Could ART injections for adolescents become available one day?

The first ever study to assess whether injectable antiretroviral treatment (ART) is safe, acceptable and effective for adolescents with HIV has reported its initial findings. 

What is the research about? 

Injectable ART for adolescents (ages 12-17). Research is being conducted by the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT) 2017, under the More Options for Children and Adolescents (MOCHA) study.  

This part of the study involved 55 adolescents with HIV from Botswana, South Africa, Thailand, Uganda and the USA. All were virally suppressed. Of these, 30 adolescents received cabotegravir injections and 25 received rilpivirine injections. Injections were given either once a month or once every two months, depending on when participants joined the study. Participants and their caregivers from the USA were interviewed as part of the research. 

In this phase, participants still took their daily ART pills. In a separate phase, which is ongoing, participating adolescents will get injections of combined cabotegravir and rilpivirine and will stop taking ART pills.  

Findings from this phase have been published in two research papers. The first assesses acceptability and tolerability. The second assesses safety and pharmacokinetics (the reactions between drugs).  

Why is this research important? 

Trials have found that injectable ART using cabotegravir and rilpivirine is safe and effective for adults with HIV. Some countries in the European Union, plus the USA, Canada and the UK have approved its use. But injectable ART has not been trialled among adolescents – until now. 

What did they find out? 

Most participants reported that pain from the injections, which go in the buttocks, were tolerable. At week four, 83% said the injection caused “no hurt” or only hurt “a little bit”. At week eight, 73% reported no or minimal pain. Only one participant (2%) rated the pain as high. 

Most adolescents reported having no injection-related symptoms or being only “a little” bothered by symptoms. Symptoms included bruising or redness from the injection, feeling discomfort from sitting or having trouble sleeping . Only a few adolescents reported being “moderately”, “very” or “extremely” bothered by injection-related symptoms. 

No safety concerns were found. Drug reactions and absorption rates were similar to those in adults.  

Most injections (98% at week 8 and 90% at week 12) fell within the allowed 7-day window of the agreed injection date. 

Most (90%) of participants remained virally suppressed during the study. Two participants (one in each group) became virally unsuppressed. But this was due to missing some ART pills. 

Most adolescents surveyed said that someday they hoped they would be able to take ART in a way that did not require daily pills. The most common reasons given was not having to remember to take pills every day and not having to worry about hiding pills. As one 12-year old girl put it: “Take the shot once a month, be over with it and you can actually live a normal life instead of taking pills in front of people every day or looking at yourself like you’re not a real human or something.” 

All interviewed adolescents said they would recommend ART injections to their peers. But a few adolescents said some of their peers might not want to get injections as it would mean having to increase their visits to clinics.  

The biggest concern adolescents gave about the injections was that they were in the buttocks. Many wanted an injection that could be given elsewhere on the body. The ability to keep to monthly or bi-monthly injection schedule was another concern. 

Caregivers were more hesitant than the adolescents about the injections. Trust in healthcare providers played a key role in caregivers’ decision to let their child have the injections. Caregivers’ acceptance of the injections rose after the injections began. 

What does this mean for HIV services? 

The high acceptability, tolerability and safety of ART injections reported in these studies suggests that ART injections are likely to become the favoured HIV treatment option for some adolescents in the future. 

The adolescents in this study had no problem taking their ART pills every day, yet they still wanted to swap to monthly or bi-monthly injections. This desire may be even stronger in adolescents who are struggling to take ART pills every day.