Hepatitis B Outcomes After Switching to Long-Acting Cabotegravir/Rilpivirine in People With HIV: Reactivation, Incident Infection, and Liver Safety Across Diverse Serological Profiles
Alberto Foncillas, J. Ambrosioni, Abiu Sempere, Leire Berrocal, Julia Calvo, Iván Chivite, Lorena de la Mora, Alexy Inciarte, B. Torres, María Martínez-Rebollar, José Luis Blanco, José M Miró, Elisa de Lazzari, Esteban Martínez, Josep Mallolas, Ana González-Cordón, Monserrat Laguno
Abstract
BACKGROUND: To evaluate hepatitis B virus (HBV) serological profiles and risk of HBV reactivation (HBVr) or incident infection (HBVi) in people with HIV (PWH) switching to long-acting cabotegravir/rilpivirine (LA-CAB/RPV). METHODS: Prospective cohort study of PWH initiating LA-CAB/RPV at Hospital Clínic Barcelona between February 2023 and February 2025. HBV serology, vaccination status, and liver function tests (LFTs) were assessed at baseline. Follow-up LFTs were performed routinely (weeks 12, 28, and every 6 months), and HBV serology/DNA assessed if abnormal LFTs, acute hepatitis or clinical suspicion of reactivation. HBVr was defined as conversion from HBsAg negative to positive or detectable HBV DNA in anti-HBc-positive/HBsAg-negative individuals, or as HBV DNA ≥1 log increase or ≥100 IU/mL in chronic HBV (HBsAg-positive) participants. HBVi was defined as HBsAg seroconversion in HBV unexposed individuals. RESULTS: Among 741 participants-92% cis-gender male, median age 43 (IQR 35-52) -454 (61%) had vaccine-induced immunity and 25% had prior HBV exposure (anti-HBc-positive), with 3% showing isolated anti-HBc. Median follow-up was 54 weeks (IQR 28-77). No HBVr or HBVi were observed in people without chronic hepatitis at baseline. Four individuals (0.5%) with unnoticed chronic HBV infection (HBsAg-positive) started LA-CAB/RPV; two developed clinical HBVr and two remained stable after regimen switch, all four switched back to tenofovir-containing therapy. Transaminase elevations during follow-up occurred in 17% of the cohort, regardless of HBV serostatus. CONCLUSIONS: LA-CAB/RPV appears safe in individuals with prior HBV exposure, including those with isolated anti-HBc. Comprehensive HBV screening, vaccination, and liver monitoring are essential.