Revolutionary new HIV treatment that only needs to be taken monthly has just been approved by the European Union
The European Union has approved a groundbreaking treatment for HIV – the first complete, long-lasting and once or bi-monthly injectable – in what activists have hailed as a “game-changer”.
American drug-maker ViiV Healthcare, which specialises in HIV, announced Monday (21 December) that the European Commission gas had rubber-stumped the revolutionary, long-acting regimen, after it was first submitted to the bloc’s medicine authority last year.
The treatment consists of two drugs known as cabotegravir and rilpivirine, the latter developed by Janssen Pharmaceutical Companies, that are injected once a month, or once every other month, by a healthcare provider into the buttocks.
This reduces the number times a person living with HIV receives treatment from 365, on a daily pill, to six or 12, and was found to be as effective as current daily antiviral therapy in the clinical trials in maintaining viral suppression.
The authorisation is a stunning result given that trials were initially meant to be conducted well into 2022 – they was stopped earlier this year after the drugs proved so successful.
After it was authorised by the commission, the executive arm of the EU, all 27 member states will now be able to access the regimen.
Medical experts welcomed the authorisation of the “innovative” treatment, stressing that the antiretroviral injectable presents an alternative option to those unable or unwilling to take a daily pill.
“We saw from the patient-reported outcomes in our pivotal clinical trials that approximately nine out of 10 people who switched to the long-acting regimen preferred this over their previous daily oral tablets,” said ViiV Healthcare CEO Deborah Waterhouse.
“It will potentially change the treatment experience for some people living with HIV by removing the need for daily HIV tablets.”
Matthew Hodson, executive director of NAM Aidsmap, praised it as a “significant step forward in the way we treat HIV” and said it may lead to “even more of a game-changer for HIV prevention in the future”.
“Many people living with HIV are enthusiastic about long-acting injectables, which bypass many of the challenges of taking pills on a daily basis,” he told PinkNews.
“In the UK, adherence to treatment is generally high, with 97 per cent of all those on HIV treatment achieving viral suppression to undetectable levels, which also means we can not pass the virus on during sex.”
New injectable HIV treatment will help those who struggle with daily pills.
HIV works by inserting itself into the human genome and tricking the cell into making copies. But cabotegravir prevents viral DNA from sticking itself into the machine of immune cells, known as T-cells, stopping HIV from duplicating itself.
The doses’ marketing authorisation was based on the pivotal phase III ATLAS (Antiretroviral Therapy as Long-Acting Suppression), FLAIR (First Long-Acting Injectable Regimen) and ATLAS-2M studies, which roped more than 1,200 participants from 16 countries.
Moreover, many drug-makers tend to test primarily on older, cis white gay men, but ViiV Healthcare enrolled a diverse range of participants for its clinical trials, which included trans women.
Around 55 per cent of those involved in the research said they would prefer not taking a HIV treatment every day, while 58 per cent said that a daily dose served as a constant reminder of how they live with HIV.
Hodson amplified this, saying: “A monthly or bi-monthly injection may provide the necessary support to those who struggle to take daily medication, or who find the daily ritual of pill taking a bitter reminder of their virus.
“Injections may be more discreet for those who are unable to be open about their HIV status with those they live with and will make it easier for people with HIV to travel, without having to pack medications and risk being questioned about these.
“We have been able to treat HIV effectively for 24 years,” Hodson added, “and it’s great to see that we are still improving and refining the medications that are available.
“Having choices about the medications you take, and how you take them, mean that more people are able to benefit.
“Long-acting injectables have the potential to simplify PrEP and so help protect people without HIV too.”