Long-acting antiretroviral therapy (ART) with cabotegravir plus rilpivirine is efficacious for the maintenance of virologic suppression in adults with HIV infection, according to results of a study published in Lancet HIV.
Researchers conducted a randomized, multicenter, active-controlled, open-label, phase 3b, noninferiority study among patients with virologically-suppressed HIV infection between November 2020 and May 2021. Patients were randomly assigned 2:1 to either switch to long-acting cabotegravir plus rilpivirine injections every 2 months (intervention; n=447) or continue oral bictegravir plus emtricitabine and tenofovir alafenamide (control; n=223) daily. The primary efficacy endpoint was the percentage of patients who were no longer virologically suppressed (HIV RNA, ≥50 copies/mL) at months 11 and 12.
Among patients (N=670) included in the modified intention-to-treat analysis, the median age was 37 years, 19% were aged 50 years and older, 18% were women (sex at birth), and 31% were non-White. The median duration of prior ART receipt was higher among patients in the intervention vs control group (2.58 vs 2.47 years).
At months 11 to 12, a similar percentage of patients in the intervention vs control group were no longer virologically suppressed (1% vs <1%; adjusted difference, 0.7; 95% CI, -0.7 to 2.0), indicating noninferiority. In addition, HIV virologic suppression was maintained among 90% of patients in the intervention group and 93% of those in the control group (adjusted difference, -2.7; 95% CI, -7.0 to 1.7). Patients who switched to long-term ART also experienced greater median change in CD4+ count from baseline (39.0 vs 2.0 cells/mm3).
In a safety analysis, adverse events (AEs) occurred at similar rates between patients in the intervention group and those in the control group (77% vs 76%, respectively). However, patients who switched to long-acting ART had higher rates of drug-related AEs and discontinuations. With the exception of injection site reactions, the most common AEs were COVID-19 infection and headache.
Study limitations include the lack of patients with a history of non-nucleoside reverse transcriptase inhibitor or protease inhibitor treatment, as well as challenges with enrollment due to the COVID-19 pandemic.
For the maintenance of HIV virologic suppression, “The available evidence supports long-acting cabotegravir plus rilpivirine every 2 months as a potential alternative treatment to daily oral therapies,” the researchers concluded.
Disclosure: This research was supported by ViiV Healthcare and Janssen. Please see the original reference for the full list of disclosures.
Ramgopal MN, Castagna A, Cazanave C, et al. Efficacy, safety, and tolerability of switching to long-acting cabotegravir plus rilpivirine versus continuing fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed adults with HIV, 12-month results (SOLAR): a randomised, open-label, phase 3b, non-inferiority trial. Lancet HIV. Published online August 8, 2023. doi:10.1016/S2352-3018(23)00136-4