Received Jul 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 1 | — | — |
HBsAg Negative at POD 412 Post Heart Transplant; HBV PCR Negative at POD 412 Post Heart Transplant; HBsAb Titer was 277.2 mIU/mL pre-Transplant and 449.8 mlU/mL One Year Post-Transplant; Initial report received on 19-Jun-2025. This report was retrieved from the following publication: A 71-year-old male received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and on postoperative day (POD) 412 after heart transplant, the patient's hepatitis B surface antigen (HBsAg) and hepatitis B virus (HBV) polymerase chain reaction (PCR) remained negative. Medical history included advanced heart failure due to ischemic cardiomyopathy. The patient's pre-transplant hepatitis B surface antibody (HBsAB) titer was 277.2 mIU/mL. No concomitant medications were reported. Three years prior to transplant, the patient was vaccinated with the two-dose series of a hepatitis B vaccine HEPLISAV-B (lot numbers, expiration dates and NDC numbers not available). On an unknown date, three years after receiving HEPLISAV-B, the patient received a heart from a donor who was Hepatitis B Virus (HBV) Nucleic Acid Test Positive (NAT), and hepatitis B core antibody (HBcAb) positive. The patient received one dose of hepatitis B immunoglobulin (HBIG) 20,000 units intravenously (IV) intraoperatively followed by 5,000 units IV daily for 7 days in addition to starting tenofovir alafenamide 25 mg by mouth daily on postoperative day (POD) O for approximately 1 year. HBsAg, HBsAb and HBV PCR were monitored every 3 months. One-year post-transplant, and approximately 4 years after receiving HEPLISAV-B, the patient remained immune to HBV with an HBsAb titer of 449.8 mlU/mL. At POD 412 the patient's HBsAg and HBV PCR remained negative. Tenofovir alafenamide prophylaxis was discontinued on POD 448. Liver function tests (LFTs) were normal at baseline and stable post-transplant. His allograft function is stable with the most recently calculated ejection fraction of 68.5% measured by transthoracic echocardiography. No additional information was reported. Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Heart failure (Due to Ischemic Cardiomyopathy); Ischemic cardiomyopathy
Test Name: Liver Function Tests; Test Name: Transthoracic Echocardiogram; Test Result: 68.5 %; Result Unstructured Data: Calculated Ejection Fraction