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Combined therapy LDV and SOF
LDV (ledipasvir) and SOF (sofosbuvir) are direct-acting antivirals that inhibit hepatitis C virus NS5A and NS5B polymerase, respectively, blocking viral replication.
LDV (ledipasvir) and SOF (sofosbuvir) are direct-acting antivirals that inhibit hepatitis C virus NS5A and NS5B polymerase, respectively, blocking viral replication. Used for Chronic hepatitis C virus infection (genotypes 1-6).
At a glance
| Generic name | Combined therapy LDV and SOF |
|---|---|
| Also known as | ledipasvir and sofosbuvir |
| Sponsor | Yassin Abdelghaffar Charity Center for Liver Disease and Research |
| 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 viral protein complex formation and RNA replication. Sofosbuvir is a nucleotide analog that inhibits the NS5B RNA-dependent RNA polymerase, a critical enzyme for HCV genome replication. Together, they provide potent pan-genotypic activity against hepatitis C virus with high barrier to resistance.
Approved indications
- Chronic hepatitis C virus infection (genotypes 1-6)
Common side effects
- Fatigue
- Headache
- Nausea
- Diarrhea
- Insomnia
Key clinical trials
- Efficacy and Safety of Grazoprevir (+) Uprifosbuvir (+) Ruzasvir (MK-3682B) (MK-5172 + MK-3682 + MK-8408) Fixed Dose Combination in Chronic HCV Participants Failing Prior Antiviral Treatment (MK-3682-021) (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
- Efficacy and Safety of Therapy Against HCV Based on Direct-acting Antivirals in Real-life Conditions
- Study of Oral Treatments for Hepatitis C (PHASE4)
- Harvoni in Patients With Chronic Hepatitis C Virus (HCV) Infection in Korea
- Ledipasvir/Sofosbuvir for Hepatitis B Virus Infection (PHASE2)
- DAAs Treatment for Chronic HCV/HBV Co-infection Patients(DASCO) (PHASE2, PHASE3)
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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