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Sofosbuvir + Daclatasvir
Sofosbuvir and daclatasvir are direct-acting antivirals that inhibit hepatitis C virus (HCV) NS5B polymerase and NS5A protein, respectively, blocking viral replication.
Sofosbuvir and daclatasvir 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 infection (genotypes 1-6), HCV in treatment-naïve and treatment-experienced patients.
At a glance
| Generic name | Sofosbuvir + Daclatasvir |
|---|---|
| Sponsor | Egyptian Liver Hospital |
| Drug class | Direct-acting antiviral (DAA) combination |
| Target | HCV NS5B polymerase and HCV NS5A protein |
| Modality | Small molecule |
| Therapeutic area | Virology / Hepatology |
| Phase | Phase 3 |
Mechanism of action
Sofosbuvir is a nucleotide analog inhibitor of the HCV NS5B RNA-dependent RNA polymerase, essential for viral replication. Daclatasvir is an NS5A inhibitor that disrupts viral protein complex formation and RNA replication. 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 infection (genotypes 1-6)
- HCV in treatment-naïve and treatment-experienced patients
Common side effects
- Fatigue
- Headache
- Nausea
- Diarrhea
Key clinical trials
- Study of DAA Treatment for Children and Adolescents With Active HCV Infection in Cambodia (NA)
- Four Different Experimental Drug Regimens to Standard of Care for the Treatment of Symptomatic Outpatients With COVID-19 (PHASE2)
- Treating Hepatitis C in Pakistan. Strategies to Avoid Resistance to Antiviral Drugs
- Impact of Direct-acting Antiviral Drugs on The Patterns of Gut Microbiota in Patients With HCV Related Chronic Liver Diseases
- An Efficacy, Safety and Pharmacokinetics Study of Simeprevir, Daclatasvir and Sofosbuvir in Participants With Chronic Hepatitis C Virus Genotype 1 or 4 Infection and Decompensated Liver Disease (PHASE2)
- Antiviral Agents Against COVID-19 Infection (PHASE2, PHASE3)
- DRug Use & Infections in ViEtnam - Hepatitis C (DRIVE-C) (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
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 + Daclatasvir CI brief — competitive landscape report
- Sofosbuvir + Daclatasvir updates RSS · CI watch RSS
- Egyptian Liver Hospital portfolio CI