Adolescents with HIV reported strong preference, viral suppression, and favorable safety outcomes after switching to long-acting injectable treatment.
Adolescents prefer to receive a less frequent, all-injectable treatment for Human Immunodeficiency Virus (HIV), according to recent studies published in The Lancet HIV.1
Study participants switched from oral daily HIV medications, which they had used for most of their lives, to the injectable intramuscular antiviral medications cabotegravir and rilpivirine. Alongside not experiencing any major safety concerns, these patients reported continued viral suppression and a great preference for the injectable vs oral treatment.1
“This is the first time in their lives these adolescents could formally stop taking daily oral medications for HIV treatment and just get 2 injections every 8 weeks,” said Aditya Gaur, MD, first study author and researcher at the St. Jude Department of Infectious Diseases. “After 1 year, this treatment approach appears safe and is tolerated by… adolescents.”1
While daily oral medications have been the standard for HIV treatment, this method has been linked to difficulty with medication adherence in many patients. Adolescents especially struggle with consistently taking medication, highlighting the importance of a long-lasting injectable option.1
The safety and efficacy of this method were evaluated across 2 studies. This included the IMPAACT 2017 study, also known as the MOCHA study, which is the largest and longest multinational research about this regimen to date.1
Adolescents from Botswana, South Africa, Thailand, Uganda, and the United States received injectable HIV treatment across a 48-week period. Additional eligibility criteria included weighing at least 35 kg and being virologically suppressed.2
Patients first underwent 4 weeks of taking 30 mg cabotegravir and 25 mg rilpivirine once per day. This was followed by long-acting intramuscular injections of 600 mg cabotegravir and 900 mg rilpivirine at weeks 4 and 8, then every 8 weeks.Secondary outcomes included grade 3 or worse adverse event, virological failure, and pharmacokinetic measures.2
There were 144 participants aged a median 15 years included in the final analysis, 51% of whom were female and 49% male. The median weight among these patients was 48.5 kg and the median body mass index was 19.5 kg/m2. Vertical HIV acquisition was reported in 92%.2
An injection-site reaction was reported in 34% of patients with at least 1 injection, most of which were grade 1 and resolved within 1 week. Drug-related adverse events were reported in 38%, though only 2 patients reported grade 3 or worse adverse events. Common adverse reactions included:2
A grade 4 adverse event was reported in 1 patient after week 48, which was resolved but led to discontinuation of the study drug. Virological failure did not occur in any patients receiving injections through week 48.2
Investigators also highlighted median week 48 predose cabotegravir and rilpivirine of 2.77 μg/mL and 67.9 ng/mL, respectively, which are close to measurements reported in adults. Overall, the data indicated safety, pharmacokinetics, and virological suppression. Investigators concluded this data can inform real-world use and ongoing regulatory submissions.2
“We observed no unexpected safety signals from the first-ever all-injectable combination retroviral regimen in this adolescent population,” said Gaur.1 “We saw the expected concentrations of each drug known to be effective in adults and continued virological control.”
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