Real-World Experience of Telbivudine and Lamivudine as Antiviral Prophylaxis for Chemotherapy-Related Hepatitis B Reactivation

Background: There is currently no data regarding the efficacy of prophylactic telbivudine in hepatitis B patients undergoing chemotherapy. This study aims to describe the results of preemptive telbivudine and lamivudine to prevent chemotherapy-related HBV reactivation.Methods: The medical records of all patients with HBsAg positive or HBs-Ag negative, anti-HBc positive, who were referred to the hepatology clinic between May 2014 and December 2016, were retrospectively reviewed. As this is a descriptive study, no statistical analysis was done.Results: A total of 52 patients with prophylactic telbivudine or lamivudine therapy were included, with 26 patients in each group. Rituximab-based treatment was given in nine and five patients in the telbivudine and lamivudine group, respectively. The number of patients who completed antiviral treatment up to six months after chemotherapy was 17 patients in each group. There was less incidence of HBV reactivation in the telbivudine group (2 of 17 patients, 11.8%) than in the lamivudine group (7 of 17 patients, 41.2%). Delayed reactivation was noticed in 1 of 2 patients in the telbivudine group and 3 of 7 patients in the lamivudine group. The median log10[HBV DNA] at reactivation was 4.52 (1.70 – 8.35) IU/mL. Severe hepatitis was observed in two patients in the lamivudine group and one patient in the telbivudine group. Of 34 patients who completed antiviral treatment, two patients died due to primary cancer. No interruption of chemotherapy or mortality due to hepatitis was noticed in both groups.Conclusions: Preemptive telbivudine or lamivudine in HBsAg positive or HBsAg negative, anti-HBc positive patients seems to be a good treatment option.

Association of hearing loss in the patients with treated with lamivudine: a systematic review protocol

<p class="abstract"><strong>Background:</strong> Hearing loss has been reported with lamivudine therapy. The World Health Organization (WHO) international database of suspected adverse drug reactions (Vigibase) prioritised clinical review of lamivudine and hearing loss in 2015. This manuscript provides the details of research protocol for a systematic review of association of lamivudine with hearing loss.</p><p class="abstract"><strong>Methods: </strong>English-language publications that assess hearing loss within patients who are receiving lamivudine therapy will be included. All study types like clinical trial designs, case-control study, cohort study, retrospective study, case-series or a case report will be included. Preclinical studies, studies enrolling patients with known differential diagnosis such as presbycusis etc will be excluded. Electronic databases (PubMed, Cochrane reviews, Embase and Google scholar), international clinical trials registry, clinicaltrials.gov and pharmaceutical company clinical study registries will be searched for key words related to lamivudine and hearing loss. After a thorough electronic/manual search of manuscript they will undergo a screening process and selected articles will be assessed for risk of bias using online ROBINS-I tool. We will explore outcomes as an observational systematic review.</p><p class="abstract"><strong>Conclusions:</strong> This review will provide detailed benefit-risk analysis of lamivudine with respect to hearing loss in patients with chronic conditions such as Human immunodeficiency virus (HIV) and Hepatitis B virus (HBV) infection.</p><p class="abstract"><strong>Trial Registration:</strong> PROSPERO registration number is CRD42018112205.0.001.</p>

Role of GSPT1 and GSPT2 polymorphisms in different outcomes upon Hepatitis B virus infection and prognosis to lamivudine therapy

Purpose. ERF3, having been found expressing differently in liver tissues in our previous work, including eRF3a and eRF3b, which are structural homologs named GSPT1 and GSPT2. Recent studies have indicated that eRF3b involved in the development and proliferation of HepG2 cell, and eRF3a may be associated with tumor susceptibility. Based on this, we tested the effects of GSPT1 and GSPT2 single-nucleotide polymorphisms for all major Hepatitis B virus (HBV) outcomes and lamivudine (LAM) treatment in Han Chinese. Method. A total of 1649 samples were enrolled, and peripheral blood samples were collected in the present study. The single-nucleotide polymorphisms in the GSPT1 and GSPT2 region were genotyped using MALDI-TOF MS. Results. Our study demonstrated there was no obvious relevance of either GSPT1-rs33635 or GSPT2-rs974285 polymorphisms with HBV susceptibility, spontaneous recovery, and development of HBV-related diseases. However, we showed for the first time to our knowledge that GSPT1-rs33635C was a predictor for LAM therapy (viral response: odds ratio (OR) = 2.436, P=0.022; biochemical response: OR = 3.328, P=1.73 × 10−4). Conclusions. These findings might provide potential implications for therapeutic guidance.

Reactivation of Hepatitis B Virus Infection in Aplastic Anemia Patients Receiving Immunosuppressive Therapy

Objective: The aim of this study was to assess the risk of HBV reactivation in HBsAg-positive or negative, HBcAb-positive patients with aplastic anemia (AA) receiving immunosuppressive therapy. Methods: We analyzed clinical data of 60 AA patients with HBV infection out of 201 cases. Entecavir or lamivudine therapy was initiated if HBV reactivation was encountered, or used as antiviral prophylaxis regimen for HBsAg-positive patients. Result: Among 60 AA patients, 12 were chronically infected and 48 were previously exposed. There was no difference in clinical features in AA patients with or without HBV infection. The prevalence of non-severe AA (NSAA) progressed to severe AA (SAA) was similar in two groups (35.6% vs 42.7%, p=1.0). In NSAA group, the response rate to CsA, to ATG and CsA, and progression to SAA were similar in patients with or without HBV infection (35.7% vs 35.3%, p>0.05; 42.8% vs 58.8%, p= 1.0; 35.5% vs 42.7%, p= 0.414). In SAA group, patients with or without HBV infection responded to ATG and CsA therapy similarly (83.33% vs 59.0%, p = 0.252). HBV reactivation was occurred in all 5 HBsAg positive patients without any antiviral therapy, while no HBV reactivation happened in other 7 patients received antiviral therapy. Disease course (RR=1.012, p=0.036) and absolute reticulocyte count (RR=11.556, P=0.025) were the risk factors for HBV reactivation by univariate analysis. Logistic regression indicated that HBsAg positivity without preventive therapy was the only strong factor for HBV reactivation. Conclusion: Antiviral prophylaxis is recommended for HBsAg-positive patients with AA who will receive IST because of high rate of HBV reactivation. HBV infection has no influence on the clinic course of AA, and antiviral therapy does not affect the efficacy of IST. Disclosures No relevant conflicts of interest to declare.