ViiV Healthcare’s investigational therapy, GSK’254, demonstrated antiviral activity, safety, and tolerability in its phase 2a proof-of-concept findings.
Over the course of care and many years of antiretroviral therapy (ART), people with HIV (PWH), can experience treatment failure.
When this happens, maturation inhibitors can be adopted for treatment in this patient base. These therapies use a unique mechanism of action that targets HIV differently than other antiretrovirals.
As such, they have the potential to offer new treatment options for individuals who may have experienced resistance to other classes of HIV treatment.
ViiV Healthcare has developed its maturation inhibitor, GSK’254. In its phase 2a proof-of-concept findings, the company announced it demonstrated antiviral activity, safety and tolerability. The findings were presented during the Conference on Retroviruses and Opportunistic Infections (CROI) 2021 virtual sessions.
The study showed the antiviral activity of GSK’254 established a relationship between dose and antiviral response, with the 140 mg and 200 mg doses showing the greatest reduction in plasma HIV-1 RNA.
The study was divided into 2 parts. Participants included 34 treatment-naïve adults living with HIV GSK’254 among. In part one, participants received GSK’254 10 mg, 200 mg, or placebo for 10 days. An interim analysis showed treatment emergent resistance associated mutations in the 200 mg arm after dosing was complete.
As a result, in part 2, participants received GSK’254 40 mg, 80 mg, 140 mg, or placebo for a 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.
The results showed the largest mean changes in viral load were -1.5 log10 and -2.0 log10 copies/ml in the 140 mg and 200 mg groups.
Contagion spoke to Christoph D. Spinner, MD, consultant physician, Infectious Diseases and adjunct teaching professor, Rechts der Isar University Hospital in Munich, Germany about the investigational therapy, the study, and the importance of maturation inhibitors.