Summary
Cyclosporine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Hepatitis C would be drug repurposing rather than first-in-human development. This does not mean it is approved for Hepatitis C. ClinicalTrials.gov lists 8 registered trials linking Cyclosporine to Hepatitis C: 4 have completed; 4 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT00284921). The largest enrolment is 150 participants (NCT04113915). Registration activity spans 2004 to 2019. The literature layer holds 14 publications for this pair: 2 Cochrane reviews, 2 meta-analyses, 5 randomised controlled trial publications and 5 clinical trial publications. Publication years run from 2007 to 2018. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Hepatitis C ranks 357 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Spontaneous clearance in <30% of acute cases; chronic infection rarely clears without treatment (<1%/year).
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 70.0 (trials 20.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 4 completed, 4 other |
| Linked publications | 14 (5 clinical trial publications, 5 randomised controlled trial publications, 2 Cochrane reviews, 2 meta-analyses) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | DGIdb |
| Linked via biomarker / target | AGTR1 |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT00284921 | MYPROMS-ES02: Safety and Efficacy of Basiliximab, Cyclosporine Microemulsion and Enteric-coated Mycophenolate Sodium (EC-MPS) Versus EC-MPS and Steroid Therapy in Kidney Transplant Recipients Who Are Hepatitis C Positive 2004 | terminated | Phase 3 | 60 |
| NCT00375895 | Switch From Tacrolimus to Cyclosporin in the Treatment of Recurrent Hepatitis C After Liver Transplantation 2006 | terminated | Phase 3 | 11 |
| NCT00983060 | Adaptive-design Dose Finding Study to Assess the Antiviral Efficacy and Safety of NIM811 Administered in Combination With Standard of Care (SOC) in Relapsed Hepatitis C Virus 1 (HCV-1) Infected Patients 2009 | completed | Phase 2 | 59 |
| NCT00668369 | Effect of Immunosuppression Drug Weaning on Hepatitis C Virus (HCV)-Induced Liver Damage After Liver Transplantation 2008 | completed | Phase 2 | 34 |
| NCT01467505 | An Open Label Study of the Effect of Telaprevir in Combination With Ribavirin and Peginterferon on HCV Infection in Stable Liver Transplant Patients 2012 | terminated | Phase 2 | 61 |
| NCT01479881 | A Study in Healthy Participants Investigating the Effect of TMC435 on the Pharmacokinetics of Immunosuppressants Cyclosporine and Tacrolimus 2011 | completed | Phase 1 | 29 |
| NCT03665766 | Effect of Cyclosporine A Versus Tacrolimus on Response to Antiviral Therapy After Hepatitis C Genotype -4 Recurrence Post Liver Transplantation 2014 | completed | Not applicable | 126 |
| NCT04113915 | Viral Hepatitis B and C Infection in Patients With Idiopathic Thrombocytopenic Purpura Treated With Triple Therapy 2019 | status unknown | Not applicable | 150 |
Published literature
- Clinical trial publication Sofosbuvir/velpatasvir for 12 weeks in genotype 1-4 HCV-infected liver transplant recipientsAgarwal K, Castells L, Müllhaupt B et al. · Journal of hepatology · 2018 · PMID 29886154
- Clinical trial publication Pharmacokinetic Interaction between Faldaprevir and Cyclosporine or Tacrolimus in Healthy Volunteers: A Prospective, Open-Label, Fixed-Sequence, Crossover StudyHuang F, Voelk C, Trampisch M et al. · Basic & clinical pharmacology & toxicology · 2018 · PMID 29427400
- Clinical trial publication Twice-Daily Telaprevir for Posttransplant Genotype 1 Hepatitis C Virus: A Prospective Safety, Efficacy, and Pharmacokinetics StudyRubin RA, Russo MW, Brown KA et al. · Experimental and clinical transplantation : official journal of the Middle East Society for Organ Transplantation · 2018 · PMID 27855589
- Clinical trial publication Efficacy, safety, and pharmacokinetics of simeprevir, daclatasvir, and ribavirin in patients with recurrent hepatitis C virus genotype 1b infection after orthotopic liver transplantation: The Phase II SATURN studyForns X, Berenguer M, Herzer K et al. · Transplant infectious disease : an official journal of the Transplantation Society · 2017 · PMID 28295849
- Clinical trial publication Pharmacokinetics of Tacrolimus and Cyclosporine in Liver Transplant Recipients Receiving 3 Direct-Acting Antivirals as Treatment for Hepatitis C InfectionBadri PS, Parikh A, Coakley EP et al. · Therapeutic drug monitoring · 2016 · PMID 27310199
- Randomized controlled trial Sustained virological response to antiviral therapy in a randomized trial of cyclosporine versus tacrolimus in liver transplant patients with recurrent hepatitis C infectionDuvoux C, Villamil F, Renner EL et al. · Annals of transplantation · 2015 · PMID 25588713
- Cochrane review Efficacy of immunosuppression monotherapy after liver transplantation: a meta-analysisLan X, Liu MG, Chen HX et al. · World journal of gastroenterology · 2014 · PMID 25232269
- Cochrane review Tacrolimus-based versus cyclosporine-based immunosuppression in hepatitis C virus-infected patients after liver transplantation: a meta-analysis and systematic reviewLiu Z, Chen Y, Tao R et al. · PloS one · 2014 · PMID 25198195
- Randomized controlled trial REFINE: a randomized trial comparing cyclosporine A and tacrolimus on fibrosis after liver transplantation for hepatitis CLevy G, Villamil FG, Nevens F et al. · American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2014 · PMID 24456049
- Meta-analysis Efficacy of antiviral therapy for hepatitis C after liver transplantation with cyclosporine and tacrolimus: a systematic review and meta-analysisRabie R, Mumtaz K, Renner EL · Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society · 2013 · PMID 22821730
- Randomized controlled trial Hepatitis C virus viral kinetics during α-2a or α-2b pegylated interferon plus ribavirin therapy in liver transplant recipients with different immunosuppression regimesBerenguer M, Ortíz-Cantó C, Abellán JJ et al. · Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2012 · PMID 22222052
- Randomized controlled trial The use of cyclosporine for recurrent hepatitis C after liver transplant: a randomized pilot studyFirpi RJ, Soldevila-Pico C, Morelli GG et al. · Digestive diseases and sciences · 2010 · PMID 19798576
- Randomized controlled trial Immunoadsorption apheresis and immunosuppressive drug therapy in the treatment of complicated HCV-related cryoglobulinemiaStefanutti C, Vivenzio A, Di Giacomo S et al. · Journal of clinical apheresis · 2009 · PMID 19927363
- Meta-analysis Immunosuppression with calcineurin inhibitors with respect to the outcome of HCV recurrence after liver transplantation: results of a meta-analysisBerenguer M, Royuela A, Zamora J · Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society · 2007 · PMID 17192906
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target AGTR1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Cyclosporine approved for Hepatitis C?
Cyclosporine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Hepatitis C would be drug repurposing rather than first-in-human development. This does not mean it is approved for Hepatitis C. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Cyclosporine in clinical trials for Hepatitis C?
ClinicalTrials.gov lists 8 registered trials linking Cyclosporine to Hepatitis C: 4 have completed; 4 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT00284921). The largest enrolment is 150 participants (NCT04113915). Registration activity spans 2004 to 2019.
What does the evidence show for Cyclosporine in Hepatitis C?
Cyclosporine has both completed registered trials and synthesis-level publications linked to Hepatitis C. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target AGTR1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.