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Sofosbuvir/Ledipasvir x 12 weeks
Sofosbuvir inhibits hepatitis C virus NS5B polymerase while ledipasvir inhibits NS5A protein, together blocking viral replication.
Sofosbuvir inhibits hepatitis C virus NS5B polymerase while ledipasvir inhibits NS5A protein, together blocking viral replication. Used for Chronic hepatitis C virus (HCV) infection, genotypes 1, 4, 5, and 6, HCV in patients with compensated cirrhosis.
At a glance
| Generic name | Sofosbuvir/Ledipasvir x 12 weeks |
|---|---|
| Also known as | Harvoni |
| Sponsor | Medical University of South Carolina |
| Drug class | Direct-acting antiviral (DAA) combination |
| Target | HCV NS5B polymerase and NS5A protein |
| Modality | Small molecule |
| Therapeutic area | Virology/Hepatology |
| Phase | FDA-approved |
Mechanism of action
Sofosbuvir is a nucleotide analog that acts as a chain terminator of the HCV RNA-dependent RNA polymerase (NS5B), preventing viral RNA synthesis. Ledipasvir is a non-structural protein 5A (NS5A) inhibitor that disrupts viral replication and assembly. Together, this fixed-dose combination provides direct-acting antiviral activity against hepatitis C virus across multiple genotypes.
Approved indications
- Chronic hepatitis C virus (HCV) infection, genotypes 1, 4, 5, and 6
- HCV in patients with compensated cirrhosis
Common side effects
- Headache
- Fatigue
- Nausea
- Diarrhea
- Insomnia
Key clinical trials
- Determine the Efficacy and Safety of Harvoni in Genotype 1 Chronic Hepatitis c Infected People Who Are Alcoholics (PHASE4)
- Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination +/- Ribavirin in Adolescents and Children With Chronic HCV-Infection (PHASE2)
- Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed Dose Combination in the Treatment of Hepatitis C Virus (HCV) Infection in Pediatric Participants Undergoing Cancer Chemotherapy (PHASE2)
- Immunologic Effects of HCV Therapy With HARVONI in HCV Genotype 1 Chronically Mono-infected Active and Former IDUs (PHASE4)
- LIVE-C-Free: Early and Late Treatment of Hepatitis C With Sofosbuvir/Ledipasvir in Liver Transplant Recipients (PHASE4)
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 |
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