Sex: F
Vaccine: HEP
Symptoms: Hepatitis B reactivation, Hepatitis B surface antibody positive, Hepatitis B surface antigen positive, Hepatitis C, Renal impairment
Clinical narrative: HBsAg was newly reactive with HBV DNA of 141 million IU/ml;; progressive renal dysfunction; chronic kidney disease; acute renal failure; HIV VL exceeding 500,000 copies/mL; adherence difficulties related to substance use; This serious case was reported in a literature article and described the occurrence of hepatitis b reactivation in a 57-year-old female patient who received Hepatitis B vaccine for prophylaxis. Literature Reference.  Co-suspect products included dolutegravir for hiv infection, tenofovir disoproxil fumarate for hiv infection, emtricitabine for hiv infection, atazanavir + ritonavir for hiv infection and cobicistat + darunavir for hiv infection.   Concurrent medical conditions included viral hepatitis c (untreated) and hepatitis b (isolated HBcAb reactivity). Concomitant products included HEPATITIS B VACCINE, elbasvir and grazoprevir.   On an unknown date, the patient received the 2nd dose of Hepatitis B vaccine, dolutegravir, tenofovir disoproxil fumarate, emtricitabine, atazanavir + ritonavir and cobicistat + darunavir. On an unknown date, an unknown time after receiving Hepatitis B vaccine and an unknown time after starting dolutegravir and tenofovir disoproxil fumarate, the patient experienced hepatitis b reactivation (Verbatim: HBsAg was newly reactive with HBV DNA of 141 million IU/ml;) (serious criteria GSK medically significant), kidney dysfunction (Verbatim: progressive renal dysfunction) (serious criteria GSK medically significant), chronic kidney disease (Verbatim: chronic kidney disease) (serious criteria GSK medically significant), acute renal failure (Verbatim: acute renal failure) (serious criteria GSK medically significant), virologic failure (Verbatim: HIV VL exceeding 500,000 copies/mL) and treatment nonadherence (Verbatim: adherence difficulties related to substance use). Dolutegravir was discontinued. Tenofovir disoproxil fumarate was discontinued. Emtricitabine was interrupted. Atazanavir + ritonavir was discontinued. Cobicistat + darunavir was discontinued. The outcome of the hepatitis b reactivation, kidney dysfunction, chronic kidney disease, acute renal failure and virologic failure were resolved and the outcome of the treatment nonadherence was unknown.   It was unknown if the reporter considered the hepatitis b reactivation, kidney dysfunction, chronic kidney disease, acute renal failure and virologic failure to be related to Hepatitis B vaccine. The reporter considered the hepatitis b reactivation to be related to dolutegravir. It was unknown if the reporter considered the acute renal failure to be related to dolutegravir and tenofovir disoproxil fumarate. It was unknown if the reporter considered the kidney dysfunction and chronic kidney disease to be related to tenofovir disoproxil fumarate. The reporter considered the virologic failure to be related to tenofovir disoproxil fumarate.     It was unknown if the company considered the hepatitis b reactivation, kidney dysfunction, chronic kidney disease, acute renal failure and virologic failure to be related to Hepatitis B vaccine. The company considered the hepatitis b reactivation to be related to dolutegravir. It was unknown if the company considered the acute renal failure to be related to dolutegravir and tenofovir disoproxil fumarate. It was unknown if the company considered the kidney dysfunction and chronic kidney disease to be related to tenofovir disoproxil fumarate. The company considered the virologic failure to be related to tenofovir disoproxil fumarate.   Additional Information: GSK Receipt Date: 29-Jun-2023 This case corresponds to case-3 reported in this literature article.  A 57-year-old female presented with human immunodeficiency virus (HIV) (CD4 525 cells/ml) diagnosed twenty years prior and suppressed on EMTRICITABINE (FTC)-TENOFOVIR DISOPROXIL FUMARATE (TDF) and ritonavir-boosted atazanavir (ATV/r). The patient had untreated Hepatitis C virus (HCV) and isolated Hepatitis B core antibody (HBcAb) reactivity. The patient received two of three doses of Hepatitis B virus (HBV) recombinant vaccine (unknown formulation) at zero and one month. Hepatitis B surface antibody  (HBsAb) was reactive one year after this partial series. HCV was treated with elbasvirgrazoprevir. HBsAb was sustained at 86 mIU/ml after HCV treatment and four years postvaccination. The patient developed adherence difficulties related to substance use and re-presented with CD4 of 30 cells/mL and HIV viral load (VL) exceeding 500,000 copies/mL. The patient had progressive renal dysfunction and was switched to tenofovir-sparing therapy with Dolutegravir (DTG) and cobicistat-boosted darunavir (DRV/c). The patient presented five months later in acute renal failure. Alanin transaminase (ALT) was 155 IU/mL (from normal baseline). Hepatitis B surface antigen (HBsAg) was newly reactive with Hepatitis B virus (HBV) DNA of 141 million IU/ml; HBsAb remained reactive at 79 mIU/ml. Therapy was switched to Bictegravir, Emtricitabine, and Tenofovir alafenamide (BIC-FTC-TAF). Subsequent outcomes are unavailable due to loss of follow-up. This case emphasized recognition of HBV reactivation risk in persons with HBcAb, and providing appropriate monitoring or prophylaxis after ART switch.; Sender's Comments:  US-GSK-US2023GSK091095:Same article