New injectable antiretroviral treatment for HIV patients
Posted: 3 August 2017 | Dr Zara Kassam (European Pharmaceutical Review) | No comments yet
A phase II clinical trial has paved the way to the implantation of all-injectable antiretroviral therapies with a lower frequency of administration…
A phase II clinical trial has paved the way to the implantation of all-injectable antiretroviral therapies (ATR) with a lower frequency of administration, which would imply a significant improvement of the quality of life of HIV patients.
The study involved 286 patients with previously suppressed viral loads, the effectiveness of the combination of carbotegravir – a new inegrase inhibitor – and rilpivirine – a non nucleoside injected intramuscularly every 4 or 8 weeks was tested in comparison to standard maintenance therapy, which includes three orally-administered drugs, carbotegravir, abacavir and lamivudine.
“This is the first time that all-injectable ART has been used in a trial; In addition, it consists of only 2 drugs, something that is not new but that supports the paradigm shift of 3 to 2 drugs in some virologically suppressed patients,” said Dr Podzamczer principal investigator of the Bellvitge Biomedical Research Institute (IDIBELL) and Chief of the HIV and STD Unit of the Infectious Diseases Service of Bellvitge University hospital (HUB) has contributed. The injected drugs are nanoparticles, which allows them to have a longer half-life of several weeks.
After 96 weeks, researchers found that 87% of patients in the group treated every 4 weeks and 94% in the one treated every 8 weeks maintained viral load suppression.
“With HIV, we are at a point of chronification of the disease, in a few years, we have moved from giving 14 pills a day to one or two, but it is still a daily treatment that requires strict compliance. Therefore, spacing drug administration to once every month or every two months will potentially translate into improved adherence rates and improved quality of life for patients,” explains Dr Podzamczer.
At the same time, the levels of satisfaction of the participating patients were also evaluated, at the end of the trial, about 90% of patients in the groups treated intramuscularly were very satisfied with the idea of continuing with this type of treatment.
Currently, participating centres and research teams are already working on the development of a new Phase III clinical trial that corroborates the results in terms of efficacy, safety and tolerability for both injectable treatments, every 4 and every 8 weeks.
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Bellvitge Biomedical Research Institute, Infectious Diseases Service of Bellvitge University hospital
