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Ledipasvir/Sofosbuvir
Ledipasvir inhibits hepatitis C virus NS5A protein while sofosbuvir inhibits the viral NS5B polymerase, together blocking HCV replication.
Ledipasvir inhibits hepatitis C virus NS5A protein while sofosbuvir inhibits the viral NS5B polymerase, together blocking HCV replication. Used for Chronic hepatitis C virus infection, genotypes 1, 4, 5, and 6 (with or without ribavirin), Chronic hepatitis C virus infection, genotypes 2 and 3 (in combination with sofosbuvir and ribavirin).
At a glance
| Generic name | Ledipasvir/Sofosbuvir |
|---|---|
| Also known as | LDV/SOF, Harvoni®, GS-7977, GS-5885, Harvoni |
| Sponsor | Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections |
| 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 | Virology / Hepatology |
| Phase | FDA-approved |
Mechanism of action
Ledipasvir is an NS5A inhibitor that prevents the hepatitis C virus from replicating and assembling viral particles. Sofosbuvir is a nucleotide analog that inhibits the NS5B RNA-dependent RNA polymerase, essential for viral RNA synthesis. Together, this combination directly targets two critical steps in the HCV replication cycle, achieving high cure rates across multiple HCV genotypes.
Approved indications
- Chronic hepatitis C virus infection (genotypes 1, 4, 5, 6)
- Chronic hepatitis C virus infection genotype 2 and 3 (in combination with ribavirin)
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 |
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