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; Juan Ambrosioni; Abiu Sempere; Leire Berrocal; Julia Calvo; Iván Chivite; Lorena de la Mora; Alexy Inciarte; Berta Torres; María Martínez-Rebollar; José Luis Blanco; José M Miró; Elisa de Lazzari; Esteban Martínez; Josep Mallolas; Ana González-Cordón; Montserrat Laguno

doi:10.1093/cid/ciag023

Hepatitis B Outcomes After Switching to Long-Acting Cabotegravir/Rilpivirine in People With HIV: Reactivation, Incident Infection, and Liver Safety Across Diverse Serological Profiles

Clin Infect Dis. 2026 Jan 14:ciag023. doi: 10.1093/cid/ciag023. Online ahead of print.

Authors

Alberto Foncillas^{1

2}, Juan Ambrosioni^{1

2

3}, Abiu Sempere^{1

2}, Leire Berrocal¹, Julia Calvo^{1

2}, Iván Chivite^{1

2}, Lorena de la Mora^{1

2

3}, Alexy Inciarte^{1

2

3}, Berta Torres^{1

2

3}, María Martínez-Rebollar^{1

2

3}, José Luis Blanco^{1

2

3}, José M Miró^{1

2

3

4}, Elisa de Lazzari^{1

2

3}, Esteban Martínez^{1

2

3}, Josep Mallolas^{1

2

3}, Ana González-Cordón^{1

2

3}, Montserrat Laguno^{1

2

3}

Affiliations

¹ HIV Unit, Infectious Diseases Service, Hospital Clínic Barcelona-Instituto de Investigaciones Biomédicas August Pi i Sunyer (IDIBAPS), Barcelona, Spain.
² University of Barcelona, Barcelona, Spain.
³ Centro de Investigación Biomédica en Red de Enfermedades Infecciosas (CIBERINFEC), Instituto de Salud Carlos III, Madrid Spain.
⁴ Reial Academia de Medicina de Catalunya (RAMC), Barcelona, Spain.

PMID: 41539988
DOI: 10.1093/cid/ciag023

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.

Keywords: Hepatitis B virus infection; Hepatitis B virus reactivation; Long-acting cabotegravir plus rilpivirine; Real-world cohort.

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