HARVONI (ledipasvir)
HARVONI is indicated for the treatment of Hepatitis C.
How HARVONI Works
HARVONI is composed of two direct-acting antiviral agents, ledipasvir and sofosbuvir, which target the hepatitis C virus. Ledipasvir functions as an HCV NS5A inhibitor, while sofosbuvir acts as an HCV nucleotide analog NS5B polymerase inhibitor. These components work together to inhibit the viral replication process required for the hepatitis C virus to spread.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2014-10-10
- Patent Cliff
- 2034
- Routes
- ORAL
- Dosage Forms
- TABLET, PELLETS
HARVONI Approval History
What HARVONI Treats
1 indicationsHARVONI is approved for 1 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hepatitis C
HARVONI Boxed Warning
RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with HARVONI. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfect...
WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with HARVONI. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated [see Warnings and Precautions (5.1) ]. WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV See full prescribing information for complete boxed warning. Hepatitis B virus (HBV) reactivation has been reported, in some cases resulting in fulminant hepatitis, hepatic failure, and death. ( 5.1 )
HARVONI Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to HARVONI
3 of 5FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
9 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02771405 FRI-STC | 4/2016 | Ph 3 | completed | Impact of Interferon Free Regimens in Patients With Chronic HCV and Successfully Treated HCC |
| NCT02759861 results posted | 0121-16-FB | Ph 4 | completed | Determine the Efficacy and Safety of Harvoni in Genotype 1 Chronic Hepatitis c Infected People Who Are Alcoholics |
| NCT03118674 results posted | IRB00043341 U54DK083909 | Ph 2 | completed | Harvoni Treatment Porphyria Cutanea Tarda |
| NCT02533934 STOP-CO results posted | 12044 1U01AI115714 | Ph 4 | completed | Sofosbuvir Based DAA Therapy in HIV/HCV Coinfected Pre or Post Liver Transplant |
| NCT02825212 results posted | GCO 15-2282 IN-US-337-1716 | Ph 2, Ph 3 | completed | Efficacy of All-Oral Anti-Viral Therapy for Symptomatic Hepatitis C Virus Infection-Related Cryoglobulinemia |
| NCT02705534 SL50 | 94-04-37-31023 | Ph 3 | completed | Sofosbuvir, Ledipasvir, Ribavirin for Hepatitis C Cirrhotics, Genotype 1 |
| NCT02405013 TAC | ANRS 12311 TAC | Ph 2 | completed | Feasibility, Tolerance and Efficacy of Interferon-free, Antiviral Treatment With Sofosbuvir + Ribavirin for the Treatment of Genotype 2 and Sofosbuvir/Ledipasvir for the Treatment of Genotype 1 and 4 Hepatitis C Virus-infected Patients in West and Central Africa |
| NCT01805882 results posted | 130066 13-I-0066 | Ph 2 | completed | Combination Therapy for Chronic Hepatitis C Infection |
| NCT02768961 JAILFREE-C | JCG-SOFLDP-2015-01 | Ph 4 | completed | Program of Screening, Prevention and Elimination of Hepatitis C in Penitentiary Institutions in Cantabria (JAILFREE-C) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
HARVONI FDA Label Details
Indications & Usage
FDA Label (PDF)HARVONI is indicated for the treatment of Hepatitis C.
WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with HARVONI. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing...
HARVONI Patents & Exclusivity
Patents (33 active)
Exclusivity
Pro Intelligence Preview
Deep insights for HARVONI
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2034
- • 258 active patents
Trial Analysis
- • 9 total trials
- • Stage: Declining
Competitive Landscape
- • 5 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment