Long-Acting HIV Therapy in African Adults with Adherence Challenges.
Fiona V Cresswell, Jonathan Kitonsa, Claire Norcross et al.
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In 30 seconds
This phase 3b, open-label, randomized trial compared long-acting injectable cabotegravir plus rilpivirine with daily oral dolutegravir-based therapy in adults in Kenya, South Africa, and Uganda who had suppressed HIV-1 but suboptimal adherence or care engagement. At week 48, viral load was below 50 copies per milliliter in 91.0% of participants receiving injections and 89.2% receiving oral therapy (risk difference, 1.9 percentage points; 95% CI, -3.1 to 6.9), meeting the prespecified criterion for noninferiority. Confirmed virologic failure occurred in 1.9% and 0%, respectively.
Key findings
- At week 48, viral load was below 50 copies per milliliter in 91.0% with long-acting therapy versus 89.2% with oral therapy.
- The risk difference was 1.9 percentage points (95% CI, -3.1 to 6.9), meeting the trial’s noninferiority criterion.
- Confirmed virologic failure occurred in 5 participants (1.9%) receiving injections and in no participants receiving oral therapy.
- Serious adverse events were reported in 11 of 271 participants (4.1%) with long-acting therapy and 8 of 269 (3.0%) with oral therapy.
Why it matters
Daily oral treatment can be difficult to sustain for people facing adherence or care-engagement challenges. In this trial, an injection regimen given every 8 weeks maintained viral suppression at a rate noninferior to oral dolutegravir-based therapy over 48 weeks. The observed virologic failures in the injectable group also underscore the importance of considering this outcome alongside suppression rates.
What to keep in mind
The trial was open-label, follow-up for the reported primary outcome was 48 weeks, and baseline drug-resistance testing was not performed.