2025 Southeastern Residency Conference

Title: Functional Cure of Hepatitis B Infections Among Patients Co-infected with HIV on Tenofovir-based Antiretroviral Therapy
Authors: Adesuwa Utomwen, Emily Steinbock, Minh Pham
Site: Cone Health – Moses H. Cone Memorial Hospital; Greensboro, NC

Objective: Define functional cure of HBV infections and identify the ideal guideline-directed treatment regimen used for HIV and HBV coinfected patients

Background:
Human immunodeficiency virus (HIV) affects approximately 1.2 million people in the United States, and among these patients, it is estimated that 10% are coinfected with chronic hepatitis B viral (HBV) infection. In patients with HBV, functional cure, defined by loss of hepatitis B surface antigen (HBsAg), is rare. Only 2-4% of HBV mono-infected patients receiving treatment achieve functional cure. Some studies have suggested that patients co-infected with HIV and HBV achieve higher rates of functional cure, approximately 7-10%, likely due to lifelong exposure to antiretroviral therapy (ART).  ART regimens containing tenofovir are the most widely recommended treatment for HBV co-infected patients. Patients achieving functional cure should be re-vaccinated to help stimulate the production of hepatitis B antibodies (anti-HBs). The primary objective of this study was to determine the incidence rate of functional cure among patients coinfected with HIV/HBV who were taking a tenofovir-based ART regimen.

Methods:                                                                                                         
This study was a single-centered, prospective, IRB-approved, interventional study evaluating the incidence of HBsAg loss among HIV/HBV co-infected patients over a 7-month period from August 1, 2024 to February 28, 2025. The study population was identified using a report that included patients with confirmed diagnoses of both HIV and Hepatitis B at the Cone Health Regional Center for Infectious Diseases clinic. Patients were included if they were 18 years of age or older, had confirmed HIV and HBV diagnoses, and were currently receiving care at the RCID clinic. Patients were excluded if they were lost to follow-up at the RCID clinic, diagnosed with hepatitis C viral infection, not receiving treatment with a tenofovir-containing therapy regimen, or were currently involved in another research study. For patients meeting the inclusion criteria, the researcher scheduled HBsAg labs to be collected during patients’ future appointments, notified providers of these orders, and determined the need for vaccinations based on the laboratory results.  The primary outcome was the incidence of functional cure of hepatitis B. The secondary outcome reviewed lab collection patterns. Subgroup analyses involved a comprehensive description of patients meeting the primary objective.

Results:
A total of 37 patients were included in this study. Two (5.4%) patients achieved functional cure of HBV after being treated with long-term ART (Biktarvy) for more than 2 years (95% CI 0.7-18.2). Out of the 37 enrolled patients, labs were only ordered for 31 because the remaining appointments were outside of the study time period. Ultimately, labs were collected for 12 (74%) of appointments due to logistical reasons. None of the patients who achieved functional cure of HBV were eligible for HBV re-vaccination due to the production of anti-HBs at the time of cure. Thus, both patients seroconverted without requiring the HBV vaccine. One patient with functional cure of HBV developed an anti-HB level of 10, indicating complete protection against HBV. It is uncertain if the remaining cured patient achieved full immunity because the appropriate quantitative anti-HB lab was not ordered.

Conclusion:
The incidence of functional cure amongst patients co-infected with HIV and HBV was lower than previously reported rates in the literature, which is likely due to our small sample size and high exclusion rate. Our results add new local evidence about the incidence of functional cure of hepatitis B in patients coinfected with HIV and validate the need for universal HBV therapy in this population.  Practice changing recommendations that can be gathered from this study includes implementing a new standardized workflow protocol for coinfected patients to encourage laboratory stewardship, providing additional guidance that will assist practitioners with medication management decisions for specific clinical scenarios (i.e. requiring immunosuppressive therapy) and creating opportunities to involve current on-site RCID pharmacists into this new workflow. Further local studies are needed, however, to determine the most accurate incidence of hepatitis B functional cure rates within this region and to evaluate the most appropriate means of properly monitoring this unique patient population.