An open label, multicenter, Phase-IV clinical trial to evaluate the safety and efficacy of Daclatasvir and Sofosbuvir in patients with Chronic Hepatitis C genotype 3 infection.

开始日期2018-03-08

申办/合作机构

NATCO Pharma Ltd.

SLCTR/2017/007 / RecruitingN/AIIT

Effect of combination therapy of Pegylated interferon- Alpha 2a, Sofosbuvir and Ribavirin for 12 weeks versus combination of Sofosbuvir and Ribavirin for 24 weeks on viral loads in Hepatitis C Virus (HCV) Genotype 3 chronic hepatitis & compensated cirrhosis patients

开始日期2017-04-01

申办/合作机构-

EUCTR2016-002845-46-GB / Not yet recruiting临床2期

A Phase 2a, Open-Label Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335 and Odalasvir, with or without Simeprevir, in Treatment-Naïve Subjects with Genotype 1, 2 or 3 Chronic Hepatitis C infection with or without compensated Child Pugh A Cirrhosis

开始日期2017-02-03

申办/合作机构

Alios BioPharma, Inc.

100 项与慢性丙型肝炎基因型 3 相关的临床结果

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100 项与慢性丙型肝炎基因型 3 相关的转化医学

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0 项与慢性丙型肝炎基因型 3 相关的专利（医药）

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项与慢性丙型肝炎基因型 3 相关的文献（医药）

2024-06-01·Infectious Diseases and Therapy

Real-World Efficacy and Safety of Universal 8-Week Glecaprevir/Pibrentasvir for Treatment-Naïve Patients from a Nationwide HCV Registry in Taiwan

Article

作者: Wu, Wen-Chih ; Yu, Ming-Lung ; Tsai, Pei-Chien ; Kao, Chien-Neng ; Dai, Chia-Yen ; Cheng, Chien-Yu ; Yang, Sheng-Shun ; Lin, Han-Chieh ; Lee, Pei-Lun ; Bair, Ming-Jong ; Huang, Chung-Feng ; Su, Wei-Wen ; Chong, Lee-Won ; Huang, Yi-Hsiang ; Lee, Tzong-Hsi ; Tai, Chi-Ming ; Huang, Jee-Fu ; Lin, Chih-Lang ; Peng, Cheng-Yuan ; Huang, Chien-Wei ; Kuo, Hsing-Tao ; Lin, Chih-Lin ; Hsieh, Tsai-Yuan ; Chen, Chi-Yi ; Hung, Chao-Hung ; Cheng, Pin-Nan ; Tseng, Kuo-Chih ; Yang, Chi-Chieh ; Lee, Mei-Hsuan ; Chuang, Wang-Long ; Chen, Chun-Ting ; Lo, Ching-Chu ; Huang, Chia-Sheng ; Hu, Jui-Ting ; Wang, Szu-Jen ; Chen, Guei-Ying ; Wang, Chia-Chi ; Yeh, Ming-Lun ; Yang, Chun-Chi ; Chang, Chun-Chao ; Liu, Chun-Jen ; Mo, Lein-Ray ; Chang, Te-Sheng ; Kao, Jia-Horng

INTRODUCTIONEight-week glecaprevir/pibrentasvir (GLE/PIB) is indicated for treatment-naïve (TN) patients with chronic hepatitis C (CHC), with or without compensated cirrhosis. Given that the Taiwanese government is committed to eliminating hepatitis C virus (HCV) by 2025, this study aimed to measure real-world evidence for TN patients using 8-week GLE/PIB in the Taiwan HCV Registry (TACR).METHODSThe data of patients with CHC treated with 8-week GLE/PIB were retrieved from TACR, a nationwide registry program organized by the Taiwan Association for the Study of the Liver (TASL). Treatment efficacy, defined as a sustained virologic response at posttreatment week 12 (SVR12), was assessed in the modified intention-to-treat (mITT) population, which excluded patients who were lost to follow-up or lacked SVR12 data. The safety profile of the ITT population was assessed.RESULTSA total of 7246 (6897 without cirrhosis; 349 with cirrhosis) patients received at least one dose of GLE/PIB (ITT), 7204 of whom had SVR12 data available (mITT). The overall SVR12 rate was 98.9% (7122/7204) among all patients, 98.9% (6780/6856) and 98.3% (342/348) among patients without and with cirrhosis, respectively. For the selected subgroups, which included patients with genotype 3 infection, diabetes, chronic kidney disease, people who injected drugs, and those with human immunodeficiency virus coinfection, the SVR12 rates were 95.1% (272/286), 98.9% (1084/1096), 99.0% (1171/1183), 97.4% (566/581), and 96.1% (248/258), respectively. Overall, 14.1% (1021/7246) of the patients experienced adverse events (AEs). Twenty-two patients (0.3%) experienced serious AEs, and 15 events (0.2%) resulted in permanent drug discontinuation. Only one event was considered treatment drug related.CONCLUSIONEight-week GLE/PIB therapy was effective and well tolerated in all TN patients, regardless of cirrhosis status.

2024-06-01·One Health

Immunisation of pigs with recombinant HEV vaccines does not protect from infection with HEV genotype 3

Article

作者: Eiden, Martin ; Behrendt, Patrick ; Aliabadi, Elmira ; Groschup, Martin H ; Schröder, Charlotte ; Hrabal, Isabella ; Fast, Christine ; Protzer, Ulrike ; Dähnert, Lisa

Hepatitis E virus (HEV) is a major cause of acute viral hepatitis worldwide. Up to now, no approved treatment nor a globally licensed vaccine is available. Several recombinant HEV vaccines have been developed to protect against HEV infection in humans, including the commercially available Hecolin vaccine, which are mainly based on HEV genotype 1. However, the efficacy of these vaccines against other HEV genotypes, especially genotype 3 is unknown. In this study, we evaluated the protective efficacy of Hecolin® and a novel genotype 3-based vaccine p239(gt3) against HEV-3 in a pig infection model. Pigs were divided into three groups: one group was vaccinated with Hecolin®, the second group was vaccinated with p239(gt3), and the control group received no vaccine. All pigs were subsequently challenged with HEV genotype 3 to assess the effectiveness of the vaccines. Although all immunised animals developed a high titer of neutralizing antibodies, the results showed that both vaccine applications could not provide complete protection against HEV (gt3) infection: Two out of four animals of the Hecolin® group displayed even virus shedding, and viral RNA could be detected in bile and/or liver of three out of four animals in both vaccination groups. Only one out of four animals in each group was fully protected. Neither Hecolin® nor the novel p239(gt3) vaccine provided sufficient protection against genotype 3 infection. While Hecolin® only partial protected pigs from HEV shedding, the novel p239(gt3) vaccine was at least able to prevent infected pigs from virus shedding. The results highlight the need for further development of HEV vaccines that exhibit broad protection against multiple HEV genotypes and the use of appropriate animal infection models.

2024-05-01·Digestive Diseases and Sciences

Direct-Acting Antiviral Therapy for Patients with Chronic Hepatitis C Infection and Decompensated Cirrhosis

Review

作者: Pearlman, Brian L

Patients with chronic hepatitis C virus (HCV) infection and decompensated cirrhosis are an important population for antiviral therapy yet under-represented in clinical trials. HCV direct-acting antiviral (DAA) therapies, unlike interferon-containing regimens, can be safely utilized in decompensated patients. Per guidelines from the American Association for the Study of Liver Diseases (AASLD), therapy of choice in HCV and decompensated cirrhosis is sofosbuvir, an HCV polymerase inhibitor, combined with a replication complex inhibitor (NS5A inhibitor) with or without ribavirin. Combination therapy with a HCV protease inhibitor and an NS5A inhibitor is effective in this population but is specifically not recommended in AASLD guidelines due to safety concerns. Important risk factors for further decompensation during DAA therapy are serum albumin < 3.5 g/dL, MELD (Model for End-Stage Liver Disease) score > 14, or HCV genotype 3 infection. Although sustained virologic response (SVR) is achieved less often in patients with decompensated vs compensated cirrhosis, in clinical studies response rates are > 80%. Both Child-Turcotte-Pugh Class at baseline and viral genotype can affect these response rates. Achieving SVR lowers risk of mortality, but to a lesser extent than in individuals with compensated cirrhosis. Likewise, treating patients for HCV infection along with successful treatment for hepatocellular carcinoma improves risks of both liver-related and overall mortality. In fewer than one third of cases, treating transplant-eligible, HCV-infected patients pre-transplant enables their delisting from transplant wait lists.