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Ledipasvir and sofosbuvir
Ledipasvir inhibits hepatitis C virus NS5A protein and sofosbuvir inhibits NS5B polymerase, together blocking viral replication.
Ledipasvir inhibits hepatitis C virus NS5A protein and sofosbuvir inhibits NS5B polymerase, together blocking viral replication. Used for Chronic hepatitis C virus infection (genotypes 1, 4, 5, 6), Hepatitis C virus infection in patients with compensated cirrhosis.
At a glance
| Generic name | Ledipasvir and sofosbuvir |
|---|---|
| Also known as | HARVONI® |
| Sponsor | National Taiwan University Hospital |
| Drug class | Direct-acting antiviral combination (NS5A inhibitor + nucleotide polymerase inhibitor) |
| Target | HCV NS5A protein and HCV NS5B RNA-dependent RNA polymerase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | FDA-approved |
Mechanism of action
Ledipasvir is a direct-acting antiviral (DAA) that binds to and inhibits the NS5A protein, which is essential for hepatitis C virus RNA replication and virion assembly. Sofosbuvir is a nucleotide analog that inhibits the NS5B RNA-dependent RNA polymerase, preventing viral RNA synthesis. Together, this combination targets two distinct steps in the HCV replication cycle, providing potent and broad-spectrum antiviral activity.
Approved indications
- Chronic hepatitis C virus (HCV) infection, genotypes 1-6
Common side effects
- Fatigue
- Headache
- Nausea
- Diarrhea
- Insomnia
Key clinical trials
- Switching Regimen in Treating Cirrhotic HCV GT1b Subjects (PHASE2)
- Determine the Efficacy and Safety of Harvoni in Genotype 1 Chronic Hepatitis c Infected People Who Are Alcoholics (PHASE4)
- A Registry for Participants With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection
- Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With Hepatitis C Infection (PHASE4)
- Pharmacokinetics of Ledipasvir/Sofosbuvir in Hepatitis C Virus-Infected Children With Hematological Malignancy (PHASE1, PHASE2)
- Harvoni Treatment Porphyria Cutanea Tarda (PHASE2)
- Cardiovascular Disease in HIV and Hepatitis C: Risk Outcomes After Hepatitis C Eradication (PHASE4)
- Hepatitis C Positive Donor Into Hepatitis C Negative Recipients (EARLY_PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ledipasvir and sofosbuvir CI brief — competitive landscape report
- Ledipasvir and sofosbuvir updates RSS · CI watch RSS
- National Taiwan University Hospital portfolio CI