ViiV Healthcare Showcases CAB-ULA Phase I Trial: Extends HIV Treatment Interval to Four Months

A new formulation of an HIV drug, cabotegravir ultra long-acting (CAB-ULA), has demonstrated the potential for dosing intervals of at least four months, according to phase I study results from ViiV Healthcare, a company primarily owned by GSK with Pfizer and Shionogi as shareholders. The data, which were presented at the CROI 2024 conference in Denver, suggest that CAB-ULA could offer a significant advancement in HIV treatment and prevention by reducing the frequency of clinic visits.
The study involved 70 healthy adults and evaluated two different formulations of cabotegravir. The pharmacokinetic profile of CAB-ULA indicated a slower absorption rate and a projected half-life that was either six times or twice as long as the currently approved formulation, depending on the route of administration. This suggests that a single intramuscular dose of CAB-ULA could provide similar medication exposure to the approved dose, but with less frequent administration.
ViiV Healthcare plans to conduct a registrational study in 2024 to assess CAB-ULA's efficacy in preventing HIV in adults. The company is also considering the potential for combining CAB-ULA with other medications to create a complete, ultra long-acting HIV treatment regimen.
Dr. Kimberly Smith, Head of Research & Development at ViiV Healthcare, highlighted the community's need for less burdensome, longer-acting HIV treatments. ViiV Healthcare has a history of innovation in long-acting HIV therapies, and the new CAB-ULA formulation represents a step towards achieving a four-month dosing schedule for both treatment and pre-exposure prophylaxis (PrEP).
The study also explored the use of recombinant human hyaluronidase PH20 (rHuPH20) to facilitate subcutaneous injection of another formulation, CAB200. However, this approach did not show a significant advantage in terms of dosing frequency and was associated with more injection site reactions, leading ViiV Healthcare to discontinue its pursuit of this method for ultra long-acting dosing.
ViiV Healthcare, established in 2009, is dedicated to improving HIV treatment and care, with a commitment to developing innovative and effective HIV medicines. The company's mission is to take a comprehensive approach to HIV/AIDS, surpassing the efforts of any previous company in the field.

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