HMN 2026: How less frequent, all-injectable treatment for HIV is safe and preferred by adolescents

Adolescents with Human Immunodeficiency Virus (HIV) in Botswana, South Africa, Thailand, Uganda and the United States who received the injectable intramuscular antiviral medications cabotegravir and rilpivirine for nearly a year after being switched from daily oral HIV medications, which they had been on most of their life, experienced no major safety concerns, had continued viral suppression and greatly preferred the new treatment method.

The findings, published recently in two companion papers in The Lancet HIV, are the latest results from the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network clinical trial, which is co-led by investigators at St. Jude Children’s Research Hospital in the United States and the Center for Infectious Disease Research in Zambia.

“This is the first time in their lives these adolescents could formally stop taking daily oral medications for HIV treatment and just get two injections every eight weeks,” said first and corresponding author on one study and co-senior author on the other, Aditya Gaur, MD, St. Jude Department of Infectious Diseases, who co-leads the IMPAACT 2017 study, also referred to as the More Options for Children and Adolescents (MOCHA) study. “After one year, this treatment approach appears safe and is tolerated by and acceptable to adolescents.”

All-injectable treatment regimen is safe

Adolescents with HIV currently take daily oral medications to keep the virus in check. However, taking daily medications for any chronic disease is not easy and many struggle with medication adherence. Maintaining consistent medication adherence can be challenging, especially for adolescents, underscoring the need for long-lasting injectables.

The published companion papers describing the IMPAACT 2017/MOCHA study constitute the longest and largest described multinational experience to date of this first all-injectable HIV treatment regimen in a diverse group of virologically-suppressed adolescents. Results show that after 48 weeks, there were no safety concerns, and viral loads remained suppressed.

“We observed no unexpected safety signals from the first-ever all-injectable combination retroviral regimen in this adolescent population,” Gaur said. “We saw the expected concentrations of each drug known to be effective in adults and continued virological control.”

When long-acting injectable antiviral medications emerged as an alternative to daily oral medications, it was a major milestone for prevention and treatment of HIV. This new report from the IMPAACT 2017/MOCHA study assessed the safety, antiviral activity and pharmacokinetics of the first all-injectable HIV treatment regimen of cabotegravir and rilpivirine given intramuscularly once every two months in adolescents with HIV from around the world.

This treatment regimen has already been approved for adolescents with HIV who are 12 years or older weighing 35 kilograms or more by the US Food and Drug Administration and a growing number of other regulatory agencies from around the world based on prior clinical findings from the IMPAACT 2017/MOCHA study, which the companion papers further support.

Determining what type of treatment adolescents want

Learning that the all-injectable antiviral HIV treatment regimen is safe for patients is important. However, the therapy will only be effective if patients are willing to take it. Therefore, led by Elizabeth Lowenthal based at Children’s Hospital of Philadelphia, the researchers assessed how well patients accepted and tolerated the injectable medications.

At 48 weeks, 100% of participants reported they would rather get the injectable regimen than the oral medications. In addition, of the 144 participants originally enrolled in the study, the majority (140) continued the treatment through the reported 48-week period, indicating a high level of acceptability.

“It is very exciting to enter an era of long-acting medications for HIV,” Gaur said. “Thanks to the contributions of the study participants, their families, site staff, study team and the collaboration between the NIH, ViiV Healthcare and Johnson & Johnson who made this study possible, we can now offer patients more options, such as these injectables, which provide freedom from daily medications and can be tailored based on patients’ preferences.”

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