Injectable HIV treatment in adolescents: no confirmed virological failure through 96 weeks

Design

Phase 1/2 single-arm non-comparative trial, 18 sites in five countries

Population

144 virologically suppressed adolescents aged 12 to 17, at least 35 kg

Primary outcome

Safety, antiviral activity, pharmacokinetics and acceptability to week 96

Effect

No confirmed virological failure; grade 3 or higher drug-related adverse events 2% (95% CI 0.4 to 6.0)

IMPAACT 2017/MOCHA was a phase 1/2, single-arm, non-comparative trial across 18 sites in Botswana, South Africa, Thailand, Uganda and the United States. It enrolled 144 virologically suppressed adolescents aged 12 to 17 weighing at least 35 kg. After 4 weeks of oral cabotegravir and rilpivirine, they received long-acting injections of both drugs every 8 weeks to week 96.

There were no confirmed virological failures through week 96. Grade 3 or higher adverse events occurred in 24% (35 of 144), and 3 participants (2%) had grade 3 or higher events judged drug related. Trough concentrations approximated adult values. At least 97% of those on treatment preferred injections to daily oral therapy. Six discontinued treatment prematurely, three because of pregnancy.

There was no comparison group, participants were already suppressed and selected for adherence to a trial, and access and approval differ between countries; the position in India is not addressed in the source and is unknown here.

• This regimen applies to suppressed adolescents of 35 kg or more, not to those starting treatment.
• Injection preference was high (at least 97% of those on treatment).
• Three of six early discontinuations were for pregnancy; plan contraception and pregnancy counselling.
• Check availability with your paediatric HIV service.

Why it matters

Daily tablets are a common reason adolescents lose viral suppression.

Don't overread it

A non-comparative phase 1/2 trial in suppressed adolescents does not show benefit over oral therapy.

The statistics, in plain English

A single-arm trial cannot show that injections work better than tablets, only that suppression was maintained. With 144 participants, rare failures could still occur.

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