A revolution in HIV/Aids treatment could see the daily oral pills replaced with injectable drug given six times a year, scientists have revealed.
The first two long acting injectable formulation of HIV medicines could offer a highly effective therapy if approved.
The injection, which is supposed to slowly and continuously release HIV medication into the blood of the patients, is in the Phase 11 trial.
The formulation contains cabotegravir and rilpivirine as a two-drug treatment for patients with HIV-1 infection who had already achieved viral suppression.
The two are supposed to advance HIV treatment by reducing pill burden and providing convenience for people living with HIV.
Taking oral pills every day is a burden with most people struggling to swallow the drugs every day, leading to defaults and resistance to the HIV drugs.
The results were presented on Tuesday at the International Aids Society Conference on HIV Science in Paris, France.
“As research into new medicines for HIV progresses, adherence to therapy continues to be essential to achieving viral suppression and reducing the emergence of resistance mutations,” David Margolis, one of the researchers from ViiV Healthcare, said.
The study titled LATTE-2 sought to evaluate injectable cabotegravir and rilpivirine dosed once after every four or eight weeks compared with daily oral dosing with three oral antiretroviral drug at maintaining HIV – 1 patients.
The international multicentre, open label study enrolled 309 HIV infected adults who had received prior anti-retroviral treatment.
The patients had their viral loads suppressed during a 20 week induction period with daily oral cabotegravir (30mg) plus other two drugs and subsequently selected at random into one of the three study arms in the maintenance period.
Others were given the formulation of cabotegravir (400mg) together with rilpivirine (600mg) every four weeks, others were also placed on Cabotegravir (600mg) + rilpivirine long acting formulation (900mg) every eight weeks.
The trial was conducted at 50 centres in the US, Canada, Germany, France and Spain.
“The primary end point evaluated antiviral activity and safety through 32 weeks of maintenance treatment and the study will continue up to 104 weeks of treatment,” said Dr Margolis
There was 94 per cent viral suppression on patients who were placed on two drug regime dosed every eight weeks. The four weeks reported 87 per cent as compared to 84 per cent in patients who were on oral regime.
“Neither of the patients had evidence of resistance at failure, injection site pain was the most commonly reported injection site reaction. Side effects - including diarrhoea and headache - were similar in all groups,” he said.
“ This study results was important since we now have data showing the durability and tolerability of long acting viral suppression for a two drug regime out of 96 weeks,” said Dr Jhn Pottage, chief scientist at ViiV health care and co-author of the study.
The drugs (cabotegravir and rilpivirine) are packed into tiny nanoparticles, which can be injected into muscle. This gives long-lasting protection as the nanoparticles break down and release their medicinal contents into the body.