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Atherosclerotic cardiovascular disease risk profile of patients with chronic hepatitis B treated with tenofovir alafenamide or tenofovir disoproxil fumarate for 96 weeks

Fung, Scott K; Pan, Calvin Q; Wong, Grace Lai-Hung; Seto, Wai-Kay; Ahn, Sang Hoon; Chen, Chi-Yi; Hann, Hie-Won L; Jablkowski, Maciej S; Kim, Yoon Jun; Yurdaydin, Cihan; Peng, Cheng-Yuan; Nguyen, Tuan; Yatsuhashi, Hiroshi; Flaherty, John F; Yee, Leland J; Abramov, Frida; Wang, Hongyuan; Abdurakhmanov, Dzhamal; Lim, Young-Suk; Buti, Maria
BACKGROUND:Patients with chronic hepatitis B (CHB) who switch from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF) show changes in lipid profiles. AIM/OBJECTIVE:To evaluate how these changes affect cardiovascular risk. METHODS:This pooled analysis, based on two large prospective studies, evaluated fasting lipid profiles of patients with CHB who were treated with TAF 25 mg/day or TDF 300 mg/day for 96 weeks. Patients who fulfilled the American College of Cardiology criteria (age 40-79 years, high-density lipoprotein [HDL] 20-100 mg/dL, total cholesterol [TC] 130-320 mg/dL and systolic blood pressure 90-200 mmHg) required to assess 10-year atherosclerotic cardiovascular disease (ASCVD) risk with baseline lipid data and at least one post-baseline measurement were included in the ASCVD-risk population. The 10-year ASCVD risk was calculated for patients in this population, and changes from baseline to Week 96 were assessed using intermediate- (≥7.5%) and high-risk (≥20%) cut-offs. RESULTS:Among 1632 patients, 620 (38%) met the criteria for the ASCVD-risk population. At Week 96, fasting levels of all lipids, except TC:HDL ratio, were lower with TDF than TAF. No significant increase was observed in overall ASCVD risk or in any ASCVD-risk categories during the 96-week treatment period compared with baseline. A similar proportion of patients in the TAF and TDF treatment groups (1.3% and 2.3%, respectively; p = 0.34) reported cardiovascular events. CONCLUSION/CONCLUSIONS:Despite on-treatment differences in lipid profiles with TAF and TDF, predicted cardiovascular risk and clinical events were similar for both groups after 96 weeks.
PMID: 37905449
ISSN: 1365-2036
CID: 5623602

The function role of HIGD1A in nonalcoholic steatohepatitis from chronic hepatitis B

Li, Min-Ran; Li, Jin-Zhong; Wang, De-Hua; Li, Tao-Yuan; Ye, Li-Hong; Liang, Xu-Jing; Zhang, Hai-Cong; Liu, Zhi-Quan; Zhang, Xue-Dong; Li, Jun-Qing; Liu, Yun-Yan; Pan, Calvin Q; Dai, Er-Hei
BACKGROUND/UNASSIGNED:Accompanied by the growing prevalence of nonalcoholic fatty liver disease (NAFLD), the coexistence of chronic hepatitis B (CHB) and NAFLD has increased. In the context of CHB, there is limited understanding of the factors that influence the development of NASH. METHODS/UNASSIGNED:investigations were conducted using hepatitis B virus (HBV) transgenic mice. RESULTS/UNASSIGNED:CHB model, HIGD1A was significantly higher in the NASH group than in the non-NASH group. HIGD1A knockdown impaired mitochondrial transmembrane potential and induced cell apoptosis in HepG2.2.15 cells added oleic acid and palmitate. On the contrary, hepatic HIGD1A overexpression ameliorated free fatty acids-induced apoptosis and oxidative stress. Furthermore, HIGD1A reduced reactive oxygen species (ROS) level by increasing glutathione (GSH) expression, but Adenosine 5'-monophosphate (AMP)-activated protein kinase (AMPK)/Acetyl-CoA carboxylase (ACC) pathway was not involved. CONCLUSION/UNASSIGNED:CHB model, an upward trend of HIGD1A was observed in the NASH-related inflammatory response. HIGDIA played a protective role in cells against oxidative stress. Our data suggested that HIGD1A may be a positive regulator of NASH within the CHB context.
PMID: 38053282
ISSN: 1502-7708
CID: 5595562

Incidence and predictors of elevated postpartum alanine aminotransferase in chronic hepatitis B mothers: a prospective study protocol

OuYang, Shi; Chen, Ziren; Peng, Tingting; Geng, Yawen; Qiu, Junchao; Xiao, Zhirong; Pan, Calvin Q
BACKGROUND:The majority of HBeAg-positive mothers with chronic hepatitis B have high levels of viremia and inactive disease with normal alanine aminotransferase (ALT) during pregnancy. In addition, postpartum disease activation and ALT flare have been reported in the range of 15 - 35%. However, the current International Association Guidelines have not provided clear recommendations and a risk-stratified monitoring schedule. Furthermore, data are lacking on the definition of normal ALT in the postpartum period in mothers with chronic hepatitis B. The clinical features and ALT flare patterns in HBeAg-positive mothers versus HBeAg-negative mothers are not fully explored. Thus, we design a cohort study to investigate the aforementioned area and generate data to assist healthcare providers in better managing mothers with hepatitis B. We aim to assess the frequency of postpartum ALT flares and predictors for such events. METHOD/METHODS:This study is a single-center and prospective cohort study (n = 360) that consists of two groups of patients including HBsAg-positive mothers (n = 120) and healthy mothers without HBV infection (n = 240). In HBeAg-positive mothers, antiviral therapy during late pregnancy is permitted to prevent Mother-to-child transmission (MTCT) but discontinued at delivery if there is no further indication for the treatment. Mothers are enrolled at the gestational weeks of 12-24. After delivery, both mothers and their infants will be followed up until postpartum week 24. Clinical and laboratory data are collected every 4 weeks during the study except there are no follow-up visits at the postpartum weeks 16 and 20. The primary objective is the proportion of patients with postpartum ALT flares. The secondary objectives are independent risk factors during pregnancy for predicting postpartum ALT flares and the normal range of postpartum ALT levels in healthy mothers. DISCUSSION/CONCLUSIONS:The current study focuses on the incidence of postpartum ALT flares in mothers with chronic hepatitis B including subgroup analysis based on HBeAg status. The data will have several clinical implications, such as providing evidence for an appropriate monitoring schedule in CHB mothers after delivery. Further analyses on predictors of such events may assist clinicians in identifying mothers who might develop severe postpartum ALT flares. The data generated from healthy mothers have the potential to identify the patterns of ALT changes during pregnancy and postpartum, so we can gain a better understanding of the normal range of ALT in this subpopulation. TRIAL REGISTRATION NUMBER AT THE CHINESE CLINICAL TRIAL REGISTRY/UNASSIGNED:ChiCTR2200061130.
PMCID:10640741
PMID: 37951866
ISSN: 1471-230x
CID: 5610022

Reply to: "Does currently recommended maternal antiviral prophylaxis against mother-to-child transmission of hepatitis B virus require enhancement?"

Matthews, Philippa C; Ocama, Ponsiano; Wang, Su; El-Sayed, Manal; Turkova, Anna; Ford, Deborah; Torimiro, Judith; Garcia Ferreira, Ana Cristina; Miranda, Angélica Espinosa; De La Hoz Restrepo, Fernando Pio; Seremba, Emmanuel; Mbu, Robinson; Pan, Calvin Q; Razavi, Homie; Dusheiko, Geoffrey; Spearman, C Wendy; Hamid, Saeed
PMCID:10563044
PMID: 37822785
ISSN: 2589-5559
CID: 5604452

Correction to: Diagnosis and Management of Hepatitis Delta Virus Infection

Pan, Calvin; Gish, Robert; Jacobson, Ira M; Hu, Ke-Qin; Wedemeyer, Heiner; Martin, Paul
PMID: 37558801
ISSN: 1573-2568
CID: 5619992

Prognostic risk factors for patients with hepatic sinusoidal obstruction syndrome caused by pyrrolizidine alkaloids

Du, Xiaofei; Liu, Zhenli; Yu, Haibin; Wang, Yu; Zou, Zhengsheng; Wei, Hongshan; Liang, Jing; Yang, Daokun; Liu, Yali; Zhang, Jing; Pan, Calvin Q
Pyrrolizidine alkaloids induced hepatic sinusoidal obstruction syndrome (PA-HSOS) often occurs after consuming herbs or a dietary supplement containing the plant Tu-San-Qi. Limited data exists to identify patients with fatal outcomes for early interventions. We aimed to analyze the predictors for 3-month survival. We retrospectively enrolled PA-HSOS patients in 5 hospitals and extracted data from the onset of PA-HSOS to 36 months. Outcome measurements were 3-month and 36-month survival rates, baseline prognostic predictors for survival, and the effects of anticoagulant therapy. Among 49 enrollees, the median age was 60 and 49% male. At the onset of PA-HSOS, patients with Child-Turcotte-Pugh (CTP) class of A, B, or C were 8.2% (4/49), 42.8% (21/49) and 49.0% (24/49), respectively. None of them received a transjugular intrahepatic portosystemic shunt or a liver transplant. The 3-month and 36-month survival rates were 86% and 76%, respectively. Compared to the CTP class A or B, class C at baseline independently predicted lower survival rates at both 3 and 36 months. However, anticoagulation therapy treatment within the first 3 months independently predicted significantly higher survival rates at both time points. CTP class C and anticoagulant therapy were the independent predictors for short-term and long-term survival. Anticoagulant therapy could decrease mortality rate of CTP class C patients. The greatest benefit of anticoagulant evaluated by 3-month survival rate was in patients with CTP class C compared with those without treatment (93% vs 40%, P = .009). There were no bleeding complications reported in patients treated with the anticoagulant.
PMCID:10419670
PMID: 37565875
ISSN: 1536-5964
CID: 5595342

Enhancing interventions for prevention of mother-to-child- transmission of hepatitis B virus

Matthews, Philippa C.; Ocama, Ponsiano; Wang, Su; El-Sayed, Manal; Turkova, Anna; Ford, Deborah; Torimiro, Judith; Garcia Ferreira, Ana Cristina; Espinosa Miranda, Angélica; De La Hoz Restrepo, Fernando Pio; Seremba, Emmanuel; Mbu, Robinson; Pan, Calvin Q.; Razavi, Homie; Dusheiko, Geoffrey; Spearman, C. Wendy; Hamid, Saeed
Prevention of mother-to-child transmission of hepatitis B virus (HBV) infection is a cornerstone of efforts to support progress towards elimination of viral hepatitis. Current guidelines recommend maternal screening, antiviral therapy during the third trimester of high-risk pregnancies, universal and timely HBV birth dose vaccination, and post-exposure prophylaxis with hepatitis B immunoglobulin for selected neonates. However, serological and molecular diagnostic testing, treatment and HBV vaccination are not consistently deployed, particularly in many high endemicity settings, and models predict that global targets for reduction in paediatric incidence will not be met by 2030. In this article, we briefly summarise the evidence for current practice and use this as a basis to discuss areas in which prevention of mother-to-child transmission can potentially be enhanced. By reducing health inequities, enhancing pragmatic use of resources, filling data gaps, developing advocacy and education, and seeking consistent investment from multilateral agencies, significant advances can be made to further reduce vertical transmission events, with wide health, societal and economic benefits.
SCOPUS:85164398621
ISSN: 2589-5559
CID: 5548402

Hepatitis D double reflex testing of all hepatitis B carriers in low-HBV- and high-HBV/HDV-prevalence countries

Razavi, Homie A; Buti, Maria; Terrault, Norah A; Zeuzem, Stefan; Yurdaydin, Cihan; Tanaka, Junko; Aghemo, Alessio; Akarca, Ulus S; Al Masri, Nasser M; Alalwan, Abduljaleel M; Aleman, Soo; Alghamdi, Abdullah S; Alghamdi, Saad; Al-Hamoudi, Waleed K; Aljumah, Abdulrahman A; Altraif, Ibrahim H; Asselah, Tarik; Ben-Ari, Ziv; Berg, Thomas; Biondi, Mia J; Blach, Sarah; Braga, Wornei S M; Brandão-Mello, Carlos E; Brunetto, Maurizia R; Cabezas, Joaquin; Cheinquer, Hugo; Chen, Pei-Jer; Cheon, Myeong-Eun; Chuang, Wan-Long; Coffin, Carla S; Coppola, Nicola; Craxi, Antonio; Crespo, Javier; De Ledinghen, Victor; Duberg, Ann-Sofi; Etzion, Ohad; Ferraz, Maria Lucia G; Ferreira, Paulo R A; Forns, Xavier; Foster, Graham R; Gaeta, Giovanni B; Gamkrelidze, Ivane; García-Samaniego, Javier; Gheorghe, Liliana S; Gholam, Pierre M; Gish, Robert G; Glenn, Jeffrey; Hercun, Julian; Hsu, Yao-Chun; Hu, Ching-Chih; Huang, Jee-Fu; Janjua, Naveed; Jia, Jidong; Kåberg, Martin; Kaita, Kelly D E; Kamal, Habiba; Kao, Jia-Horng; Kondili, Loreta A; Lagging, Martin; Lázaro, Pablo; Lazarus, Jeffrey V; Lee, Mei-Hsuan; Lim, Young-Suk; Marotta, Paul J; Navas, Maria-Cristina; Naveira, Marcelo C M; Orrego, Mauricio; Osiowy, Carla; Pan, Calvin Q; Pessoa, Mário G; Raimondo, Giovanni; Ramji, Alnoor; Razavi-Shearer, Devin M; Razavi-Shearer, Kathryn; Ríos-Hincapié, Cielo Y; Rodríguez, Manuel; Rosenberg, William M C; Roulot, Dominique M; Ryder, Stephen D; Safadi, Rifaat; Sanai, Faisal M; Santantonio, Teresa A; Sarrazin, Christoph; Shouval, Daniel; Tacke, Frank; Tergast, Tammo L; Villalobos-Salcedo, Juan Miguel; Voeller, Alexis S; Yang, Hwai-I; Yu, Ming-Lung; Zuckerman, Eli
Hepatitis D virus (HDV) infection occurs as a coinfection with hepatitis B and increases the risk of hepatocellular carcinoma, decompensated cirrhosis, and mortality compared to hepatitis B virus (HBV) monoinfection. Reliable estimates of the prevalence of HDV infection and disease burden are essential to formulate strategies to find coinfected individuals more effectively and efficiently. The global prevalence of HBV infections was estimated to be 262,240,000 in 2021. Only 1,994,000 of the HBV infections were newly diagnosed in 2021, with more than half of the new diagnoses made in China. Our initial estimates indicated a much lower prevalence of HDV antibody (anti-HDV) and HDV RNA positivity than previously reported in published studies. Accurate estimates of HDV prevalence are needed. The most effective method to generate estimates of the prevalence of anti-HDV and HDV RNA positivity and to find undiagnosed individuals at the national level is to implement double reflex testing. This requires anti-HDV testing of all hepatitis B surface antigen-positive individuals and HDV RNA testing of all anti-HDV-positive individuals. This strategy is manageable for healthcare systems since the number of newly diagnosed HBV cases is low. At the global level, a comprehensive HDV screening strategy would require only 1,994,000 HDV antibody tests and less than 89,000 HDV PCR tests. Double reflex testing is the preferred strategy in countries with a low prevalence of HBV and those with a high prevalence of both HBV and HDV. For example, in the European Union and North America only 35,000 and 22,000 cases, respectively, will require anti-HDV testing annually.
PMID: 37030400
ISSN: 1600-0641
CID: 5502712

Diagnosis and Management of Hepatitis Delta Virus Infection

Pan, Calvin; Gish, Robert; Jacobson, Ira M; Hu, Ke-Qin; Wedemeyer, Heiner; Martin, Paul
Hepatitis D virus (HDV) depends on hepatitis B virus (HBV) to enter and exit hepatocytes and to replicate. Despite this dependency, HDV can cause severe liver disease. HDV accelerates liver fibrosis, increases the risk of hepatocellular carcinoma, and hastens hepatic decompensation compared to chronic HBV monoinfection. The Chronic Liver Disease Foundation (CLDF) formed an expert panel to publish updated guidelines on the testing, diagnosis, and management of hepatitis delta virus. The panel group performed network data review on the transmission, epidemiology, natural history, and disease sequelae of acute and chronic HDV infection. Based on current available evidence, we provide recommendations for screening, testing, diagnosis, and treatment of hepatitis D infection and review upcoming novel agents that may expand treatment options. The CLDF recommends universal HDV screening for all patients who are Hepatitis B surface antigen-positive. Initial screening should be with an assay to detect antibodies generated against HDV (anti-HDV). Patients who are positive for anti-HDV IgG antibodies should then undergo quantitative HDV RNA testing. We also provide an algorithm that describes CLDF recommendations on the screening, diagnosis, testing, and initial management of Hepatitis D infection.
PMID: 37338616
ISSN: 1573-2568
CID: 5535122

Efficacy and Safety of Sofosbuvir-based Regimens in Hepatitis C Patients With Decompensated Cirrhosis: A Systematic Review and Meta-analysis

Zhang, Wenyan; Zhang, Jing; Tang, Shan; Liu, Yali; Du, Xiaofei; Qiu, Lixia; Liu, Menglu; Yu, Haibin; Pan, Calvin Q
BACKGROUND AND AIMS/UNASSIGNED:Decompensated cirrhotic patients with hepatitis C (HCV) are often under-represented in clinical trials. We aimed to evaluate pooled data on the efficacy and safety of sofosbuvir (SOF)-based regimens in these patients. METHODS/UNASSIGNED:We conducted a systemic review and meta-analysis by searching multiple databases for studies published from October 2010 to October 2020. Outcomes of interest were sustained virologic response (SVR) and safety of SOF-based regimens in decompensated HCV patients. Two reviewers independently performed the study selection and data extraction. RESULTS/UNASSIGNED:=0.76)] in decompensated patients, which was also true in subgroup analyses for each regimen within the same treatment duration. However, adding ribavirin significantly increased the frequency of adverse events from 52.9% (95% CI: 28.0-77.1) to 89.2% (95% CI: 68.1-99.9) and frequency of severe events. The pooled incidence of hepatocellular carcinoma and case-fatality of decompensated patients were 3.1% (95% CI: 1.5-5.0) and 4.6% (95% CI: 3.1-6.3), respectively. The overall heterogeneity was high. There was no publication bias. CONCLUSIONS/UNASSIGNED:The analysis found that 12 weeks of SOF/velpatasvir without ribavirin is the preferred therapy, with a significantly higher SVR compared with other SOF-based regimens in decompensated HCV patients.
PMCID:9647115
PMID: 36406321
ISSN: 2310-8819
CID: 5383992