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1. Bulevirtide monotherapy in patients with chronic HDV: Efficacy and safety results through week 96 from a phase III randomized trial

Author

Wedemeyer, Heiner, Aleman, Soo, Brunetto, Maurizia, Blank, Antje, Andreone, Pietro, Bogomolov, Pavel, Chulanov, Vladimir, Mamonova, Nina, Geyvandova, Natalia, Morozov, Viacheslav, Sagalova, Olga, Stepanova, Tatyana, Berger, Annemarie, Ciesek, Sandra, Manuilov, Dmitry, Mercier, Renee-Claude, Da, Ben L., Chee, Grace M., Li, Mingyang, Flaherty, John F., Lau, Audrey H., Osinusi, Anu, Schulze zur Wiesch, Julian, Cornberg, Markus, Zeuzem, Stefan, and Lampertico, Pietro

Published
2024
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2. Switching to tenofovir alafenamide in patients with virologically suppressed chronic hepatitis B and renal or hepatic impairment: final week 96 results from an open-label, multicentre, phase 2 study

Author

Janssen, Harry L A, Lim, Young-Suk, Lampertico, Pietro, Heo, Jeong, Chen, Chi-Yi, Fournier, Claire, Tsang, Tak Yin Owen, Bae, Ho, Chen, Chien-Hung, Coffin, Carla S, Ahn, Sang Hoon, Trinh, Huy, Flaherty, John F, Abramov, Frida, Zhao, Yang, Liu, Yang, Lau, Audrey, German, Polina, Chuang, Wan-Long, Agarwal, Kosh, and Gane, Edward

Published
2024
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4. Nutritional needs, resources, and barriers among unhoused adults cared for by a street medicine organization in Chicago, Illinois: a cross-sectional study

Author

Adams, Elizabeth J., Lu, Michelle, Duan, Richard, Chao, Alyssa K., Kessler, Helen C., Miller, Charles D., Richter, Adam G., Latyshev, Daniel G., Dastoor, Jehannaz D., Eckburg, Adam J., Kadambi, Namrata S., Suresh, Nila R., Bales, Cayla E., Green, Hannah M., Camp, Daniel M., Jara, Rolando, and Flaherty, John P.

Published
2023
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5. EXPLORATORY ELECTROCARDIOGRAPHY

Author

BLUMENSCHEIN, SARAH D., primary, SPACH, MADISON S., additional, FLAHERTY, JOHN T., additional, BOINEAU, JOHN P., additional, BARR, ROGER C., additional, and GALLIE, THOMAS M., additional

Published
2023
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8. Tenofovir alafenamide and tenofovir disoproxil fumarate reduce incidence of hepatocellular carcinoma in patients with chronic hepatitis B

Author

Lim, Young-Suk, Chan, Henry L.Y., Ahn, Sang Hoon, Seto, Wai Kay, Ning, Qin, Agarwal, Kosh, Janssen, Harry L.A., Pan, Calvin Q., Chuang, Wan Long, Izumi, Namiki, Fung, Scott, Shalimar, Brunetto, Maurizia, Hui, Aric Josun, Chang, Ting-Tsung, Lim, Seng Gee, Abramov, Frida, Flaherty, John F., Wang, Hongyuan, Yee, Leland J., Kao, Jia-Horng, Gane, Edward, Hou, Jinlin, and Buti, Maria

Published
2023
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9. No virologic resistance to bulevirtide monotherapy detected in patients through 24 weeks treatment in phase II and III clinical trials for chronic hepatitis delta

Author

Hollnberger, Julius, Liu, Yang, Xu, Simin, Chang, Silvia, Martin, Ross, Manhas, Savrina, Aeschbacher, Thomas, Han, Bin, Yazdi, Tahmineh, May, Lindsey, Han, Dong, Shornikov, Alex, Flaherty, John, Manuilov, Dmitry, Suri, Vithika, Asselah, Tarik, Lampertico, Pietro, Wedemeyer, Heiner, Aleman, Soo, Richards, Christopher, Mateo, Roberto, Maiorova, Evguenia, Cihlar, Tomas, Mo, Hongmei, and Urban, Stephan

Published
2023
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10. TOP-400 Impact of bulevirtide given with or without nucleos (t)ide analogues on 48-week virologic outcomes in patients with chronic hepatitis delta virus infection

Author

Lampertico, Pietro, primary, Brunetto, Maurizia, additional, Buti, Maria, additional, Aleman, Soo, additional, Bogomolov, Pavel, additional, Chulanov, Vladimir, additional, Mamonova, Nina, additional, Morozov, Viacheslav, additional, Sagalova, Olga, additional, Stepanova, Tatyana, additional, Flaherty, John F., additional, Li, Mingyang, additional, Manuilov, Dmitry, additional, Da, Ben L., additional, Mercier, Renee-Claude, additional, Chee, Grace M., additional, Cornberg, Markus, additional, Wedemeyer, Heiner, additional, and Asselah, Tarik, additional

Published
2024
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11. FRI-390 Off-treatment outcomes after discontinuing tenofovir-based treatment in hepatitis B e antigen-positive and hepatitis B e antigen-negative patients with chronic hepatitis B virus

Author

Buti, Maria, primary, Chan, Henry L.Y., additional, Fung, Scott K., additional, Peng, Cheng-Yuan, additional, Abramov, Frida, additional, Tedesco, Dana, additional, Wang, Hongyuan, additional, Yee, Leland J., additional, Flaherty, John F., additional, Gane, Edward J., additional, Lim, Young-Suk, additional, Janssen, Harry L.A., additional, and Agarwal, Kosh, additional

Published
2024
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12. Bulevirtide monotherapy in patients with chronic HDV: Efficacy and safety results through week 96 from a phase 3 randomized trial

Author

Wedemeyer, Heiner, primary, Aleman, Soo, additional, Brunetto, Maurizia, additional, Blank, Antje, additional, Andreone, Pietro, additional, Bogomolov, Pavel, additional, Chulanov, Vladimir, additional, Mamonova, Nina, additional, Geyvandova, Natalia, additional, Morozov, Viacheslav, additional, Sagalova, Olga, additional, Stepanova, Tatyana, additional, Berger, Annemarie, additional, Ciesek, Sandra, additional, Manuilov, Dmitry, additional, Mercier, Renee-Claude, additional, Da, Ben L., additional, Chee, Grace M., additional, Li, Mingyang, additional, Flaherty, John F., additional, Lau, Audrey H., additional, Osinusi, Anu, additional, Schulze zur Wiesch, Julian, additional, Cornberg, Markus, additional, Zeuzem, Stefan, additional, and Lampertico, Pietro, additional

Published
2024
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13. Five-year Treatment with Tenofovir Alafenamide Achieves High Rates of Viral Suppression, Alanine Aminotransferase Normalization, and Favorable Bone and Renal Safety in Chinese Chronic Hepatitis B Patients

Author

Hou, Jinlin, primary, Ning, Qin, additional, Duan, Zhongping, additional, Chen, Yu, additional, Xie, Qing, additional, Zhang, Lunli, additional, Wu, Shanming, additional, Tang, Hong, additional, Li, Jun, additional, Lin, Feng, additional, Yang, Yongfeng, additional, Gong, Guozhong, additional, Luo, Yanwen, additional, Xie, Shelley, additional, Wang, Hongyuan, additional, Mateo, Roberto, additional, Yazdi, Tahmineh, additional, Abramov, Frida, additional, Yee, Leland J., additional, Flaherty, John, additional, Chen, Chengwei, additional, Huang, Yan, additional, Zhang, Mingxiang, additional, and Jia, Jidong, additional

Published
2024
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14. Randomized, placebo-controlled window trial of EGFR, Src, or combined blockade in head and neck cancer

Author

Bauman, Julie E, Duvvuri, Umamaheswar, Gooding, William E, Rath, Tanya J, Gross, Neil D, Song, John, Jimeno, Antonio, Yarbrough, Wendell G, Johnson, Faye M, Wang, Lin, Chiosea, Simion, Sen, Malabika, Kass, Jason, Johnson, Jonas T, Ferris, Robert L, Kim, Seungwon, Hirsch, Fred R, Ellison, Kimberly, Flaherty, John T, Mills, Gordon B, and Grandis, Jennifer R

Subjects
Dental/Oral and Craniofacial Disease, Orphan Drug, Prevention, Rare Diseases, Cancer, Clinical Trials and Supportive Activities, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Aged, Biomarkers, Tumor, Double-Blind Method, ErbB Receptors, Female, Head and Neck Neoplasms, Humans, Male, Middle Aged, Placebos, STAT3 Transcription Factor, Signal Transduction, Squamous Cell Carcinoma of Head and Neck, src-Family Kinases
Abstract

BACKGROUND. EGFR and Src family kinases are upregulated in head and neck squamous cell carcinoma (HNSCC). EGFR interacts with Src to activate STAT3 signaling, and dual EGFR-Src targeting is synergistic in HNSCC preclinical models. pSrc overexpression predicted resistance to the EGFR inhibitor, erlotinib, in a prior window trial. We conducted a 4-arm window trial to identify biomarkers associated with response to EGFR and/or Src inhibition. METHODS. Patients with operable stage II-IVa HNSCC were randomized to 7-21 days of neoadjuvant erlotinib, the Src inhibitor dasatinib, the combination of both, or placebo. Paired tumor specimens were collected before and after treatment. Pharmacodynamic expression of EGFR and Src pathway components was evaluated by IHC of tissue microarrays and reverse-phase protein array of tissue lysates. Candidate biomarkers were assessed for correlation with change in tumor size. RESULTS. From April 2009 to December 2012, 58 patients were randomized and 55 were treated. There was a significant decrease in tumor size in both erlotinib arms (P = 0.0014); however, no effect was seen with dasatinib alone (P = 0.24). High baseline pMAPK expression was associated with response to erlotinib (P = 0.03). High baseline pSTAT3 was associated with resistance to dasatinib (P = 0.099). CONCLUSIONS. Brief exposure to erlotinib significantly decreased tumor size in operable HNSCC, with no additive effect from dasatinib. Baseline pMAPK expression warrants further study as a response biomarker for anti-EGFR therapy. Basal expression of pSTAT3 may be independent of Src, explain therapeutic resistance, and preclude development of dasatinib in biomarker-unselected cohorts. TRIAL REGISTRATION. NCT00779389. FUNDING. National Cancer Institute, American Cancer Society, Pennsylvania Department of Health, V Foundation for Cancer Research, Bristol-Myers Squibb, and Astellas Pharma.

Published
2017

15. Long-Term Treatment With Tenofovir Alafenamide for Chronic Hepatitis B Results in High Rates of Viral Suppression and Favorable Renal and Bone Safety

Author

Chan, Henry L.Y., Buti, Maria, Lim, Young Suk, Agarwal, Kosh, Marcellin, Patrick, Brunetto, Maurizia, Chuang, Wan Long, Janssen, Harry L.A., Fung, Scott, Izumi, Namiki, Abdurakhmanov, Dzhamal, Jabłkowski, Maciej, Celen, Mustafa K., Ma, Xiaoli, Caruntu, Florin, Flaherty, John F., Abramov, Frida, Wang, Hongyuan, Camus, Gregory, Osinusi, Anu, Pan, Calvin Q., Shalimar, Seto, Wai Kay, Gane, Edward, Chan, Henry L.Y., Buti, Maria, Lim, Young Suk, Agarwal, Kosh, Marcellin, Patrick, Brunetto, Maurizia, Chuang, Wan Long, Janssen, Harry L.A., Fung, Scott, Izumi, Namiki, Abdurakhmanov, Dzhamal, Jabłkowski, Maciej, Celen, Mustafa K., Ma, Xiaoli, Caruntu, Florin, Flaherty, John F., Abramov, Frida, Wang, Hongyuan, Camus, Gregory, Osinusi, Anu, Pan, Calvin Q., Shalimar, Seto, Wai Kay, and Gane, Edward

Abstract

INTRODUCTION: The results from 2 phase 3 studies, through 2 years, in chronic hepatitis B infection showed tenofovir alafenamide (TAF) had similar efficacy to tenofovir disoproxil fumarate (TDF) with superior renal and bone safety. We report updated results through 5 years. METHODS: Patients with HBeAg-negative or HBeAg-positive chronic hepatitis B infection with or without compensated cirrhosis were randomized (2:1) to TAF 25 mg or TDF 300 mg once daily in double-blind (DB) fashion for up to 3 years, followed by open-label (OL) TAF up to 8 years. Efficacy (antiviral, biochemical, and serologic), resistance (deep sequencing of polymerase/reverse transcriptase and phenotyping), and safety, including renal and bone parameters, were evaluated by pooled analyses. RESULTS: Of 1,298 randomized and treated patients, 866 receiving TAF (DB and OL) and 432 receiving TDF with rollover to OL TAF at year 2 (n = 180; TDF→TAF3y) or year 3 (n = 202; TDF→TAF2y) were included. Fifty (4%) TDF patients who discontinued during DB were excluded. At year 5, 85%, 83%, and 90% achieved HBV DNA <29 IU/mL (missing 5 failure) in the TAF, TDF→TAF3y, and TDF→TAF2y groups, respectively; no patient developed TAF or TDF resistance. Median estimated glomerular filtration rate (by using Cockcroft-Gault) declined <2.5 mL/min, and mean declines of <1% in hip and spine bone mineral density were seen at year 5 in the TAF group; patients in the TDF→TAF groups had improvements in these parameters at year 5 after switching to OL TAF. DISCUSSION: Long-term TAF treatment resulted in high rates of viral suppression, no resistance, and favorable renal and bone safety.

Published
2024

16. Under Construction: Benchmark Assessments and Common Core Math Implementation in Grades K-8. Formative Evaluation Cycle Report for the Math in Common Initiative, Volume 1

Author

WestEd, Flaherty, John, Sobolew-Shubin, Alexandria, Heredia, Alberto, Chen-Gaddini, Min, Klarin, Becca, and Finkelstein, Neal D.

Abstract

Math in Common® (MiC) is a five-year initiative that supports a formal network of 10 California school districts as they implement the Common Core State Standards in mathematics (CCSS-M) across grades K-8. As the MiC initiative moves into its second year, one of the central activities that each of the districts is undergoing to support CCSS implementation involves putting in place new or revised student assessment processes or systems to better align with the new standards. This report examines the MiC districts' strategies and initial implementation efforts related to benchmark assessments used throughout the school year to assess student mastery of the CCSS-M and signal districts' progress. The report also highlights the range of approaches to developing and implementing benchmark assessments used across the MiC district community, in order to illuminate the challenges and headway that many districts in California, and perhaps beyond, are facing as they work to implement CCSS-M, specifically across grades K-8. [For Volume 2, see ED559582.]

Published
2014

17. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in virologically suppressed patients with chronic hepatitis B: a randomised, double-blind, phase 3, multicentre non-inferiority study

Author

Lampertico, Pietro, Buti, Maria, Fung, Scott, Ahn, Sang Hoon, Chuang, Wan-Long, Tak, Won Young, Ramji, Alnoor, Chen, Chi-Yi, Tam, Edward, Bae, Ho, Ma, Xiaoli, Flaherty, John F, Gaggar, Anuj, Lau, Audrey, Liu, Yang, Wu, George, Suri, Vithika, Tan, Susanna K, Subramanian, G Mani, Trinh, Huy, Yoon, Seung-Kew, Agarwal, Kosh, Lim, Young-Suk, and Chan, Henry L Y

Published
2020
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19. A pharmacogenetic candidate gene study of tenofovir-associated Fanconi syndrome

Author

Dahlin, Amber, Wittwer, Matthias, de la Cruz, Melanie, Woo, Jonathan M, Bam, Rujuta, Scharen-Guivel, Valeska, Flaherty, John, Ray, Adrian S, Cihlar, Tomas, Gupta, Samir K, and Giacomini, Kathleen M

Subjects
Biological Sciences, Biomedical and Clinical Sciences, Genetics, Prevention, Kidney Disease, 2.1 Biological and endogenous factors, Aetiology, Adenine, Alleles, Anti-HIV Agents, Biomarkers, Pharmacological, Case-Control Studies, Fanconi Syndrome, Genetic Association Studies, HEK293 Cells, HIV Infections, HIV-1, Humans, Multidrug Resistance-Associated Protein 2, Organophosphonates, Pharmacogenetics, Polymorphism, Single Nucleotide, Sequence Analysis, DNA, Tenofovir, Fanconi syndrome, HIV, pharmacogenetics, tenofovir, transporter, Pharmacology and Pharmaceutical Sciences, Pharmacology & Pharmacy, Pharmacology and pharmaceutical sciences
Abstract

BackgroundTenofovir disoproxil fumarate (TDF) is a widely used antiretroviral agent with favorable efficacy, safety, and tolerability profiles. However, renal adverse events, including the rare Fanconi syndrome (FS), may occur in a small subset of patients treated for HIV infections.ObjectivesThe aim of this study was to identify genetic variants that may be associated with TDF-associated FS (TDF-FS).MethodsDNA samples collected from 19 cases with TDF-FS and 36 matched controls were sequenced, and genetic association studies were conducted on eight candidate genes: ATP-binding cassette (ABC) transporters ABCC2 (MRP2) and ABCC4 (MRP4), solute carrier family members SLC22A6 (OAT1) and SLC22A8 (OAT3), adenylate kinases 2 (AK2) and 4 (AK4), chloride transporter CIC-5 CLCN5, and Lowe syndrome protein OCRL. The functional effects of a single nucleotide polymorphism (SNP) predicted to alter the transport of tenofovir were then investigated in cells expressing an identified variant of ABCC4.ResultsThe case group showed a trend toward a higher proportion of rare alleles. Six SNPs in ABCC2 (three SNPs), ABCC4 (one SNP), and OCRL (two SNPs) were associated with TDF-FS case status; however, this association did not remain significant after correction for multiple testing. Six SNPs, present in OCRL (four SNPs) and ABCC2 (two SNPs), were significantly associated with increased serum creatinine levels in the cases, and this association remained significant after multiple test correction (P < 2 × 10). One synonymous SNP in ABCC2 (rs8187707, P = 2.10 × 10, β = -73.3 ml/min/1.73 m(2)) was also significantly associated with the decreased estimated glomerular filtration rate of creatinine among cases. However, these results were driven by rare SNPs present in a small number of severely affected cases. Finally, a previously uncharacterized, nonsynonymous SNP, rs11568694, that was predicted to alter MRP4 function had no significant effect on tenofovir cellular accumulation in vitro.ConclusionAlthough no single predictive genetic marker for the development of TDF-FS was identified, the findings from our study suggest that rare variants in multiple genes involved in the renal handling of tenofovir, and/or renal cell homeostasis, may be associated with increased susceptibility to TDF-FS.

Published
2015

21. Longitudinal Assessment of Comprehensive School Reform Program Implementation and Outcomes: First-Year Report

Author

WestEd, San Francisco, CA. and Tushnet, Naida C., Flaherty, John, Smith, And

Abstract

The Longitudinal Assessment of Comprehensive School Reform Implementation and Outcomes (LACIO) responds to the No Child Left Behind Act's requirement for an evaluation of the federal Comprehensive School Reform (CSR) program. The legislation stipulates two broad goals for the evaluation: (1) to evaluate the implementation and outcomes achieved by schools after three years of implementing comprehensive school reforms; and (2) to assess the effectiveness of comprehensive school reform in schools with diverse characteristics. In order to address these requirements, the study focused on four evaluation questions: (1) How are CSR funds being targeted? (2) How is comprehensive school reform implemented in schools receiving CSR funds, in schools receiving Title I funds and in other schools? (3) What is the relationship between CSR implementation and student achievement outcomes? (4) What conditions (at the state and district level) influence the implementation of comprehensive reform programs? This report presents data collected from a random sample of 400 CSR schools that received funding in 2002 and 400 non-CSR schools with similar demographic and achievement characteristics. It draws from three data sources?school-level surveys of principals and teachers, the National School-Level State Assessment Score Database and the National Center for Educational Statistics (NCES) Common Core of Data (CCD). The data were collected in spring 2003 at the end of the first year of CSR implementation (2002-03). The emphasis in this report is on the first two evaluation questions that focus on school reform activities and the targeting of CSR program funds.

Published
2004

23. Five-year Treatment with Tenofovir Alafenamide Achieves High Rates of Viral Suppression, Alanine Aminotransferase Normalization, and Favorable Bone and Renal Safety in Chinese Chronic Hepatitis B Patients.

Author

Jinlin Hou, Qin Ning, Zhongping Duan, Yu Chen, Qing Xie, Lunli Zhang, Shanming Wu, Hong Tang, Jun Li, Feng Lin, Yongfeng Yang, Guozhong Gong, Yanwen Luo, Shelley Xie, Hongyuan Wang, Mateo, Roberto, Yazdi, Tahmineh, Abramov, Frida, Yee, Leland J., and Flaherty, John

Subjects
HEPATITIS B, HEPATITIS associated antigen, CHRONIC hepatitis B, DUAL-energy X-ray absorptiometry, HEPATIC fibrosis, SEXUALLY transmitted diseases
Published
2024
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24. Atherosclerotic cardiovascular disease risk profile of patients with chronic hepatitis B treated with tenofovir alafenamide or tenofovir disoproxil fumarate for 96 weeks

Author

Fung, Scott K., primary, Pan, Calvin Q., additional, Wong, Grace Lai‐Hung, additional, Seto, Wai‐Kay, additional, Ahn, Sang Hoon, additional, Chen, Chi‐Yi, additional, Hann, Hie‐Won L., additional, Jablkowski, Maciej S., additional, Kim, Yoon Jun, additional, Yurdaydin, Cihan, additional, Peng, Cheng‐Yuan, additional, Nguyen, Tuan, additional, Yatsuhashi, Hiroshi, additional, Flaherty, John F., additional, Yee, Leland J., additional, Abramov, Frida, additional, Wang, Hongyuan, additional, Abdurakhmanov, Dzhamal, additional, Lim, Young‐Suk, additional, and Buti, Maria, additional

Published
2023
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25. S1617 Elevations in Total Serum Bile Acids During Bulevirtide Treatment Show No Association With Adverse Events of Interest in Patients With Chronic Hepatitis Delta: An Integrated Safety Analysis of 48-Week Data

Author

Lampertico, Pietro, primary, Aleman, Soo, additional, Asselah, Tarik, additional, Streinu-Cercel, Adrian, additional, Bogomolov, Pavel, additional, Morozov, Vlacheslav, additional, Stepanova, Tatyana, additional, Lazar, Stefan, additional, Bacic, Ana, additional, Manuilov, Dmitry, additional, Mercier, Renee-Claude, additional, Flaherty, John F., additional, Suri, Vithika, additional, Ye, Lei, additional, Tseng, Steve, additional, Christian-Cox, Florence, additional, Brunetto, Maurizia, additional, and Wedemeyer, Heiner, additional

Published
2023
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26. P132 Continued treatment of early nonresponder or partial virologic responders with bulevirtide monotherapy in patients with chronic hepatitis delta (CHD) through week 96 leads to improvement in virologic and biochemical responses

Author

Lampertico, Pietro, primary, Wedemeyer, Heiner, additional, Brunetto, Maurizia, additional, Bogomolov, Pavel, additional, Stepanova, Tatyana, additional, Ciesek, Sandra, additional, Berger, Annemarie, additional, Manuilov, Dmitry, additional, An, Qi, additional, Lau, Audrey, additional, Da, Ben, additional, Flaherty, John, additional, Mercier, Renee-Claude, additional, Zeuzem, Stefan, additional, Cornberg, Markus, additional, Buti, Maria, additional, and Aleman, Soo, additional

Published
2023
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27. P134 Efficacy and safety at 96 weeks of bulevirtide 2 mg or 10 mg monotherapy for chronic hepatitis delta: results from an interim analysis of a phase 3 randomized study

Author

Wedemeyer, Heiner, primary, Aleman, Soo, additional, Brunetto, Maurizia, additional, Blank, Antje, additional, Andreone, Pietro, additional, Bogomolov, Pavel, additional, Chulanov, Vladimir, additional, Mamonova, Nina, additional, Geyvandova, Natalia, additional, Morozov, Viacheslav, additional, Sagalova, Olga, additional, Stepanova, Tatyana, additional, Manuilov, Dmitry, additional, Mercier, Renee-Claude, additional, An, Qi, additional, Flaherty, John, additional, Osinusi, Anu, additional, Lau, Audrey, additional, Wiesch, Julian Schulze zur, additional, Cornberg, Markus, additional, Zeuzem, Stefan, additional, and Lampertico, Pietro, additional

Published
2023
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28. Freedom and Innovation in California's Charter Schools.

Author

Far West Lab. for Educational Research and Development, San Francisco, CA., Southwest Regional Lab., Los Alamitos, CA., Corwin, Ronald G., and Flaherty, John F.

Abstract

The charter-schools movement provides the opportunity to observe whether granting schools freedom from most state regulations actually produces more freedom for school administrators and teachers, and whether this autonomy produces other distinctive outcomes. This report summarizes findings of Southwest Regional Laboratory's (SWRL's) statewide survey of California charter schools. During 1994-95, 54 administrators and 230 teachers returned questionnaires that had been mailed to the 66 charter schools operating in California at the time. Survey responses were also received from 46 principals of noncharter (comparison) schools in California and 63 charter schools across the United States. Data are presented on school characteristics, institutional autonomy, educational innovation, teacher characteristics and effectiveness, and access to education. High-autonomy schools more often reported greater freedom and less cooperative relationships with unions; fewer purchasing restrictions and more money for instruction; more parent participation; and more at-risk students. Compared to their counterparts in regular schools, charter-school teachers reported that they had more influence but heavier workloads. Teachers in new charters were the least secure about their jobs but were among the most satisfied with their jobs. The most common innovations were related to instructional strategies, site-based governance, and parental participation. The data indicate that, as a group, charter schools do not select the most able, privileged students, nor do they exclude those who have been traditionally underserved. However, some evidence suggests that, in comparison to other schools, charter schools tend to skim students who come from low-income families, have below-average test scores; and qualify for special education, and/or they tend to select students from privileged families. Certain types of charter schools are less accessible than others to underserved, at-risk children. A total of 43 figures and 15 tables are included. (Contains 45 references.) (LMI)

Published
1995

29. Report on Workstation Uses: Effects of Success for All on the Reading Achievement of First Graders in California Bilingual Programs.

Author

Southwest Regional Lab., Los Alamitos, CA., Dianda, Marcella R., and Flaherty, John F.

Abstract

A study assessed the effectiveness of the Success for All Program for grade-one English-as-a-Second-Language (ESL) learners in bilingual or ESL programs in three California elementary schools. The reading instruction program provides both native (in this case, Spanish) language support as well as English language instruction and materials. The three schools in question were matched with comparison schools in their districts, that were similar in level of student disadvantage and other factors. The 2-year evaluation measured student (n=313) progress from kindergarten entry (receptive vocabulary) to the end of first grade (phonetic synthesis skills, recognition of common sight words, and text comprehension). Analysis of the results indicates that the 2 years of instruction in the Success for All program were effective for both students taught in Spanish-English bilingual programs and in ESL programs. While the instruction raised the average student performance, it also raised the performance of the lowest-performing students, with some of the largest treatment effects occurring in this group. A suggested area for further research is the monitoring of achievement over time. (MSE)

Published
1995

30. Promising Practices, and Program Adaptations & Successes. Annual Report.

Author

Southwest Regional Lab., Los Alamitos, CA., Dianda, Marcella, and Flaherty, John

Abstract

Through its Metropolitan Educational Trends and Research Outcomes (METRO) Center, the Southwest Regional Laboratory (SWRL) helps school districts implement research-based programs for educationally disadvantaged students. The most prominent of these is Success for All, a nationally recognized school restructuring program. In 1992, SWRL made a major commitment to adapt and implement Success for All in the Western region. The program's developers at Johns Hopkins University designated SWRL as the first Success for All regional training center. This report focuses on the adaptation of Success for All for the Western region. It chronicles the evolution of the training center and details plans for future growth. Of special importance are the first results from a longitudinal study of Success for All in California, especially for students whose primary language is Spanish. The purpose of Success for All remains that of its developers: to ensure that every student in a high-poverty school will successfully acquire basic skills, particularly reading skills, in the early grades. Success for All is designed to prevent learning deficits through a comprehensive approach that emphasizes early education. Twelve tables and two figures accompany the discussion. (Contains 31 references.) (Author/SLD)

Published
1995

31. A Phase 3, Randomized Trial of Bulevirtide in Chronic Hepatitis D

Author

Wedemeyer, Heiner, primary, Aleman, Soo, additional, Brunetto, Maurizia Rossana, additional, Blank, Antje, additional, Andreone, Pietro, additional, Bogomolov, Pavel, additional, Chulanov, Vladimir, additional, Mamonova, Nina, additional, Geyvandova, Natalia, additional, Morozov, Viacheslav, additional, Sagalova, Olga, additional, Stepanova, Tatyana, additional, Berger, Annemarie, additional, Manuilov, Dmitry, additional, Suri, Vithika, additional, An, Qi, additional, Da, Ben, additional, Flaherty, John, additional, Osinusi, Anu, additional, Liu, Yang, additional, Merle, Uta, additional, Schulze zur Wiesch, Julian, additional, Zeuzem, Stefan, additional, Ciesek, Sandra, additional, Cornberg, Markus, additional, and Lampertico, Pietro, additional

Published
2023
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32. Relationship of hepatitis D viral load, ALT levels, and liver stiffness in untreated patients with chronic hepatitis D

Author

Aleman, Soo, primary, Lampertico, Pietro, additional, Brunetto, Maurizia, additional, Bogomolov, Pavel, additional, Chulanov, Vladimir, additional, Mamonova, Nina, additional, Stepanova, Tatyana, additional, Manuilov, Dmitry, additional, An, Qi, additional, Da, Ben, additional, Flaherty, John F., additional, Mercier, Renee-Claude, additional, Lau, Audrey, additional, Zeuzem, Stefan, additional, Cornberg, Markus, additional, and Wedemeyer, Heiner, additional

Published
2023
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33. Efficacy and safety at 96 weeks of bulevirtide 2 mg or 10 mg monotherapy for chronic hepatitis D: results from an interim analysis of a phase 3 randomized study

Author

Wedemeyer, Heiner, primary, Aleman, Soo, additional, Brunetto, Maurizia, additional, Blank, Antje, additional, Andreone, Pietro, additional, Bogomolov, Pavel, additional, Chulanov, Vladimir, additional, Mamonova, Nina, additional, Geyvandova, Natalia, additional, Viacheslav, Morozov, additional, Sagalova, Olga, additional, Stepanova, Tatyana, additional, Manuilov, Dmitry, additional, Mercier, Renee-Claude, additional, An, Qi, additional, Flaherty, John F., additional, Osinusi, Anu, additional, Lau, Audrey, additional, zur Wiesch, Julian Schulze, additional, Cornberg, Markus, additional, Zeuzem, Stefan, additional, and Lampertico, Pietro, additional

Published
2023
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34. Continued treatment of early non-responder or partial virologic responders with bulevirtide monotherapy in patients with chronic hepatitis D through week 96 leads to improvement in virologic and biochemical responses

Author

Lampertico, Pietro, primary, Wedemeyer, Heiner, additional, Brunetto, Maurizia, additional, Bogomolov, Pavel, additional, Stepanova, Tatyana, additional, Ciesek, Sandra, additional, Berger, Annemarie, additional, Manuilov, Dmitry, additional, An, Qi, additional, Lau, Audrey, additional, Da, Ben, additional, Flaherty, John F., additional, Mercier, Renee-Claude, additional, Zeuzem, Stefan, additional, Cornberg, Markus, additional, Buti, Maria, additional, and Aleman, Soo, additional

Published
2023
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35. HDV full genome sequencing and sensitive HBV genotyping from a large cohort of HBV/HDV co-infected patients

Author

Manhas, Savrina, primary, Xu, Simin, additional, Chang, Silvia, additional, Aeschbacher, Thomas, additional, Mateo, Roberto, additional, Martin, Ross, additional, Liu, Yang, additional, Narguet, Stephanie, additional, Abdurakhmanov, Dzhamal, additional, Lampertico, Pietro, additional, Manuilov, Dmitry, additional, Flaherty, John F., additional, Mo, Hongmei, additional, Svarovskaia, Evguenia S, additional, and Asselah, Tarik, additional

Published
2023
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36. Factors Associated With Persistent Increase in Level of Alanine Aminotransferase in Patients With Chronic Hepatitis B Receiving Oral Antiviral Therapy

Author

Jacobson, Ira M., Washington, Mary K., Buti, Maria, Thompson, Alexander, Afdhal, Nezam, Flisiak, Robert, Akarca, Ulus Salih, Tchernev, Konstantin G., Flaherty, John F., Aguilar Schall, Raul, Myers, Robert P., Subramanian, G. Mani, McHutchison, John G., Younossi, Zobair, Marcellin, Patrick, and Patel, Keyur

Published
2017
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37. Atherosclerotic cardiovascular disease risk profile of patients with chronic hepatitis B treated with tenofovir alafenamide or tenofovir disoproxil fumarate for 96 weeks.

Author

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, and Buti, Maria

Subjects
CHRONIC hepatitis B, CARDIOVASCULAR diseases risk factors, CARDIOVASCULAR diseases, TENOFOVIR, SYSTOLIC blood pressure
Abstract

Summary: Background: Patients with chronic hepatitis B (CHB) who switch from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF) show changes in lipid profiles. Aim: 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: 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. [ABSTRACT FROM AUTHOR]

Published
2024
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41. P1- HIGH VIRAL SUPPRESSION AND IMPROVED SAFETY PROFILE OF TENOFOVIR ALAFENAMIDE RELATIVE TO TENOFOVIR DISOPROXIL FUMARATE IN CHRONIC HEPATITIS B PATIENTS TREATED FOR 5 YEARS

Author

Seto, Wai Kay, primary, Chang, Ting-Tsung, additional, Chowdhry, Abhijit, additional, Chen, Chi-Yi, additional, Celen, Mustafa Kemal, additional, Ma, Xiaoli, additional, Ma, Mang, additional, Duseja, Ajay, additional, Yoon, Ki Tae, additional, Chow, Wan Cheng, additional, Yee, Leland, additional, Weber, Gregor, additional, Youn, Ms Jin, additional, Flaherty, John F., additional, Gaggar, Anuj, additional, Gao, Bing, additional, Camus, Gregory, additional, Bassetti, Eric, additional, Hwang, Jae Seok, additional, Inokuma, Tetshuro, additional, Lin, Young- Suk, additional, and Gane, Edward J., additional

Published
2023
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42. Atherosclerotic cardiovascular disease risk profile of patients with chronic hepatitis B treated with tenofovir alafenamide or tenofovir disoproxil fumarate for 96 weeks

Author

Yurdaydın, Cihan (ORCID 0000-0002-5419-7158 & YÖK ID 189330), 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; Peng, Cheng-Yuan; Nguyen, Tuan; Yatsuhashi, Hiroshi; Flaherty, John F.; Yee, Leland J.; Abramov, Frida; Wang, Hongyuan; Abdurakhmanov, Dzhamal; Lim, Young-Suk; Buti, Maria, School of Medicine, Yurdaydın, Cihan (ORCID 0000-0002-5419-7158 & YÖK ID 189330), 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; Peng, Cheng-Yuan; Nguyen, Tuan; Yatsuhashi, Hiroshi; Flaherty, John F.; Yee, Leland J.; Abramov, Frida; Wang, Hongyuan; Abdurakhmanov, Dzhamal; Lim, Young-Suk; Buti, Maria, and School of Medicine

Abstract

Background: patients with chronic hepatitis B (CHB) who switch from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF) show changes in lipid profiles. Aim: 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: 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., This work has been funded by Gilead Sciences Ltd.

Published
2023

43. Tenofovir alafenamide and tenofovir disoproxil fumarate reduce incidence of hepatocellular carcinoma in patients with chronic hepatitis B

Author

Lim, Young Suk, Chan, Henry L.Y., Ahn, Sang Hoon, Seto, Wai Kay, Ning, Qin, Agarwal, Kosh, Janssen, Harry L.A., Pan, Calvin Q., Chuang, Wan Long, Izumi, Namiki, Fung, Scott, Shalimar, Brunetto, Maurizia, Hui, Aric Josun, Chang, Ting Tsung, Lim, Seng Gee, Abramov, Frida, Flaherty, John F., Wang, Hongyuan, Yee, Leland J., Kao, Jia Horng, Gane, Edward, Hou, Jinlin, Buti, Maria, Lim, Young Suk, Chan, Henry L.Y., Ahn, Sang Hoon, Seto, Wai Kay, Ning, Qin, Agarwal, Kosh, Janssen, Harry L.A., Pan, Calvin Q., Chuang, Wan Long, Izumi, Namiki, Fung, Scott, Shalimar, Brunetto, Maurizia, Hui, Aric Josun, Chang, Ting Tsung, Lim, Seng Gee, Abramov, Frida, Flaherty, John F., Wang, Hongyuan, Yee, Leland J., Kao, Jia Horng, Gane, Edward, Hou, Jinlin, and Buti, Maria

Abstract

Background & Aims: Antiviral therapy may attenuate the risk of hepatocellular carcinoma (HCC) in patients with chronic hepatitis B (CHB). We aimed to explore how tenofovir alafenamide (TAF) and tenofovir disoproxil fumarate (TDF) affect HCC risk in patients with CHB. Methods: The REACH-B, aMAP, and mPAGE-B models were utilized to assess HCC risk in patients with CHB from two global randomized-controlled trials evaluating the impact of TAF vs. TDF treatment. Standard incidence ratios (SIRs) were calculated using data from the REACH-B model as a ratio of observed HCC cases in the TAF- or TDF-treated patients vs. predicted HCC cases for untreated historical controls. Proportions of treated patients shifting aMAP and mPAGE-B risk categories between baseline and Week 240 were calculated. Results: Of the 1,632 patients (TAF, n = 1,093; TDF, n = 539) followed for up to 300 weeks, 22 HCC cases developed. Those receiving TAF had an SIR that was lower compared to the SIR of individuals receiving TDF: 0.32 (p <0.001) vs. 0.56 (p = 0.06). In the general study population, individuals without cirrhosis at baseline had an SIR that was lower compared to the SIR of individuals with cirrhosis at baseline: 0.37 (p <0.001) vs. 0.58 (p = 0.15). Of the patients at low risk of HCC at baseline, the majority (97%) remained low risk by mPAGE-B and aMAP scoring at Week 240. Among those at medium or high risk at baseline, substantial portions shifted to a lower risk category by Week 240 (mPAGE-B: 22% and 42%; aMAP: 39% and 63%, respectively). Conclusions: This evaluation provides evidence that treatment with TAF or TDF can reduce HCC risk in patients with CHB, particularly in patients without cirrhosis. Impact and implications: Despite the substantial impact of HCC on long-term outcomes of patients with CHB, the differential risk of HCC development among those receiving treatment with

Published
2023

44. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of patients with HBeAg-negative chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial

Author

Buti, Maria, Gane, Edward, Seto, Wai Kay, Chan, Henry L Y, Chuang, Wan-Long, Stepanova, Tatjana, Hui, Aric-Josun, Lim, Young-Suk, Mehta, Rajiv, Janssen, Harry L A, Acharya, Subrat K, Flaherty, John F, Massetto, Benedetta, Cathcart, Andrea L, Kim, Kyungpil, Gaggar, Anuj, Subramanian, G Mani, McHutchison, John G, Pan, Calvin Q, Brunetto, Maurizia, Izumi, Namiki, and Marcellin, Patrick

Published
2016
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45. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of HBeAg-positive chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial

Author

Chan, Henry L Y, Fung, Scott, Seto, Wai Kay, Chuang, Wan-Long, Chen, Chi-Yi, Kim, Hyung Joon, Hui, Aric Josun, Janssen, Harry L A, Chowdhury, Abhijit, Tsang, Tak Yin Owen, Mehta, Rajiv, Gane, Edward, Flaherty, John F, Massetto, Benedetta, Gaggar, Anuj, Kitrinos, Kathryn M, Lin, Lanjia, Subramanian, G Mani, McHutchison, John G, Lim, Young-Suk, Acharya, Subrat K, and Agarwal, Kosh

Published
2016
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46. Large-scale viral genome analysis identifies novel clinical associations between hepatitis B virus and chronically infected patients

Author

Podlaha, Ondrej, Gane, Edward, Brunetto, Maurizia, Fung, Scott, Chuang, Wan-Long, Pan, Calvin Q., Jiang, Zhaoshi, Liu, Yang, Bhardwaj, Neeru, Mukherjee, Prasenjit, Flaherty, John, Gaggar, Anuj, Subramanian, Mani, Izumi, Namiki, Shalimar, Lim, Young-Suk, Marcellin, Patrick, Buti, Maria, Chan, Henry L. Y., and Agarwal, Kosh

Published
2019
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47. Treatment with Bulevirtide Improves Patient-reported Outcomes in Patients with Chronic Hepatitis Delta: An Exploratory Analysis of a Phase 3 Trial at 48 Weeks

Author

Buti, Maria, additional, Wedemeyer, Heiner, additional, Aleman, Soo, additional, Chulanov, Vladimir, additional, Morozov, Viacheslav, additional, Sagalova, Olga, additional, Stepanova, Tatyana, additional, Gish, Robert, additional, Lloyd, Andrew, additional, Kaushik, Ankita, additional, Suri, Vithika, additional, Manuilov, Dmitry, additional, Osinusi, Anu, additional, Flaherty, John, additional, and Lampertico, Pietro, additional

Published
2023
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48. Strong decline of intrahepatic HDV markers and signs of liver inflammation after 48 weeks of treatment with Bulevirtide in chronic hepatitis D patients: Combined intrahepatic results from the clinical trials MYR203 and MYR301

Author

Allweiss, Lena, additional, Volmari, Annika, additional, Ladiges, Yvonne, additional, Eggers, Corinna, additional, Suri, Vithika, additional, Wallin, Jeffrey, additional, Flaherty, John, additional, Manuilov, Dmitry, additional, Lütgehetmann, Marc, additional, Wedemeyer, Heiner, additional, Urban, Stephan, additional, Bockmann, Jan-Hendrik, additional, and Dandri, Maura, additional

Published
2023
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49. Efficacy and Safety of Bulevirtide Monotherapy Given at 2 mg or 10 mg Dose Level Once Daily for Treatment of Chronic Hepatitis Delta: Week 48 Primary Endpoint Results from a Phase 3 Randomized, Multicenter, Parallel Design Study

Author

Wedemeyer, Heiner, additional, Aleman, Soo, additional, Brunetto, Maurizia, additional, Blank, Antje, additional, Andreone, Pietro, additional, Bogomolov, Pavel, additional, Chulanov, Vladimir, additional, Mamonova, Nina, additional, Geyvandova, Natalia, additional, Morozov, Viacheslav, additional, Sagalova, Olga, additional, Stepanova, Tatyana, additional, Manuilov, Dmitry, additional, Suri, Vithika, additional, An, Qi, additional, Flaherty, John, additional, Osinusi, Anu, additional, zur Wiesch, JulianSchulze, additional, Cornberg, Markus, additional, Zeuzem, Stefan, additional, and Lampertico, Pietro, additional

Published
2023
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