HIV Virologic Suppression Maintained After Switch to Long-Acting ART

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.