Summary
Ombitasvir 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 Ombitasvir to Hepatitis C: 8 have completed. The most advanced is Phase 4 (NCT02786537). It plans or enrolled 1275 participants. Registration activity spans 2013 to 2017. The literature layer holds 16 publications for this pair: 5 Cochrane reviews, 3 meta-analyses, 3 randomised controlled trial publications and 5 clinical trial publications. Publication years run from 2016 to 2023. 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 | 77.5 (trials 27.5, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 8 completed, 0 other |
| Linked publications | 16 (5 Cochrane reviews, 5 clinical trial publications, 3 meta-analyses, 3 randomised controlled trial publications) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
| NCT03050905 | Proof of Concept Study To Evaluate the Efficacy and Justification Of OBV/PTV/r and DSV In Adults With Chronic Hepatitis C Virus Genotype 2K/1B 2017 | completed | Phase 4 | 7 |
| NCT01833533 | A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1a Infection 2013 | completed | Phase 3 | 305 |
| NCT01995071 | A Study to Evaluate the Safety and Antiviral Effect of Multiple Doses of ABT-493 and ABT-530 in Adults With Genotype 1 Hepatitis C Virus (HCV) 2013 | completed | Phase 2 | 89 |
| NCT03341988 | Evaluation of Treatment of Chronic HCV Patients in Chronic Kidney Disease Versus End Stage Renal Disease Patients 2017 | completed | Phase 1 | 100 |
| NCT02615145 | Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Germany (LIFE-C) 2015 | completed | Not applicable | 472 |
| NCT02618928 | The Effectiveness of Paritaprevir/Ritonavir - Ombitasvir, ± Dasabuvir, ± Ribavirin in France 2015 | completed | Not applicable | 735 |
| NCT03053180 | Real World Evidence of the Effectiveness of Paritaprevir/Ritonavir (r) - Ombitasvir, + Dasabuvir Without Ribavirin in Participants With Chronic Hepatitis C and Compensated Liver Cirrhosis in the Russian Federation 2017 | completed | Not applicable | 60 |
Published literature
- 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
- 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
- Clinical trial publication A Pragmatic, Randomized Controlled Trial of Oral Antivirals for the Treatment of Chronic Hepatitis C: The PRIORITIZE StudySulkowski MS, Moon JS, Sherman KE et al. · Hepatology (Baltimore, Md.) · 2021 · PMID 34255381
- Clinical trial publication Impact of IL28B gene polymorphism on efficacy and safety of direct acting antivirals in hepatitis C Egyptian patientsEbid AIM, Ahmed OA, Agwa SH et al. · International journal of clinical pharmacy · 2020 · PMID 32712884
- Clinical trial publication Hepatitis C Virus (HCV) Direct-Acting Antiviral Therapy in Persons With Human Immunodeficiency Virus-HCV Genotype 1 Coinfection Resulting in High Rate of Sustained Virologic Response and Variable in Normalization of Soluble Markers of Immune ActivationAnthony DD, Sulkowski MS, Smeaton LM et al. · The Journal of infectious diseases · 2020 · PMID 32406487
- Clinical trial publication High success rates for the use of sofosbuvir/ombitasvir/paritaprevir/ritonavir + ribavirin and sofosbuvir/simeprevir/daclatasvir + ribavirin in retreatment of chronic hepatitis C infection after unsuccessful sofosbuvir/daclatasvir therapy: a real-life experienceSaid EM, Abdulaziz BA, El Kassas M et al. · Archives of virology · 2020 · PMID 32356185
- Clinical trial publication Ombitasvir/paritaprevir/ritonavir & dasabuvir ± ribavirin following protease inhibitors failure - a prospective multi-centre trialDeutsch L, Houri I, Ben-Ari Z et al. · BMC infectious diseases · 2020 · PMID 32245397
- 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
- Randomized controlled trial Safety, efficacy and cost of two direct-acting antiviral regimens: A comparative study in chronic hepatitis C Egyptian patientsIbrahim Mohammed Ebid AH, Ashraf Ahmed O, Hassan Agwa S et al. · Journal of clinical pharmacy and therapeutics · 2020 · PMID 31889322
- 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 Sustained Virological Response in Special Populations with Chronic Hepatitis C Using Interferon-Free Treatments: A Systematic Review and Meta-analysis of Observational Cohort StudiesFerreira VL, Leonart LP, Tonin FS et al. · Clinical drug investigation · 2018 · PMID 29435907
- Randomized controlled trial [Efficacy and safety of paritaprevir/ritonavir/ombitasvir combined with dasabuvir in non-cirrhotic Asian adult patients with newly diagnosed and treated chronic HCV genotype 1b infection: a randomized, double-blind, placebo-controlled study - China data]Wei L, Cheng J, Luo J et al. · Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2018 · PMID 29996204
- Randomized controlled trial Outcome and adverse events in patients with chronic hepatitis C treated with direct-acting antivirals: a clinical randomized studySølund C, Andersen ES, Mössner B et al. · European journal of gastroenterology & hepatology · 2018 · PMID 29994874
- Cochrane review Efficacy and safety of direct-acting antivirals-based antiviral therapies for hepatitis C virus patients with stage 4-5 chronic kidney disease: a meta-analysisLi T, Qu Y, Guo Y et al. · Liver international : official journal of the International Association for the Study of the Liver · 2017 · PMID 27943605
- Meta-analysis Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir with or without Ribavirin for Treatment of Hepatitis C Virus Genotype 1: A Systematic Review and Meta-analysisAhmed H, Abushouk AI, Menshawy A et al. · Clinical drug investigation · 2017 · PMID 28871475
- Cochrane review Safety of interferon-free therapies for chronic hepatitis C: a network meta-analysisFerreira VL, Assis Jarek NA, Tonin FS et al. · Journal of clinical pharmacy and therapeutics · 2016 · PMID 27440554
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 Ombitasvir approved for Hepatitis C?
Ombitasvir 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 Ombitasvir in clinical trials for Hepatitis C?
ClinicalTrials.gov lists 8 registered trials linking Ombitasvir to Hepatitis C: 8 have completed. The most advanced is Phase 4 (NCT02786537). It plans or enrolled 1275 participants. Registration activity spans 2013 to 2017.
What does the evidence show for Ombitasvir in Hepatitis C?
Ombitasvir 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.