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Hepatitis: HELP
Articles by Jingjun Qiu
Based on 2 articles published since 2009
(Why 2 articles?)
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Between 2009 and 2019, Jingjun Qiu wrote the following 2 articles about Hepatitis.
 
+ Citations + Abstracts
1 Clinical Trial Elbasvir/Grazoprevir for Patients With Hepatitis C Virus Infection and Inherited Blood Disorders: A Phase III Study. 2017

Hézode, Christophe / Colombo, Massimo / Bourlière, Marc / Spengler, Ulrich / Ben-Ari, Ziv / Strasser, Simone I / Lee, William M / Morgan, Leslie / Qiu, Jingjun / Hwang, Peggy / Robertson, Michael / Nguyen, Bach-Yen / Barr, Eliav / Wahl, Janice / Haber, Barbara / Chase, Robert / Talwani, Rohit / Marco, Vito Di / Anonymous4420898. ·Henri Mondor Hospital, Paris, France. · Humanitas Clinical and Research Center, Rozzano, Italy. · Hôpital Saint Joseph, Marseille, France. · University Hospital Bonn, Bonn, Germany. · Sheba Medical Center, Ramat Gan, Israel. · University of Sydney, Sydney, NSW, Australia. · University of Texas Southwestern Medical Center, Dallas, TX. · Merck & Co., Inc, Kenilworth, NJ. · University of Palermo, Palermo, Italy. ·Hepatology · Pubmed #28256747.

ABSTRACT: Direct-acting antiviral agents have not been studied exclusively in patients with inherited blood disorders and hepatitis C virus (HCV) infection. The objective of the randomized, placebo-controlled, phase III C-EDGE IBLD study was to assess the safety and efficacy of elbasvir/grazoprevir (EBR/GZR) in patients with inherited bleeding disorders and HCV infection. One hundred fifty-nine adults with HCV infection and sickle cell anemia, thalassemia, or hemophilia A/B or von Willebrand disease were enrolled at 31 study sites in the United States, Europe, Australia, Canada, Israel, and Thailand. Patients were given an oral, once-daily, fixed-dose combination of EBR/GZR 50 mg/100 mg for 12 weeks and randomized to the immediate-treatment group (ITG) or deferred-treatment group (DTG; placebo followed by active treatment). The primary endpoints were the proportion of patients in the ITG with unquantifiable HCV RNA 12 weeks posttreatment (sustained virological response 12 weeks after completion of study treatment; SVR12) and the comparison of safety in the ITG and DTG. In the ITG, 100 of 107 patients (93.5%) achieved SVR12, 6 relapsed, and 1 was lost to follow-up. SVR12 was achieved in 94.7% (18 of 19), 97.6% (40 of 41), and 89.4% (42 of 47) of patients with sickle cell disease, β-thalassemia, and hemophilia A/B or von Willebrand disease, respectively. Serious adverse events were reported by 2.8% (n = 3) and 11.5% (n = 6) of patients in the ITG and DTG, respectively. Hemoglobin levels and international normalized ratio values were similar in patients receiving EBR/GZR and placebo; among patients with hemoglobinopathies, change in mean hemoglobin levels was similar in those receiving EBR/GZR compared to those receiving placebo. CONCLUSION: These results add to the expanding pool of data available for EBR/GZR, indicating a high level of efficacy and favorable tolerability in patients with HCV infection. (Hepatology 2017;66:736-745).

2 Clinical Trial Efficacy and safety of elbasvir/grazoprevir and sofosbuvir/pegylated interferon/ribavirin: A phase III randomized controlled trial. 2016

Sperl, Jan / Horvath, Gabor / Halota, Waldemar / Ruiz-Tapiador, Juan Arenas / Streinu-Cercel, Anca / Jancoriene, Ligita / Werling, Klara / Kileng, Hege / Koklu, Seyfettin / Gerstoft, Jan / Urbanek, Petr / Flisiak, Robert / Leiva, Rafael / Kazenaite, Edita / Prinzing, Renate / Patel, Sushma / Qiu, Jingjun / Asante-Appiah, Ernest / Wahl, Janice / Nguyen, Bach-Yen / Barr, Eliav / Platt, Heather L. ·Institut Klinické a Experimentální Medicíny (IKEM), Prague, Czech Republic. Electronic address: jase@medicon.cz. · Budai Hepatólogiai Centrum, Budapest, Hungary. · Department of Infectious Diseases and Hepatology, Faculty of Medicine, Nicolaus Copernicus University, Bydgoszcz, Poland. · Hospital Universitario Donostia, Gipuzkoa, Spain. · Carol Davila University of Medicine and Pharmacy, National Institute for Infectious Diseases "Prof. Dr. Matei Balș", Bucharest, Romania. · Vilnius University, Department of Infectious and Chest Diseases, Dermatovenerology and Alergology, Vilnius University Hospital Santariškių Klinikos, Vilnius, Lithuania. · Semmelweis Egyetem, Budapest, Hungary. · UNN Universitetssykehuset Nord Norge, Tromsø, Norway. · Hacettepe University Medical Faculty, Ankara, Turkey. · Klinik for Infektionsmedicin, Rigshospitalet, University of Copenhagen, Denmark. · Department of Internal Medicine, 1st Medical Faculty Charles University and Central Military Hospital, Prague, Czech Republic. · Department of Infectious Diseases and Hepatology, Medical University of Bialystok, Bialystok, Poland. · Haukeland University Hospital, Bergen, Norway. · Vilnius University, Faculty of Medicine, Vilnius University Hospital Santariškių Klinikos, Vilnius, Lithuania. · Merck & Co., Inc., Kenilworth, NJ, United States. ·J Hepatol · Pubmed #27542322.

ABSTRACT: BACKGROUND & AIMS: Direct-acting antiviral agents have improved treatment outcomes for patients with hepatitis C virus (HCV) infection; however, head-to-head comparisons are limited. The C-EDGE Head-2-Head Study compared the safety and efficacy of elbasvir/grazoprevir (EBR/GZR) with sofosbuvir plus pegylated interferon/ribavirin (SOF/PR) in patients with HCV infection. METHODS: This was a randomized, open-label, phase III trial. Two hundred fifty-seven patients with HCV genotype (GT)1 or 4 infection and baseline viral load >10,000IU/ml were randomized to receive 12weeks of EBR/GZR 50mg/100mg once daily (n=129) or sofosbuvir (400mg once daily) plus PR (n=128). Primary efficacy objective was sustained virologic response 12weeks after the end of therapy (SVR12, HCV RNA <15IU/ml). The primary safety objective was the proportion of patients experiencing a tier 1 safety event. RESULTS: The majority of patients were non-cirrhotic (83.1%), treatment-naïve (74.9%) and had HCV GT1b infection (82.0%). SVR12 rates were 99.2% (128/129) and 90.5% (114/126) in the EBR/GZR and SOF/PR groups, respectively. The estimated adjusted difference in SVR12 was 8.8% (95% confidence interval [CI], 3.6-15.3%). Because the lower bound of the 1-sided 1-sample exact test was greater than -10% and greater than zero, both non-inferiority and superiority of EBR/GZR vs. SOF/PR were established. The frequency of tier 1 safety events was lower among patients receiving EBR/GZR than SOF/PR (0.8% vs. 27.8%, between group difference, 27.0% [95% CI, -35.5% to -19.6%; p<0.001]). CONCLUSIONS: EBR/GZR has a superior efficacy and safety profile in patients with HCV GT1 or 4 infection compared with SOF/PR. LAY SUMMARY: The combination of elbasvir/grazoprevir for 12weeks was highly effective in treating patients with chronic hepatitis C, genotypes 1 or 4 infection. This regimen was more effective than sofosbuvir/pegylated interferon/ribavirin for 12weeks, and was notably superior in patients regarded as difficult to treat, including those with previous treatment failure, cirrhosis, or a high baseline viral load. The combination of elbasvir/grazoprevir also demonstrated a superior safety and tolerability profile based on fewer serious adverse events, no serious drug-related adverse events, and no treatment discontinuations. CLINICAL TRIAL REGISTRATION: Clinical trials.gov Identifier: NCT02358044.