ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, announced week 96 and end‑of‑study results from the phase I/II IMPAACT 2017 (MOCHA) study, the first trial to evaluate a complete injectable long‑acting treatment regimen in adolescents living with HIV.
Results showed 94.4% of virologically suppressed adolescents aged 12 to <18 years who switched from daily oral HIV treatment to long-acting cabotegravir + rilpivirine (CAB + RPV LA) every two months maintained viral suppression at week 96, with >97% indicating a preference for injections over daily oral therapy at all weeks.
The data were presented today at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI 2026) in Denver, Colorado.
Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare, said
IMPAACT 2017 is a landmark trial and the first to show that the only complete injectable long-acting regimen, cabotegravir + rilpivirine, can maintain virologic suppression in adolescents for nearly two years, with a clear preference for injections over daily pills. For adolescents – one of the most vulnerable and underserved populations in the HIV epidemic – long-acting cabotegravir + rilpivirine offers an important alternative to the daily pill burden and stigma that can come with it. IMPAACT 2017 is a powerful example of ViiV’s commitment to developing innovative treatment options that address individual needs for everyone living with HIV.
Aditya Gaur, M.D., St. Jude Children’s Research Hospital and co-lead investigator of IMPAACT 2017 (MOCHA) said
Adolescents living with HIV often face unique developmental, social and adherence challenges, so the dosing flexibility and freedom offered by long-acting injectables is especially important. In IMPAACT 2017, every adolescent who expressed a preference after almost two years of treatment chose the injectable regimen over daily pills. For many, it was the first time in their lives they did not have to take an oral HIV medicine every day, and moving to a brief clinic visit every 2 months can help reduce daily reminders of HIV.
The International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network 2017 / MOCHA is a phase I/II study evaluating a complete injectable regimen of CAB + RPV LA in 144 virologically suppressed adolescents aged 12 to <18 years and ≥35 kg who switched from daily oral ART.
Week 96 and end‑of‑study results showed that CAB + RPV LA given every two months maintained viral suppression (94.4% n=136/144) with no confirmed virologic failures. At all weeks evaluated, >97% (n=138/142; week 8) of participants preferred long-acting injections over daily oral antiretroviral therapy. At week 96, 95% (n=137/144) completed treatment, and preference for injections was 100% (n=135/135).
The long-acting regimen was generally well tolerated, with 42% (n=60/144) experiencing a drug-related adverse event (AE), the most common of which were cough (31.9% n=46), headache (26.4% n=38) and upper respiratory tract infections (20.1% n=29). Of 142 participants with at least one injection, 37% (n=52/142) reported injection site reactions, which were mostly mild to moderate injection site pain that typically resolved within one week. Two drug-related grade 3 AEs and one grade 4 reaction were observed, and all resolved.
These findings show that a complete injectable long‑acting regimen can provide sustained viral suppression and is generally well tolerated for adolescents living with HIV.
IMPAACT 2036 extends CAB + RPV LA to younger children, including those under 20 kg
Interim data from IMPAACT 2036, an ongoing phase I/II study in virologically suppressed children aged 2 to <12 years and weighing 10 to <40 kg, provide the first pharmacokinetic and safety evidence for CAB + RPV LA in young children, including those weighing less than 20 kg, informing the potential of extending long‑acting injectable treatment to earlier paediatric age and lower weight groups.
Results showed that CAB + RPV LA achieved protocol‑defined pharmacokinetic targets, with plasma concentrations similar to those observed in adolescents and adults receiving long‑acting therapy. No new or unexpected safety signals were seen; grade ≥3 adverse events occurred in 10% (n=6/61) of children, including two drug-related grade 2 and one grade 3 post-injection reaction; all events resolved. Injection site pain was the most common adverse event, reported in 46% (n=28/61) of children, and was limited to grade 1-2.
IMPAACT 2017 (MOCHA; More Options for Children and Adolescents) and IMPAACT 2036 (CRAYON; Cabotegravir and Rilpivirine Long-Acting Injections in Young Children) are supported collaborative studies, sponsored by the Division of AIDS (DAIDS) within the National Institutes of Health (NIH) and conducted by the IMPAACT Network. Both trials are funded with support from ViiV Healthcare and Johnson & Johnson.
For more information, read the original press release.
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