Disease × agent evidence record

Sofosbuvir for Hepatitis C: evidence, trials and status

Sofosbuvir 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.

8 registered trials 0 recruiting 16 publications Evidence tier A · Strong Score 74.0
Research Tracker › Pairs › Hepatitis C › Sofosbuvir
Research map, not treatment advice. This page aggregates registry and literature records. It does not evaluate efficacy, dosing or safety for any individual. Discuss any treatment decision with a qualified clinician.

Summary

Sofosbuvir 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trials linking Sofosbuvir to Hepatitis C: 1 is active or not yet recruiting; 4 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT02786537). It plans or enrolled 1275 participants. Registration activity spans 2013 to 2022. The literature layer holds 16 publications for this pair: 5 Cochrane reviews, 3 meta-analyses, 1 systematic review, 2 randomised controlled trial publications and 5 clinical trial publications. Publication years run from 2022 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).

Open in Repurposing ExplorerHepatitis C hubHepatitis C biomarkers & interventionsChEMBLOpen Targets

Evidence table

Evidence tierA · Strong
Evidence score74.0 (trials 24.0, literature 30.0, tier 15, approved bonus 5.0)
Registered trials8 total: 0 recruiting, 1 active / not yet recruiting, 4 completed, 3 other
Linked publications16 (5 Cochrane reviews, 5 clinical trial publications, 3 meta-analyses, 2 randomised controlled trial publications, 1 systematic review)
Agent typeDrug (Small molecule)
Development stage (any indication)Approved
Mechanism / classNot recorded
Data sourcesOpen 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 IDTitleStatusPhaseEnrolment
NCT03057847Sofosbuvir/Velpatasvir in Postpartum Women With Opioid Use Disorder and Chronic Hepatitis C Infection
2018
completedPhase 432
NCT02786537Study of Oral Treatments for Hepatitis C
2016
completedPhase 41,275
NCT03369327Sofosbuvir and Daclatasvir for Treating Hepatitis C in 200 Patients Co-infected With Human Immunodeficiency Virus
2017
completedPhase 3232
NCT03809533The Use of Hepatitis C Positive Kidneys in Hepatitis C Negative Kidney Transplant Recipients
2019
active, not recruitingPhase 230
NCT01994486Open-Label Safety Study of Telaprevir and Sofosbuvir in Chronic Hepatitis C Genotype 1
2013
completedPhase 220
NCT0260530412 Weeks of Ledipasvir (LDV)/Sofosbuvir (SOF) With Weight-based Ribavirin vs. 24 Weeks of LDV/SOF
2016
terminatedPhase 27
NCT04948801SOF/VEL±RBV: Efficacy and Safety in GT 3 and 6 HCV Patients
2018
status unknownNot applicable150
NCT03158857Hepatitis C Treatment Study in Myanmar
2022
withdrawnNot applicable—

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Published literature

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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 Sofosbuvir approved for Hepatitis C?

Sofosbuvir 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 Sofosbuvir in clinical trials for Hepatitis C?

ClinicalTrials.gov lists 8 registered trials linking Sofosbuvir to Hepatitis C: 1 is active or not yet recruiting; 4 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT02786537). It plans or enrolled 1275 participants. Registration activity spans 2013 to 2022.

What does the evidence show for Sofosbuvir in Hepatitis C?

Sofosbuvir 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

Open Source Medicine Foundation. Sofosbuvir for Hepatitis C: evidence, trials and status. OSMF Research Tracker. Updated 2026-07-05. https://research.opensourcemed.info/pairs/hepatitis-c/sofosbuvir.html

Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.

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This is a research map, not treatment advice. Evidence tiers and scores summarise what has been studied, not whether a treatment works or is safe for you.