Manzoor A Wani1, Jaswinder S Sodhi2, Showkat A Zargar2, Ghulam N Yatoo2, Altaf Shah2, Sheikh A Aziz3, Sajad Geelani4, Inaamul Haq6, Ghulam M Gulzar2, Mushtaq Khan2, Inaamul Haq6. 1. Gastroenterology and Hepatology, Jawahar Lal Nehru Memorial Hospital(JLNMH), Rainawari, Srinagar, J&K, India. 2. Department of Gastroenterology and Hepatology, Sheri Kashmir Institute of Medical Sciences(SKIMS), India. 3. Department of Medical Oncology, SKIMS, India. 4. Department of Clinical Hematology, SKIMS, India. 5. Department of Community Medicine, GMC Srinagar, India. 6. Department of Community Medicine, Government Medical College (GMC), Jammu and Kashmir, Bemina, Srinagar, 190010, India.
Abstract
OBJECTIVE: Hepatitis B infection is common in patients with cancer, and prompt treatment is necessary; otherwise, it can result in life-threatening complications. The objective of this study was to assess the long-term safety and efficacy of entecavir in immunocompromised children with hepatitis B. METHODS: This single-center prospective study was conducted on children with different malignancies referred to our department with evidence of hepatitis B infection. Only those children were included in the study who had HBsAg positive and alanine aminotransferase (ALT) more than 2 times the upper limit of normal and whose hepatitis B virus (HBV) DNA was more than 20,000IU/ml. These children were put on entecavir and prospectively observed upto 192 weeks. Primary efficacy end point was the proportion of patients who achieved undetectable HBV DNA at 48 weeks of treatment. Other efficacy end points were the proportion of patients with HBeAg seroconversion, undetectable HBV DNA, and ALT normalization at weeks 48 and 96 weeks. RESULTS: A total of 41 children met the inclusion criteria, of which 5 children died because of malignancy and 5 were lost to follow-up. Mean log DNA was 7.67 at the start which after starting entecavir reduced to 4.1, 2.8, 1.19, 1.09, and 0.84 at 12, 24, 48, 72, and 96 weeks, respectively (P value < 0.0001). Mean ALT decreased from 332.5 which reduced to 190, 115, 63, and 46 at 4, 12, 24, and 48 weeks, respectively (P < 0.0001). 67.7% achieved the primary outcome and had undetectable DNA at 48 weeks which increased to 26 (83.9%) at 96 weeks. At 48 weeks, 80.6% patients achieved ALT normalization. Thirty percent developed HBeAg seroconversion. Two patients developed virological breakthrough, one at 96 weeks and another at 192 weeks. No significant adverse effects were observed. CONCLUSION: Entecavir is safe and effective in long term for the treatment of hepatitis B in immunocompromised children.
OBJECTIVE: Hepatitis B infection is common in patients with cancer, and prompt treatment is necessary; otherwise, it can result in life-threatening complications. The objective of this study was to assess the long-term safety and efficacy of entecavir in immunocompromised children with hepatitis B. METHODS: This single-center prospective study was conducted on children with different malignancies referred to our department with evidence of hepatitis B infection. Only those children were included in the study who had HBsAg positive and alanine aminotransferase (ALT) more than 2 times the upper limit of normal and whose hepatitis B virus (HBV) DNA was more than 20,000IU/ml. These children were put on entecavir and prospectively observed upto 192 weeks. Primary efficacy end point was the proportion of patients who achieved undetectable HBV DNA at 48 weeks of treatment. Other efficacy end points were the proportion of patients with HBeAg seroconversion, undetectable HBV DNA, and ALT normalization at weeks 48 and 96 weeks. RESULTS: A total of 41 children met the inclusion criteria, of which 5 children died because of malignancy and 5 were lost to follow-up. Mean log DNA was 7.67 at the start which after starting entecavir reduced to 4.1, 2.8, 1.19, 1.09, and 0.84 at 12, 24, 48, 72, and 96 weeks, respectively (P value < 0.0001). Mean ALT decreased from 332.5 which reduced to 190, 115, 63, and 46 at 4, 12, 24, and 48 weeks, respectively (P < 0.0001). 67.7% achieved the primary outcome and had undetectable DNA at 48 weeks which increased to 26 (83.9%) at 96 weeks. At 48 weeks, 80.6% patients achieved ALT normalization. Thirty percent developed HBeAg seroconversion. Two patients developed virological breakthrough, one at 96 weeks and another at 192 weeks. No significant adverse effects were observed. CONCLUSION: Entecavir is safe and effective in long term for the treatment of hepatitis B in immunocompromised children.
Keywords:
AASLD, American Association of Study of Liver Diseases; ADR, adverse drug reaction; ALT, alanine aminotransferase; CHB, chronic hepatitis B; CT, chemotherapy; EASL, European Association of Study of Liver; HBV, hepatitis B virus; HBVR, hepatitis B virus reactivation; HCC, hepatocellular carcinoma; INASL, Indian National Association of Study of Liver; PCR, polymerase chain reaction; TAF, tenofovir alafenamide; USG, ultrasonography; chemotherapy; reactivation; transfusion
Authors: Chee-Kin Hui; Winnie W W Cheung; Hai-Ying Zhang; Wing-Yan Au; Yui-Hung Yueng; Anskar Y H Leung; Nancy Leung; John M Luk; Albert K W Lie; Yok-Lam Kwong; Raymond Liang; George K K Lau Journal: Gastroenterology Date: 2006-07 Impact factor: 22.682
Authors: Nobokrishna Ghosh; M A Mannan; Forhad Monjur; Farhana Rizwan; A F M Salim Journal: Southeast Asian J Trop Med Public Health Date: 2010-05 Impact factor: 0.267