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sofosbuvir/ledipasvir
Sofosbuvir/ledipasvir is a fixed-dose combination that inhibits hepatitis C virus (HCV) NS5B polymerase and NS5A protein, blocking viral replication.
Sofosbuvir/ledipasvir is a fixed-dose combination that inhibits hepatitis C virus (HCV) NS5B polymerase and NS5A protein, blocking viral replication. Used for Chronic hepatitis C virus (HCV) infection, genotypes 1, 4, 5, and 6, HCV/HIV-1 coinfection, HCV in patients with compensated cirrhosis.
At a glance
| Generic name | sofosbuvir/ledipasvir |
|---|---|
| Also known as | Harvoni |
| Sponsor | University of Texas Southwestern Medical Center |
| Drug class | Direct-acting antiviral (DAA) combination |
| Target | HCV NS5B polymerase and NS5A protein |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | FDA-approved |
Mechanism of action
Sofosbuvir is a nucleotide analog inhibitor of the HCV NS5B RNA-dependent RNA polymerase, essential for viral replication. Ledipasvir is an NS5A inhibitor that disrupts viral protein function and assembly. Together, they provide direct-acting antiviral activity against HCV with high barrier to resistance.
Approved indications
- Chronic hepatitis C virus (HCV) infection, genotypes 1, 4, 5, and 6
- HCV/HIV-1 coinfection
- HCV in patients with compensated cirrhosis
Common side effects
- Headache
- Fatigue
- 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 |