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.
READ: Monthly injections to save patients from oral ARVs
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