Journal ArticleDOI
Glecaprevir plus pibrentasvir for chronic hepatitis C virus genotype 1, 2, 4, 5, or 6 infection in adults with compensated cirrhosis (EXPEDITION-1): a single-arm, open-label, multicentre phase 3 trial
Xavier Forns,Samuel S. Lee,Joaquin Mario Valdes,Sabela Lens,Reem Ghalib,Humberto Aguilar,Franco Felizarta,Tarek Hassanein,Holger Hinrichsen,Diego Rincón,Rosa Maria Morillas,Stefan Zeuzem,Yves Horsmans,David R. Nelson,Yao Yu,Preethi Krishnan,Chih-Wei Lin,Jens Kort,Federico J. Mensa +18 more
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TLDR
The results show that 99% of patients treated with once-daily glecaprevir plus pibrentasvir achieved a sustained virological response at 12 weeks, and this drug regimen had a favourable safety profile in previously treated or untreated patients with chronic HCV genotype 1, 2, 4, 5, or 6 infection and compensated cirrhosis.Abstract:
Summary Background The once-daily, ribavirin-free, pangenotypic, direct-acting antiviral regimen, glecaprevir coformulated with pibrentasvir, has shown high rates of sustained virological response in phase 2 and 3 studies. We aimed to assess the efficacy and safety of 12 weeks of coformulated glecaprevir and pibrentasvir in patients with hepatitis C virus (HCV) infection and compensated cirrhosis. Methods We did this single-arm, open-label, multicentre phase 3 study at 40 sites in Belgium, Canada, Germany, South Africa, Spain, and the USA. We enrolled patients aged 18 years or older with HCV genotype 1, 2, 4, 5, or 6 infection and compensated cirrhosis. Patients were either HCV treatment-naive or had not responded to treatment with interferon or pegylated interferon with or without ribavirin, or sofosbuvir plus ribavirin with or without pegylated interferon. Oral glecaprevir (300 mg) coformulated with pibrentasvir (120 mg) was administered once daily for 12 weeks. The primary efficacy endpoint was sustained virological response at post-treatment week 12 (HCV RNA Findings Between Dec 7, 2015, and May 4, 2016, we enrolled 146 patients with compensated cirrhosis, of whom 48 (33%) had genotype 1a HCV infection, 39 (27%) had genotype 1b infection, 34 (23%) had genotype 2 infection, 16 (11%) had genotype 4 infection, two (1%) had genotype 5 infection, and seven (5%) had genotype 6 infection. 12 weeks after treatment, 145 patients (99%, 95% CI 98–100) achieved sustained virological response, with one (1%) relapse at post-treatment week 8. We recorded 101 (69%) adverse events, of which 65 (64%) were mild. The most common adverse events were fatigue (n=28 [19%]) and headache (n=20 [14%]). 11 (8%) patients had serious adverse events, none of which were deemed related to study drugs. No patients had elevations in alanine aminotransferase and no patients prematurely discontinued treatment because of adverse events. Interpretation Our results show that 99% of patients treated with once-daily glecaprevir plus pibrentasvir achieved a sustained virological response at 12 weeks. Furthermore, this drug regimen had a favourable safety profile in previously treated or untreated patients with chronic HCV genotype 1, 2, 4, 5, or 6 infection and compensated cirrhosis. These findings could help simplify treatment algorithms and reduce treatment burden. Funding AbbVie.read more
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EASL Recommendations on Treatment of Hepatitis C
Jean-Michel Pawlotsky,Alessio Aghemo,Geoffrey Dusheiko,Xavier Forns,Massimo Puoti,Christophe Sarrazin +5 more
TL;DR: The optimal management of patients with acute and chronic HCV infections in 2018 and onwards is described, as well as developments in diagnostic procedures and improvements in therapy and prevention.
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EASL recommendations on treatment of hepatitis C: Final update of the series ☆
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TL;DR: These European Association for the Study of the Liver recommendations on treatment of hepatitis C describe the optimal management of patients with recently acquired and chronic HCV infections in 2020 and onwards.
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Hepatitis C Guidance 2018 Update: AASLD-IDSA Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection
Raymond T. Chung,Marc G. Ghany,Arthur Y. Kim,Kristen M. Marks,Susanna Naggie,Hugo E. Vargas,Andrew Aronsohn,Debika Bhattacharya,Tina Broder,Oluwaseun Falade-Nwulia,Robert J. Fontana,Stuart C. Gordon,Theo Heller,Scott D. Holmberg,Ravi Jhaveri,Maureen M. Jonas,Jennifer J. Kiser,Benjamin P. Linas,Vincent Lo Re,Timothy R. Morgan,Ronald Nahass,Marion G. Peters,K. Rajender Reddy,Andrew Reynolds,John D. Scott,Gloria Searson,Tracy Swan,Norah A. Terrault,Stacey Trooskin,John B. Wong,Kimberly A. Workowski +30 more
TL;DR: This update summarizes the latest release of the HCV guidance and focuses on new or amended recommendations since the previous September 2015 print publication.
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Hepatitis C Guidance 2019 Update: American Association for the Study of Liver Diseases–Infectious Diseases Society of America Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection
Marc G. Ghany,Timothy R. Morgan +1 more
TL;DR: The American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) initiated the hepatitis C virus guidance project (hereafter HCV guidance) in 2013 and disseminates up-to-date, peer-reviewed, unbiased, evidence-based recommendations to aid clinicians making decisions regarding the testing, management, and treatment of HCV infection.
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Scaling up prevention and treatment towards the elimination of hepatitis C: a global mathematical model
TL;DR: The worldwide impact of scaling up interventions that reduce risk of transmission, improve access to treatment, and increase screening for HCV infection is estimated, and the impact on the global epidemic of removing certain key countries from the package of interventions is assessed.
References
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Journal ArticleDOI
EASL Recommendations on Treatment of Hepatitis C
Jean-Michel Pawlotsky,Alessio Aghemo,Geoffrey Dusheiko,Xavier Forns,Massimo Puoti,Christophe Sarrazin +5 more
TL;DR: The optimal management of patients with acute and chronic HCV infections in 2018 and onwards is described, as well as developments in diagnostic procedures and improvements in therapy and prevention.
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Global epidemiology of hepatitis C virus infection: new estimates of age-specific antibody to HCV seroprevalence.
TL;DR: The high prevalence of global HCV infection necessitates renewed efforts in primary prevention, including vaccine development, as well as new approaches to secondary and tertiary prevention to reduce the burden of chronic liver disease and to improve survival for those who already have evidence of liver disease.
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Global epidemiology and genotype distribution of the hepatitis C virus infection
TL;DR: The total number of HCV infections reported here are lower than previous estimates, and the exclusion of data from earlier studies conducted at the peak of the HCV epidemic, along with adjustments for reduced prevalence among children, are likely contributors.
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Morbidity and mortality in compensated cirrhosis type C: A retrospective follow-up study of 384 patients
Giovanna Fattovich,G. Giustina,F Degos,F Tremolada,G. Diodati,Piero Luigi Almasio,Frederik Nevens,Antonio Solinas,D. Mura,J T Brouwer,H Thomas,C. Njapoum,C Casarin,Bonetti P,P. Fuschi,J. Basho,A. Tocco,A. Bhalla,R. Galassini,Franco Noventa,S W Schalm,G Realdi +21 more
TL;DR: In this cohort of patients, life expectancy is relatively long, in agreement with the morbidity data showing a slowly progressive disease.
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