- Design
- Phase 1/2, multinational, single-arm trial
- Population
- 144 virologically suppressed adolescents aged 12–17 with HIV-1
- Primary outcome
- Safety, virological suppression and pharmacokinetics through 96 weeks
- Effect
- No confirmed virological failures; grade ≥3 drug-related adverse events 2%
The MOCHA trial enrolled 144 adolescents aged 12 to 17, weighing at least 35 kg and virologically suppressed, at 18 sites in Botswana, South Africa, Thailand, Uganda and the US. After a month of oral lead-in, they received intramuscular long-acting cabotegravir plus rilpivirine at weeks 4 and 8 and then every eight weeks.
There were no confirmed virological failures through 96 weeks. Grade 3 or higher adverse events occurred in 24%, but only 2% were judged drug-related. Drug levels were similar to those in adults. At least 97% of those on treatment preferred injections to daily tablets.
This was a single-arm phase 1/2 study, so it shows the regimen works and is acceptable in adolescents rather than that it beats oral treatment. Adolescence is when adherence to daily tablets most often fails, and an option that removes the daily pill could matter most here. The regimen requires a clinic visit every two months and is not widely available in India; its regulatory status here should be checked before discussing it.
- Tell suppressed adolescents who struggle with daily tablets that two-monthly injections are an option where approved.
- Expect injection-site reactions, which are common with this regimen.
- Plan for a clinic visit every eight weeks, since missed injections risk resistance.
- Discuss contraception and pregnancy plans, as three participants stopped treatment because of pregnancy.
Why it matters
It offers a way around the daily-pill adherence problem at the age it is most acute.
The statistics, in plain English
With no comparison group, the trial cannot say how injections compare with tablets. No confirmed failures among 144 adolescents over two years is reassuring, but rare failures could still occur in larger use.
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