Favorable Virological Outcome, Characteristics of Injection Site Reactions, Decrease in Renal Function Biomarkers in Asian People with HIV Receiving Long-Acting Cabotegravir Plus Rilpivirine

Abstract

Long-acting cabotegravir plus rilpivirine has revolutionized the concept of antiretroviral therapy, but as the causes of virological failure and satisfaction can depend on patient background, real-world data are needed. In this single-center study, we reviewed clinical records of people with HIV (PWH) who received injectable cabotegravir plus rilpivirine between June 2022 and January 2023. We assessed virological and safety outcomes, including injection site reactions (ISRs) and changes in serum creatinine and cystatin C. Seventy-four patients were included. There were no virological failures. Approximately 80% of individuals achieved HIV-RNA undetectable in all visits up to 14 months (median 13 months) after switching. Pain upon injection was significantly more common at the rilpivirine injection site, while delayed pain was significantly more common at the cabotegravir injection site. The serum creatinine (mean difference -0.12 mg/dL, p < .0001) and the cystatin C (mean difference -0.077 mg/dL, p < .0001) decreased significantly after switching, and in multivariable regression analysis, baseline characteristics did not affect the decrease in these renal function markers. Long-acting cabotegravir plus rilpivirine showed excellent antiviral efficacy and safety in PWH in Japan. ISRs were characterized differently at the cabotegravir and rilpivirine injection sites. Although cystatin C showed decrease after the regimen switch, further confirmation is needed whether cabotegravir plus rilpivirine can improve renal function.

Keywords: HIV; antiretroviral therapy; cabotegravir plus rilpivirine; injection site reaction; long-acting drug.

FIG. 1.

Proportion (95% confidence interval) of patients with HIV-RNA less than 50 copies/mL at each visit. “OLI,” the start of the oral lead-in. “month 0,” the start of cabotegravir plus rilpivirine injectable.

FIG. 2.

Proportion (95% confidence interval) of patients with target not detected at each visit (A) and the Kaplan–Meier estimates of the probability of maintenance of undetectable HIV-RNA among patients whose HIV-RNA was undetectable at the start of cabotegravir plus rilpivirine injectable (B). “OLI,” the start of the oral lead-in. “month 0,” the start of cabotegravir plus rilpivirine injectable.

FIG. 3.

The changes in renal function biomarker after switching to cabotegravir plus rilpivirine. Serum creatinine (A) and cystatin C (B) are shown. The p values in the graphs are calculated by paired t-test comparing the values at baseline and at month 3. “Baseline,” at the start of oral-lead-in.