ViiV Healthcare highlights new pipeline data for 2 investigational HIV treatment therapies

GSK has recently announced that ViiV Healthcare has released data from its phase 1 study of long-acting formulations of VH184, the first, third-generation integrase strand transfer inhibitor in development for HIV. Results show a single-dose injection could maintain drug levels for up to six months. In-vitro data from a separate study demonstrate improved potency and an enhanced resistance profile versus bictegravir in resistant HIV strains.

Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare, said: “Our R&D efforts are built around delivering best-in-class, long-acting therapies that challenge the status quo and help make HIV treatment a smaller, less frequent part of people’s lives. The data we’re presenting on VH184, our third-generation INSTI, indicate a potential high barrier to resistance and twice-yearly dosing intervals. Early results for VH499, a capsid inhibitor, point to its potential for dosing every six months. These data underscore how ViiV Healthcare is working to define the future of HIV care through ultra long-acting options designed to address the needs and preferences of people living with HIV and will inform our plans to introduce the first INSTI-based, twice-yearly regimen for people with HIV.”

VH184 shows potential for dosing intervals of up to twice-yearly and improved activity versus bictegravir. In the phase 1 study of long-acting formulations in adults without HIV, VH184 was given as a single subcutaneous or intramuscular injection in one of two formulations. Both formulations demonstrated long-acting properties, with one maintaining steady drug levels through Month 7, indicating the potential for twice-yearly dosing.

In addition, the VH184 formulations were generally well tolerated, with most side effects limited to mild grade 1 injection site reactions such as erythema, pain, and nodules, with fewer grade 2 and grade 3 ISRs. The safety profile is consistent with previous studies and is similar to that of approved INSTIs.

Note that, in an in vitro study also presented at CROI, VH184 demonstrated an improved virology profile, specifically an enhanced resistance profile compared with bictegravir, when evaluated against HIV with mutations linked to resistance to second‑generation INSTIs. VH184 retained activity against a broad range of resistant virus strains, including those with multiple INSTI‑associated substitutions, indicating a potential higher barrier to resistance.

 

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Related Topics and Keywords

GSK, HIV, ViiV Healthcare