A long-acting HIV treatment that could free people with the virus from having to take daily pills has shown its worth in two phase 3 trials.
The combination of GlaxoSmithKline subsidiary ViiV integrase inhibitor cabotegravir and Johnson & Johnson’s non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine, given once every four weeks, was as effective as a standard three-drug oral regime at suppressing levels of HIV, according to the studies, which involved more than 1,000 subjects.ealthcare’s
The two trials – ATLAS and FLAIR – will form the basis of regulatory filings for the regimen later this year, said GSK.
The results were presented today at the Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle, Washington, this week and showed that as well as being as effective as daily oral drugs, the injectable treatment was preferred by “nearly all” the subjects in the trials, according to ViiV’s chief scientific and medical officer John Pottage (below).
The long-acting antiretroviral therapy (ART) could mean that more patients adhere to the treatment regimen needed to suppress HIV, and avoid the risk of skipped doses that can help viral levels bounce back and potentially put people and their sexual partners at risk.
It could also make it easier for people with HIV who may not be able to attend clinics regularly to receive supplies of medicines and, hypothetically at least, reduce the risk of resistant strains developing by providing consistent antiretroviral activity over time.
“If approved, this two-drug regimen would give people living with HIV one month between each dose of antiretroviral therapy, changing HIV treatment from 365 dosing days per year, to just 12,” said Pottage.
ATLAS involved patents who had previously been treated with ART, and showed that cabotegravir plus rilpivirine matched standard therapy on viral suppression rates. In three patients on the injectable (1%) there was a failure to suppress HIV, with four cases on oral therapy. Two of the failures in cabotegravir/rilpivirine involved patients who had prior resistance to NNRTI drugs.
FLAIR recruited newly-diagnosed patients and along with data showing non-inferiority to oral treatment revealed a similar 1% rate of treatment failure, caused by the emergence of resistant strains.
It’s worth noting that all the failure cases across both studies were from Russia and had HIV-1 A subtypes that are encountered in Russia, Eastern Europe and East Africa but are uncommon elsewhere, and that pattern will be investigated.
ViiV and J&J are also conducting the ATLAS-2M study, which will see if the combination can be given every other month without affecting antiretroviral efficacy and is due to read out later this year.
The new studies represent an uptick in the HIV treatment arms race between ViiV and rival Gilead Sciences, which between them dominate the market although the latter has the biggest share.
Both companies make billions of dollars each year selling daily oral medicines for HIV, so a monthly injectable could have a big impact on the dynamic of the category.
ViiV has been pushing a raft of two-drug oral therapies through the pipeline taken as a single tablet once daily to win market share from Gilead, which was the first company to bring a single-tablet triple therapy to market.
Having an injectable alternative could help ViiV’s ambition of becoming the largest HIV company by sales in the next few years.
The overall value of the HIV market is not expected to change dramatically in the coming years, according to GlobalData, although there will be a shift towards greater use of simpler, single-tablet regimens and the big-selling products will change.