Summary
Ledipasvir 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C. ClinicalTrials.gov lists 8 registered trials linking Ledipasvir to Hepatitis C: 7 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT02786537). It plans or enrolled 1275 participants. Registration activity spans 2010 to 2016. The literature layer holds 15 publications for this pair: 5 Cochrane reviews, 2 meta-analyses, 1 systematic review, 2 randomised controlled trial publications and 5 clinical trial publications. Publication years run from 2019 to 2026. 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 | 76.5 (trials 26.5, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 7 completed, 1 other |
| Linked publications | 15 (5 Cochrane reviews, 5 clinical trial publications, 2 meta-analyses, 2 randomised controlled trial publications, 1 systematic review) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT02786537 | Study of Oral Treatments for Hepatitis C 2016 | completed | Phase 4 | 1,275 |
| NCT01975675 | Efficacy and Safety of Sofosbuvir/Ledipasvir ± Ribavirin in Japanese Participants With Chronic Genotype 1 HCV Infection 2013 | completed | Phase 3 | 341 |
| NCT01434498 | GS-5885, GS-9451, Tegobuvir and Ribavirin (RBV) in Interferon Ineligible or Intolerant Subjects With Chronic Genotype 1a or 1b Hepatitis C Virus (HCV) Infection 2011 | completed | Phase 2 | 163 |
| NCT02081079 | Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 4 or 5 HCV Infection 2014 | completed | Phase 2 | 85 |
| NCT02413593 | Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination Tablet With Ribavirin for 12 Weeks in Treatment-naive Adults With Chronic HCV Genotype 3 Infection 2015 | completed | Phase 2 | 111 |
| NCT02605304 | 12 Weeks of Ledipasvir (LDV)/Sofosbuvir (SOF) With Weight-based Ribavirin vs. 24 Weeks of LDV/SOF 2016 | terminated | Phase 2 | 7 |
| NCT01193478 | A Multiple Ascending Dose Study of GS 5885 in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C 2010 | completed | Phase 1 | 71 |
| NCT03063723 | Dynamic Changes of Monocytes and NK Cells of CHC Patient Treated by DAAs 2016 | completed | Not applicable | 25 |
Published literature
- Systematic review Cost-effectiveness of sofosbuvir- ledipasvir for Hepatitis C treatment: a systematic reviewJaberi N, Afshari S, Khalili F et al. · European journal of clinical pharmacology · 2026 · PMID 41942791
- Clinical trial publication Feasibility, safety, efficacy and potential scaling-up of sofosbuvir-based HCV treatment in Central and West Africa: (TAC ANRS 12311 trial)Lacombe K, Moh R, Chazallon C et al. · Scientific reports · 2024 · PMID 38702350
- Cochrane review The efficacy and safety of direct-acting antiviral regimens for end-stage renal disease patients with HCV infection: a systematic review and network meta-analysisChen R, Xiong Y, Zeng Y et al. · Frontiers in public health · 2023 · PMID 37841743
- Clinical trial publication Statins Increase the Bioavailability of Fixed-Dose Combination of Sofosbuvir/Ledipasvir by Inhibition of P-glycoproteinAbdelkawy KS, Belal F, Abdelaziz A et al. · Drug research · 2022 · PMID 35724670
- Clinical trial publication Sustainable and equivalent improvements in symptoms and functional well-being following viral cure from ledipasvir/sofosbuvir versus elbasvir/grazoprevir for chronic hepatitis C infection: Findings from the randomized PRIORITIZE trialEvon DM, Dong M, Reeve BB et al. · Journal of viral hepatitis · 2022 · PMID 35657133
- Clinical trial publication Efficacy of Sofosbuvir plus Ledipasvir in Egyptian patients with COVID-19 compared to standard treatment: a randomized controlled trialElgohary MA, Hasan EM, Ibrahim AA et al. · Journal of medicine and life · 2022 · PMID 35449996
- Clinical trial publication Safety and efficacy of sofosbuvir-velpatasvir-voxilaprevir for re-treatment of chronic hepatitis C virus infection in patients with previous direct-acting antiviral treatment failure in Rwanda (SHARED-3): a single-arm trialGupta N, Manirambona L, Shumbusho F et al. · The lancet. Gastroenterology & hepatology · 2022 · PMID 35248212
- Cochrane review Cost-Effectiveness of Elbasvir/Grazoprevir for the Treatment of Chronic Hepatitis C: A Systematic ReviewLiu J, Guo M, Ke L et al. · Frontiers in public health · 2022 · PMID 35646774
- Randomized controlled trial Predictors of 007 triphosphate concentrations in dried blood spots in persons with hepatitis C and active drug or alcohol useBrooks KM, Castillo-Mancilla JR, Morrow M et al. · The Journal of antimicrobial chemotherapy · 2022 · PMID 35194648
- Randomized controlled trial Nonadherence to Ledipasvir/Sofosbuvir Did Not Predict Sustained Virologic Response in a Randomized Controlled Trial of Human Immunodeficiency Virus/Hepatitis C Virus Coinfected Persons Who Use DrugsWard KM, Falade-Nwulia O, Moon J et al. · The Journal of infectious diseases · 2022 · PMID 34543417
- Cochrane review Effect of sofosbuvir-based DAAs on changes in lower-density lipoprotein in HCV patients: a systematic review and meta-analysisWang YW, Lee WP, Huang YH et al. · BMC infectious diseases · 2021 · PMID 34548026
- Cochrane review Efficacy and safety of ledipasvir/sofosbuvir for hepatitis C among drug users: a systematic review and meta-analysisYang X, Tang Y, Xu D et al. · Virology journal · 2021 · PMID 34315488
- Meta-analysis Efficacy and safety of direct acting antiviral regimens for hepatitis C virus and human immunodeficiency virus co-infection: systematic review and network meta-analysisZheng YX, Ma SJ, Xiong YH et al. · Journal of gastroenterology and hepatology · 2020 · PMID 32246857
- Cochrane review Sustained virologic response to direct-acting antiviral therapy in patients with chronic hepatitis C and hepatocellular carcinoma: A systematic review and meta-analysisJi F, Yeo YH, Wei MT et al. · Journal of hepatology · 2019 · PMID 31096005
- Meta-analysis Systematic Review with Meta-Analysis: Efficacy and Safety of Direct-Acting Antivirals for Chronic Hepatitis C Genotypes 5 and 6Due OT, Chaikledkaew U, Genuino AJM et al. · BioMed research international · 2019 · PMID 31815126
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 Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Ledipasvir approved for Hepatitis C?
Ledipasvir 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 Ledipasvir in clinical trials for Hepatitis C?
ClinicalTrials.gov lists 8 registered trials linking Ledipasvir to Hepatitis C: 7 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT02786537). It plans or enrolled 1275 participants. Registration activity spans 2010 to 2016.
What does the evidence show for Ledipasvir in Hepatitis C?
Ledipasvir 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 Open Targets and ChEMBL. 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.