Studies show that less frequent, all-injectable treatment for HIV is safe and preferred by adolescents
A multinational clinical trial co-led by investigators at St. Jude Children’s Research Hospital and the Centre for Infectious Disease Research in Zambia found the long-term HIV treatment regimen is safe and favored by adolescents.
St. Jude Children's Research Hospital
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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.
view moreCredit: Courtesy of St. Jude Children's Research Hospital
(MEMPHIS, Tenn. – January 15, 2026) 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 National Institutes of Health (NIH)-funded 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 Centre 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 was already 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.
Finding out 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.”
For more information about the study, please see ClinicalTrials.gov using the identifier NCT03497676.
Authors and funding
The authors of the injectable-only safety study are Kristin Baltrusaitis, St. Jude; Edmund Capparelli and Brookie Best, University of California San Diego; John Moye, Eunice Kennedy Shriver National Institute of Child Health and Human Development; Dwight Yin and Ellen Townley, National Institute of Allergy and Infectious Diseases; Gaerolwe Masheto, Botswana Harvard Health Partnership; Sarah Buisson and Rachel Scheckter, FHI 360; Conn Harrington, ViiV Healthcare; Mark Marzinke, Johns Hopkins University School of Medicine; Elizabeth Lowenthal, Children’s Hospital of Philadelphia; Andi Ace and Kyle Whitson, Frontier Science Foundation; Shawn Ward and Ryan Milligan, Frontier Science Foundation; Jenny Huang, Amy Cheung and Gilly Roberts, GlaxoSmithKline; Thomas Kakuda and Eileen Birmingham, Johnson & Johnson; Sisinyana Mathiba, University of Witwatersrand; Linda Aurpibul, Chiang Mai University; Violet Korutaro, Baylor College of Medicine Children’s Foundation Uganda; Christiana Smith, University of Colorado School of Medicine; Faeezah Patel, University of Witwatersrand; Evette Moodley, CAPRISA; and Carolyn Bolton Moore, Centre for Infectious Disease Research in Zambia.
The study was supported by funding from ViiV Healthcare and Johnson & Johnson.
The other authors of the preference study include first and corresponding author Elizabeth Lowenthal, Children’s Hospital of Philadelphia. The study’s other co-senior author is Carolyn Bolton-Moore, Centre for Infectious Disease Research in Zambia/University of Alabama Birmingham. Additional authors include Jennifer Chapman, Chermiqua Tsosie and Martina Vaca, The Children’s Hospital of Philadelphia; Kaleb Branch, University of Pennsylvania Perelman School of Medicine; Kristin Baltrusaitis and Grace Kovic, Harvard T.H. Chan School of Public Health; Sanjna Merchant, University of Pennsylvania College of Arts and Sciences; Barbara Heckman and Andi Ace, Frontier Science Foundation; Rodica Van Solingen-Ristea, Johnson & Johnson; Conn Harrington and Irina Kolobova, Viiv Healthcare; Dwight Yin and Ellen Townley, National Institute of Allergy and Infectious Diseases; Michael Whitton and Sarah Buisson, FHI 360 IMPAACT Operations Center; Allison Agwu, Johns Hopkins University School of Medicine; Christiana Smith, University of Colorado School of Medicine; Mary Paul, Baylor College of Medicine; Avy Violari, University of Witwatersrand; Evette Moodley, Centre for the AIDS Programme of Research in South Africa; Maxensia Owor, MU-JHU Care Limited; Kulkanya Chokephaibulkit, Mahidol University; Samantha Fry, FAMCRU; Jennifer Jao, Northwestern University Feinberg School of Medicine and Charles Mitchell, University of Miami Miller School of Medicine.
The study was supported by grants from the National Institutes of Health (UM1AI068632, UM1AI068616, UM1AI106716 and HHSN275201800001I) and ViiV Healthcare Inc.
Viiv Healthcare
Viiv Healthcare is a global specialist HIV company dedicated to delivering advances in treatment and care for people living with HIV and for people who could benefit from HIV prevention. For more information, visit viivhealthcare.com.
St. Jude Children's Research Hospital
St. Jude Children’s Research Hospital is leading the way the world understands, treats, and cures childhood catastrophic diseases. From cancer to life-threatening blood disorders, neurological conditions, and infectious diseases, St. Jude is dedicated to advancing cures and means of prevention through groundbreaking research and compassionate care. Through global collaborations and innovative science, St. Jude is working to ensure that every child, everywhere, has the best chance at a healthy future. To learn more, visit stjude.org, read St. Jude Progress, a digital magazine, and follow St. Jude on social media at @stjuderesearch.
Journal
The Lancet
Method of Research
Experimental study
Subject of Research
People
Article Title
Acceptability and tolerability of long-acting injectable cabotegravir–rilpivirine in adolescents with HIV-1 (IMPAACT 2017/MOCHA): 48-week results of a multicentre, open-label, non-comparative phase 1/2 trial Safety, antiviral activity, and pharmacokinetics of long-acting injectable cabotegravir–rilpivirine in virologically suppressed adolescents living with HIV-1 (IMPAACT 2017/MOCHA): 48-week results of a multinational, phase 1/2, single-arm study
Article Publication Date
15-Jan-2026
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