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B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event An 81-year-old woman developed hepatitis B virus reverse seroconversion (HBV-RS) during treatment with prednisone and azathioprine for microscopic polyangiitis. Hepatitis B virus reverse seroconversion was confirmed with an HBV titre of 79,200 IU/mL and positive hepatitis B surface antigen and hepatitis B e-antigen [ I exact duration of treatment to reaction onset not stated i ]. [Extracted from the article]

B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event A study described 28 adult patients [ I sexes and exact aged not stated i ] who received treatment between March 2002 and July 2008 and developed drug resistance or exhibited treatment failure during treatment with adefovir dipivoxil or lamivudine for the chronic hepatitis-B virus (HBV) infection [ I routes not stated i ]. However, after a treatment duration of 24-180 weeks, 24 patients developed resistance to lamivudine and the remaining 4 patients exhibited treatment failure with virological breakthrough. [Extracted from the article]

HBV surface antigen (HBsAg), antibody to HBV surface antigen (anti-HBs antibody), HBe antigen, antibody to HBe antigen (anti-HBe antibody) and HBV-DNA were found to be negative. Treatment with cyclophosphamide, dexamethasone, doxorubicin, etoposide, thalidomide, melphalan and vincristine was considered as a risk factor for hepatitis-B reactivation. B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event In a study involving 90 patients who were assessed for hepatitis-B related events in autologous haematopoietic stem cell transplantation (HSCT) recipients from September 2003 to July 2008, a 55-year-old man was described, who developed hepatitis-B reactivation during treatment with cyclophosphamide, dexamethasone, doxorubicin, etoposide, thalidomide, melphalan and vincristine [ I dosages and routes not stated i ] The man was diagnosed with multiple myeloma. [Extracted from the article]

B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event Amongst two patients, an 81-year-old woman (case 2) was described, who experienced occult reactivation of hepatitis B virus (HBV) infection during treatment with dexamethasone and bendamustine for multiple myeloma [ I routes, dosages and durations of treatments to reactions onset not stated i ]. It was suspected that she had undetected occult HBV before seroconversion, which developed to occult reactivation of HBV infection, secondary to immunosuppression. [Extracted from the article]

Analysis of mutations in the reverse transcriptase domain of HBV polymerase in adefovir-resistant HBV patients. B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event In a study of 107 patients with chronic hepatitis B (CHB) treated with adefovir from April 2006 to October 2011, three patients [ I ages and sexes not stated i ] were described, who exhibited emergence of adefovir resistance due to gene mutation following treatment with adefovir. However, following adefovir treatment, the patients exhibited adefovir resistance due to gene mutation. [Extracted from the article]

B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event In a retrospective study of 154 patients with chronic hepatitis B (CHB) treated and followed up between May 2004 and February 2010, a patient [ I age and sex not stated i ] was described, who developed severe hypophosphataemia (phosphate level <1.5 mg/dL) during treatment with adefovir dipivoxil 10mg daily for CHB [ I route, duration of treatment to reaction onset and outcome not stated i ]. The patient's past medication consisted of lamivudine. Treatment strategies using adefovir dipivoxil for individuals with lamivudine-resistant chronic hepatitis B. World Journal of Gastroenterology 18: 6987-6995, No. 47, 21 Dec 2012. [Extracted from the article]

B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event In a retrospective study involving patients with myeloproliferative neoplasm (MPN) and previous hepatitis B virus infection, one patient [ I age and sex not stated i ] was described, who experienced hepatitis B virus reactivation while receiving ruxolitinib for myeloproliferative neoplasm. Risk of hepatitis B virus reactivation in HBsAg-negative, anti-HBc-positive patients with myeloproliferative neoplasms treated with ruxolitinib. The patient had a history of hepatitis B virus infection and the patient had known anti-hepatitis B surface antigen antibodies. [Extracted from the article]

The patients experienced hepatitis flare-up with the hepatitis B virus DNA level at 5.7-8.0 log copies/mL, which was consistent with the development of lamivudine resistance. During treatment, the hepatitis B virus DNA level at nadir was <2.6-5.6 log copies/mL. The patients had liver cirrhosis and positive hepatitis B e antigen (n=7), liver cirrhosis (=4) and positive hepatitis B e antigen (n=7). [Extracted from the article]

Diclofenac and the Risk of Rhabdomyolysis: Analysis of Publications and the WHO Global Pharmacovigilance Database Drugs - Real World Outcomes: 7 Apr 2021. Relative Risk Analysis of Liver-related Adverse Drug Reactions in Children Based on China's National Spontaneous Reporting System. Below is a list of other recently published drug safety-related scientific literature. [Extracted from the article]

The remaining one patient developed cytomegalovirus-related infections, and it led to the patient's death. B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event A retrospective study of international pharmacovigilance database (inquired data from FAERS public dashboard between 1 January 2011 and 31 December 2019 described three patients [1] [including a 65-year-old woman; I sexes and ages of the remaining two patients not stated i ], who developed hepatitis B reactivation or cytomegalovirus-related infections during treatment with mogamulizumab [ I indications i , I routes, dosages, durations of treatments to reactions onsets not stated; not all outcomes stated i ]. [Extracted from the article]

B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event A 52-year-old man experienced worsening of infectious meningitis due to I Cryptococcus neoformans i during treatment with dexamethasone for suspected sensorineural hearing loss. In addition, he developed anaemia, elevated aminotransferase levels, hypercreatinaemia, hypokalaemia, metabolic acidosis and secondary bacterial infections during treatment with amphotericin-B-liposomal for infectious meningitis caused by I Cryptococcus neoformans i [ I times to reactions onsets not clearly stated i ]. A lumbar puncture showed clear, colourless CSF, with increased WBC, increased protein, reduced glucose and opening pressure over 330mm H SB 2 sb O. These findings strongly supported the diagnosis of meningitis. [Extracted from the article]

B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event In a retrospective observational study of 16 patients with psoriasis receiving biological therapy between August 2014 and September 2019, a 63-year-old woman was described, who experienced hepatitis B virus (HBV) reactivation during treatment with infliximab and methotrexate for psoriasis [ I dosages and routes not stated i ]. Hepatitis B virus reactivation in patients with psoriasis on biologic therapies: A retrospective study. Her serum HBV DNA viral load was 52000 IU/mL [ I duration of treatment to reaction onset not stated i ]. [Extracted from the article]

Hepatitis B Virus Reactivation in Gastrointestinal Stromal Tumor Patients Treated With Imatinib. However, positron emission tomography-computed tomography did not indicate recurrence or metastasis of GIST and other tumours. B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event In a retrospective study of 869 patients conducted between January 2007 and June 2020, three patients [1 woman and 2 men] aged 50-59 years were described, who developed liver damage, chronic hepatitis B virus (HBV) reactivation, oedema of eyelids, hands and ankles, systemic oedema, severe liver failure or hepatitis during treatment with imatinib for gastrointestinal stromal tumours (GISTs) [ I routes not stated; not all outcomes stated i ]. [Extracted from the article]

B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event In a single-center retrospective study involving 75 patients treated with biological agents from January 2011 to December 2018, 7 patients including 4 adult patients [ I sexes not stated; ages not clearly stated i ] were described who developed herpes zoster infection, hepatitis B reactivation, folliculitis on the scalp with lymphadenopathy, oesophageal cancer, rectal cancer or hepatocellular carcinoma during treatment with secukinumab or ustekinumab for psoriasis vulgaris [ I not all routes and doses stated; duration of treatments to reactions onset and outcomes not stated i ]. In the secukinumab group, the adult patients developed treatment-related adverse events including herpes zoster infection (one patient), folliculitis on scalp with lymphadenopathy (one patient), rectal cancer (one patient) and hepatocellular carcinoma (one patient). In the ustekinumab group, the patients developed treatment-related adverse events including herpes zoster infection (one patient), hepatitis-B reactivation (one patient) and esophageal cancer (one patient). [Extracted from the article]

B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event A 42-year-old man developed lymphocytosis, thrombocytopenia, hepatic toxicity and thyroid dysfunction during an off-label treatment with pembrolizumab for metastatic thymomas. Blood tests prior to the admission showed lymphocytosis, thrombocytopenia, and abnormal liver enzymes. At hospitalisation, blood workup showed a further increase in his lymphocytosis, thrombocytopenia and grade IV hepatic toxicity. [Extracted from the article]

B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event A 72-year-old woman experienced reactivation of hepatitis B virus (HBV) infection during treatment with daratumumab for multiple myeloma. To prevent HBV reactivation-related hepatitis, she underwent regular HBV DNA monitoring during and at least 1 year after myeloma treatment. Hepatitis B virus reactivation in a myeloma patient with resolved infection who received daratumumab-containing salvage chemotherapy. [Extracted from the article]

B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event In a study to investigate the incidence and outcomes of hepatitis B virus (HBV) reactivation in HBsAg-negative/anti-HBc-positive patients receiving chemotherapy for solid tumors, three patients (2 women and 1 man) aged 46-79 years were described, who developed HBV reactivation during treatment with bevacizumab, fluorouracil, gemcitabine, irinotecan or temozolomide [ I routes and times to reactions onsets not stated i ]. The pre-chemotherapy laboratory results were as follows: HBsAg negative, anti HBs negative, anti HBc-IGG positive, ALT 19 U/L and AST 20 U/L. After three courses of chemotherapy, laboratory results were as follows: HBsAg positive, anti HBs negative, ALT 545 U/L, AST 719 U/L, total bilirubin 0.4 mg/dL and HBV-DNA 3200 IU/mL. Hepatitis B reactivation in HBsAg-negative/anti-HBc-positive patients receiving cytotoxic chemotherapy for solid tumors. [Extracted from the article]

B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event A 74-year-old woman developed fanconi nyndrome leading to hypophosphatemic osteomalacia during treatment with adefovir dipivoxil for chronic hepatitis-B. The woman presented to the emergency department with a history of worsening generalized myalgia and bone pain, which she had been experiencing for 2 years. A severe hip pain was noted on even minor passive movements of her bilateral hips and knees. Radiographs showed bilateral atraumatic fracture of the neck of the femur, a severe compression fracture of the twelfth thoracic vertebra, spiral fracture of the left distal femoral shaft and a fracture of the right clavicle. [Extracted from the article]

Rapidly prednisolone was weaned but the bilirubin plateaued at around 400 mol/L. Again prednisolone dose was increased and the bilirubin level improved with normalisation of creatinine. Upon presentation, his laboratory tests showed creatinine 97 mol/L, bilirubin 181 mol/L, ALP 66 IU/L and ALT 257 IU/L. He underwent a liver screen and urgent follow-up was scheduled. [Extracted from the article]

B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event A 56-year-old man developed hepatitis B reactivation during treatment with etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin for metastatic angioimmunoblastic T cell lymphoma [ I dosages, routes and time to reaction onset not stated i ]. At the time chemotherapy initiation, metabolic panel and blood counts were within normal limits, and liver chemistries were notable only for an elevation in aspartate aminotransferase (AST) to 40 U/L. Hepatitis B virus surface antigen (HBsAg) was negative, hepatitis B surface antibody (HBsAb) was negative, but the HBV total core antibody (anti-HBc) was positive. Viral hepatitis serologies and polymerase chain reaction assays for HBV and the herpes viruses were performed, which showed positive HBsAg and HBV e antigen (HBeAg) with negative HBV e antibody (HBeAb) and a hepatitis B viral load of 6.28 log values. [Extracted from the article]

B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event In a study of 115 patients treated with tyrosine kinase inhibitors for chronic myeloid leukaemia between October 2019 and February 2020, a patient [ I age and sex not stated i ] was described, who experienced hepatitis-B virus (HBV) reactivation during treatment with imatinib for chronic myeloid leukaemia. After the initiation of imatinib, the patient showed reactive hepatitis B e-antigen (HBeAg), hepatitis B surface antigen (HBsAg) and anti-hepatitis B core antigen (HBcAg), findings consistent with HBV reactivation [ I duration of treatment to reaction onset not stated i ]. The patient was treated with entecavir and presented undetectable PCR for HBV after 2 years of treatment. [Extracted from the article]

B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event A 60-year-old woman developed hypercalcaemia and cryptococcal infection during treatment with mycophenolate-mofetil and prednisone for myasthenia gravis. She had a history of hypertension, type 2 diabetes, stage 3 chronic kidney disease (CKD 3), hepatitis B and received unspecified treatment, osteoporosis and myasthenia gravis. A subsequent chest CT scan confirmed the lesion and positron emission tomography (PET) scan was suspicious for malignancy. [Extracted from the article]

Direct genome sequencing for identification of drug resistance and immune escape-associated mutations throughout the therapy revealed coexistence of sA159V mutations with entecavir resistance mutations in the same viral genome. Direct genome sequencing for identification of drug resistance and immune escape-associated mutations throughout the therapy revealed coexistence of sA159V mutations with adefovir-dipivoxil resistance mutations in the same viral genome. Direct genome sequencing for identification of drug resistance and immune escape-associated mutations throughout the therapy revealed coexistence of sA159V mutations with adefovir-dipivoxil resistance mutations in the same viral genome. [Extracted from the article]

B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event A 53-year-old woman developed fulminant hepatic failure due to reactivation of hepatitis-B following treatment with belimumab, hydroxychloroquine, methotrexate and prednisone [ I routes and dosages not stated i ]. Serum chemistries demonstrated total bilirubin of 23 mg/dl, alkaline phosphatase 173 IU/L, AST 136 U/L, ALT 178 U/L, INR 4.8, creatinine 1.2 and sodium 141 mEq/L. Hepatitis B surface antigen, hepatitis B core IgM and IgG were positive. [Extracted from the article]

B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event In a retrospective, single-center, observational cohort study (UMIN000008475) involving 52 patients, who underwent living-and deceased-donor kidney transplantation between 1 August 2012 to 31 December 2018 (Japan), 2 patients [ I ages and sexes not stated i ] were described, who developed hepatitis B virus (HBV) reactivation following immunosuppressant therapy with basiliximab, methylprednisolone and tacrolimus for immunosuppression [ I routes, dosages and durations of treatments to reactions onsets not stated i ]. Following one month, one of the patients became negative for serum HBV-DNA while the other patient continued to exhibit serum HBV-DNA for 11 months. Hepatitis B virus reactivation in kidney transplant patients with resolved hepatitis B virus infection: Risk factors and the safety and efficacy of preemptive therapy. [Extracted from the article]

B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event A 61-year-old woman developed drug-induced liver injury and acute liver failure secondary to chronic hepatitis-B reactivation following treatment with doxycycline for community acquired pneumonia (CAP). Additionally, she exhibited lack of efficacy during treatment with tenofovir for acute liver failure secondary to chronic hepatitis-B reactivation. Her tests were positive for hepatitis B core antibody and surface antigen, which was indicative of reactivation of chronic untreated hepatitis B infection. [Extracted from the article]

B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event In a study of 33 patients, 3 patients [ I ages and sexes not stated i ] were described who developed allergic reaction, aspergilosis of lung or hepatitis B reactivation during treatment with brentuximab vedotin for Hodgkin's lymphoma (HL). The patients with HL who relapsed after an autologous stem cell transplantation (ASCT), received brentuximab vedotin [ I route and dosage not stated i ]; however during treatment the patients developed allergic reaction (n=1), aspergilosis of lung (n=1) and hepatitis B reactivation (n=1) associated with brentuximab vedotin. [Extracted from the article]

B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event In a study of 20 patients, 7 patients [ I ages and sexes not stated i ] were described, who had emergence of drug resistance during treatment with adefovir, entecavir or lamivudine for chronic hepatitis B virus (HBV) infection [ I dosages and routes not stated i ]. Patient 1: The patient with chronic HBV infection was initially treated with lamivudine for 8 months. After 45 months of continued treatment with adefovir plus lamivudine combined, the patient had undetectable HBV DNA levels of less than 1.08 copies/mL. [Extracted from the article]

B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event A 58-year-old man developed Fanconi syndrome and hypophosphataemia osteomalacia during treatment with adefovir dipivoxil for chronic hepatitis B virus (HBV) infection. Based on MRI and bone scintigraphy he was diagnosed with adefovir dipivoxil induced Fanconi syndrome and hypophosphataemia osteomalacia [ I time to reaction onset not stated i ]. Laboratory investigations revealed improvement of renal tubular injury, glycosuria, kidney dysfunction, phosphorus, bicarbonate, uric acid and chloride levels. [Extracted from the article]

B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event In a retrospective, multicentre, single-arm national cohort study of 71 pregnant women conducted between 4 December 2018 and 18 May 2020, three women [ I ages not stated i ] were described, who developed drug resistance manifested as virological breakthrough or alanine transferase (ALT) flares during treatment with tenofovir alafenamide for preventing mother-to-child transmission of hepatitis B virus during pregnancy [ I dosage, duration of treatment to reaction onsets and outcome not stated i ]. All the pregnant women, who had a history of chronic hepatitis B, were above 20 years of age and had hepatitis B e-antigen (HBeAg) positivity with HBV DNA levels above 200000 IU/mL during pregnancy were included in the study. Efficacy and safety of tenofovir alafenamide fumarate for preventing mother-to-child transmission of hepatitis B virus: a national cohort study. [Extracted from the article]

B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event In a prospective study conducted from October 2012 to October 2018 which included 1206 patients, 16 patients [4 women and 12 men] aged 55-91 years were described, who experienced hepatitis B virus reactivation while receiving bortezomib, carboplatin, cisplatin, cyclophosphamide, dexamethasone, doxorubicin, etoposide, hydroxycarbamide, lenalidomide, methotrexate, mogamulizumab, pemetrexed, prednisolone, prednisone, rituximab, unspecified steroids, tegafur/uracil or vincristine. The patients, who had a history of hepatitis-B, were diagnosed with malignant lymphoma (8 patients), lung cancer (3 patients), plasmacytoma (1 patient), essential thrombocythemia (1 patient), multiple myeloma (1 patient), vasculitis (1 patient) and rheumatoid arthritis (1 patient). [Extracted from the article]

B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event In a single-center retrospective study to evaluate the safety and efficacy of PD-1 inhibitor monotherapy with toripalimab, camrelizumab, or sintilimab, or a combination therapy among patients with hepatitis B virus-associated hepatocellular carcinoma from November 2018 to June 2020, one patient [ I age and sex not stated i ] was described, who developed myocarditis during treatment with camrelizumab for hepatitis B virus-associated hepatocellular carcinoma. The patient, who had hepatitis B virus-associated hepatocellular carcinoma, started receiving IV camrelizumab 200mg every 2-3 weeks. Effectiveness and safety of toripalimab, camrelizumab, and sintilimab in a real-world cohort of hepatitis B virus associated hepatocellular carcinoma patients. [Extracted from the article]

At the time, serum hepatitis B virus DNA level was negative. The hepatitis B virus strain (HB16-1360) found to be genotype A. Ultrasound sonography and abdominal CT scan showed chronic changes in the liver without ascites or liver atrophy consistent with hepatitis B virus reactivation secondary to the sofosbuvir and ribavirin use. Six months after treatment with entecavir, the serum hepatitis B DNA level decreased to 3.6 LogIU/mL. [Extracted from the article]

B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event In a prospective study of 36 patients, who had chronic hepatitis B (CHB) and who were treated between 2012 and 2017 in Serbia, 3 adult patients [ I sexes and exact ages not stated i ] were described, who developed ovarian cancer, depression, debilitating myalgia, arthralgia, neutropenia or thyroiditis during treatment with peginterferon-alfa-2a for CHB [ I not all durations of treatments to reactions onsets and outcomes not stated i ]. However, two patients developed neutropenia (1 patient) and thyroiditis (1 patient). Treatment with peginterferon-alfa-2a was stopped for one patient, who had debilitating myalgia, arthralgia, ovarian cancer and depression. [Extracted from the article]

B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event In a retrospective study of 561 patients who had undergone haematopoietic stem cell transplants between 1994 and 2015, 3 men aged 36-54 years were described, who exhibited lack of effect of during prophylactic antiviral therapy with lamivudine to prevent reactivation of hepatitis-B virus (HBV) or during treatment with lamivudine or tenofovir for HBV reactivation [ I dosages and routes not stated i ]. Two of the 3 men developed HBV reactivation despite the prophylaxis; these two men received tenofovir treatment for HBV reactivation, which proved to be effective in one man; while the another man died eventually due to the fulminant hepatitis despite tenoofovir therapy. Hepatitis B reactivation in hematopoietic stem cell transplanted patients: 20 years of experience of a single center from a middle endemic country. [Extracted from the article]

B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event A 44-year-old woman developed fatal hepatitis B reactivation following treatment with cisplatin and carboplatin in addition to concurrent radiation for cervical cancer. Treatment was recommended to her, but she did not return to the clinic for the start of therapy. Later, her treatment was switched from interstitial brachytherapy to intracavitary brachytherapy to minimise the bleeding risk. [Extracted from the article]

B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event A 43-year-old woman developed tumour lysis syndrome during treatment with nivolumab and sorafenib for advanced hepatocellular carcinoma (HCC) [ I not all routes stated i ]. However, due to the rapid progression of tumour burden, she started receiving IV nivolumab 200mg (2.1 mg/day) from the 8th day of hospitalisation. [Extracted from the article]

B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event In a case series, two women (58-year-old and 67-year-old) were described; who developed hepatitis B virus (HBV) reactivation during treatment with combination of dasabuvir and ombitasvir/paritaprevir/ritonavir for chronic Hepatitis C [ I dosages and routes not stated i ]. Case 1: A 58-year-old woman presented to a hospital with hepatitis B surface antigen (HBsAg), hepatitis B envelope antibody (anti-HBe) positivity and anti-hepatitis C virus (HCV). Case 2: A 67-year-old woman with HBsAg positive and HCV genotype 1b was diagnosed with chronic hepatitis due to HBV/HCV coinfection with serum levels of HCV RNA of 1,976,544 IU/mL, ALT of 25 IU/L, AST of 32 IU/L, and undetectable HBV DNA. [Extracted from the article]

He had been receiving prophylactic treatment with entecavir prior to CD19-chimeric-antigen-receptor-T2-cell-therapy-Guangdong-Zhaotai-InVivo therapy to control the replication and recurrence of HBV. Following the treatment with CD19-chimeric-antigen-receptor-T2-cell-therapy-Guangdong-Zhaotai-InVivo, he developed grade 4 cytokine release syndrome (CRS) with a significant increase in the IL-6 level. [Extracted from the article]

B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event A 55-year-old man developed acute kidney injury (AKI) during treatment with tenofovir disoproxil fumarate for chronic hepatitis B (CHB) [ I route and duration of treatment to reaction onset not stated i ]. Laboratory investigations revealed the following: blood urea nitrogen 92 mg/dL, serum creatinine concentration 15.7 mg/dL, urine creatinine 56.1 mg/dL, serum sodium 134 mEq/L; urine sodium 54 mEq/L; (fractional excretion of sodium 11.3%), potassium 5.3 mg/dL; serum calcium 8.6 mg/dL; phosphorus 7.3 mg/dL; serum uric acid, 8.7 mg/dL; urine uric acid, 24.8 mg/dL (fractional excretion of uric acid, 79.8%); a marked elevation in urinary 2-microglobulin with a urinary anion gap of 33.3 mEq/L: serum ALT 319 IU/L, serum albumin was 2.7 g/dL and prothrombin time was 1.03 INR. He was initiated on haemodialysis due to suspicion of oliguric AKI with metabolic acidosis. [Extracted from the article]

B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event * First published case report A 55-year-old man developed lichenoid drug eruption during treatment with entecavir for chronic hepatitis-B. The man presented after experiencing generalised pruritic and erythematous rash for 2 weeks. His medical history included chronic kidney disease stage 3, ischaemic heart disease, hypertension and diabetes mellitus. The WHO ADR database contained 9 reports of Drug eruption associated with entecavir i .". [Extracted from the article]

B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event In a retrospective, observational case series study of 5 pregnant women hospitalised between January 2010 and November 2018, a 37-year-old woman was described, who developed hepatitis B virus (HBV) reactivation during treatment with telbivudine for chronic HBV. The woman (G3P1), whose medical history was notable for acute-on-chronic liver failure and chronic hepatitis B, initially received antiviral therapy with interferon. Acute-on-Chronic Liver Failure in Pregnant Patients with Chronic Hepatitis B: A Retrospective Observational Case Series Study. [Extracted from the article]

B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event An approximately 62-year-old man developed hepatitis B reactivation (HBVr) during treatment with ibrutinib for chronic lymphocytic leukaemia (CLL). HBV serology showed negative hepatitis B surface antigen (HBsAg), positive anti-HBc IgG and positive anti-HBs. After 1 year, at the age of ~62 years while he had been receiving ibrutinib monotherapy, HBV serology showed HBVr with positive HBsAg, positive HBcIgG and negative anti-HBs. [Extracted from the article]

B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event A 77-year-old man developed diffuse large B-cell lymphoma following treatment with sofosbuvir/ledipasvir for chronic hepatitis C. The man, who had been diagnosed with chronic hepatitis C in April 2000, started receiving convnentional therapy with interferon for 24 weeks from August 2000 to January 2001. Lymph node biopsy showed diffuse proliferation of large abnormal cells. 18F-fluorodeoxyglucose positron emission tomography (FDG-PET/CT) with computed tomography revealed increased FDG uptake in the right cervical, right submandibular, mediastinal and mesenteric lymph nodes and maximum standardised uptake values in these lesions were 18.83, 10.38, 4.75 and 4.89 respectively. [Extracted from the article]

B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event A 54-year-old woman developed hepatitis B reactivation and anaemia during treatment with carboplatin, pemetrexed, bevacizumab and dexamethasone. On the same day, she was found to be hepatitis B surface antigen (HBsAg (>2,000 IU/ml) and hepatitis B virus DNA positive (>8.1 Log IU/mL). A Case of Acute Exacerbation of Hepatitis B by Pembrolizumab for a Lung Adenocarcinoma Patient with Hepatitis B Surface Antigen. [Extracted from the article]