Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: Twenty-three subjects were anti-HBs negative, two were subsequently vaccinated, and one of the two demonstrated seroconversion; This literature marketed report was received from the authors of an article entitled as stated below. The purpose of this article was to determine the authors' center adherence to the guidelines that chronically transfused patients received annual human immunodeficiency virus (HIV), hepatitis C (HCV), and hepatitis B (HBV) screening, to assess the rates of HBV immunity, and to determine whether patients without evidence of HBV immunity were subsequently immunized.  This case refers to an adult patient of an unknown age and gender. The authors included adults with sickle cell disease (SCD), aged 18 years or older, with 12 or more months since initiation of chronic transfusion therapy between 01-OCT-2014 and 30-SEP-2019. The authors excluded patients who only received on-demand transfusions. The authors performed a systematic chart review from their electronic medical record (EMR) and stored data in a database. They collected basic demographics (age, sex, and race), the number of transfusions per month, and total number of months on a chronic transfusions. Among 144 chronically transfused adults at the authors' center, 85 who were chronically transfused during the study period were included. Patients were 2373 years old (median 34 years) 52% female.   The authors captured the screening interval, and results of all HIV, HCV, and HBV testing. They considered patients screened for HIV, HCV, or HBV if a test result for the corresponding transfusion transmitted infections (TTI) were available during the study period. The TTI tests used were a fourth-generation enzyme linked immunosorbent assay for HIV1/2Ag/Ab, an Enzyme Immunoassay (EIA) for IgG anti-HCV antibody, EIA for HBV surface antigen (HBsAg), EIA for HBV core antibody (anti-HBc), and immunochemiluminescent assay for HBV surface antibody (anti-HBs). To establish baseline HIV, HCV, or HBV infection, they collected results available from the soonest HIV, HCV, and HBV tests preceding the study period.  The authors collected anti-HBs, a marker of HBV immunity from vaccination or past infection. Vaccination records were collected from the EMR and if those records were incomplete, they contacted the primary care providers (PCPs) for records and/or approached the patients directly for this information. For anti-HBs negative patients, they collected documentation of subsequent HBV vaccination and immune response. Anti-HBc antibody distinguishes the immune response from infection rather than vaccination and helps identify individuals who did not express hepatitis B antigen, but have occult HBV (HbsAg mutants i.e., HBV infection). They classified patients as being (1) actively infected (HBsAg positive), (2) immune after infection (anti-HBc positive and anti-HBs positive), (3) immune after vaccination (anti-HBc negative and anti- HBs positive), (4) nonimmune (anti-HBc negative and anti-HBs negative), or (5) unknown (tests unavailable). To calculate the vaccine seroconversion rate, the authors correlated vaccination records with serologic testing.  At the beginning of the study period (baseline), two patients had positive HIV tests, two had positive HCV tests, none were HBV positive and 15 had HBV immunity. Over 5 years, no patients were screened annually for HIV or HCV; 68 (80%) were screened at least once for HIV and 60 (71%) at least once for HCV. No new HIV infections were identified. One patient without previous HCV testing tested positive for HCV. The mode of HCV transmission was unclear and may have preceded initiation of chronic transfusions. HBV testing varied.  Fifty-three patients were tested for HBsAg, 32 for anti-HBc and 31 for anti-HBs. The proportion of patients screened for HIV, HCV, and HBV decreased over time. Fifty-eight patients had serologic data and 17 patients had vaccination data available. For patients without vaccination data in the EMR, the authors used PCP and patients records which provided no additional evidence of HBV vaccination. Among the 58 patients with HBV testing, 30 had immunity attributable to vaccination, 5 had evidence of past infection and 23 had no immunity.   It was reported that twenty-three patients were anti-HBs negative, on unknown dates, two patients were subsequently vaccinated with unspecified doses of Hepatitis B Vaccine (Recombinant) (manufacturer unknown) for prophylaxis (strength, dosage schedule, route, anatomical location, lot numbers and expiration dates were not reported). It was reported that on an unknown date, one of the two demonstrated seroconversion, therefore one patient did not seroconvert (anti-HBs negative).  This article raised several issues related to HBV testing and vaccination. First, the guidelines indicated an approach to HBV testing or clarify whether HBV vaccination was the province of the SCD specialist or primary care doctor. Testing in the authors population was inconsistent and (re)vaccination infrequent. At their center, they usually defer this vaccine to PCPs. Second, whether measures of immune response to vaccination were valid for individuals with SCD was unclear. In the general population, anti-Hbs seroconversion after vaccination did not always occur and could be lost over time. SCD may lead to impaired seroconversion to vaccinations due to abnormalities in lymphocyte subsets and functional asplenia.    A copy of the published article is attached as further documentation of the patient's experience.  This is one of two reports received from the same literature article.; Sender's Comments:  US-009507513-2203USA007489: