Real World Evidence of the Effectiveness and Clinical Practice Use of Glecaprevir/Pibrentasvir in DAA Treatment-Experienced Patients With Chronic Hepatitis C Genotype 1 in Russian Federation (CHOICE)

Hepatitis C virus (HCV) infection is among the most common of all chronic liver diseases. HCV predominantly affects liver cells and causes the liver to become inflamed and damaged. This can lead to cirrhosis (scarring of the liver), liver cancer or the need for liver transplant. This study will evaluate how effective glecaprevir/pibrentasvir (GLE/PIB) is in participants with chronic HCV infection. Effectiveness will be assessed as the achievement of sustained virologic response.
GLE/PIB is an approved drug for the treatment of HCV. Participants 12 years or older with chronic HCV infection will be enrolled. This is a prospective (conducted in future) study in therapy of direct-acting antiviral (DAA) treatment-experienced participants with chronic hepatitis C genotype 1. Around 67 participants will be enrolled at multiple sites in Russian Federation.
Participants will receive oral GLE/PIB tablets as prescribed by the physician in accordance with local clinical practice, international guidelines and/or label. Prescription is independent from this study and is decided before providing opportunity to the participate in the study.
There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice and participants will be followed for 12 weeks.

开始日期2020-10-07

申办/合作机构

AbbVie, Inc.

EUCTR2019-003736-22-3RD

/ Unknown status临床1期

Bioavailability and Food Effect of Experimental Glecaprevir + Pibrentasvir Pediatric Formulation in Healthy Adult Subjects

开始日期2020-07-08

申办/合作机构

AbbVie, Inc.

JPRN-jRCTs031200042

/ Completed临床4期

Safety and efficacy of glecaprevir and pibrentasvir in patients with hepatitis C virus infection and end-stage renal disease undergoing dialysis; a prostective study

开始日期2020-06-01

申办/合作机构-

100 项与哌仑他韦相关的临床结果

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100 项与哌仑他韦相关的转化医学

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100 项与哌仑他韦相关的专利（医药）

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441

项与哌仑他韦相关的文献（医药）

2026-09-01·PHYTOTHERAPY RESEARCH

In Vivo Evidence of Human Organic Anion Transporting Polypeptide ( OATP ) 1B1 and OATP1B3 Mediated Disposition of Glycyrrhizin and Its Drug–Drug Interactions in Humanized Mice

Article

作者: Geng, Doudou ; Zhong, Jiajing ; Wang, Xiangnan ; Dong, Jiajia ; Chen, Zhipeng ; Mao, Chunqin ; Lu, Tulin

ABSTRACT:

Organic anion‐transporting polypeptide (OATP) transporters have a significant influence on the disposition of drugs, significantly influencing their efficacy and toxicity. Humans express two transporters (OATP1B1 and OATP1B3), while murine possess only a single ortholog (Oatp1b2). To elucidate the impact of OATP1B1 and 1B3 on the pharmacokinetics of the hepatoprotective agent glycyrrhizin and its potential drug–drug interactions, we conducted a study utilizing wild‐type, murine Oatp1b2 knockout, and newly generated humanized OATP1B1 and OATP1B3 transgenic mice ( Slco1b2−/−; 1B1/1B3tg ). These models were characterized physiologically and biochemically, followed by intravenous administration of glycyrrhizin for pharmacokinetic analysis. Compared to wild‐type controls, Oatp1b2 knockout mice exhibited a 2‐fold decrease in liver AUC 0–7h and up to 26.9‐fold reduction in liver‐to‐plasma ratios, indicating impaired hepatic uptake of glycyrrhizin. Additionally, the absence of Oatp1b2 resulted in a 2.8‐fold increase in plasma AUC 0–7h and enhanced renal distribution of glycyrrhizin. However, the knock‐in of human OATP1B1 and OATP1B3 partially or fully restored the impaired hepatic uptake and reduced plasma levels of glycyrrhizin in Oatp1b2 knockout mice. Furthermore, we evaluated drug–drug interactions between glycyrrhizin and glecaprevir/pibrentasvir, a clinically relevant combination. Glecaprevir/pibrentasvir inhibited OATP1B1/1B3‐mediated hepatic uptake of glycyrrhizin at therapeutic concentrations, increasing systemic exposure and highlighting drug–drug interaction risks. Our study provides the first in vivo evidence of glycyrrhizin hepatic transport by human OATP1B1 and OATP1B3, emphasizing the need for careful dosing in patients with variable OATP1B/1B3 activity due to transporter‐mediated drug–drug interactions. Additionally, this humanized mouse model can serve as a robust in vivo tool for the prediction of human OATP1B1 and 1B3 function.

2026-09-01·Open Forum Infectious Diseases

IMPAACT 2041: Designing the Study of Glecaprevir/Pibrentasvir Treatment During Pregnancy

Article

作者: Rowry, Chitara ; Brooks, Kristina M ; Zhang, Zhongli J ; Lee, Sonia ; Browning, Renee ; Kakarla, Vindya ; Burroughs, Margaret ; Mainella, Vincent ; Jhaveri, Ravi ; Iacob, Alexandru ; McCarthy, Katie ; Kaur, Jatinder ; Flynn, Patricia M ; Stotz, Chelsea ; Chen, Mong-Jen ; Nelson, Bryan S ; McMunn, Andrea ; Dyer, Molly ; Brozik, Haley ; Yates, Franklin ; Furukawa, Nathan ; Pindyck, Talia ; Marcinak, John ; Corcorran, Maria ; Small, Hannah ; Chiou, Christine ; Marzinek, Philip ; Duffy, Emma ; Tierney, Camlin ; Spalding, Leah ; Eke, Ahizechukwu C ; Jennings, Cheryl

Abstract:

The significant increase in hepatitis C virus (HCV) infection prevalence among young adults, including those who may become pregnant, has led to a corresponding increase in the number of infants exposed to and infected with HCV. Despite a recommendation for universal HCV screening during pregnancy, there is not always a clear pathway to immediately initiate treatment for maternal cure, which could also prevent vertical transmission like the approach for human immunodeficiency virus (HIV) or hepatitis B virus. In 2019, the American Association for the Study of Liver Diseases/Infectious Diseases Society of America HCV Guidelines panel endorsed the use of shared decision making between providers and patients when considering HCV treatment during pregnancy. Direct-acting antivirals, including glecaprevir/pibrentasvir (GLE/PIB), have been tremendously effective in curing >95% of individuals who begin treatment along with an overall well-characterized safety profile, but data supporting their use when initiated during pregnancy are more limited. International Maternal Pediatric Adolescent AIDS Clinical Trials 2041 is a multicenter single-arm phase I/II clinical trial designed to evaluate the pharmacokinetics and safety of GLE/PIB treatment initiated in pregnant women with HCV mono-infection or HCV/HIV co-infection. In this paper, we describe the relevant background data assembled from various sources to write the protocol and design the study.

2026-08-01·EUROPEAN JOURNAL OF PHARMACOLOGY

Elevation of anticancer drug-induced cytotoxicity by velpatasvir through downregulation of claudin-14 expression in human colorectal cancer cells

Article

作者: Tosaki, Shiemi ; Morimoto, Kazushi ; Endo, Satoshi ; Hashimoto, Shotaro ; Matsuhashi, Nobuhisa ; Ishikawa, Yoshinobu ; Ando, Tomoka ; Yoshino, Yuta ; Shinoda, Takehiro ; Ikari, Akira ; Shirouzu, Mikako ; Matsunaga, Toshiyuki ; Mizukami, Yuko

Claudin-14 (CLDN14) is a tight junction protein that contributes to the development of chemoresistant phenotypes in human colorectal cancer (CRC) cells. CLDN14 may represent a potential therapeutic target for CRC. In this study, we identified velpatasvir (VEL), a clinically approved hepatitis C virus nonstructural protein 5 A (NS5A) inhibitor, as a potent suppressor of CLDN14 protein expression using in silico screening and Western blot analysis. CLDN14 expression was not decreased by other NS5A inhibitors, including ledipasvir, pibrentasvir, and daclatasvir. Quartz crystal microbalance analysis revealed that VEL directly binds to recombinant CLDN14 protein with a dissociation constant of 1.8 ± 0.2 μM. VEL treatment did not affect CLDN14 mRNA levels, suggesting that CLDN14 expression is regulated at a post-transcriptional level. Pharmacological inhibition of clathrin-mediated endocytosis and lysosomal degradation significantly reversed the VEL-induced reduction in CLDN14 protein levels, suggesting the involvement of endocytosis-lysosomal degradation pathway. Functionally, VEL increased paracellular permeability to mineral ions and enhanced the transepithelial flux of aqueous fluorescent tracers. In DLD-1 spheroids, VEL attenuated intracellular oxidative stress and reduced the expression of nuclear factor erythroid 2-related factor 2 (Nrf2), a central regulator of redox homeostasis. Consequently, VEL promoted the intracellular accumulation of doxorubicin and significantly potentiated its cytotoxic effects. Moreover, VEL enhanced the antitumor efficacy of other chemotherapeutic agents, including oxaliplatin and SN-38, the active metabolite of irinotecan. These findings suggest that VEL enhances anticancer drug sensitivity in CRC cells through lysosome-dependent downregulation of CLDN14 protein and suppression of Nrf2-dependent oxidative stress responses.

154

项与哌仑他韦相关的新闻（医药）

2026-10-04

·Pharm-Patent

哌仑他韦研究进展（V1,20226.10.4更新）

1、研究机构：艾伯维生物制药 2、别名：ABT-530、匹布伦他韦、2WU922TK3L、A-1325912.0、Pibrentasvir 3、靶点：NS5A 4、剂型及给药途径：普通片剂; 口服给药 5、结构式 6、适应症及进展适应症进展最新进展日期丙型病毒性肝炎 II/III期 2024-02-07 7、发表论文标题内容类型适应症企业技术平台来源发表日期 Highlights of the Structure-Activity Relationships of Benzimidazole Linked Pyrrolidines Leading to the Discovery of the Hepatitis C Virus NS5A Inhibitor Pibrentasvir (ABT-530)文章解读药物发现基因1型丙型肝炎, 基因2型丙型肝炎, 基因3型丙型肝炎, 基因4型丙型肝炎, 基因5型丙型肝炎, 基因6型丙型肝炎艾伯维生物制药 J Med Chem IF=7.3 2018-05-10 8、专利布局公开（公告）号专利主题发明名称申请日法律状态 CN103172620B 化合物抗病毒化合物 2010-06-10 CN103153988B 化合物抗病毒化合物 2011-10-12 CN106986861A 化合物抗病毒化合物 2011-10-12 视为撤回 CN104193729A 化合物抗病毒化合物 2011-10-12 驳回 CN103596941B 化合物抗病毒化合物 2012-02-24 CN115197197A 晶型晶型 2015-05-08 视为撤回 CN106458989A 晶型晶型 2015-05-08 驳回 9、研究历程 2019年10月29日，治疗丙型肝炎的研究暂无进展。（NCT02441283） 2017年02月08日，治疗丙型肝炎和慢性丙型肝炎的研究暂无进展。（NCT02243293） 2016年02月18日，治疗肾功能不全的研究暂无进展。（NCT02442258） 2015年10月20日，治疗肝功能衰退的研究暂无进展。（NCT02296905） 2015年06月22日，由艾伯维在澳大利亚、比利时和加拿大等国家和地区开展临床三期试验，用于治疗丙型肝炎。（NCT02441283） 2015年06月09日，治疗纤维化的研究暂无进展。（NCT01995071） 2015年03月01日，由艾伯维在新西兰和美国开展临床一期试验，用于治疗肾功能不全。（NCT02442258） 2014年10月01日，由艾伯维在新西兰和美国开展临床一期试验，用于治疗肝功能衰退。（NCT02296905） 2014年09月19日，由艾伯维开展临床三期试验，用于治疗丙型肝炎和慢性丙型肝炎。（NCT02243293） 2013年11月01日，由艾伯维开展临床二期试验，用于治疗丙型肝炎、慢性丙型肝炎和纤维化。（NCT01995071; NCT02068222; NCT02243280） 10、临床试验登记号试验标题试验药适应症原始适应症申办/合作机构试验状态试验分期开始日期完成日期国家/地区 EUCTR2017-002221-37-IT Glecaprevir/ pibrentasvir plus fixed-dose combination for 6 weeks in patients with acute hepatitis C virus: a pilot study. 格卡瑞韦 (薄膜包衣片, 口服) | 哌仑他韦 (薄膜包衣片, 口服) 丙型肝炎 Acute HCV infection | Viral hepatitis C Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Not yet recruiting 临床4期 2018-11-12 - 意大利 NCT04577482 Real World Evidence of the Effectiveness and Clinical Practice Use of Glecaprevir/Pibrentasvir in DAA Treatment-Experienced Patients With Chronic Hepatitis C Genotype 1 in Russian Federation (CHOICE) 格卡瑞韦 | 哌仑他韦慢性丙型肝炎基因型 1 Hepatitis C Virus (HCV) AbbVie, Inc. Completed N/A 2020-10-07 2022-09-03 俄罗斯 EUCTR2019-003736-22-3RD Bioavailability and Food Effect of Experimental Glecaprevir + Pibrentasvir Pediatric Formulation in Healthy Adult Subjects 格卡瑞韦 (颗粒剂, 口服) | 哌仑他韦 (颗粒剂, 口服) 慢性丙型肝炎 Hepatitis C virus (HCV) infection | HCV AbbVie, Inc. Unknown status 临床1期 2020-07-08 - - JPRN-jRCTs031200042 Safety and efficacy of glecaprevir and pibrentasvir in patients with hepatitis C virus infection and end-stage renal disease undergoing dialysis; a prostective study 格卡瑞韦 | 哌仑他韦肝性脑病 | 纤维化 | 食道静脉出血 | 终末期肾脏病 | 慢性丙型肝炎 | 腹水 Anti-viral therapy | Chronic hepatitis C infection - Completed 临床4期 2020-06-01 2021-06-24 日本 NCT04366973 New Care Pathways to Achieve HCV Elimination in the Community: Real-world Outcomes From HCV Infected Patients Treated in Addiction Centers in France 格卡瑞韦 | 哌仑他韦丙型肝炎 Hepatitis C Virus (HCV) AbbVie, Inc. Completed N/A 2020-05-26 2023-12-31 法国 NCT04352309 REAl World Evidence Of The Effectiveness And Clinical Practice Use Of Glecaprevir/Pibrentasvir For 8 Weeks Treatment In Patients With Chronic HepatitiS C GenotYpes 1 to 6 And Liver Cirrhosis In Russian Federation (EASY) 格卡瑞韦 | 哌仑他韦肝硬化 | 慢性丙型肝炎 Hepatitis C Virus (HCV) AbbVie, Inc. Completed N/A 2020-05-29 2021-06-11 俄罗斯 NCT04189627 Real World EviDEnce of the EffecTIveness and Clinical Practice Use of Glecaprevir/Pibrentasvir in Adolescents 12 to <18 Years of Age With Chronic Hepatitis C Genotypes 1 to 6 in Russian Federation (DETI-2) 格卡瑞韦 | 哌仑他韦慢性丙型肝炎 Hepatitis C Virus (HCV) AbbVie, Inc. Completed N/A 2020-02-17 2021-06-24 俄罗斯 JPRN-UMIN000031615 Efficacy and safety of Glecaprevir/Pibrentasvir plus Ribavirin in Patients who failed Direct-acting antivirals; DAAs with chronic hepatitis C 格卡瑞韦 | 哌仑他韦 | 利巴韦林慢性丙型肝炎 chronic hepatitis C Tokai University Suspended N/A 2018-03-20 - 日本 NCT03868163 Real World Evidence of the Effectiveness and Clinical Practice Use of Glecaprevir Plus Pibrentasvir in Patients With Chronic Hepatitis C Genotypes 1 to 6 in Russian Federation 格卡瑞韦 | 哌仑他韦慢性丙型肝炎 Chronic Hepatitis C (CHC) AbbVie, Inc. Completed N/A 2019-02-28 2020-09-04 俄罗斯 NCT03740230 Post-marketing Surveillance to Assess the Safety and Effectiveness of Maviret (Glecaprevir/Pibrentasvir) for Korean Chronic Hepatitis C Genotypes 1 to 6 Patients According to the "Standard for Re-examination of New Drugs" 格卡瑞韦 | 哌仑他韦慢性丙型肝炎 Hepatitis C AbbVie, Inc. Completed N/A 2018-09-26 2023-07-21 韩国 JPRN-UMIN000032073 Safety and efficacy of Glecaprevir / Pibrentasvir combination therapy for chronic hepatitis C - including hemodialysis patients - 格卡瑞韦 | 哌仑他韦慢性丙型肝炎 | 代偿期肝硬化 Patients with chronic hepatitis C patients and patients with type C compensated cirrhosis STMARIANNA University School of Medicine | Osaka Medical College | Takamatsu Red Cross Hospital | Nippon Medical School | Nagoya City University | Kitasato University | Jikei University School of Medicine | Juntendo University | Mitoyo General Hospital | Kagawa University | Kikkoman General Hospital | Tokyo Medical University | Yokohama City University Medical Center | National Kyushu Medical Center Completed N/A 2018-01-15 2022-03-31 日本 JPRN-UMIN000031098 Identification of Biomarkers for Prediction of Hepatocellular Carcinoma after Elimination of Hepatitis C Virus by Antiviral Medicines, mavilet 格卡瑞韦/哌仑他韦 | 格卡瑞韦 | 哌仑他韦肝细胞癌 | 丙型肝炎 Chronic hepaititis due to HCV Compensated liver cirroshis due to HCV Kanazawa University Recruiting N/A 2018-01-01 - 日本 EUCTR2017-005179-21-DK Four weeks treatment for chronic hepatitis C in patients under 50 years of age with no significant liver fibrosis 格卡瑞韦 (片剂, 口服) | 哌仑他韦 (片剂, 口服) | 利巴韦林 (片剂, 口服) 肝纤维化 | 慢性丙型肝炎 Chronic Hepatitis C | Chronic hepatitis C Danske Regioner Terminated 临床4期 2018-03-09 - 丹麦 JPRN-UMIN000030680 Comprehensive analysis of iron and mineral-bone metabolism after HCV clearance by glecaprevir and pibrentasvir therapy in HCV-infected hemodialysis patients 格卡瑞韦 | 哌仑他韦丙型肝炎 HCV patients receiving hemodialysis - Completed N/A 2018-01-04 2020-12-31 日本 NCT03341871 Glecaprevir/Pibrentasvir Drug Use Results Survey in Patients Infected With Hepatitis C Virus Genotype 1-6 格卡瑞韦 | 哌仑他韦丙型肝炎 | 慢性丙型肝炎 Hepatitis C Virus (HCV) AbbVie, Inc. Completed N/A 2017-12-27 2020-09-15 日本 JPRN-UMIN000027428 Retrospective cohort study of resistance associated substitutions and clinical course in Glecaprevir(GLE)/Pibrentasvir(PIB) treatment to hepatitis C virus 格卡瑞韦 | 哌仑他韦丙型肝炎 Hepatitis C virus infected patients - Completed N/A 2017-12-01 2030-12-31 日本 NCT03303599 Real World Evidence of the Effectiveness and Clinical Practice Use of Glecaprevir Plus Pibrentasvir in Patients With Chronic Hepatitis C Genotypes 1 to 6 格卡瑞韦 | 哌仑他韦慢性丙型肝炎 Hepatitis C AbbVie, Inc. Completed N/A 2017-11-13 2020-01-24 希腊 | 奥地利 | 比利时 | 波兰 | 意大利 | 以色列 | 法国 | 瑞士 | 葡萄牙 NCT03123965 Expanded Access to Glecaprevir/ Pibrentasvir 格卡瑞韦 | 哌仑他韦丙型肝炎 Hepatitis C Virus Infection AbbVie, Inc. Approved for marketing N/A - - 斯洛文尼亚 JPRN-UMIN000022569 To calculate the efficacy and safety of ABT-493/ABT-530 for HCV genotype 2 in Japan,Randomised non-blinded multicenter trial. 索磷布韦 | 格卡瑞韦 | 哌仑他韦 | 利巴韦林 - HCV genotype 2 Shinshu University School of Medicine Completed N/A 2016-06-06 - 日本 JPRN-UMIN000022567 To calculate the efficacy and safety of ABT-493/ABT-530 for HCV in Japan, Randmised non-blinded multicenter trial 索磷布韦 | 格卡瑞韦 | 哌仑他韦 - HCV Shinshu University School of Medicine Completed N/A 2016-06-06 - 日本 NCT02738138 A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus (HCV) Genotype 1 - 6 Infection and Human Immunodeficiency Virus-1 (HIV-1) Co-Infection (EXPEDITION-2) 格卡瑞韦 | 哌仑他韦纤维化 | HIV感染 | 慢性丙型肝炎 Hepatitis C Virus Infection | Human Immunodeficiency Virus Infection | Chronic Hepatitis C | Compensated Cirrhosis and Non-cirrhotics AbbVie, Inc. Completed 临床3期 2016-05-17 2017-06-07 - EUCTR2015-005004-28-GB Stratified Treatment OPtimisation for HCV-1 (STOPHCV-1) 奥比帕利 (薄膜包衣片, 口服) | 索磷布韦 (薄膜包衣片, 口服) | 来迪派韦 (薄膜包衣片, 口服) | 达塞布韦钠 (薄膜包衣片, 口服) | 格卡瑞韦 (薄膜包衣片, 口服) | 哌仑他韦 (薄膜包衣片, 口服) | 利巴韦林 (薄膜包衣片, 口服) 慢性丙型肝炎 Hepatitis C Infection (HCV) (genotype 1a/1b/4) | Hepatitis C infection | Chronic hepatitis C Imperial College London Completed 临床2期 2015-12-31 2019-04-04 英国 NCT02446717 A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 (or ABT-493/ABT-530) With and Without Ribavirin in Adults With Chronic Hepatitis C Virus (HCV) Infection Who Failed a Prior Direct-Acting Antiviral Agent (DAA)-Containing Therapy 格卡瑞韦 | 格卡瑞韦/哌仑他韦 | 哌仑他韦 | 利巴韦林慢性丙型肝炎 Chronic Hepatitis C | Hepatitis C Virus | HCV | Direct-Acting Antiviral Agent (DAA)-Experienced AbbVie, Inc. Completed 临床2/3期 2015-04-01 2017-01-01 - NCT02442258 Evaluation of the Pharmacokinetics and Safety of ABT-493 and ABT-530 in Subjects With Normal and Impaired Renal Function 格卡瑞韦 | 哌仑他韦肾功能不全 Renal Impairment AbbVie, Inc. Completed 临床1期 2015-03-01 2015-12-01 新西兰 | 美国 NCT02441283 A Follow-up Study to Assess Resistance and Durability of Response to AbbVie Direct-Acting Antiviral Agent (DAA) Therapy (ABT-493 and/or ABT-530) in Subjects Who Participated in Phase 2 or 3 Clinical Studies for the Treatment of Chronic Hepatitis C Virus (HCV) Infection 格卡瑞韦 | 哌仑他韦慢性丙型肝炎 Hepatitis C AbbVie, Inc. Completed 临床2/3期 2015-06-22 2019-10-15 新西兰 | 加拿大 | 美国 | 比利时 | 英国 | 澳大利亚 | 德国 NCT02296905 Pharmacokinetics and Safety of ABT-493 and/or ABT-530 in Subjects With Normal and Impaired Hepatic Function 格卡瑞韦 | 哌仑他韦肝功能不全 Hepatic Impairment AbbVie, Inc. Completed 临床1期 2014-10-01 2015-09-01 新西兰 | 美国 NCT02243293 A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without RBV in Subjects With Chronic Hepatitis C Virus (HCV) Genotypes 2, 3, 4, 5 or 6 Infection (SURVEYOR-II) 格卡瑞韦 | 格卡瑞韦/哌仑他韦 | 哌仑他韦 | 利巴韦林慢性丙型肝炎 Chronic Hepatitis C | Hepatitis C Virus AbbVie, Inc. Completed 临床2/3期 2014-09-19 2017-02-23 - NCT02243280 An Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without Ribavirin in Subjects With Chronic Hepatitis C Virus (HCV) Genotype 1, 4, 5, and 6 Infection (SURVEYOR-I) 格卡瑞韦 | 哌仑他韦慢性丙型肝炎 Chronic Hepatitis C | Hepatitis C Virus | HCV AbbVie, Inc. Completed 临床2期 2014-08-01 2016-02-01 - NCT02068222 An Open-Label Pilot Study to Evaluate the Antiviral Activity, Safety, Tolerability, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-530, With and Without Ribavirin (RBV) in Treatment-Naïve Subjects With Genotype 3 Chronic Hepatitis C Virus (HCV) Infection 帕利普韦 | 哌仑他韦 | 利巴韦林 | 利托那韦慢性丙型肝炎基因型 3 Chronic Hepatitis C | Hepatitis C Virus AbbVie, Inc. Completed 临床2期 2014-04-01 2015-03-01 - NCT01995071 A Randomized, Open-Label, Dose Ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Multiple Doses of ABT-493 and ABT-530 in Adult Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection 奥比帕利 | 格卡瑞韦 | 哌仑他韦 | 利巴韦林慢性丙型肝炎基因型 1 | 代偿期肝硬化 Chronic Hepatitis C | Hepatitis C Virus | Compensated Cirrhosis AbbVie, Inc. Completed 临床2期 2013-11-01 2015-06-01 - 11、临床结果标题登记号来源分期适应症评价人数用药方案结果评价发布日期申办/合作机构主要研究药物来源链接 Synapse链接 ULTRA-SHORT GLECAPREVIR/PIBRENTASVIR PLUS EZETIMIBE PREVENTS CHRONIC HCV IN HCV-INFECTED RECIPIENTS OF HCV-UNINFECTED NON-LIVER TRANSPLANTS: 6-YEAR OUTCOMES OF THE TORONTO PROTOCOL - AASLD N/A 丙型肝炎 113 Glecaprevir/Pibrentasvir + Ezetimibe Anti-HCV surface antibodies = 24.0 % 积极 2025-11-07 Toronto General Hospital | University Health Network 哌仑他韦 | 格卡瑞韦 | 依折麦布 https://journals.lww.com/hep/fulltext/10.1097/hep.0000000000001493~the-liver-meeting-2025-abstracts https://synapse.zhihuiya.com/clinical-result-detail/d932d455a285424859a283554aaaa285 GLECAPREVIR/PIBRENTASVIR IN CHRONIC HCV: AN INTEGRATED ANALYSIS OF PATIENTS ON MULTIPLE CONCOMITANT MEDICATIONS - AASLD N/A 慢性丙型肝炎 6569 Glecaprevir/Pibrentasvir SVR12 = 98.6 % 积极 2024-11-15 Imperial College Healthcare NHS Trust | AbbVie, Inc. 哌仑他韦 | 格卡瑞韦 https://journals.lww.com/hep/fulltext/10.1097/hep.0000000000001077~the-liver-meeting-san-diego-california-nov-15-19-2024 https://synapse.zhihuiya.com/clinical-result-detail/22da252e428200ad32a9888a2d5e5e22 IMPLEMENTATION OF GLECAPREVIR-PIBRENTASVIR TREATMENT FOR CHILDREN AGED 3-12 YEARS WITH CHRONIC HEPATITIS C: MULTICENTER REAL-WORLD DATA - AASLD N/A 慢性丙型肝炎 10 Glecaprevir-Pibrentasvir AE = One patient had a high fever and malaise for two days due to Covid-19 infection during treatment. Nevertheless, treatment was not discontinued. No other adverse events were reported. 积极 2024-11-15 Soroka University Medical Center | Shaare Zedek Medical Center 哌仑他韦 | 格卡瑞韦 https://journals.lww.com/hep/fulltext/10.1097/hep.0000000000001077~the-liver-meeting-san-diego-california-nov-15-19-2024 https://synapse.zhihuiya.com/clinical-result-detail/d205ee58a8e293aa99e0a82a4aa50ded ONGOING EXPERIENCE OF IMPLEMENTING THE TORONTO PROTOCOL: AN ULTRA-SHORT COURSE GLECAPRIVER/ PIBRENTASVIR WITH EZETIMIBE FOR SOLID ORGAN TRANSPLANTATION FROM HCV-INFECTED DONORS TO HCV?UNINFECTED RECIPIENTS - AASLD N/A - 88 Glecaprevir/pibrentasvir + Ezetimibe HCV antibodies = 27 (46%) patients developed HCV antibodies that persisted post-treatment - 2023-11-10 University Health Network 哌仑他韦 | 依折麦布 https://journals.lww.com/hep/fulltext/2023/10001/the_liver_meeting__boston,_massachusetts_nov.1.aspx https://synapse.zhihuiya.com/clinical-result-detail/483295aa44895e94e90943aa2258d08e Effectiveness and safety of 8-week glecaprevir/pibrentasvir in HCV treatment naïve patients with compensated cirrhosis: real- world experience from Taiwan HCV registry - EASL N/A 丙型肝炎 | 代偿期肝硬化 806 Glecaprevir/pibrentasvir 8-week regimen AE = 24.9 % - 2022-06-24 Mackay Medical College | 慈济学校财团法人慈济大学 | 辅仁大学 | 国立成功大学医学院附属医院哌仑他韦 | 格卡瑞韦 https://easl.eu/wp-content/uploads/2022/06/EASL_2022_Version-4_Latest-version_compressed-1.pdf https://synapse.zhihuiya.com/clinical-result-detail/329500e92a82352582da5ee3d258e235 Durability of sustained virological response to glecaprevir/pibrentasvir and resistance development: A long-term follow-up study. NCT02441283 Pubmed 临床2/3期慢性丙型肝炎 384 Glecaprevir/pibrentasvir-containing regimen SVR(durability of sustained virologic response) = 99.5 % 积极 2022-02-26 AbbVie, Inc. 哌仑他韦 | 格卡瑞韦 https://pubmed.ncbi.nlm.nih.gov/35220658/ | https://doi.org/10.1111/liv.15211 https://synapse.zhihuiya.com/clinical-result-detail/a8348839da83292eea49e52282585825 Real-World Outcomes in Historically Underserved Patients with Chronic Hepatitis C Infection Treated with Glecaprevir/Pibrentasvir. NCT03303599 Pubmed N/A - 2036 Glecaprevir/pibrentasvir Adverse Event: glecaprevir/pibrentasvir-related adverse events led to discontinuation = Six glecaprevir/pibrentasvir-related adverse events led to discontinuation - 2021-06-14 AbbVie, Inc. 哌仑他韦 | 格卡瑞韦 https://pubmed.ncbi.nlm.nih.gov/34125405/ | https://doi.org/10.1007/s40121-021-00455-1 | https://pubmed.ncbi.nlm.nih.gov/34529256/ https://synapse.zhihuiya.com/clinical-result-detail/eed95e02edda05d2a28e58355e5e9e28 A Follow-up Study to Assess Resistance and Durability of Response to AbbVie Direct-Acting Antiviral Agent (DAA) Therapy (ABT-493 and/or ABT-530) in Subjects Who Participated in Phase 2 or 3 Clinical Studies for the Treatment of Chronic Hepatitis C Virus (HCV) Infection NCT02441283 CTgov 临床2/3期慢性丙型肝炎 384 ABT-493+ABT-530 Percentage of Participants Who Maintained a Sustained Virologic Response (SVR) Out of Those Who Achieved SVR12 in a Prior Study With an ABT-493- and/or ABT-530-containing Regimen = 99.5 % - 2020-09-21 AbbVie, Inc. 哌仑他韦 | 格卡瑞韦 https://clinicaltrials.gov/ct2/show/results/NCT02441283 https://synapse.zhihuiya.com/clinical-result-detail/9a3308ea2a05a050d8e952a25538aee3 Second-generation DAAs for HCV: real-life efficacy in the resist- HCV cohort - EASL N/A 丙型肝炎 - Sofosbuvir plus Velpatasvir Adverse Event: Adverse events = Twenty patients (0.5%) discontinued treatment due to adverse events 积极 2020-08-27 University of Messina - https://easl.eu/wp-content/uploads/2020/12/digital-ilc-2020-abstract.pdf https://synapse.zhihuiya.com/clinical-result-detail/58335a34e08aee88ee855d8d088a5220 Second-generation DAAs for HCV: real-life efficacy in the resist- HCV cohort - EASL N/A 丙型肝炎 - Glecaprevir plus Pibrentasvir Adverse Event: Adverse events = Twenty patients (0.5%) discontinued treatment due to adverse events 积极 2020-08-27 University of Messina - https://easl.eu/wp-content/uploads/2020/12/digital-ilc-2020-abstract.pdf https://synapse.zhihuiya.com/clinical-result-detail/58335a34e08aee88ee855d8d088a5220 Virological patterns of HCV-patients with failure to second generation direct-acting antivirals - EASL N/A 丙型肝炎 63 Sofosbuvir+Velpatasvir HCV RNA = 2.27E + 06 IU/mL 积极 2020-08-27 - - https://easl.eu/wp-content/uploads/2020/12/digital-ilc-2020-abstract.pdf https://synapse.zhihuiya.com/clinical-result-detail/a2e9d8832e558a8549d2a5a242989d82 Virological patterns of HCV-patients with failure to second generation direct-acting antivirals - EASL N/A 丙型肝炎 63 Glecaprevir+Pibrentasvir NS3-RAS = 9.1 % 积极 2020-08-27 - - https://easl.eu/wp-content/uploads/2020/12/digital-ilc-2020-abstract.pdf https://synapse.zhihuiya.com/clinical-result-detail/a2e9d8832e558a8549d2a5a242989d82 Adherence to pan-genotypic glecaprevir/pibrentasvir and efficacy in HCV-infected patients: A pooled analysis of clinical trials. NCT02604017 | NCT02636595 | NCT02446717 | NCT02642432 | NCT02640157 | NCT02651194 | NCT02640482 | NCT02243293 Pubmed 临床2/3期丙型肝炎 2091 Glecaprevir/pibrentasvir therapy SVR12 = 99 % - 2020-04-01 AbbVie, Inc. 哌仑他韦 | 格卡瑞韦 https://pubmed.ncbi.nlm.nih.gov/31568620/ | https://doi.org/10.1111/liv.14266 https://synapse.zhihuiya.com/clinical-result-detail/22da2e242992d32dd59822e5852832a9 Glecaprevir/pibrentasvir for chronic hepatitis Cin large real world experience study - UEGW N/A 慢性丙型肝炎 381 Glecaprevir/pibrentasvir 12 weeks regimen = 28 % 积极 2019-10-01 Medical University of Lublin | Jan Kochanowski University In Kielce | Medical University of Gdansk | Medical University of Silesia 哌仑他韦 | 格卡瑞韦 https://onlinelibrary.wiley.com/doi/epdf/10.1177/2050640619854671 https://synapse.zhihuiya.com/clinical-result-detail/089d282dd92e2295e322a855a83e2880 Integrated analysis of 8-week glecaprevir/pibrentasvir in Japanese and overseas patients without cirrhosis and with hepatitis C virus genotype 1 or 2 infection. NCT02604017 | NCT02738138 | NCT02243280 | NCT02723084 | NCT02707952 | NCT02243293 Pubmed 临床2/3期丙型肝炎 899 Glecaprevir/pibrentasvir SVR12(sustained virologic response 12 weeks post-treatment) = 98.9 % - 2019-08-01 AbbVie, Inc. 哌仑他韦 | 格卡瑞韦 https://pubmed.ncbi.nlm.nih.gov/30868245/ | https://doi.org/10.1007/s00535-019-01569-7 https://synapse.zhihuiya.com/clinical-result-detail/5284593095200253ada2d24ee4a8a233 Real-world effectiveness and safety of glecaprevir plus pibrentasvir in HCV: A multi-country analysis of postmarketing observational studies - EASL N/A 丙型肝炎 815 Glecaprevir plus pibrentasvir Adverse Event: asthenia = 2% - 2019-04-11 Enanta Pharmaceuticals, Inc. | AbbVie, Inc. 格卡瑞韦 https://2019.ilc-congress.eu/wp-content/uploads/2019/04/EASL-ILC2019-AbstractBook-13042019-Final.pdf https://synapse.zhihuiya.com/clinical-result-detail/a0a4883324edeed424e8ed284a292582 Real-world effectiveness and safety of glecaprevir plus pibrentasvir in HCV: A multi-country analysis of postmarketing observational studies - EASL N/A 丙型肝炎 815 Placebo Adverse Event: asthenia = 2% - 2019-04-11 Enanta Pharmaceuticals, Inc. | AbbVie, Inc. 格卡瑞韦 https://2019.ilc-congress.eu/wp-content/uploads/2019/04/EASL-ILC2019-AbstractBook-13042019-Final.pdf https://synapse.zhihuiya.com/clinical-result-detail/a0a4883324edeed424e8ed284a292582 Efficacy and safety of glecaprevir/pibrentasvir treatment for 8 weeks in treatment-naive patients with chronic hepatitis C virus infection without cirrhosis or with compensated cirrhosis: Analysis of data pooled from phase 2 and 3 studies - EASL N/A 慢性丙型肝炎 | 代偿期肝硬化 1163 Glecaprevir/pibrentasvir Adverse Event: fatigue = 10% - 2019-04-11 Enanta Pharmaceuticals, Inc. | AbbVie, Inc. 哌仑他韦 | 格卡瑞韦 https://2019.ilc-congress.eu/wp-content/uploads/2019/04/EASL-ILC2019-AbstractBook-13042019-Final.pdf https://synapse.zhihuiya.com/clinical-result-detail/280940aa08d089e222208d2295d328ea Glecaprevir/pibrentasvir in patients with chronic HCV and recent drug use: An integrated analysis of 7 phase III studies. NCT02604017 | NCT02640157 | NCT02636595 | NCT02651194 | NCT02642432 | NCT02738138 | NCT02640482 Pubmed 临床3期慢性丙型肝炎 1819 Glecaprevir/pibrentasvir SVR12(sustained virologic response at 12 weeks posttreatment) = 93 % 积极 2019-01-01 AbbVie, Inc. 哌仑他韦 | 格卡瑞韦 https://pubmed.ncbi.nlm.nih.gov/30529905/ | https://doi.org/10.1016/j.drugalcdep.2018.11.007 https://synapse.zhihuiya.com/clinical-result-detail/a9d385e80ae9e2d22555de2ad5423292 A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus (HCV) Genotype 1 - 6 Infection and Human Immunodeficiency Virus-1 (HIV-1) Co-Infection (EXPEDITION-2) NCT02738138 CTgov 临床3期纤维化 | HIV感染 | 慢性丙型肝炎 153 ABT-493+ABT-530(ABT-493/ABT-530 for 8 Weeks) 其他（不包括严重）不良反应 = 50 Pts - 2018-05-09 AbbVie, Inc. 哌仑他韦 | 格卡瑞韦 https://clinicaltrials.gov/ct2/show/results/NCT02738138 https://synapse.zhihuiya.com/clinical-result-detail/a2aee5289a43409a9aa25ee2d204445d A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus (HCV) Genotype 1 - 6 Infection and Human Immunodeficiency Virus-1 (HIV-1) Co-Infection (EXPEDITION-2) NCT02738138 CTgov 临床3期纤维化 | HIV感染 | 慢性丙型肝炎 153 ABT-493+ABT-530(ABT-493/ABT-530 for 12 Weeks) 其他（不包括严重）不良反应 = 7 Pts - 2018-05-09 AbbVie, Inc. 哌仑他韦 | 格卡瑞韦 https://clinicaltrials.gov/ct2/show/results/NCT02738138 https://synapse.zhihuiya.com/clinical-result-detail/a2aee5289a43409a9aa25ee2d204445d Efficacy of Glecaprevir/Pibrentasvir for 8 or 12 Weeks in Patients With Hepatitis C Virus Genotype 2, 4, 5, or 6 Infection Without Cirrhosis. NCT02636595 | NCT02640482 | NCT02243293 Pubmed 临床3期纤维化 | 丙型肝炎 - Glecaprevir/Pibrentasvir 8 weeks SVR12(sustained virologic response at 12 weeks after treatment) = 98 % (95%CI, 94.1 ~ 99.3) - 2018-03-01 AbbVie, Inc. 哌仑他韦 | 格卡瑞韦 https://pubmed.ncbi.nlm.nih.gov/28951228/ https://synapse.zhihuiya.com/clinical-result-detail/e3d39429de802a35a02e5884e228eee5 Efficacy of Glecaprevir/Pibrentasvir for 8 or 12 Weeks in Patients With Hepatitis C Virus Genotype 2, 4, 5, or 6 Infection Without Cirrhosis. NCT02636595 | NCT02640482 | NCT02243293 Pubmed 临床3期纤维化 | 丙型肝炎 - Glecaprevir/Pibrentasvir 12 weeks SVR12(sustained virologic response at 12 weeks after treatment) = 99.5 % (95%CI, 98.5 ~ 100) - 2018-03-01 AbbVie, Inc. 哌仑他韦 | 格卡瑞韦 https://pubmed.ncbi.nlm.nih.gov/28951228/ https://synapse.zhihuiya.com/clinical-result-detail/e3d39429de802a35a02e5884e228eee5 Effects of Renal Impairment and Hemodialysis on the Pharmacokinetics and Safety of the Glecaprevir and Pibrentasvir Combination in Hepatitis C Virus-Negative Subjects NCT02442258 Pubmed 临床1期肾功能不全 46 Glecaprevir+Pibrentasvir(stage 2 to 5 chronic kidney disease who were not on dialysis or who had normal renal function) AE = Adverse events were mostly mild, with the most common being self-limited fatigue (3 subjects). 积极 2018-02-23 AbbVie, Inc. 哌仑他韦 | 格卡瑞韦 https://pubmed.ncbi.nlm.nih.gov/29263061/ https://synapse.zhihuiya.com/clinical-result-detail/4a22e28a22e40990eaa802aa2d0a52e9 Effects of Renal Impairment and Hemodialysis on the Pharmacokinetics and Safety of the Glecaprevir and Pibrentasvir Combination in Hepatitis C Virus-Negative Subjects NCT02442258 Pubmed 临床1期肾功能不全 46 Glecaprevir+Pibrentasvir(requiring hemodialysis) AE = Adverse events were mostly mild, with the most common being self-limited fatigue (3 subjects). 积极 2018-02-23 AbbVie, Inc. 哌仑他韦 | 格卡瑞韦 https://pubmed.ncbi.nlm.nih.gov/29263061/ https://synapse.zhihuiya.com/clinical-result-detail/4a22e28a22e40990eaa802aa2d0a52e9 EXPEDITION-4: Efficacy and Safety of Glecaprevir/Pibrentasvir in Patients with Chronic Hepatitis C Genotype 1-6 Infection by Dialysis Status - ASN 临床3期慢性丙型肝炎 104 Glecaprevir/Pibrentasvir (G/P) SVR12 = 98 % 积极 2017-10-31 Enanta Pharmaceuticals, Inc. | AbbVie, Inc. 哌仑他韦 | 格卡瑞韦 https://www.asn-online.org/education/kidneyweek/archives/KW17Abstracts.pdf https://synapse.zhihuiya.com/clinical-result-detail/34823222e8e9299a28a2d909e2288ada MAGELLAN-2: Glecaprevir/Pibrentasvir for 12 Weeks in Renal Transplant Patients With Chronic Hepatitis C Virus Genotypes 1–6 - ASN 临床3期慢性丙型肝炎 20 Glecaprevir/Pibrentasvir 300/120 mg Adverse Event: decreased creatinine clearance = One patient had decreased creatinine clearance (<30 mL/min) during treatment 2 days after the last G/P dose, which was not related to the DAA 积极 2017-10-31 AbbVie, Inc. 哌仑他韦 | 格卡瑞韦 https://www.asn-online.org/education/kidneyweek/archives/KW17Abstracts.pdf https://synapse.zhihuiya.com/clinical-result-detail/a0a2e022eeda2a2282495a420925239a A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 (or ABT-493/ABT-530) With and Without Ribavirin in Adults With Chronic Hepatitis C Virus (HCV) Infection Who Failed a Prior Direct-Acting Antiviral Agent (DAA)-Containing Therapy NCT02446717 CTgov 临床2/3期慢性丙型肝炎 141 ABT-493+ABT-530(ARM A) Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) = 100 % (95%CI, 61.0 ~ 100.0) - 2017-09-15 AbbVie, Inc. 哌仑他韦 | 格卡瑞韦/哌仑他韦 | 格卡瑞韦 | 利巴韦林 https://clinicaltrials.gov/ct2/show/results/NCT02446717 https://synapse.zhihuiya.com/clinical-result-detail/48a5a22a8a2a4a2525e2955050aa5828 A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 (or ABT-493/ABT-530) With and Without Ribavirin in Adults With Chronic Hepatitis C Virus (HCV) Infection Who Failed a Prior Direct-Acting Antiviral Agent (DAA)-Containing Therapy NCT02446717 CTgov 临床2/3期慢性丙型肝炎 141 ABT-493+ABT-530+ribavirin (RBV)(ARM B) Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) = 95.5 % (95%CI, 78.2 ~ 99.2) - 2017-09-15 AbbVie, Inc. 哌仑他韦 | 格卡瑞韦/哌仑他韦 | 格卡瑞韦 | 利巴韦林 https://clinicaltrials.gov/ct2/show/results/NCT02446717 https://synapse.zhihuiya.com/clinical-result-detail/48a5a22a8a2a4a2525e2955050aa5828 An Open-Label Pilot Study to Evaluate the Antiviral Activity, Safety, Tolerability, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-530, With and Without Ribavirin (RBV) in Treatment-Naïve Subjects With Genotype 3 Chronic Hepatitis C Virus (HCV) Infection NCT02068222 CTgov 临床2期慢性丙型肝炎基因型 3 10 ABT-450+ABT-530+Ribavirin (RBV)+r+ritonavir The Percentage of Subjects Who Achieve 12-week Sustained Virologic Response (SVR12) = 90 % (95%CI, 55.5 ~ 99.7) - 2017-02-02 AbbVie, Inc. 哌仑他韦 | 帕利普韦 | 利巴韦林 | 利托那韦 https://clinicaltrials.gov/ct2/show/results/NCT02068222 https://synapse.zhihuiya.com/clinical-result-detail/a9a3deee8a438a324e5238e533540d44 High antiviral activity of NS5A inhibitor ABT-530 with paritaprevir/ritonavir and ribavirin against hepatitis C virus genotype 3 infection NCT02068222 Pubmed 临床2期丙型肝炎 10 paritaprevir/ritonavi+ribavirin+ABT-530 SVR = 90 % 积极 2016-08-01 AbbVie, Inc. 哌仑他韦 https://pubmed.ncbi.nlm.nih.gov/26778412/ | https://doi.org/10.1111/liv.13067 https://synapse.zhihuiya.com/clinical-result-detail/a50228588452395d2ea585523aa3ea42 Potent Antiviral Activities of the Direct-Acting Antivirals ABT-493 and ABT-530 with Three-Day Monotherapy for Hepatitis C Virus Genotype 1 Infection NCT01995071 Pubmed 临床2期丙型肝炎 - ABT-493 HCV RNA(Maximal Decrease) = 4 log10 IU/mL 积极 2015-12-28 AbbVie, Inc. 哌仑他韦 | 格卡瑞韦 https://pubmed.ncbi.nlm.nih.gov/26711747/ | https://doi.org/10.1128/aac.02264-15 https://synapse.zhihuiya.com/clinical-result-detail/e222954222240522543aa88d5a50ade8 Potent Antiviral Activities of the Direct-Acting Antivirals ABT-493 and ABT-530 with Three-Day Monotherapy for Hepatitis C Virus Genotype 1 Infection NCT01995071 Pubmed 临床2期丙型肝炎 - ABT-530 HCV RNA(Maximal Decrease) = 4 log10 IU/mL 积极 2015-12-28 AbbVie, Inc. 哌仑他韦 | 格卡瑞韦 https://pubmed.ncbi.nlm.nih.gov/26711747/ | https://doi.org/10.1128/aac.02264-15 https://synapse.zhihuiya.com/clinical-result-detail/e222954222240522543aa88d5a50ade8 12、转化医学研究亮点主题期刊/会议出版日期药物适应症机构 Epidemiologic Characteristics Determining the Choice of Direct-Acting Antiviral Therapy in HCV Patients: An Italian Real-World Evidence Study - 真实世界研究 Pathogens 2025-11-18 索磷布韦 | 格卡瑞韦 | 维帕他韦 | 哌仑他韦丙型肝炎 Humanitas University | Gilead Sciences, Inc. | Istituto Superiore di Sanità | Istituto di Ricovero e Cura (IRCCS) Casa Sollievo della Sofferenza | IRCCS Humanitas Research Hospital | Campus Bio-Medico ULTRA-SHORT GLECAPREVIR/PIBRENTASVIR PLUS EZETIMIBE PREVENTS CHRONIC HCV IN HCV-INFECTED RECIPIENTS OF HCV-UNINFECTED NON-LIVER TRANSPLANTS: 6-YEAR OUTCOMES OF THE TORONTO PROTOCOL 多伦多方案评估了7天短疗程格卡瑞韦/哌仑他韦联合依折麦布（移植前1剂、术后7天）预防HCV阳性供者移植给HCV阴性受者感染的效果。回顾性纳入113例非肝实体器官移植受者，随访中位156周。所有患者术后12周HCV RNA均不可检测，未发生病毒血症、需再次治疗、HCV相关并发症或药物不良事件。6个月患者生存率96%，移植物生存率99%。结果表明，该方案疗程超短、安全、耐受性好且可在出院前完成，有望扩大HCV阳性供者器官的安全利用。真实世界研究 AASLD 2025 2025-11-07 格卡瑞韦 | 依折麦布 | 哌仑他韦丙型肝炎 - IMPLEMENTATION OF GLECAPREVIR-PIBRENTASVIR TREATMENT FOR CHILDREN AGED 3-12 YEARS WITH CHRONIC HEPATITIS C: MULTICENTER REAL-WORLD DATA 一项全国多中心回顾性研究评估了2022—2023年GLE/PIB治疗3~12岁慢性丙肝患儿的真实世界效果。共纳入10例（中位年龄6.8岁），基因1b型占50%，均无肝硬化或合并乙肝、艾滋病。所有患儿按体重接受口服GLE/PIB 8周，治疗依从性良好；仅1例治疗期间因新冠感染出现发热、乏力，未停药，未见其他不良事件。治疗结束后12周，所有患儿均达到持续病毒学应答（SVR），HCV RNA不可测。结果表明，GLE/PIB用于3~12岁儿童疗效高、安全性及耐受性良好，早期治疗有助于预防肝损伤并减少传播。真实世界研究 AASLD 2024 2024-11-15 格卡瑞韦 | 哌仑他韦慢性丙型肝炎 - Real-World Efficacy and Safety of Universal 8-Week Glecaprevir/Pibrentasvir for Treatment-Naïve Patients from a Nationwide HCV Registry in Taiwan - 真实世界研究 Infect Dis Ther 2024-04-28 格卡瑞韦 | 哌仑他韦丙型肝炎 Show Chwan Health Care System | 财团法人奇美医院 | Buddhist Tzu Chi Medical Foundation | Show Chwan Memorial Hospital Infrequent hepatitis C genotypes/subtypes in patients treated with DAA-based regimens: successes and failures - 真实世界研究 EASL 2022 2022-06-24 索磷布韦 | 来迪派韦 | 格卡瑞韦 | 维帕他韦 | 哌仑他韦丙型肝炎 Centre Hospitalier de l'Universite de Montreal | Institut national de santé publique du Québec Repurposed antibiotic and antiviral drugs inhibit the immune evasive endoribonuclease of SARS-CoV-2 and restrict coronavirus infection in vitro 本研究利用机器学习虚拟配体筛选算法FRAGSITE，对FDA批准的化合物库进行筛选，发现11种药物能够在体外抑制SARS-CoV-2内源核糖核酸酶(nsp15)的活性，并且其中6种药物还能通过焦点形成实验限制相关的人类OC43冠状病毒在人类A549气道上皮细胞中的感染。在这6种候选药物中，pibrentasvir对HCoV-OC43的活性最强(IC50 < 0.625μM)。研究结果表明，nsp15抑制剂治疗部分恢复了HCoV-OC43感染细胞中的抗病毒应激颗粒形成，尽管IFNβ产生和RNase L激活保持不变。这些初步结果为开发针对SARS-CoV-2和其他相关冠状病毒的抗病毒药物提供了新的方向。 Emory School of Medicine的资助支持了本研究。药物发现/临床前 AAI 2022 2022-05-01 哌仑他韦冠状病毒感染 Emory University Durability of sustained virological response to glecaprevir/pibrentasvir and resistance development: A long-term follow-up study. 本研究旨在评估接受格来沙韦/匹伐他韦治疗的丙型肝炎病毒感染者持续病毒学应答（SVR）的持久性。研究结果显示，在先前的临床试验中，99.7%的参与者达到了SVR12，随访3年后，99.5%的参与者仍然保持SVR。格来沙韦/匹伐他韦在实现SVR12后表现出长期疗效。在持续观察的参与者中，76%的参与者保持了SVR。对于抗药性突变的持久性结论不明确，因为病毒失败的发生率较低。总体而言，格来沙韦/匹伐他韦在SVR12后表现出长期持久的疗效，且未出现与肝脏相关的恶化事件。 2/3期临床研究 Liver Int 2022-02-26 哌仑他韦慢性丙型肝炎 AbbVie, Inc. Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Children With Chronic HCV: Part 2 of the DORA Study 研究总结了格来沙韦/匹伯替韦在3至12岁慢性丙型肝炎患儿中的药代动力学、安全性和疗效。研究结果显示，格来沙韦/匹伯替韦对这个年龄段的患儿具有高效性和良好耐受性，对丙型肝炎的治疗效果显著。研究为这一年龄段患儿确定了适宜的药物剂量，为临床治疗提供了重要参考。 2/3期临床研究 Pubmed 2021-07-01 格卡瑞韦 | 哌仑他韦慢性丙型肝炎 AdventHealth for Children | Hospital Universitario La Paz | AbbVie, Inc. | San Jorge Children’s Hospital,San Juan,Puerto Rico | Department of Pediatrics,Harvard Medical School,Boston,MA | Division of Gastroenterology, Hepatology, and Nutrition,Boston Children’s Hospital,Boston,MA | Digestive Health Institute,Children’s Hospital Colorado,Section of Pediatric Gastroenterology,Hepatology, and Nutrition,Department of Pediatrics University of Colorado School of Medicine,Aurora,CO Real-World Outcomes in Historically Underserved Patients with Chronic Hepatitis C Infection Treated with Glecaprevir/Pibrentasvir. 本研究评估了格来沙韦/匹伐他韦在历史上未受关注的慢性丙型肝炎患者中的真实世界疗效、安全性和患者报告的结果。研究数据来自九个国家，共2036名患者，其中83.5%接受了8周的格来沙韦/匹伐他韦治疗。结果显示，治疗后12周持续病毒学应答率为98.0%，患者的心理和身体健康总结分数均有所改善。格来沙韦/匹伐他韦在患者中表现出高效、耐受性好，并改善了生活质量。这些多国后市场观察性研究已在ClinicalTrials.gov注册，编号为NCT03303599。真实世界研究 Infect Dis Ther 2021-06-14 格卡瑞韦 | 哌仑他韦 - AbbVie, Inc. BK Polyomavirus Nephropathy After Kidney Transplantation from HCV-Infected Donor to HCV-Uninfected Recipient BK多瘤病毒肾病是肾移植后重要的排异原因。此前的研究已发现，从丙型肝炎（HCV）阳性供肾移植至阴性受者可能增加BK多瘤病毒DNA血症/肾病的风险。本文报告了一例接受HCV阳性供肾移植的受者出现严重的BK多瘤病毒DNA血症/肾病，与HCV治疗失败时间密切相关。患者在接受HCV治疗后出现急性肾损伤和严重的BK多瘤病毒DNA血症，最终通过治疗获得了SVR并稳定了移植肾功能。这一结果表明，从HCV阳性供肾移植至阴性受者可能会增加BK多瘤病毒DNA血症/肾病的风险，需要密切监测和有效治疗。药物发现/临床前 ASN 2020 2020-10-19 格卡瑞韦 | 哌仑他韦肾移植术后多瘤病毒相关性肾病 VA Medical Center | The University of Tennessee Health Science Center Prodrug Strategies to Improve the Solubility of the HCV NS5A Inhibitor Pibrentasvir (ABT-530) 该研究发现了HCV NS5A抑制剂Pibrentasvir（PIB）的磷酸甲基类似物2和三甲基锁定（TML）前药9，通过连接到苯并咪唑氮原子的氧甲基链接，以便在肠碱性磷酸酶去除磷酸酯后迅速完全释放药物以便吸收。这些前药在水相缓冲液（pH 7）和FESSIF（pH 5）中均具有良好的水解稳定性和改善的溶解度。TML前药9在小鼠、狗和猴子的PK研究中提供了优越的体内性能，提供了高浓度的PIB。这些磷酸盐前药的改善溶解性能使它们具有简化PIB含量的HCV治疗药物剂型的潜力。药物发现/临床前 J Med Chem 2020-09-03 哌仑他韦 - AbbVie, Inc. Adherence to pan-genotypic glecaprevir/pibrentasvir and efficacy in HCV-infected patients: A pooled analysis of clinical trials. 本文分析了对丙型肝炎病毒（HCV）感染的患者进行泛基因型格来普韦/匹伯替韦（G/P）治疗的依从性及其对治疗效果的影响。研究发现，大多数患者对G/P治疗保持了良好的依从性，而且无论是否依从，患者的持续病毒学应答率（SVR12）都很高。酒精使用是与G/P治疗不依从性相关的唯一基线特征。因此，患者教育对于治疗依从性仍然是HCV治疗的重要组成部分。 2/3期临床研究 Liver Int 2020-04-01 哌仑他韦丙型肝炎 AbbVie, Inc. Glecaprevir/pibrentasvir for chronic hepatitis Cin large real world experience study 本研究旨在追踪慢性丙型肝炎（CHC）患者在实际临床中使用格来普韦/匹伯替韦（GP）全基因型方案的患者特征和疗效。研究选取了2015年至2018年在EpiTer2数据库中接受CHC治疗的10,161名患者中的381名使用GP治疗的患者进行分析。结果显示，GP治疗的患者中，女性比例为51%，平均年龄为49岁，与总体人群相似。大多数GP患者感染基因型1b（51%）或3（39%），与总体人群不同。GP患者中，69%为治疗初次感染者，低于总体人群的85%。治疗失败率为3例，意向治疗持续病毒学应答率为96%，符合总体人群数据。总之，GP相较于其他方案更常用于感染基因型3和治疗经验丰富的患者，该新方案在实际临床中的疗效高达97%。更多亚人群分析将于2019年中期公布。真实世界研究 UEGW 2019 2019-10-01 格卡瑞韦 | 哌仑他韦慢性丙型肝炎 - Integrated analysis of 8-week glecaprevir/pibrentasvir in Japanese and overseas patients without cirrhosis and with hepatitis C virus genotype 1 or 2 infection. 本研究对日本和海外非肝硬化且患有丙型肝炎病毒基因型1或2感染的患者进行了8周格来普韦/匹伯替韦的综合分析。研究结果显示，DAA-幼稚患者中，无论基线特征、共病或联合用药如何，8周的治疗方案均安全有效，SVR12率高达98.9%，且几乎没有病毒学失败的情况。总体而言，少于1%的患者因不良事件而中止治疗，1.6%的患者出现严重不良事件。因此，8周的格来普韦/匹伯替韦治疗对于非肝硬化且患有HCV GT1或GT2感染的患者来说是安全且有效的。 2/3期临床研究 J Gastroenterol 2019-08-01 哌仑他韦丙型肝炎 AbbVie, Inc. ns5a resistance profile of genotype 1b virological failures that impacts outcome of re-treatment by glecaprevir/pibrentasvir: Nation-wide real world study - 真实世界研究 EASL 2019 2019-04-13 格卡瑞韦 | 哌仑他韦慢性丙型肝炎 Musashino Red Cross Hospital, Department of Gastroenterology and Hepatology, Tokyo, Japan Glecaprevir/pibrentasvir in patients with chronic HCV and recent drug use: An integrated analysis of 7 phase III studies. 该研究对慢性丙型肝炎（HCV）患者进行了整合分析，结果显示G/P对注射吸毒者的治疗效果良好，治疗依从性高，SVR12达到93%，且未出现HCV再感染。研究表明，G/P是一种耐受性好、有效的全基因型HCV治疗方案，适用于近期或活跃吸毒者。 3期临床研究 Drug Alcohol Depend 2019-01-01 哌仑他韦慢性丙型肝炎 AbbVie, Inc. Efficacy and safety of glecaprevir/pibrentasvir in patients with chronic hepatitis C virus genotype 5 or 6 infection (ENDURANCE-5,6): an open-label, multicentre, phase 3b trial 本研究评估了格来沙韦/匹伐他韦治疗丙型肝炎病毒（HCV）5型或6型感染的疗效和安全性。研究结果显示，在未经治疗或治疗经验的患者中，格来沙韦/匹伐他韦在12周后的持续病毒学应答率（SVR12）为97.6%，且耐受性良好。因此，格来沙韦/匹伐他韦可作为治疗HCV 5型或6型感染的有效选择。 3期临床研究 Pubmed 2019-01-01 格卡瑞韦 | 哌仑他韦 - AbbVie, Inc. | CHU Estaing, Clermont Ferrand, France. | Division of Gastroenterology and Hepatology, National University Health System, Singapore. | Centre de Recherche sur l'Inflammation, INSERM UMR 1149, Université Paris Diderot, Department of Hepatology, AP-HP Hôpital Beaujon, Clichy, France. Electronic address: tarik.asselah@aphp.fr. Highlights of the Structure–Activity Relationships of Benzimidazole Linked Pyrrolidines Leading to the Discovery of the Hepatitis C Virus NS5A Inhibitor Pibrentasvir (ABT-530) 这篇文章总结了苯并咪唑偶氮丙烷结构活性关系的要点，从而发现了丙戊他韦（ABT-530）这一丙型肝炎病毒NS5A抑制剂。文章指出，当前治疗肝炎病毒感染的方法需要机制正交的直接作用抗病毒药物的组合，而HCV NS5A抑制剂通常是这些治疗的共同组成部分。第一代FDA批准的治疗方法以及其中的NS5A抑制剂对HCV病毒1-6基因型的疗效不等。因此，研究者对NS5A抑制剂的结构进行了修改，最终发现了丙戊他韦（ABT-530），该药物具有强效抑制野生型基因型1-6 HCV复制的能力，并且对显示对第一代NS5A抑制剂耐药的变异体有改进的活性。这一发现使得对基因型1-6 HCV感染的功能性治愈以及更广泛基因型的缩短治疗周期成为可能。药物发现/临床前 J Med Chem 2018-04-13 哌仑他韦丙型肝炎 AbbVie, Inc. Efficacy of Glecaprevir/Pibrentasvir for 8 or 12 Weeks in Patients With Hepatitis C Virus Genotype 2, 4, 5, or 6 Infection Without Cirrhosis. 该研究评估了格来沙韦/匹伯替尼联合用药治疗慢性丙型肝炎2、4、5或6基因型感染患者的安全性和有效性。研究结果显示，患者使用格来沙韦/匹伯替尼联合用药8周或12周后，持续病毒学应答率（SVR12）分别达到98%-99.5%。在未出现肝硬化的患者中，该药物组合的安全性与安慰剂组相似。因此，格来沙韦/匹伯替尼联合用药对慢性丙型肝炎2、4、5或6基因型感染患者具有较高的治疗效果和良好的安全性。 3期临床研究 Pubmed 2018-03-01 哌仑他韦纤维化 | 丙型肝炎 AbbVie, Inc. Effects of Renal Impairment and Hemodialysis on the Pharmacokinetics and Safety of the Glecaprevir and Pibrentasvir Combination in Hepatitis C Virus-Negative Subjects - 1期临床研究 Pubmed 2018-03-01 格卡瑞韦 | 哌仑他韦丙型肝炎 Clinical Research, Orlando Clinical Research Center, Orlando, Florida, USA | Clinical Pharmacology and Pharmacometrics, AbbVie Inc., North Chicago, Illinois, USA MAGELLAN-2: Glecaprevir/Pibrentasvir for 12 Weeks in Renal Transplant Patients With Chronic Hepatitis C Virus Genotypes 1–6 该研究评估了格来普韦/匹伐他韦（G/P）对慢性HCV感染的肾移植患者的安全性和有效性。结果显示，12周的G/P治疗对慢性HCV GT1-6感染的肾移植患者具有高效性，SVR12率达100％。G/P耐受性良好，无需停药。研究表明，G/P可能成为肾移植患者治疗慢性HCV感染的有效选择。 3期临床研究 ASN 2017 2017-10-31 格卡瑞韦 | 哌仑他韦慢性丙型肝炎 - EXPEDITION-4: Efficacy and Safety of Glecaprevir/Pibrentasvir in Patients with Chronic Hepatitis C Genotype 1-6 Infection by Dialysis Status 该研究报告了在慢性丙型肝炎（HCV）基因型1-6感染患者中，使用格来沙韦/匹伐他韦治疗的疗效和安全性，根据透析状态进行了分析。研究结果显示，无论患者是否接受透析，格来沙韦/匹伐他韦均表现出高效和良好的安全性。该研究由AbbVie赞助，格来沙韦和匹伐他韦是正在研究中的药物。研究结果显示，在透析前和透析患者中，格来沙韦/匹伐他韦治疗12周后的SVR12和SVR24率分别为98%和96%，无病毒学失败。严重不良事件发生率分别为26%（透析前）和24%（透析），且均不与药物治疗相关。透析前患者肌酐清除率从基线到第12周的平均变化为-1.4 ± 3.6 mL/min。 3期临床研究 ASN 2017 2017-10-31 格卡瑞韦 | 哌仑他韦慢性丙型肝炎 - Glecaprevir and pibrentasvir yield high response rates in patients with HCV genotype 1–6 without cirrhosis 该研究评估了格来沙韦和匹伯替尼在HCV基因型1-6感染的非肝硬化患者中的疗效和安全性。结果显示，8或12周的治疗方案在未患肝硬化的患者中取得了高达97-100%的持续病毒学应答率。格来沙韦和匹伯替尼的联合应用为HCV基因型1-6感染提供了一种全口服、全基因型的治疗方案。该疗法耐受性良好，临床试验结果显示实验药物的疗效和安全性。 2期临床研究 Pubmed 2017-08-01 格卡瑞韦 | 哌仑他韦 - eStudySite, Inc. | Stanford University | AbbVie, Inc. | Southern California GI and Liver Centers and Southern California Research Center | Private Practice | Louisiana Research Center | Kirby Institute, UNSW Sydney, and St. Vincent's Hospital, Sydney, NSW, Australia. Glecaprevir/pibrentasvir fixed dose combination for 8 or 12 weeks in patients co-infected with HCV and HIV-1: a sub-analysis of the phase 3 ENDURANCE-1 study 该研究是对HCV和HIV-1共感染患者进行的亚组分析，研究结果表明，G/P联合治疗方案在HCV感染患者中表现出高效性。在HCV/HIV-1共感染患者中，8周或12周的G/P治疗方案均能实现持续病毒学应答率（SVR12）达到100％，且耐受性良好。因此，该研究结果表明HIV共感染对G/P疗效没有影响。 3期临床研究 IAS 2017 2017-01-01 格卡瑞韦 | 哌仑他韦慢性丙型肝炎 University Hospitals | Tel Aviv Doctor | Abb, North Chicago, United States | University of Puerto Rico, San Juan, Puerto Rico | AbbVie, North Chicago, United States | University Hospital, Zurich, Switzerland | AbbVie, Redwood City, United States | AO Ospedale Niguarda | Private Practice, Bakersfield, United States Efficacy and safety of glecaprevir/pibrentasvir in patients co-infected with hepatitis C virus and human immunodeficiency virus-1: the EXPEDITION-2 study 该研究评估了慢性丙型肝炎（HCV）基因型1-6感染和HIV-1共感染患者的疗效和安全性，包括代偿性肝硬化患者。研究结果显示，患者在治疗结束时和治疗后第4周的应答率分别为98.7%和98.6%，SVR12率为99.35%。最常见的不良事件是疲劳（10%）和恶心（8%）。研究表明，慢性HCV基因型1-6感染和HIV-1共感染患者使用glecaprevir/pibrentasvir治疗8周（非肝硬化患者）或12周（肝硬化患者）是一种耐受性良好且高效的全基因型治疗方法。 3期临床研究 IAS 2017 2017-01-01 格卡瑞韦 | 哌仑他韦丙型肝炎 Ruane Medical & Liver Health Institute | The Johns Hopkins University School of Medicine | St. Michael's Medical Center | Universitätsklinikum Bonn | Abb, North Chicago, United States | Inn, Bayamon, Puerto Rico | Université Pierre et Marie Curie, Paris, France High Efficacy of ABT-493 and ABT-530 Treatment in Patients With HCV Genotype 1 or 3 Infection and Compensated Cirrhosis ABT-493和ABT-530联合治疗对HCV基因型1或3感染和代偿性肝硬化患者具有高效性。研究结果显示，在肝功能代偿的HCV基因型1或3感染患者中，ABT-493加ABT-530联合治疗在治疗后12周的持续病毒学应答率（SVR12）高达96%-100%，并且耐受性良好。这项研究为HCV感染的治疗提供了新的方向和选择。ClinicalTrials.gov识别号NCT02243280和NCT02243293。 2期临床研究 Pubmed 2016-10-01 格卡瑞韦 | 哌仑他韦 - Auckland University | Quest Clinical Research, Inc. | AbbVie, Inc. | Southern California GI and Liver Centers and Southern California Research Center | Louisiana Research Center High antiviral activity of NS5A inhibitor ABT-530 with paritaprevir/ritonavir and ribavirin against hepatitis C virus genotype 3 infection 本研究评估了ABT-530与帕利瑞韦/利托那韦和利巴韦林联合治疗对基因型3丙型肝炎病毒（HCV）感染的疗效、药代动力学和安全性。结果显示，90%的患者在治疗后12周和24周均取得持续病毒学应答。一名患者在治疗第6周出现病毒学失败。序列分析显示，该患者的HCV变异株对帕利瑞韦或ABT-530没有耐药性，但对ABT-530的耐药性增加了5000倍。该研究表明，ABT-530有望成为HCV基因型3感染的直接抗病毒治疗方案的一部分。研究结果对生物医药领域具有重要意义。 2期临床研究 Liver Int 2016-08-01 哌仑他韦丙型肝炎 AbbVie, Inc. Potent Antiviral Activities of the Direct-Acting Antivirals ABT-493 and ABT-530 with Three-Day Monotherapy for Hepatitis C Virus Genotype 1 Infection - 2期临床研究 Antimicrob Agents Chemother 2015-12-28 格卡瑞韦 | 哌仑他韦丙型肝炎 AbbVie, Inc.

2026-09-14

·有驾

乙肝丙肝有新药？最新治疗指南，这几点关键

提起病毒性肝炎，很多人第一反应就是“慢性病”“难根治”，甚至觉得确诊了就是判了“无期”。其实，随着医学技术的进步，特别是近几年的新药研发，病毒性肝炎的治疗格局已经发生了很大变化。今天咱们就来聊聊病毒性肝炎的最新治疗方法，看看对于大众来说，哪些手段是真正安全有效的。首先要明确一个概念：病毒性肝炎主要包括甲、乙、丙、丁、戊五种类型。其中，甲肝和戊肝通常是急性感染，通过消化道传播，大多数人可以自愈；而乙肝和丙肝因为容易慢性化，甚至发展为肝硬化、肝癌，所以是大家最关心的重点。最新的疗法主要集中在乙肝的“功能性治愈”探索，以及丙肝的“彻底治愈”突破上。一、丙肝：已经迎来“治愈时代” 如果你或者家人查出来有丙肝，先别慌。目前，丙型肝炎是可以彻底治愈的疾病。以前的老办法是用干扰素，副作用大，疗效还不稳定。但现在，直接抗病毒药物（DAA）已经成为主流。 1. 高效治愈率现代DAA药物的病毒学应答率（也就是我们常说的“治愈率”）已经超过95%，甚至接近98%-100%。这意味着，绝大多数丙肝患者经过规范治疗后，体内病毒可以被完全清除。 2. 疗程短、副作用小以往的干扰素治疗需要打半年到一年，还可能有流感样症状、脱发、情绪低落等副作用。而现在的DAA口服药，疗程通常只需8-12周，每天吃一片，副作用非常轻微，很多人几乎感觉不到不适。 3. 常用药物目前临床上常用的方案包括索磷布韦/维帕他韦、格卡瑞韦/哌仑他韦等。这些药物已经纳入国家医保，价格大幅降低，普通家庭也能负担得起。但请注意，所有具体药方必须经专科医生评估后使用，禁止自行购药服用。二、乙肝：从“控制”走向“功能性治愈” 相比丙肝，乙肝的治疗难度更大。因为乙肝病毒会在肝细胞内形成cccDNA，像“地雷”一样潜伏着，很难彻底清除。目前的乙肝治疗目标，已经从单纯的“病毒检测不到”，升级到了“临床治愈”或“功能性治愈”，即停药后乙肝表面抗原（HBsAg）转阴，甚至出现表面抗体。 1. 核苷（酸）类似物（NAs）仍是基石对于大多数乙肝患者，恩替卡韦、替诺福韦、丙酚替诺福韦（TAF）等强效低耐药的口服抗病毒药物，依然是长期抑制病毒复制的首选。它们能有效阻止病情进展，降低肝硬化和肝癌风险。 2. 干扰素的优化应用聚乙二醇干扰素α（PEG-IFN-α）在特定人群中（如年轻、病程短、表面抗原水平低的患者）仍具有重要价值。通过联合或序贯使用干扰素，部分患者有机会实现表面抗原转阴，达到临床治愈。 3. 最新疗法：新药研发进展近年来，针对乙肝治愈的新药研发火热进行中，主要包括：衣壳抑制剂*：阻止病毒衣壳组装，干扰病毒复制。 RNA干扰药物（siRNA）*：能显著降低乙肝表面抗原水平，为临床治愈创造条件。治疗性疫苗*：试图激活人体免疫系统来清除病毒。靶向进入抑制剂*：阻止病毒进入肝细胞。虽然这些新药大多还在临床试验阶段，尚未大规模普及，但已展现出巨大潜力。对于追求更高治疗目标的乙肝患者，建议定期随访，密切关注新药动态，并在专业医生指导下制定个体化方案。三、其他类型的肝炎除了乙肝和丙肝，丁型肝炎只感染乙肝患者，因此在有效防控乙肝的同时，丁肝也会随之被阻断。戊型肝炎目前虽有疫苗（在中国已上市），但对于急性戊肝患者，仍以支持治疗为主，慢性戊肝患者需在医生指导下使用抗病毒药物。四、治疗期间的注意事项无论采用哪种治疗方案，以下几点至关重要：1. 定期复查：治疗期间需每3-6个月检查肝功能、病毒载量、甲胎蛋白（AFP）和肝脏超声，监测疗效和副作用。2. 绝对禁酒：酒精会加重肝脏损伤，与治疗药物产生协同毒性，务必滴酒不沾。3. 谨慎用药：避免滥用保健品、中草药或止痛药，以免增加肝脏代谢负担。4. 健康生活方式：均衡饮食、适量运动、充足睡眠，增强免疫力，有助于病毒清除和病情稳定。五、科学看待，拒绝焦虑病毒性肝炎早已不是“不治之症”。丙肝可治愈，乙肝可控可治，甚至有望实现临床治愈。关键在于早发现、早诊断、规范治疗。不要轻信偏方、秘方，也不要因为“没症状”就忽视复查。请务必前往正规医院的肝病科或感染科就诊，遵循医嘱。最后再次提醒：所有治疗方案均需由专业医生根据患者具体情况制定，本文仅供参考，不构成医疗建议。希望这些信息能帮助您或家人更清晰地了解当前治疗现状，积极配合医生，重获健康。【引用】1. 《慢性乙型肝炎防治指南（2022年版）》2. 《丙型肝炎防治指南（2022年版）》3. 世界卫生组织（WHO）： hepatitis fact sheets4. 中华医学会肝病学分会相关共识与专家意见

2026-09-14

·百度百家

乙肝丙肝有新药？最新治疗指南，这几点关键

100 项与哌仑他韦相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10816	哌仑他韦	J05AP57	DB13878

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
纤维化	临床3期	-	AbbVie, Inc.	2016-05-17
HIV感染	临床3期	-	AbbVie, Inc.	2016-05-17
丙型肝炎	临床3期	美国	AbbVie, Inc.	2015-06-22
丙型肝炎	临床3期	澳大利亚	AbbVie, Inc.	2015-06-22
丙型肝炎	临床3期	加拿大	AbbVie, Inc.	2015-06-22
丙型肝炎	临床3期	德国	AbbVie, Inc.	2015-06-22
丙型肝炎	临床3期	新西兰	AbbVie, Inc.	2015-06-22
丙型肝炎	临床3期	波多黎各	AbbVie, Inc.	2015-06-22
丙型肝炎	临床3期	英国	AbbVie, Inc.	2015-06-22
慢性丙型肝炎	临床3期	美国	AbbVie, Inc.	2015-06-22

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


AASLD2025	N/A	丙型肝炎	113	Glecaprevir/Pibrentasvir + Ezetimibe	鬱遞壓膚醖鹽齋膚膚齋(獵構醖鑰積鹽淵簾餘淵) = 艱獵網繭糧廠願獵膚簾網鹽鹹構壓構膚衊鏇衊 (鏇淵壓構艱願窪蓋廠糧 ) 更多	积极	2025-11-07
AASLD2024	N/A	慢性丙型肝炎	10	Glecaprevir-Pibrentasvir	構網廠糧積憲憲廠鹹窪(艱膚齋窪齋艱觸鹹構壓) = One patient had a high fever and malaise for two days due to Covid-19 infection during treatment. Nevertheless, treatment was not discontinued. No other adverse events were reported. 製糧鑰膚夢範願壓鏇艱 (夢繭築積襯窪蓋鑰膚艱 ) 更多	积极	2024-11-15
AASLD2024	N/A	慢性丙型肝炎	6,569	Glecaprevir/Pibrentasvir	遞醖醖夢壓築願製餘壓(窪夢網簾遞築餘淵鏇選) = 鹹膚壓簾鑰蓋網壓簾醖壓簾獵築衊築廠鬱鹽衊 (築齋糧襯鏇醖繭簾遞網 ) 更多	积极	2024-11-15
AASLD2023	N/A	-	88	Glecaprevir/pibrentasvir + Ezetimibe	窪壓繭鏇簾齋窪餘齋淵(獵獵選鹽襯壓醖憲製鑰) = 27 (46%) patients developed HCV antibodies that persisted post-treatment 網憲鹹齋醖顧構獵衊網 (醖窪膚糧顧醖範鏇簾襯 )	-	2023-11-10
EASL2022	N/A	丙型肝炎 \| 代偿期肝硬化	806	Glecaprevir/pibrentasvir 8-week regimen	鑰鑰製遞醖築襯淵鹹簾(齋選襯艱餘壓觸襯膚齋) = 窪膚簾遞網憲廠製窪範簾觸鏇醖製築鬱醖範壓 (鑰夢憲獵糧製糧製鹽糧 ) 更多	-	2022-06-24
NCT02441283 (M13-576, Pubmed \| Liver Int)	临床2/3期	慢性丙型肝炎	384	Glecaprevir/pibrentasvir-containing regimen	網淵鑰選選壓願積範觸(簾膚夢鑰構繭憲蓋選淵) = 獵願鹹網鹹齋鹽鬱願糧鏇鑰遞構壓夢鹹蓋蓋襯 (遞蓋構遞醖糧積遞襯製 )	积极	2022-02-26
NCT03303599 (Pubmed 1 \| Pubmed 2 \| Infect Dis Ther)	N/A	-	2,036	Glecaprevir/pibrentasvir	顧製憲獵簾構夢餘壓範(遞網網鹹範鏇餘簾築艱) = Six glecaprevir/pibrentasvir-related adverse events led to discontinuation 窪窪齋齋艱顧淵蓋壓窪 (鹽鹽觸範顧觸範衊鹽醖 ) 更多	-	2021-06-14
NCT02441283 (M13-576, CTgov)	临床2/3期	慢性丙型肝炎	384	ABT-493+ABT-530	壓積鹹憲衊鏇網鹹選製 = 鏇範製淵範齋齋蓋衊廠願淵鹹艱繭鹹餘築廠網 (鏇鹽憲網鹹範製鑰製遞, 鹽遞範觸蓋繭蓋窪積網 ~ 範艱範鹽選憲簾鬱鬱壓) 更多	-	2020-09-21
NCT02636595 \| NCT02604017 \| NCT02642432 \| NCT02446717 \| NCT02640157 \| NCT02651194 \| NCT02640482 \| NCT02243293 (Pubmed \| Liver Int)	临床2/3期	丙型肝炎	2,091	Glecaprevir/pibrentasvir therapy	鑰製積觸鹽齋願鬱醖淵(糧顧繭襯壓遞築製夢艱) = 遞遞艱齋艱窪範艱鏇構憲齋齋膚簾膚糧繭醖範 (觸衊積範齋餘壓窪網鹽 ) 更多	-	2020-04-01
EpiTer2 (UEGW2019)	N/A	慢性丙型肝炎	381	Glecaprevir/pibrentasvir	鏇觸製積廠廠壓簾糧顧(範壓壓淵觸憲簾壓醖鹹) = 衊簾網壓壓憲壓構鹽夢網鹹夢憲鑰窪選齋網鏇 (憲網襯簾製網夢遞餘糧 ) 更多	积极	2019-10-01