ViiV: Positive proof-of-concept data for GSK3640254, novel HIV treatment

 ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, presented positive data from its phase IIa proof-of-concept study of the investigational maturation inhibitor GSK3640254 (GSK’254). The study showed the antiviral activity of GSK’254, establishing a relationship between dose and antiviral response, with the 140 mg and 200 mg doses showing the greatest reduction in plasma HIV-1 RNA. These findings were presented today at the (virtual) 2021 Conference on Retroviruses and Opportunistic Infections (CROI).

Maturation inhibitors are a class of antiretroviral medicines that target the late stage of the HIV viral life cycle. They can prevent the HIV replication process by blocking key enzyme activity at this stage, which results in the formation of immature virus particles. Because maturation inhibitors use a unique mechanism of action that targets HIV differently than other antiretrovirals currently available, they have the potential to offer new treatment options for individuals who may have experienced resistance to other classes of HIV treatment.

The phase IIa study was adaptive in design and divided into two parts to evaluate the antiviral activity, safety, and tolerability of once-daily GSK’254 among 34 treatment-naïve adults living with HIV. In part one, participants received GSK’254 10 mg, 200 mg, or placebo for 10 days. A planned interim analysis showed treatment emergent resistance associated mutations in the 200 mg arm after dosing was complete. As a result, in part two, participants received GSK’254 40 mg, 80 mg, 140 mg, or placebo for a shortened period of seven days. The primary endpoint was the maximum change in plasma HIV-1 RNA during parts one and two while secondary endpoints measured safety, tolerability, and pharmacokinetic (PK) parameters.

At the conclusion of the study, the largest mean changes in viral load were -1.5 log 10 and -2.0 log 10 copies/ml in the 140 mg and 200 mg groups, respectively.

Treatment with GSK’254 was generally well-tolerated throughout the study. There were no adverse events (AEs) leading to discontinuation and no deaths reported. AEs were reported by 22 (65%) participants, with the most common being headache (n=4).

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