Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Therapy non-responder
Clinical narrative: Information has been received from the author of a literature. To assess the potential impact of hepatitis B virus (HBV) immunization of human immunodeficiency virus (HIV)-negative adolescents and high-risk adults upon the risk of HBV infection occurring after HIV diagnosis, the author evaluated the associations between the timing of HBV immunization relative to HIV diagnosis, vaccine responses, and risk of HBV infection after HIV diagnosis in the local Study cohort. All study participants enrolled between 1989 and May 2008 with a documented date of HIV seropositivity and without HBV infection at the time of HIV diagnosis (defined as nonreactive initial tests for both hepatitis B surface antigen (HBsAg) and total antibody to hepatitis B core antigen (HBcAb) after HIV diagnosis) were included in the current analysis. Vaccination was defined as receipt of at least 1 dose of HBV vaccine, and HBV infection was defined as reactive results for 2 of the following 3 tests on 1 occasion: hepatitis B surface antigen (HBsAg), antibody to hepatitis B core antigen (HBcAb), and hepatitis B surface antibody; or reactivity for HBcAB or HBsAg on at least 2 separate occasions. Chronic HBV infection was defined as HBsAg reactivity on 2 or more separate occasions at least 6 months apart. Highly active antiretroviral therapy (HAART) was defined as a combination of at least 3 antiretroviral agents. Eligible participants were initially classified into one of 4 exclusive groups on the basis of their vaccination history: those who received vaccine only prior to HIV diagnosis (the vaccinated-before (VB) group), those who received vaccine both before and after HIV diagnosis (the vaccinated-before and-after (VBA) group), those who received vaccine only after HIV diagnosis (the vaccinated-after (VA) group), and those who did not receive vaccine during study follow-up (the not-vaccinated (NV) group). For the subset of persons with available data on antibody to hepatitis B surface antigen (anti-HBs) following vaccination, response to HBV vaccine was categorized by anti-HBs status within 1 year after HIV diagnosis for the VB group and within 1 year of the last vaccine dose for the VBA and VA groups. A positive vaccine response was defined as anti-HBs level equal to or more than 10 IU/L. RESULTS: Of the 1,877 participants who met the inclusion criteria, 441 (23%) had documented receipt of 1 or more doses of HBV vaccine prior to HIV diagnosis (262 in the VB group and 179 in the VBA group), and 1,436 (77%) had no history of HBV vaccination at the time of HIV diagnosis (879 in the VA group and 557 in the NV group). The median age at HIV diagnosis did not vary by vaccination group. The proportions of persons with an HIV diagnosis before 1996 were significantly higher in the VA and NV groups than in the VB group. Overall, 186 (10%) participants developed HBV infection during 10,202 person-years of observation (median, 4.4 years; interquartile range, 1.8-7.7), resulting in an overall HBV infection rate of 1.82 (95% confidence interval (CI): 1.56, 2.09) per 100 person-years. Of the 4 vaccination groups, the highest rate was observed in the NV group (4.05 per 100 person-years, 95% CI: 3.15, 4.95), whereas the lowest rate was observed in the VB group (1.06 per 100 person-years; 95% CI: 0.46, 1.66). In the VB and VBA groups, the proportions of participants receiving 2:3 doses of vaccine prior to mv diagnosis were 62% and 41%, respectively (P < 0.001). However, including doses given after IDV diagnosis, 90% of the VBA group ultimately received equal to or more than 3 doses of vaccine (P < 0.001 compared with 62% for the VB group). The median time from first vaccine dose to HIV diagnosis was 36.9 months (interquartile range, 18.6-75.2) for the VB group as compared with 21.6 months (interquartile range, 5.9-58.7) for the VBA group (P < 0.001). Vaccine responses were known for 230 (88%), 137 (77%), and 646 (73%) participants from the VB, VBA, and VA groups, respectively. The proportion of those responding to vaccine was significantly higher for the VB group (80% overall and 82% for the subset receiving equal to or more than 3 doses) than for any other vaccinated group. Of the 186 HBV infections, 39 (21%) were subsequently classified as chronic infections (2/12 (17%) in the VB group, 2/16 (13%) in the VBA group, 18/80 (23%) in the VA group, and 17/78 (22%) in the NV group (P = 0.89). Of the 538 vaccine responders in the VB, VBA, and VA groups, 29 (5%) developed HBV, as compared with 66 (14%) of the 475 non-responders (P < 0.001). Of participants with a positive response, only 1 (0.2%) developed chronic HBV infection, as compared with 20 (4%) non-responders (P < 0.001). These data suggested that completion of the vaccine series prior to HIV infection may be the optimal strategy for preventing this significant comorbid infection in HIV-infected persons. This report refers to the 382 patients (unknown age and gender) who were enrolled in the VA group of this retrospective study. On unknown dates, the patients were vaccinated with hepatitis B vaccine (recombinant) (manufacturer unknown) (lot#, dose, route and dose number were unspecified). On unknown dates, the patients had negative vaccine response (anti-HBs level <10 IU/L). The outcome of the event was unspecified. The reporter considered the event to be related to hepatitis B vaccine (recombinant) (manufacturer unknown). This is one of three reports from the same literature (Linked report MARRS # 1611USA000366 and 1611USA000007). Additional information has been requested.