Hepatitis B Reactivation Associated With Immune Suppressive and Biological Modifier Therapies: Current Concepts, Management Strategies, and Future Directions.

Hepatitis B infection is the leading cause of chronic hepatitis, cirrhosis and hepatocellular carcinoma and is thought to be responsible for million deaths per year globally. Management of patients with resolved or active hepatitis B and cancer is a challenge and these patients are at higher risk of hepatitis B related complications due to immunosuppression and loss of prior immunity. The treating hematologist needs to understand the biology of this common virus, its potential for long-term harm, the necessary laboratory monitoring for their identification and characterization, and the pharmacological interventions for their control. This review offers a general approach to prevention and treatment of hepatitis B reactivation in patients with hematological malignancies and transplant recipients. Practitioners are also encouraged to seek advice and consultation from experts in the design of specific protocols for screening, monitoring and prevention.

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Hepatitis B Reactivation in Patients with Hematological Malignancies and Stem Cell Transplantation

https://journals.sagepub.com/doi/pdf/10.1177/0963689720966980

The Roles of γδ T Cells in Hematopoietic Stem Cell Transplantation.

Although the risk of reactivation of hepatitis B in patients treated with immunosuppressants has been known for years and, if there are recommendations, data from some surveys indicate that the study of the serological profile of HBV infection before starting immunosuppressive treatment is not universal practice. Taking into account the serious consequences that the reactivation of the infection with HBV may entail, we believe that it is necessary to disclose the importance of this problem among the health professionals who prescribe these treatments as well as the recommendations to be followed. In fact, in recent years, the use of chemotherapy and potent immunosuppressants in patients with neoplastic processes and in non-neoplastic pathology of various specialties has been increasingly frequent, increasing the population of patients at risk of reactivation of HBV.

Reactivation of hepatitis B associated with immunosuppressants and chemotherapy. Natural history, risk factors and recommendations for prevention.

Hepatitis B Virus Reactivation in the Setting of Immunosuppressive Drug Therapy.

Reactivation of resolved hepatitis B virus (HBV) infection is a frequent complication in allogeneic hematopoietic SCT (HSCT) recipients. In a retrospective assessment among patients with resolved HBV infection (hepatitis B core Ab-positive, hepatitis B surface Ag-negative), the cumulative risk of HBV reactivation rose from 9 to 13% per year of survival after HSCT, resulting in a cumulative probability of 42.9% at 4 years after HSCT. The risk for liver cirrhosis increases significantly with the level of the circulating virus. Patients with nucleos(t)ide analogue therapy have a significantly lower incidence of hepatocellular cancer compared with untreated patients (2.8 vs 6.4%, P 0.003). Therefore, patients may benefit from antiviral therapy. HBV reactivation may usually be treated with the nucleoside analog lamivudine, since it is recommended as first choice for antiviral therapy in HSCT recipients and is proved to be well tolerated, with no major toxicity in a large number of patients and on long-term follow-up. Because the prolonged use of lamivudine may favor the emergence of mutant lamivudine-resistant HBV strains that are associated with poor outcomes, we decided to use the more recent anti-HBV agent tenofovir in two patients with severe chronic GVHD (cGVHD) and HBV reactivation. To our knowledge, this is the first report on the use of tenofovir in patients after allogeneic HSCT. Before HSCT both patients had a history of resolved HBV infection. Case 1: A 40-year-old female patient was diagnosed with acute myeloid leukemia and received HSCT from matched unrelated donor in May 2005 after conditioning with fludarabine, CY, cytarabine, amsacrine, TBI and ATG (FLAMSA). Four months after HSCT she developed severe cutaneous de novo cGVHD with scleroderma and secondary Sjögren’s syndrome. At the time of hepatitis B reactivation (genotype A2, HBsAg-subtype adw2) she received immunosuppressive therapy with everolimus and prednisolone (10mg). The liver function tests were slightly elevated at the time of diagnosis of HBV reactivation. Case 2: A 56-year-old female patient was diagnosed with CML and received HSCT from a matched related donor in August 2005 after conditioning with treosulfan/fludarabine. Acute cutaneous GVHD III started on day þ 39 after HSCT and was treated with CYA and methylprednisolone. Eight months after HSCT she developed severe cGVHD of the lung. At the time of diagnosis of HBV reactivation (genotype A2, HBsAg-subtype adw2) in March 2009 she only complained about fatigue, but had no signs of liver dysfunction. Immunosuppression consisted of rapamycin, mycophenolate sodium and prednisolone (30mg). After diagnosis of HBV reactivation, both patients received an oral administration of 245mg tenofovir daily and responded with continuous reduction of HBV-DNA replication (Figure 1). The antiviral therapy was well tolerated without any side effects. HBV reactivation is a common late complication of allogeneic HSCT among patients with serologic evidence of resolved HBV infection before transplantation and is significantly associated with the development of cGVHD. Hammond et al. reported an adjusted hazard ratio of 7.21 among patients who developed extensive cGVHD. Consequently, periodic post-HSCT screening for HBV reactivation is recommended, especially in patients with cGVHD and evidence of resolved HBV infection before HSCT. Chronic GVHD patients are immunocompromised for a long time. Therefore, prolonged use of antiviral drugs may be required, which may predispose to the emergence of drug resistance. The more recent anti-HBV agents (tenofovir, entecavir) have a lower risk to develop drug resistance and are recommended as first-line monotherapy by the European Association for the Study of the Liver (EASL). Tenofovir disoproxil fumarate (Viread) is a nucleotide analogue reverse transcriptase inhibitor with potent antiviral activity and a higher barrier to the development of resistance, but the long-term effect, safety and tolerability of tenofovir are still unknown. The efficacy of tenofovir against HBV has been evaluated in two large randomized, phase III clinical studies in hepatitis B envelope Ag (HBeAg)-negative or HBeAg-positive adults with compensated liver function. In addition, a previously

Tenofovir for treatment of hepatitis B virus reactivation in patients with chronic GVHD.

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Tenofovir for treatment of hepatitis B virus reactivation in patients with chronic GVHD.