ViiV's injection still suppresses HIV when taken every two months - study

GSK’s ViiV Healthcare joint venture has announced data backing an injection taken that can suppress the HIV virus even if it is taken only six times a year, instead of every month.

ViiV said the phase 3 ATLAS-2M study of the long-acting, injectable two-drug regimen of cabotegravir and Janssen’s rilpivirine taken every two months was comparable in performance with an injection containing the same ingredients taken monthly.

The FDA began its review of the monthly injection option at the end of April, based on two large studies comparing the injection with daily oral drug combinations, and is due to make a regulatory decision by the end of December.

The company is a joint venture majority owned by GlaxoSmithKline, with Pfizer and Shionogi as shareholders, and is attempting to develop HIV drugs that are more convenient than approved drugs, as well as more effective and easier to tolerate.

Reducing the number of injections would be welcomed by patients who rely on cocktails of drugs to suppress HIV and prevent them from developing AIDS.

Last month ViiV’s Dovato was approved in the EU, giving patients the option of a single daily pill containing only two active ingredients, with the aim of providing a convenient treatment with fewer side-effects than rivals based on a three-drug cocktail.

The ATLAS-2M trial was designed to demonstrate the non-inferior antiviral activity and safety of long-acting cabotegravir and rilpivirine administered every eight weeks (two months) compared to every four weeks (monthly) over a 48-week treatment period in adults living with HIV-1 infection whose viral load is suppressed and who are not resistant to cabotegravir or rilpivirine.

The study met its primary endpoint, showing that the long-acting regimen of cabotegravir and rilpivirine, injected every two months, was non-inferior to cabotegravir and rilpivirine administered every month at Week 48.

Non-inferiority was assessed by comparison of the proportions of participants with plasma HIV-RNA of at least 50 copies per millilitre using the FDA Snapshot algorithm at Week 48 in an Intent-to-Treat Exposed [ITTE] population.

Overall safety, virologic response and drug resistance results for the every-two-months injectable regimen were consistent with results from the phase 3 ATLAS study, one of the trials assessing the monthly injection. Further details will be announced at a forthcoming medical conference, the company said.