Trial reportClinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association2015
Efficacy of Sofosbuvir and Daclatasvir in Patients With Fibrosing Cholestatic Hepatitis C After Liver Transplantation.
Trial report in Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01944527 (Cohort of Liver Transplanted Patients With Hepatitis C Virus Recurrence and Treated With Direct-acting Antiviral Agents), which is not on this map. Cited by 31 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Cohort of Liver Transplanted Patients With Hepatitis C Virus Recurrence and Treated With Direct-acting Antiviral Agents
Who cites it
31 citing papers in PubMed, 133 citations in OpenAlex.
- Highly replicating hepatitis C virus variants emerge in immunosuppressed patients causing severe disease.Nature communications · 2025Article
- Revolution in the diagnosis and management of hepatitis C virus infection in current era.World journal of hepatology · 2022Article
- Transplantation of Organs from Hepatitis C Virus-Positive Donors under Direct-Acting Antiviral Regimens.Journal of clinical medicine · 2022Review
- Efficacy and safety of sofosbuvir-containing regimens in patients with chronic hepatitis C virus infection after liver transplantation: a meta-analysis.Annals of translational medicine · 2020Article
- Assessment of Renal Function in Post-Liver Transplant HCV-Positive Patients Treated with Direct Acting Antivirals.International journal of nephrology and renovascular disease · 2020Article
- Expanding the donor pool: Hepatitis C, hepatitis B and human immunodeficiency virus-positive donors in liver transplantation.World journal of gastroenterology · 2019Review
- Usage of HCV viremic organs in liver transplantation to anti-HCV negative recipients: The current status and review of literature.The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology · 2019Review
- Transplantation of HCV Viremic Livers into HCV Viremic Recipients Followed by Direct-acting Antiviral Therapy.Journal of clinical and translational hepatology · 2019Article
- Solid Organ Transplantation in HIV-Infected Recipients: History, Progress, and Frontiers.Current HIV/AIDS reports · 2019Review
- Infectious Disease Transmission in Solid Organ Transplantation: Donor Evaluation, Recipient Risk, and Outcomes of Transmission.Transplantation direct · 2019Article
- Daclatasvir and sofosbuvir treatment of decompensated liver disease or post-liver transplant hepatitis C virus recurrence in patients with advanced liver disease/cirrhosis in a real-world cohort.Hepatology communications · 2018Article
- Significance of growth differentiation factor 15 in chronic HCV patients.Journal, genetic engineering & biotechnology · 2017Article
- Effectiveness of Ledipasvir/Sofosbuvir with/without Ribavarin in Liver Transplant Recipients with Hepatitis C.Journal of clinical and translational hepatology · 2017Article
- Hepatitis C Virus and Liver Transplantation.Gastroenterology & hepatology · 2017Article
- Early Acute Severe HCV Recurrence After Transplantation: From Universal Mortality to Cure.Journal of clinical and experimental hepatology · 2017Article
- Use of Hepatitis C-Positive Donor Livers in Liver Transplantation.Current hepatology reports · 2017Article
- Successful Pre- and Posttransplant Sofosbuvir-Based Anti-Hepatitis C Virus Treatment in Persons Living With Human Immunodeficiency Virus Infection.Open forum infectious diseases · 2017Article
- Anti-hepatitis C virus drugs and kidney.World journal of hepatology · 2016Review
- Article
- Fibrosing Cholestatic Hepatitis in a Complicated Case of an Adult Recipient After Liver Transplantation: Diagnostic Findings and Therapeutic Dilemma.The American journal of case reports · 2016Article
Corrections and comments
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Authors and funding
18 authors at 16 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND &
aimsFibrosing cholestatic hepatitis (FCH) is a life-threatening disorder that develops in patients with recurrent hepatitis C virus (HCV) infection after liver transplantation. Until recently, therapeutic options have been limited. We evaluated the efficacy and safety of sofosbuvir- and daclatasvir-based regimens.
methodsWe analyzed data from 23 patients with FCH who participated in a prospective cohort study in France and Belgium of the effects of antiviral agents in patients with recurrence of HCV infection after liver transplantation, from October 2013 through April 2014. Most of the patients had genotype 1 infections that had not responded to previous treatment; 4 patients also were infected with human immunodeficiency virus. Eight patients (37%) had ascites and 15 patients (65%) had bilirubin levels greater than 100 mmol/L; their median serum level of HCV RNA was 7 log IU/mL. The median time between transplantation and treatment initiation was 5 months. Subjects were given either sofosbuvir and daclatasvir (n = 15) or sofosbuvir and ribavirin (n = 8) for 24 weeks. The primary outcome was complete clinical response (survival without re-transplantation, bilirubin level <34 μmol/L, and no ascites or hepatic encephalopathy 36 weeks after treatment began).
resultsAll patients survived, without re-transplantation, until week 36. Rapid and dramatic improvements in clinical status were observed. The patients' median bilirubin concentration decreased from 122 μmol/L at baseline to a normal value at week 12 of treatment. Twenty-two patients (96%) had a complete clinical response at week 36. Despite the low rate of rapid virologic response, 22 patients (96%) achieved a sustained virologic response at week 12. The only relapse of HCV infection occurred in a patient with human immunodeficiency virus infection who received sofosbuvir and ribavirin. Tolerance was satisfactory, with no grade 3 or 4 adverse events related to sofosbuvir or daclatasvir and no significant interactions among drugs.
conclusionsSofosbuvir therapy with daclatasvir or ribavirin leads to major clinical improvement and high rates of sustained virologic response at week 12 in most patients with recurrence of HCV infection and FCH after liver transplantation. ClinicalTrial.gov no: NCT01944527.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.