Sex: M
Vaccine: HEP
Symptoms: Hepatic steatosis, Hepatitis B surface antibody positive, Incorrect route of drug administration, Liver function test increased, Steatohepatitis
Clinical narrative: This literature market report has been received from the authors of the published literature article. A 46-year-old male with a 10-year history human immunodeficiency virus(HIV) infection was referred to Clinic for chronically elevated liver function tests. He initially started on treatment with efavirenz(manufacturer unknown)(oral, strength, dose and frequency were unknown)/emtricitabine/tenofovir at the time of his HIV diagnosis and later changed to tenofovir/emtricitabine/ raltegravir potassium(manufacturer unknown) (oral, strength, dose and frequency were unknown) due to elevated liver function tests. He reported compliance and remained asymptomatic with stable virologic suppression. On subsequent primary care office visits, he was noted to have persistently elevated transaminases prompting the referral to hepatology clinic. At the time of consultation his aspartate aminotransferase(AST) was 69 units/L, alanine aminotransferase(ALT) 245 units/L, and alkaline phosphatase was 119 units/L. He denied any IV drug use, excess alcohol consumption, or recent blood transfusions. He was otherwise asymptomatic, and there was no family history of chronic liver disease. A liver biopsy was performed which demonstrated macroand microvesicular steatosis involved 70% to 80% of hepatic parenchyma with ballooning degeneration and some periportal inflammation, mild interface, and lobular activity. This was consistent with moderate steatohepatitis with marked steatosis. Concomitant chronic liver disease workup including autoimmune and viral titers was negative except for elevated aldolase levels  deemed to be due to myositis from his current antiretroviral therapy (captured in MARRS #1712USA007408). Hepatitis B serologies demonstrated negative hepatitis B surface antigen and hepatitis B surface antibody indicative of vaccine nonresponse(Anti-HBs titers less than 10 mIU/mL) despite prior documentation of receiving standard 3 dose of Hepatitis B Vaccine (Recombinant)(manufacturer unknown)(20microgram) intramuscular (IM) vaccine(frequency, lot and expiration date were unknown). During office visit, the patient was repeated a standard 3 dose of Hepatitis B Vaccine (Recombinant)(manufacturer unknown)(20microgram) intramuscular (IM) (frequency, lot and expiration date were unknown) regimen (inappropriate schedule of drug administration), however, no surface antibody was detected on 3 different occasions(Anti-HBs titers less than10 mIU/mL). He subsequently received an increased dose (40 microgram) booster Hepatitis B Vaccine (Recombinant)(manufacturer unknown) intramuscular (IM) (frequency, lot and expiration date were unknown) with no seroconversion noted(Anti-HBs titers less than 10 mIU/mL). His CD4 count was normal with the most recent over 800, and his viral load was undetectable. The patient was then considered to be a nonresponder and in order to develop a protective antibody against hepatitis B virus(HBV) he was vaccinated with 2 intradermal (ID) innoculations (1 month apart) of high dose (40 microgram) Hepatitis B Vaccine (Recombinant)(manufacturer unknown)(frequency, lot and expiration date were unknown) over each deltoid after obtaining informed consent(Inappropriate route of vaccination). Serum antibody titers were obtained 3 months after the series of ID vaccine was administered and antibody titer was 126 mIU/mL indicative of seroconversion. Patient's consent was obtained to include data in this case report. The outcome of "Therapy non-responder" was unknown. Causality between Hepatitis B Vaccine (Recombinant)(manufacturer unknown) and the event was unknown. This is one of several reports received from the same literature article.; Sender's Comments: US-009507513-1712USA007408: