Background and importance The Spanish Agency for Medicines and Health Products (AEMPS) in July 2014 made recommendations on the prophylaxis related to the reactivation of hepatitis B secondary to immunosuppressive treatment, particularly with rituximab (RTX), after observing a reactivation frequency higher than that found with classic chemotherapy.
Aim and objectives To determine the degree of compliance with the recommendations of the AEMPS in our centre after several years.
Material and methods All patients treated with RTX from August 2014 to May 2020 were included. Compliance with serological screening was measured through the registration of the following markers of the hepatitis B virus (HBV) carried out in the Microbiology Service: HBsAg, anti-HBc IgG antibodies and HBV-DNA levels.
To determine the degree of compliance of prophylactic treatment, tenofovir and lamivudine dispensations were reviewed. As demographic variables of the study population, gender and age were recorded.
Results 230 patients received RTX and a serological study of HBV infection was carried out in 210 (91.3%). 50.5% (106/210) of the patients were women and the median age was 52.14 (IQR43.01–67.64) years. Of these, 35 patients (16.67%) had positive anti-HBc and 2 positive HBsAg. The HBV-DNA was positive in 27 of them (77.14%) and in all cases it was less than 2000 IU/mL (median 153 IU/mL, IQR 56–447 IU/mL). Of these 35 patients with positive serology and an indication for prophylaxis, only 15 (42.85%) received treatment with tenofovir, with a median duration of 267 (IQR 248.5–471) days. 2 patients with negative serology also received prophylactic tenofovir (median 475.5 days, IQR 335.75–595.25 days). Only 2 patients completed at least 12 months of prophylactic treatment after completing RTX according to the recommendations. 5 patients finished tenofovir before the end of RTX and of the remainder (10) 4 did not achieved a complete month after finishing RTX and 6 had a median duration of treatment of 141 (IQR 127.25–153.25) days.
Conclusion and relevance In our centre, hepatitis B screening in patients receiving immunosuppressive treatment with rituximab is high, but prophylactic treatment is prescribed in less than half of the candidate patients and generally does not meet the recommendations for duration after completion of treatment with rituximab.
Conflict of interest No conflict of interest
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