Injectable HIV Treatment Shows High Acceptance Among Adolescents in Global Clinical Trial
核心洞察
Adolescents with HIV (搜索) who switched from daily oral medications to injectable cabotegravir and rilpivirine every eight weeks showed no major safety concerns and maintained viral suppression after 48 weeks.
The IMPAACT 2017/MOCHA study enrolled 144 participants across five countries and represents the largest multinational experience with all-injectable HIV (搜索) treatment in adolescents.
All participants (100%) reported preferring the injectable regimen over daily oral medications, with 140 of 144 continuing treatment through the 48-week study period.
Adolescents with HIV (搜索) across five countries demonstrated strong preference and maintained viral suppression when switched from daily oral medications to an injectable treatment regimen administered every eight weeks, according to new findings from the largest multinational study of its kind published in The Lancet HIV.
The IMPAACT 2017/MOCHA study, co-led by investigators at St. Jude Children's Research Hospital and the Centre for Infectious Disease Research in Zambia (搜索), followed 144 adolescents in Botswana, South Africa, Thailand, Uganda, and the United States who received injectable cabotegravir and rilpivirine for nearly a year after switching from lifelong daily oral HIV (搜索) medications.
Safety and Efficacy Results
After 48 weeks of treatment, researchers observed no unexpected safety signals from the all-injectable combination antiretroviral regimen. "We saw the expected concentrations of each drug known to be effective in adults and continued virological control," said Dr. Aditya Gaur, first and corresponding author on one study and co-senior author on the other from St. Jude's Department of Infectious Diseases.
The study represents the longest and largest described multinational experience to date of this first all-injectable HIV (搜索) treatment regimen in a diverse group of virologically-suppressed adolescents. All participants maintained viral suppression throughout the treatment period with no major safety concerns identified.
Patient Preference and Adherence
The treatment's acceptability proved remarkably high among study participants. At 48 weeks, 100% of participants reported they would rather receive the injectable regimen than oral medications. Of the 144 participants originally enrolled, 140 continued treatment through the reported 48-week period, indicating strong patient acceptance.
"This is the first time in their lives these adolescents could formally stop taking daily oral medications for HIV (搜索) treatment and just get two injections every eight weeks," Gaur explained. The treatment approach addresses a significant challenge in HIV care, as maintaining consistent medication adherence can be particularly difficult for adolescents with chronic diseases.
Regulatory Status and Clinical Impact
The cabotegravir and rilpivirine injectable regimen has already received approval from the US Food and Drug Administration and other regulatory agencies worldwide for adolescents with HIV (搜索) who are 12 years or older and weigh 35 kilograms or more, based on prior clinical findings from the IMPAACT 2017/MOCHA study.
Elizabeth Lowenthal from Children's Hospital of Philadelphia, who led the patient preference assessment, emphasized the significance of these findings in the context of long-acting HIV (搜索) medications. The research was supported by funding from the National Institutes of Health, ViiV Healthcare, and Johnson & Johnson.
Study Design and Global Collaboration
The IMPAACT 2017/MOCHA study assessed the safety, antiviral activity, and pharmacokinetics of the intramuscular injectable treatment given once every two months. The research represents a collaborative effort between the NIH-funded International Maternal Pediatric Adolescent AIDS Clinical Trials Network and pharmaceutical partners.
"It is very exciting to enter an era of long-acting medications for HIV (搜索)," Gaur noted. "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."
