TOPLINE:

Among patients with HIV, switching to a long-acting cabotegravir/rilpivirine regimen appeared to be a safe therapeutic option in those with prior hepatitis B virus (HBV) exposure, including patients with isolated HB core antibody (anti-HBc), with no HBV reactivation or incident infection observed. 

METHODOLOGY:

• This prospective, real-world cohort study evaluated HBV serologic profiles and the risk of HBV reactivation or incident HBV infection after switching to long-acting cabotegravir/rilpivirine in 741 patients with HIV (median age, 43 years; 92% cisgender men).
• Baseline assessments included recent measurements of HB surface antigen (HBsAg) levels, anti-HBc levels, and HB surface antibody (anti-HBs) levels, along with the HBV vaccination status; patients underwent routine monitoring for transaminase levels at weeks 12 and 28 and every 6 months thereafter.
• Patients were classified into five HBV serologic groups: chronic HBV infection, serologically resolved HBV infection, isolated anti-HBc, no previous HBV exposure or immunity, or vaccine-induced immunity.
• HBV reactivation was defined as the reappearance of HBsAg or detectable HBV DNA levels in patients with past HBV infection, or a significant increase in HBV DNA levels in those with chronic HBV infection. Incident HBV infection was defined as HBsAg seroconversion in patients not previously exposed to HBV.
• The median follow-up duration was 54 weeks.

TAKEAWAY:

• At baseline, 61% of the patients had vaccine-induced immunity, 22% had serologically resolved HBV infection, 12% had no prior HBV exposure or immunity, 3% had isolated anti-HBc, and 0.5% had chronic HBV infection.
• No HBV reactivation or incident HBV infection occurred in patients with serologically resolved HBV infection, isolated anti-HBc, or no prior HBV exposure. Among patients with chronic HBV, the reactivation incidence rate was 118.95 per 100 person-years at risk (95% CI, 14.41-429.69).
• Four patients with previously unrecognized chronic HBV started the long-acting cabotegravir/rilpivirine regimen. Two developed confirmed reactivation and the other two remained clinically stable. All four were subsequently switched back to tenofovir-containing therapy.
• During the follow-up period, 17% of the patients had elevated transaminase levels, predominantly of grade 1 severity, with no significant differences across HBV serologic groups.

IN PRACTICE:

“This study provides reassuring evidence that LA-CAB/RPV [long-acting cabotegravir/rilpivirine] is a safe treatment option for PWH [people with HIV] with previous HBV exposure, whether anti-HBs positive or isolated anti-HBc. NRTI [nucleos(t)ide reverse transcriptase inhibitor]-sparing regimens should be avoided in individuals with chronic HBV infection,” the authors wrote.

SOURCE:

The study was led by Alberto Foncillas, Hospital Clinic Barcelona-Instituto de Investigaciones Biomedicas August Pi i Sunyer, Barcelona, Spain. It was published online on January 14, 2026, in Clinical Infectious Diseases.

LIMITATIONS:

HBV testing was performed only when clinically indicated; therefore, subclinical reactivations may have been missed. The observational design limited causal inference, and residual confounding could not be excluded. Vaccination records were incomplete, follow-up anti-HBs titers were often unavailable, and whole-genome sequencing was not performed.

DISCLOSURES:

No study-specific funding was reported. Several authors disclosed receiving honoraria for lectures, research grants, or travel support; participating on advisory boards; or having other relationships with pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.