Sex: U
Vaccine: HEP, HEP, HEP, UNK
Symptoms: Hepatitis B surface antigen negative, Laboratory test, Liver function test, Vaccination failure
Clinical narrative: Suspected Vaccination failure; developed HBV viremia/ lead to HBV reactivation; This case was reported in a literature article and described the occurrence of vaccination failure in a patient who received Hepatitis B vaccine for hepatitis prophylaxis.   Co-suspect products included Hepatitis B vaccine for hepatitis prophylaxis, Hepatitis B vaccine for hepatitis prophylaxis, cabotegravir, rilpivirine (Cabotegravir + Rilpivirine) suspension for injection for hiv infection, cabotegravir + rilpivirine syringe device injection syringe (batch number Unknown, expiry date unknown) for hiv infection, cabotegravir + rilpivirine needle device injection needle (batch number Unknown, expiry date unknown) for hiv infection and cabotegravir + rilpivirine vial adaptor device administration system for hiv infection.   Concomitant products included emtricitabine + rilpivirine + tenofovir alafenamide fumarate, dolutegravir and cabotegravir + rilpivirine.   On an unknown date, the patient received the 1st dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine, the 3rd dose of Hepatitis B vaccine, Cabotegravir + Rilpivirine (injection) at an unknown dose and frequency, cabotegravir + rilpivirine syringe device, cabotegravir + rilpivirine needle device and cabotegravir + rilpivirine vial adaptor device. On an unknown date, unknown after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine and an unknown time after starting Cabotegravir + Rilpivirine, cabotegravir + rilpivirine syringe device, cabotegravir + rilpivirine needle device and cabotegravir + rilpivirine vial adaptor device, the patient experienced vaccination failure (serious criteria GSK medically significant) and hepatitis b (serious criteria GSK medically significant). Cabotegravir + Rilpivirine was discontinued (Dechallenge was positive). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the hepatitis b was recovered/resolved.   The reporter considered the vaccination failure and hepatitis b to be related to Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine. The reporter considered the hepatitis b to be related to Cabotegravir + Rilpivirine. It was unknown if the reporter considered the hepatitis b to be related to cabotegravir + rilpivirine syringe device, cabotegravir + rilpivirine needle device and cabotegravir + rilpivirine vial adaptor device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:   19 Jan 2023  Author Comment:  This case corresponds to the patient A from figure 1 as described in literature article. The author had described three cases of HBV low-level viremia in patients switched to LAI CAB/RPV and who were HBcAb positive and sAg negative. The author conducted a retrospective case series of patients with HIV switching to LAI CAB/RPV who were HBcAb positive and sAg negative and reviewed pre-switch HBV studies, history of HBV vaccination, current ART, CD4 cell count, and HIV viral load, and liver function tests (LFTs) where available. After switching to LAI CAB/RPV, we reviewed patients' HBV DNA PCR, HBVsAg, and ART management. Of the 149 patients in clinic who were switched to LAI CAB/RPV, 38 (25.5 percentage) were HBcAb positive and sAg negative. Of these 38 patients, three (7.9 percentage) developed HBV viremia. The patient was receiving Dolutegravir plus emtricitabine + rilpivirine + tenofovir alafenamide fumarate for HIV infection and had received HBV vaccination series (3) x 2 in past. The patient's CD4 count was 677 cells/uL ,HBV sAb was 6.5 mIU/L,  HIV viral load and HBV DNA were undetectable at that time. The patient was switched to long-acting injectable cabotegravir and rilpivirine and the patient's HBV DNA was increased to 95 iu/ml from less than 10. So, the patient was switched back to a TFV-containing three-drug regimen with subsequent suppression of HBV DNA levels.  Additional Supportive Information:  The author concluded "The case series describes three cases of HBV low-level viremia following a switch off of HBV-active ART to LAI CAB/RPV. The clinical significance of this low-level viremia is unclear and warrants further investigation."  This case was considered to be a suspected vaccination failure case, as the details regarding the vaccination schedule and time to onset were unknown. This is one of the 3 cases reported in this literature article. ; Sender's Comments:  US-GSK-US2023GSK009476:Same Publication US-GSK-US2023GSK009477:Same Publication