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HIV antiretroviral injection equally safe as oral drug

Injections could reduce daily burden of oral HIV treatment

Adrian O'Dowd

Monday, 24 July 2017

People with HIV could be treated just as effectively by receiving a monthly or bi-monthly antiretroviral (ART) injection as taking daily oral medication, suggests a study* published today in The Lancet.

An international team of researchers found that long-acting antiretroviral injection of two drugs was safe and as effective as daily oral medication for HIV.

Their trial was presented today at the International AIDS Society meeting being held in Paris, France.

An estimated 36.7 million people worldwide are living with HIV, and advances in ART have led to improved survival and quality of life for people with HIV.

However, current treatment requires a person taking a daily dose of medication for the rest of their lives and poor compliance can result in treatment failure or the emergence of drug-resistant mutations.

Given that long-acting injectable drugs potentially offer a more convenient way of managing the disease, the researchers studied 286 participants who were randomly assigned to receive injectable cabotegravir plus rilpivirine at four-week intervals (115 patients), at eight-week intervals (115 patients) or continue on the daily oral dose of cabotegravir and abacavir-lamivudine (56 patients).

Eight months after randomisation, viral suppression was maintained in 91% (51/56) of patients in the oral medication group, 94% (108/115) in the four-week group, and 95% (109/115) in the eight-week group.

At 96 weeks, viral suppression was maintained in 84% (47/56) of patients in the oral medication group, 87% (100/115) in the four-week group, and 94% (108/115) in the eight-week group.

Pain at the site of the injection was the most commonly reported adverse event, but most reactions were mild or moderate and lasted an average of three days. Other adverse events reported included nasopharyngitis, diarrhoea, and headache, and rates were similar in all three groups.

The trial was done at 50 sites in the USA, Germany, Canada, Spain, France and Germany and most (91%) of the participants were male. Participants were only eligible for the trial if they had a CD4+ cell count of at least 200 cells per mm3, which does not necessarily represent the global population living with HIV.

One of the authors, Dr David Margolis of ViiV Healthcare, USA, 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.

“The introduction of single tablet medication represented a leap forward in ART dosing, and long-acting antiretroviral injections may represent the next revolution in HIV therapy by providing an option that circumvents the burden of daily dosing. 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.”

Professor Joe Eron, University of North Carolina, USA, another author of the study, said: “The results show that a long-acting injectable antiretroviral regimen has the potential to be both highly effective and well tolerated over a long period of time.”

* Margolis D, 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. DOI: 10.1016/S0140-6736(17)31917-7

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