resistance mutations were observed at the end of the study.
• Long-acting formulations of VH184 in adults without HIV are being evaluated in an ongoing phase 1 study.

• The trial of VH499 showed that all oral doses (25mg, 100mg, and 250mg) led to a decrease in HIV-1 viral load ranging from -2.2 log10 copies/mL in the 250mg arm to -1.8 log10 copies/mL in the 25mg and 100mg arms. VH499 was well tolerated, with all adverse events being mild to moderate in severity.
• There were no adverse events leading to withdrawal, and no serious adverse events were reported
• On day 11, one individual on the 25mg dose developed a single mutation associated with reduced susceptibility to capsid inhibitors.

ViiV Healthcare is majority owned by GSK Plc GSK, with Pfizer Inc PFE and Shionogi as shareholders.

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