What is the benefit of prophylaxis to prevent HBV reactivation in HBsAg‐negative anti‐HBc‐positive patients? Meta‐analysis and decision curve analysis

Author:

Celsa Ciro12ORCID,Rizzo Giacomo E. M.134ORCID,Di Maria Gabriele5,Enea Marco5,Vaccaro Marco6,Rancatore Gabriele14,Graceffa Pietro1,Falco Giuseppe1,Petta Salvatore1ORCID,Cabibbo Giuseppe1ORCID,Calvaruso Vincenza1ORCID,Craxì Antonio1,Cammà Calogero1ORCID,Di Marco Vito1ORCID

Affiliation:

1. Department of Health Promotion, Section of Gastroenterology and Hepatology, Mother and Child Care, Internal Medicine and Medical Specialties, PROMISE University of Palermo Palermo Italy

2. Department of Surgery & Cancer Imperial College London London UK

3. Department of Precision Medicine in Medical, Surgical and Critical Care (Me.Pre.C.C.) University of Palermo Palermo Italy

4. Department of Diagnostic and Therapeutic Services The Mediterranean Institute for Transplantation and Highly Specialized Therapies (ISMETT) Palermo Italy

5. Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, PROMISE University of Palermo Palermo Italy

6. Department of Economic, Business and Statistical Sciences University of Palermo Palermo Italy

Abstract

AbstractBackground and AimsPatients with overt or occult hepatitis B virus (HBV) infection receiving immunosuppressive treatments have a wide risk of HBV reactivation (HBVr). We performed meta‐analysis with decision curve analyses (DCA) to estimate the risk of HBVr in HBsAg‐negative anti‐HBc‐positive patients naïve to nucleos(t)ide analogues (NAs) receiving immunosuppressive treatments.Approach and ResultsStudies were identified through literature search until October 2022. Pooled estimates were obtained using random‐effects model. Subgroup analyses were performed according to underlying disease and immunosuppressive treatments. DCA was used to identify the threshold probability associated with the net benefit of antiviral prophylaxis in HBsAg‐negative anti‐HBc‐positive patients. We selected 68 studies (40 retrospective and 28 prospective), including 8034 patients with HBsAg negative anti‐HBc positive. HBVr was 4% (95% CI 3%–6%) in HBsAg‐negative anti‐HBc‐positive patients, with a significantly high heterogeneity (I2 69%; p < .01). The number‐needed‐to‐treat (NNT) by DCA ranged from 8 to 24 for chemotherapy plus rituximab, from 12 to 24 for targeted therapies in cancer patients and from 13 to 39 for immune‐mediated diseases. Net benefit was small for monoclonal antibodies.ConclusionsOur DCA in HBsAg‐negative anti‐HBc‐positive patients provided evidence that NA prophylaxis is strongly recommended in patients treated with chemotherapy combined with rituximab and could be appropriate in patients with cancer treated with targeted therapies and in patients with immune‐mediated diseases. Finally, in patients with cancer treated with monoclonal antibodies or with chemotherapy without rituximab, the net benefit is even lower.

Publisher

Wiley

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