Sex: M
Vaccine: HEP, UNK
Symptoms: Acute hepatitis B, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase increased, Hepatitis B surface antibody positive
Clinical narrative: suspected vaccination failure; having acute HBV infection; AST 22 to 900; ALT 28 to 2,876; Alk Phos 72 to 132; This serious case was reported by a pharmacist via sales rep and described the occurrence of vaccination failure in a male patient who received cabotegravir, rilpivirine (Cabenuva) suspension for injection for drug use for unknown indication.   Co-suspect products included Hepatitis B vaccine for prophylaxis.   In SEP-2023, the patient started Cabenuva. On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, an unknown time after starting Cabenuva and an unknown time after receiving Hepatitis B vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), acute hepatitis b (Verbatim: having acute HBV infection) (serious criteria GSK medically significant), aspartate aminotransferase increased (Verbatim: AST 22 to 900), alanine aminotransferase increased (Verbatim: ALT 28 to 2,876) and alkaline phosphatase increased (Verbatim: Alk Phos 72 to 132). Cabenuva was discontinued. The outcome of the vaccination failure was unknown and the outcome of the acute hepatitis b, aspartate aminotransferase increased, alanine aminotransferase increased and alkaline phosphatase increased were not reported.   It was unknown if the reporter considered the acute hepatitis b, aspartate aminotransferase increased, alanine aminotransferase increased and alkaline phosphatase increased to be related to Cabenuva, Cabenuva Needle Device, Cabenuva Syringe Device, Cabenuva Vial Adaptor Device and Hepatitis B vaccine. It was unknown if the reporter considered the vaccination failure to be related to Hepatitis B vaccine.     The company considered the vaccination failure and acute hepatitis b to be unrelated to Cabenuva, Cabenuva Needle Device, Cabenuva Syringe Device and Cabenuva Vial Adaptor Device. It was unknown if the company considered the aspartate aminotransferase increased, alanine aminotransferase increased and alkaline phosphatase increased to be related to Cabenuva, Cabenuva Needle Device, Cabenuva Syringe Device, Cabenuva Vial Adaptor Device and Hepatitis B vaccine. The company considered the vaccination failure to be related to Hepatitis B vaccine. The company considered the acute hepatitis b to be unrelated to Hepatitis B vaccine.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   GSK receipt date: 18-JUN-2024 Patient developed elevated liver functions test at most recent visit on 17Jun2024 compared to prior visit in April 2024. Aspartate aminotransferase was 22 to 900, Alanine aminotransferase 28 to 2,876, Alkaline Phosphate 72 to 132 aka liver functions tests were greater than 3x. According to Health care profesisonal, Hepatitis B virus vaccinations were up to date, Hepatitis C virus was unreactive, rapid plasma reagin was negative, and Hepatitis B virus surface antibody was 14.5. Patient had been on Cabenuva since September 2023 without complaint prior to this visit. As of evening of 18Jun20224 patient was sent to the emergency room and was identified as having acute Hepatitis B virus infection, therefore Cabenuva was discontinued and patient was switched to Biktarvy. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for Hepatitis B virus infection and laboratory confirmation regarding Hepatitis B virus infection were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (related to hepatitis b vaccine) is considered unrelated to GSK drug Cabenuva and Cabenuva needle, syringe and vial adaptor devices Vaccination failure is a listed event which is considered related to GSK drug Hepatitis B vaccine Acute hepatitis B is an unlisted event which is considered unrelated to GSK drug Cabenuva and Cabenuva needle, syringe and vial adaptor devices and Hepatitis B vaccine