Background: Chemo-immunotherapy (CIT) is associated to an in- creased risk of HBV reactivation in patients (pts) affected by lympho- proliferative disorders. Occult hepatitis B infection (OBI) is defined by the presence of anti-HBc antibodies, HBsAg negativity with or without anti-HBs antibodies and HBV-DNA serum negativity. Guidelines suggest lamivudine prophylaxis in OBI/CLL pts treated with CIT. No data are available about the need for prophylaxis in OBI/CLL pts treated with BTK inhibitors. Aims: The objective of this study is to evaluate if OBI/CLL pts need lamivudine or HBV-DNA monitoring. Methods:We analyzed 111 OBI/CLL pts (14%), among 781 CLL pts treated with IBR in 22 Italian GIMEMA centres until January 2019. Me- dian age was 64 years. At IBR start, 9%, 48%, 42% pts were on Binet stage A, B, C respectively; 71% pts had unmutated IGHV, 26% pts had 17p deletion. Twenty-six (23%) OBI/CLL pts were treatment naïve at IBR start; 44 (40%) pts, 18 (16%) and 23 (20%) had been previously treated with 1, 2 or >2 lines of CIT respectively. Seventy-three OBI/CLL pts on IBR underwent prophylaxis with lamivudine, while 38 pts were only subjected to HBV-DNA monitoring every 3 months. Table1. Results:Viral reactivation was observed in 5 pts. Four of them (2 with clinical reactivation and 2 with serological one) belonged to the HBV- DNA monitoring group; one patient experienced clinical reactivation on the lamivudine prophylaxis group (p=0.046). Both kinds of reactivation occurred in the first 3-6 months of IBR. In the HBV-DNA monitoring group, one patient was treatment naïve and experienced only serological reactivation; 3 pts were previously treated with CIT, at least 12 months before the IBR, and experienced both serological (1) and clinical (2) ac- tivation Table1. Serological reactivation was only recorded on the HBV- DNA monitoring group as those were the only pts who underwent a systematic screening schedule in the following months, thus were diag- nosed with HBV reactivation (and treated with lamivudine) in the ab- sence of any clinical suspicion. Conclusions:From the collected evidence, it seems reasonable to sug- gest that prophylactic treatment should be considered appropriate and started in pts who were previously treated with CIT. For the treatment naïve group, a clinical choice could be performed, knowing that reacti- vation could seldomly occur and be detected in time to promptly treat the pts, but prophylaxis is not mandatory for a favourable clinical course.
HBV REACTIVATION IN CLL PATIENTS WITH OCCULT HBV INFECTION TREATED WITH IBRUTINIB WITH OR WITHOUT VIRAL PROPHYLAXIS. A RETROSPECTIVE MULTICENTRIC GIMEMA STUDY
F. M. Quaglia;
2021-01-01
Abstract
Background: Chemo-immunotherapy (CIT) is associated to an in- creased risk of HBV reactivation in patients (pts) affected by lympho- proliferative disorders. Occult hepatitis B infection (OBI) is defined by the presence of anti-HBc antibodies, HBsAg negativity with or without anti-HBs antibodies and HBV-DNA serum negativity. Guidelines suggest lamivudine prophylaxis in OBI/CLL pts treated with CIT. No data are available about the need for prophylaxis in OBI/CLL pts treated with BTK inhibitors. Aims: The objective of this study is to evaluate if OBI/CLL pts need lamivudine or HBV-DNA monitoring. Methods:We analyzed 111 OBI/CLL pts (14%), among 781 CLL pts treated with IBR in 22 Italian GIMEMA centres until January 2019. Me- dian age was 64 years. At IBR start, 9%, 48%, 42% pts were on Binet stage A, B, C respectively; 71% pts had unmutated IGHV, 26% pts had 17p deletion. Twenty-six (23%) OBI/CLL pts were treatment naïve at IBR start; 44 (40%) pts, 18 (16%) and 23 (20%) had been previously treated with 1, 2 or >2 lines of CIT respectively. Seventy-three OBI/CLL pts on IBR underwent prophylaxis with lamivudine, while 38 pts were only subjected to HBV-DNA monitoring every 3 months. Table1. Results:Viral reactivation was observed in 5 pts. Four of them (2 with clinical reactivation and 2 with serological one) belonged to the HBV- DNA monitoring group; one patient experienced clinical reactivation on the lamivudine prophylaxis group (p=0.046). Both kinds of reactivation occurred in the first 3-6 months of IBR. In the HBV-DNA monitoring group, one patient was treatment naïve and experienced only serological reactivation; 3 pts were previously treated with CIT, at least 12 months before the IBR, and experienced both serological (1) and clinical (2) ac- tivation Table1. Serological reactivation was only recorded on the HBV- DNA monitoring group as those were the only pts who underwent a systematic screening schedule in the following months, thus were diag- nosed with HBV reactivation (and treated with lamivudine) in the ab- sence of any clinical suspicion. Conclusions:From the collected evidence, it seems reasonable to sug- gest that prophylactic treatment should be considered appropriate and started in pts who were previously treated with CIT. For the treatment naïve group, a clinical choice could be performed, knowing that reacti- vation could seldomly occur and be detected in time to promptly treat the pts, but prophylaxis is not mandatory for a favourable clinical course.
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