GSK monthly HIV treatment meets targets
Two late-stage clinical trials by GlaxoSmithKline's ViiV Healthcare joint venture of its novel, investigational, long-acting HIV treatment have both met their primary aims.
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Data produced from 48 weeks of the Flair and Atlas phase III studies showed that the combination of ViiV's cabotegravir and Janssen's rilpivirine, injected every four weeks, was found to be non-inferior in maintaining viral suppression in adults infected with HIV type-1 compared to the current standard of a daily oral three-drug regimen.
ViiV plans to submit applications to regulatory authorities later this year, said ViiV chief scientific and medical officer, John C. Pottage Jr.
The trials have shown that the monthly injectable regimen has similar efficacy, safety and tolerability to the daily three-drug regime, Pottage said.
"We are also encouraged by patient preference data showing that nearly all participants who switched to the long-acting injectable regimen preferred it over their prior oral therapy.
Chloe Orkin, consultant physician and clinical professor at Queen Mary University of London and Flair principal investigator, said: "The robust results of the FLAIR study lend further evidence to the potential of cabotegravir and rilpivirine as an alternative option for people currently on daily, oral therapy.
"This long-acting, injectable two-drug regimen may provide an opportunity to change the paradigm for people living with HIV by breaking the cycle of a daily pill, which has been a defining characteristic of HIV therapy for several decades."
There were 13 serious adverse events and 10 adverse event withdrawals out of 308 Atlas participants, mostly mild or moderate.
Three participants in both trials, or around 1% of the study population, who received the combined treatment plus developed confirmed virologic failure later shown to be a resistance mutations to one or both agents. Two of the three cases were identified with re-existing resistance and two of the three individuals were from Russia and all three had HIV-1 A subtypes, which are seen frequently in Russia, Eastern Europe and East Africa, though are seen infrequently in other parts of the world.
"This unexpected pattern warrants further investigation," ViiV said.
The development of resistance, said Shore Capital’s Adam Barker, "is an interesting finding and warrants further investigation given the consistency across the Flair and Atlas trials. If ultimately found to be a recurring theme this could limit the use of the injectable two-drug regimen in this smaller patient population, in our view. In addition, we would also note that in the Flair trial, whereas all examples of CVF in the injectable arm resulted from treatment-emergent resistance, none of the CVF in patients using Triumeq developed in response to the drug."
Overall, he felt long-acting injectable therapies are most likely to be adopted by a smaller number of HIV patients, but as clearly offering convenience and adherence benefits. But guessed that the development of treatment-emergent resistance in the injectable arm "will not be viewed as favourable".
Liberum said the news "should help to boost GSK’s overall HIV franchise by bringing a once monthly therapy for some patients however forecasts for cabotegravir remain modest with consensus expecting just £362m by 2023".