ViiV Healthcare, an HIV-focused company that is majority-owned by GSK, alongside shareholders Pfizer and Shionogi, revealed that its Phase III clinical trial investigating a combination treatment of cabotegravir and rilpivirine met its primary endpoint of non-inferiority.
The injection delivered every eight weeks demonstrated similar efficacy in suppressing the HIV virus in patients when compared with a dosing regimen every four weeks.
“The ATLAS-2M study results mean that people living with HIV could maintain viral suppression with six total treatments per year, instead of a daily oral treatment 365 times per year,” said Kimberly Smith, head of global R&D at ViiV Healthcare.
Currently, oral tablets are the standard treatment for patients with HIV – ViiV received approval for its own two-drug daily tablet in April.
The approval of ViiV’s daily pill reduced the number of active drugs contained within the HIV treatment from the standard of care, which uses three drugs, to two. However, an injection also containing two drugs but with a dosing interval of two months would represent “a significant change in the HIV treatment paradigm,” Smith suggested.
In Phase III trials results previously published for the monthly dosing schedule, the injection displayed virologic suppression rates similar to that of standard care, at 92.5% for the injection against the standard of care at 95%. In addition, patient satisfaction was higher with the long-acting treatment, with 86.4% preferring the injection.
The long-acting injection is being co-developed in collaboration with Janssen, which owns the proprietary rights to rilpivirine. ViiV has already submitted for regulatory approval in the US, Canada, and Europe, based on results from its previous Phase Iii studies.
The company announced that it expects a decision from US Food and Drug Administration (FDA) by the end of the year.