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Sofosbuvir plus Ledipasvir
Sofosbuvir and ledipasvir are direct-acting antivirals that inhibit hepatitis C virus (HCV) NS5B polymerase and NS5A protein, respectively, blocking viral replication.
Sofosbuvir and ledipasvir are direct-acting antivirals that inhibit hepatitis C virus (HCV) NS5B polymerase and NS5A protein, respectively, blocking viral replication. Used for Chronic hepatitis C virus (HCV) infection, genotypes 1, 4, 5, and 6, Chronic hepatitis C virus (HCV) infection, genotype 2 and 3 (with ribavirin).
At a glance
| Generic name | Sofosbuvir plus Ledipasvir |
|---|---|
| Also known as | Oseltamivir plus Hydroxychloroquine & Azithromycin, Harvoni |
| Sponsor | Almaza Military Fever Hospital |
| Drug class | Direct-acting antiviral (DAA) combination |
| Target | HCV NS5B polymerase and HCV NS5A protein |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | Phase 3 |
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, this combination targets two critical steps in the HCV replication cycle, achieving high cure rates across multiple HCV genotypes.
Approved indications
- Chronic hepatitis C virus (HCV) infection, genotypes 1, 4, 5, and 6
- Chronic hepatitis C virus (HCV) infection, genotype 2 and 3 (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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Sofosbuvir plus Ledipasvir CI brief — competitive landscape report
- Sofosbuvir plus Ledipasvir updates RSS · CI watch RSS
- Almaza Military Fever Hospital portfolio CI