Injectable antiretroviral therapy may be as effective as standard oral treatment in patients with HIV, according to the results of a Phase II clinical trial.
The 286-patient study, published in The Lancet, compared a nanoparticle therapy that was injected intramuscularly every four or eight weeks with standard maintenance therapy.
“This is the first time that all-injectable ART has been used in a trial,” principal investigator Dr. Daniel Podzamczer said in prepared remarks. “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.”
Researchers from the Bellvitge Biomedical Research Institute reported that after 96 weeks, 87% of patients treated every four weeks and 94% of those treated every eight weeks maintained viral load suppression. In the standard oral treatment group, 84% of patients 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,” Podzamczer said.
The team said that they are working to launch a Phase III trial to evaluate the safety, efficacy and tolerability for the injectable treatments every four and eight weeks.