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LDV/SOF FDC
LDV/SOF is a fixed-dose combination of ledipasvir (NS5A inhibitor) and sofosbuvir (nucleotide NS5B polymerase inhibitor) that directly inhibits hepatitis C virus replication.
LDV/SOF is a fixed-dose combination of ledipasvir (NS5A inhibitor) and sofosbuvir (nucleotide NS5B polymerase inhibitor) that directly inhibits hepatitis C virus replication. Used for Chronic hepatitis C virus infection (genotypes 1, 4, 5, 6), Chronic hepatitis C virus infection with compensated cirrhosis.
At a glance
| Generic name | LDV/SOF FDC |
|---|---|
| Sponsor | HepNet Study House, German Liverfoundation |
| Drug class | Direct-acting antiviral (DAA) combination |
| Target | HCV NS5A protein and NS5B RNA-dependent RNA polymerase |
| Modality | Small molecule |
| Therapeutic area | Virology / Hepatology |
| Phase | FDA-approved |
Mechanism of action
Ledipasvir blocks the NS5A protein required for HCV RNA replication and virion assembly, while sofosbuvir is a nucleotide analog that inhibits the NS5B RNA-dependent RNA polymerase. Together, they provide direct-acting antiviral activity against hepatitis C virus across multiple genotypes, achieving high cure rates with minimal resistance development.
Approved indications
- Chronic hepatitis C virus infection (genotypes 1, 4, 5, 6)
- Chronic hepatitis C virus infection 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)
- 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)
- DAAs Treatment for Chronic HCV/HBV Co-infection Patients(DASCO) (PHASE2, PHASE3)
- Efficacy of All-Oral Anti-Viral Therapy for Symptomatic Hepatitis C Virus Infection-Related Cryoglobulinemia (PHASE2, PHASE3)
- Hepatitis C Virus(HCV) Heart and Lung Study (PHASE4)
- Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Chronic HCV and HBV Coinfection (PHASE3)
- Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Participants With Chronic Genotype 1 HCV Infection (PHASE3)
- Ledipasvir/Sofosbuvir in Adults With Chronic Hepatitis C Virus (HCV) Infection Who Are on Dialysis for End Stage Renal Disease (PHASE2)
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:
- LDV/SOF FDC CI brief — competitive landscape report
- LDV/SOF FDC updates RSS · CI watch RSS
- HepNet Study House, German Liverfoundation portfolio CI