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A long-acting injectable antiretroviral therapy may be just as effective as a daily oral dose in treating HIV, a trial has shown.
Delegates at the 2017 International AIDS Society meeting in Paris heard that long-acting injectable treatment with cabotegravir and rilpivirine has the potential to reduce the burden for HIV patients having to take lifelong daily treatment.
The trial of 309 people across five countries started with 20 weeks of daily oral doses of the drugs to pick out any adverse effects and ensure patients achieved viral suppression.
Then 286 patients who went on to the second stage of the trial either had the dual therapy injection every four weeks (115), every eight weeks (115) or continued on the daily dose (56).
Results, also published in The Lancet (online, 24 July 2017), showed that by 32 weeks viral suppression was maintained in 91% (51/56) of patients in the oral medication group, 94% (108/115) in the four-week injection group, and 95% (109/115) in the eight-week injection group[1]
After 96 weeks, viral suppression was maintained in 84% (47/56) of patients in the oral dose group, 87% (100/115) in the four-week injection group , and 94% (108/115) in the eight-week injection group , the researchers reported.
Further phase 3 trials of the treatment are already in progress and more evidence will be needed in wider groups of patients but the results from the LATTE-2 study on long-acting therapy could well be the ‘next revolution in HIV therapy’, researchers said.
Dr David Margolis, study leader and director of HIV drug development at ViiV Healthcare, North Carolina, US, said: “Adherence to medication remains an important challenge in HIV treatment.
“Long-acting injectable ART could provide some patients with a more convenient approach to manage HIV infection that avoids daily oral dosing, and the need to keep, store, and transport medications as they go about their daily lives.”
He added: “The results through to 96 weeks with this two-drug regimen are encouraging, and we now need further research, including the ongoing phase 3 trial, to confirm these findings.”
Most patients reported pain at the injection site but in most cases it was mild to moderate.
Two patients stopped participating due to injection intolerance, the researchers reported, with a total of 11 patients (4%) developing an adverse event and withdrawing during the initial stages of the study.
In a linked editorial (online, 24 July 2017), Australian experts Professor Mark Boyd, University of Adelaide, and Professor David Cooper, University of New South Wales, pointed out inevitably there will be “a trade-off between the convenience of not having to adhere to oral therapy and the inconvenience and discomfort associated with injectable long-acting ART”[2]
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They added that there would need to be changes to healthcare systems to be able to deliver “regular, recurrent injections in a timely and convenient way to people who are well”.
Michael Brady, medical director at the Terrence Higgins Trust, said the history of HIV therapy has been one of constant evolution.
References
[1] Margolis DA, Gonzalez-Garcia J, Stellbrink HJ et al. Long-acting intramuscular cabotegravir and rilpivirine in adults with HIV-1 infection (LATTE-2): 96-week results of a randomised, open-label, phase 2b, non-inferiority trial. Lancet doi: 10.1016/ S0140-6736(17)31917-7
[2] Boyd MA & Cooper DA. Long-acting injectable ART: next revolution in HIV? Lancet doi: 10.1016/S0140-6736(17)31962-1
