Factors Influencing Hepatitis B Virus Reactivation in Lymphoma Patients Treated With Rituximab
Condition: Patients With Diffuse Large B-cell Lymphoma or Follicular Lymphoma; Patients Treated With Rituximab-CHOP or Rituximab-CVP
MeSH terms: Hepatitis B; Lymphoma; Lymphoma, Large B-Cell, Diffuse; Hepatitis
Study type: Observational

Summary: 
      This study is a retrospective analysis to identify factors influencing hepatitis B virus
      reactivation in patients treated with rituximab containing chemotherapy. Rituximab monoclonal
      antibody targeting CD20 induces B-cell depletion resulting in prolonged immune suppression.
      This leads to frequent reactivation of patients with a previous history of exposure to HBV or
      HBV carrier.

      We collect the clinical features and laboratory findings of patients satisfied the inclusion
      criteria as follows.

        1. Patients diagnosed with diffuse large B-cell lymphoma (DLBCL) or \ follicular B-cell
           lymphoma (FL).

        2. Patients who had received at least two cycles of rituximab-CHOP or rituximab-CVP as a
           primary treatment

        3. Patients with a history of previous exposure to HBV

             -  HBV surface antigen (HBs Ag) positive Or

             -  HBV core antibody (IgG anti-HBc antibody) positive

      Then, we compare the HBV reactivation group with the control group (HBV reactivation does not
      happen) to find factors influencing HBV reactivation.
    

Detailed description: 
      Description of factors associated with Hepatitis B virus reactivation:

        -  Laboratory parameters defining HBV status/activity at time of treatment initiation

        -  Lymphoma stage at rituximab treatment initiation (Ann Arbor, B-symptoms, bone marrow
           involvement, IPI, ECOG-score, LDH)

        -  Immunochemotherapy regimen (treatment line, rituximab dose and cycle)

        -  Disease status at time of HBV reactivation

        -  Antiviral prophylaxis (medication, dose, duration at time at time of reactivation)

        -  Patient demographics (age, gender, residence, ethnic origin, smoking status, alcohol
           consumption and occupation)

      Time to Hepatitis B virus reactivation

        -  The time from start of rituximab-containing immunochemotherapy until first evidence of
           HBV reactivation meeting the criteria

        -  Description of prophylaxis and treatment with antiviral medication HBV vaccination Time
           of initiation of antiviral therapy of prophylaxis relating to clinical or laboratory
           signs of possible HBV reactivation Anti-viral medication used in prophylaxis or therapy

        -  Description of outcomes Outcomes of the HBV reactivation Outcomes of the
           rituximab-containing immunochemotherapy Demographics and previous infection history:
           Age, gender, nationality, race, social history, past medical history

        -  Parameters associated with lymphomas: Ann Arbor stage, number of extranodal involvement,
           serum LDH, serum β2-microglobulin, ECOG performance status, presence of B symptoms,
           International Prognostic Index, bone marrow invasion

        -  Laboratory parameters associated with hepatitis B virus:

      hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti- HBs), hepatitis B e
      antigen (HBeAg), hepatitis B core antibody (anti-HBc), hepatitis B e antibody (anti-HBe),
      serum HBV DNA

        -  Lymphoma treatment history:

      Line of treatment (first line, second line), rituximab and chemotherapy administration (dose,
      schedule), start date, last treatment date

        -  Prophylaxis or treatment against HBV reactivation:

      antiviral drug (dose, schedule, duration)

        -  Hepatitis B virus reactivation:

      onset, serologic markers, outcome
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with hepatitis B virus positivity and treated with rituximab-containing
        chemotherapy to treat their disease, diffuse large B-cell lymphoma or follicular lymphoma
      
Keywords: rituximab, lymphoma, hepatitis B virus