Sex: M
Vaccine: HEP, HEP, HEPAB, HEPAB, HEPAB
Symptoms: Alanine aminotransferase increased, CD4 lymphocytes, Condition aggravated, Death, HIV infection
Clinical narrative: vaccination failure; HBsAg was newly reactive; HIV genotype revealed M184V, M41L,  L210L, T215T, D67T, M46I, I54V, V82F; HBsAb post-vaccination was nonreactive; This serious case was reported in a literature article and described the occurrence of vaccination failure in a 65-year-old male patient who received HAB (Twinrix adult) for prophylaxis.   Co-suspect products included HAB (Twinrix adult) for prophylaxis, HAB (Twinrix adult) for prophylaxis, HBV (Engerix B adult) for prophylaxis, HBV (Engerix B adult) for prophylaxis, abacavir sulphate (Abacavir) for hiv infection, lamivudine (Lamivudine Hiv) for hiv infection, dolutegravir, rilpivirine (Dolutegravir + Rilpivirine) for hiv infection and fosamprenavir + ritonavir for hiv infection.   Concurrent medical conditions included treatment failure. Concomitant products included nevirapine.   On an unknown date, the patient received the 3rd dose of Twinrix adult 20 ug, the 2nd dose of Twinrix adult 20 ug, the 1st dose of Twinrix adult 20 ug, Engerix B adult 20 ug, Engerix B adult 20 ug, Abacavir, Lamivudine Hiv, Dolutegravir + Rilpivirine and fosamprenavir + ritonavir. On an unknown date, an unknown time after receiving Twinrix adult, Twinrix adult, Twinrix adult, Engerix B adult and Engerix B adult and an unknown time after starting Abacavir, Lamivudine Hiv and Dolutegravir + Rilpivirine, the patient experienced vaccination failure (Verbatim: vaccination failure) (serious criteria GSK medically significant), hepatitis b (Verbatim: HBsAg was newly reactive) (serious criteria GSK medically significant), viral mutation identified (Verbatim: HIV genotype revealed M184V, M41L,  L210L, T215T, D67T, M46I, I54V, V82F) and therapy non-responder (Verbatim: HBsAb post-vaccination was nonreactive). The action taken with Abacavir was unknown. The action taken with Lamivudine Hiv was unknown. The action taken with Dolutegravir + Rilpivirine was unknown. The action taken with fosamprenavir + ritonavir was unknown. The outcome of the vaccination failure, viral mutation identified and therapy non-responder were unknown and the outcome of the hepatitis b was resolved.   It was unknown if the reporter considered the vaccination failure and hepatitis b to be related to Twinrix adult, Twinrix Pre-Filled Syringe Device, Twinrix adult, Twinrix Pre-Filled Syringe Device, Twinrix adult, Twinrix Pre-Filled Syringe Device, Engerix B adult, Engerix B Pre-Filled Syringe Device, Engerix B adult and Engerix B Pre-Filled Syringe Device. The reporter considered the viral mutation identified to be related to Abacavir and Lamivudine Hiv. The reporter considered the hepatitis b to be related to Dolutegravir + Rilpivirine.     It was unknown if the company considered the vaccination failure and hepatitis b to be related to Twinrix adult, Twinrix Pre-Filled Syringe Device, Twinrix adult, Twinrix Pre-Filled Syringe Device, Twinrix adult, Twinrix Pre-Filled Syringe Device, Engerix B adult, Engerix B Pre-Filled Syringe Device, Engerix B adult and Engerix B Pre-Filled Syringe Device. The company considered the viral mutation identified to be related to Abacavir and Lamivudine Hiv. The company considered the hepatitis b to be related to Dolutegravir + Rilpivirine.   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: 29-Jun-2023 This case corresponds to case-1 reported in this literature article. The patient presented with Human immunodeficiency virus (HIV) (CD4 190 cells/mL) diagnosed twenty years prior and virologically suppressed on abacavir (ABC), Lamivudine (3TC), nevirapine (NVP) and ritonavir-boosted fosemprenavir (FPV/r) following initial treatment failure. Hepatitis B surface antigen (HBsAg), Hepatotis B core antibody (HBcAb), and Hepatitis B surface antibody (HBsAb) were nonreactive. The patient received three 20-mcg doses of combined hepatitis A inactivated/HBV recombinant vaccine (Twinrix® GlaxoSmithKline) at zero, one, and six months. HBsAb post-vaccination was nonreactive. The patient received two additional 20-mcg doses of HBV recombinant vaccine (Engerix-B®, GlaxoSmithKline) at zero and three months. HBsAb remained nonreactive. The patient expressed interest in single-tablet anti-retroviral therapy (ART). HIV genotype revealed M184V, M41L, L210L, and T215T mutations, though preserved non-nucleoside reverse transcriptase inhibitor (NNRTI) susceptibility. The patient was switched to Dolutegravir-Rilpivirine (DTG-RPV). The patient presented five months later with alanine aminotransferase (ALT) of 570 IU/mL from normal baseline. HBsAg was newly reactive; Hepatitis B Virus (HBV) DNA was 1.75 million IU/mL. The patient denied recent sexual or needle-borne exposures. Tenofovir disoproxil fumarate (TDF)-emtricitabine (FTC) were initiated. HBV DNA suppression and ALT normalization were achieved after ten months of therapy and maintained for six months before the patient expired from unrelated causes. This case highlighted the risk of HBV infection in persons with vaccine nonresponse, which may be heightened after discontinuing HBV-active ART; Sender's Comments:  US-GSK-US2023GSK092142:Same article