Evidence of the long-term efficacy and safety of long-acting injectable therapies for HIV infection is needed, particularly in regions where the HIV burden is highest, such as sub-Saharan Africa. Kityo et al. now report week 96 efficacy and safety findings from a multicentre, open-label phase IIIb trial of intramuscular cabotegravir (an integrase inhibitor) and rilpivirine (a non-nucleoside reverse transcriptase inhibitor (NNRTI)) in adults living with HIV from Uganda, Kenya and South Africa.
Between September 2021 and August 2022, 512 adults with HIV-1 were enrolled from 8 sites across Uganda, Kenya and South Africa. Inclusion requirements were that participants were stable on first-line oral therapy (tenofovir and lamivudine or emtricitabine; with either dolutegravir, efavirenz or nevirapine), had a screening plasma viral load <50 copies per ml and had no past history of virological failure. Individuals were randomly assigned (1:1) to continue their oral therapy, or to switch to cabotegravir (600 mg) and rilpivirine (900 mg) intramuscular injections every 8 weeks (the long-acting therapy group), with an optional 4-week oral lead-in. Viral load was monitored every 24 weeks, and the primary outcome was 96-week viral load <50 copies per ml.
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