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Sofosbuvir + Daclatasvir + Ribavirin
Sofosbuvir + Daclatasvir + Ribavirin is a Direct-acting antiviral (DAA) combination Small molecule drug developed by Egyptian Liver Hospital. It is currently in Phase 3 development for Chronic hepatitis C virus infection (genotype-dependent, likely genotypes 1-6), Treatment-naïve and treatment-experienced HCV patients.
This combination inhibits hepatitis C virus replication by blocking the NS5B polymerase (sofosbuvir), NS5A protein (daclatasvir), and reducing viral load through ribavirin's direct antiviral activity.
This combination inhibits hepatitis C virus replication by blocking the NS5B polymerase (sofosbuvir), NS5A protein (daclatasvir), and reducing viral load through ribavirin's direct antiviral activity. Used for Chronic hepatitis C virus infection (genotype-dependent, likely genotypes 1-6), Treatment-naïve and treatment-experienced HCV patients.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Sofosbuvir + Daclatasvir + Ribavirin |
|---|---|
| Sponsor | Egyptian Liver Hospital |
| Drug class | Direct-acting antiviral (DAA) combination |
| Target | NS5B polymerase, NS5A protein |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | Phase 3 |
Mechanism of action
Sofosbuvir is a nucleotide analog that inhibits the NS5B RNA-dependent RNA polymerase, essential for HCV replication. Daclatasvir is an NS5A inhibitor that blocks viral protein function and replication complex formation. Ribavirin is a nucleoside analog with broad antiviral activity that enhances the efficacy of the direct-acting antivirals and may boost immune response.
Approved indications
- Chronic hepatitis C virus infection (genotype-dependent, likely genotypes 1-6)
- Treatment-naïve and treatment-experienced HCV patients
Common side effects
- Fatigue
- Headache
- Nausea
- Anemia (ribavirin-related)
- Insomnia
- Diarrhea
Key clinical trials
- 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
- Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With Hepatitis C Infection (PHASE4)
- Sofosbuvir, Daclatasvir, Ribavirin for Hepatitis C Virus (HCV) Cirrhotics (PHASE3)
- Effect of New Oral Treatment for Hepatitis C Virus on Seminal Parameters (PHASE2, PHASE3)
- Treatment of Hepatitis c by Using Direct-acting Antiviral
- Re-treatment of HCV Following DAA Failure (NA)
- 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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Sofosbuvir + Daclatasvir + Ribavirin CI brief — competitive landscape report
- Sofosbuvir + Daclatasvir + Ribavirin updates RSS · CI watch RSS
- Egyptian Liver Hospital portfolio CI
Frequently asked questions about Sofosbuvir + Daclatasvir + Ribavirin
What is Sofosbuvir + Daclatasvir + Ribavirin?
How does Sofosbuvir + Daclatasvir + Ribavirin work?
What is Sofosbuvir + Daclatasvir + Ribavirin used for?
Who makes Sofosbuvir + Daclatasvir + Ribavirin?
What drug class is Sofosbuvir + Daclatasvir + Ribavirin in?
What development phase is Sofosbuvir + Daclatasvir + Ribavirin in?
What are the side effects of Sofosbuvir + Daclatasvir + Ribavirin?
What does Sofosbuvir + Daclatasvir + Ribavirin target?
Related
- Drug class: All Direct-acting antiviral (DAA) combination drugs
- Target: All drugs targeting NS5B polymerase, NS5A protein
- Manufacturer: Egyptian Liver Hospital — full pipeline
- Therapeutic area: All drugs in Infectious Disease / Virology
- Indication: Drugs for Chronic hepatitis C virus infection (genotype-dependent, likely genotypes 1-6)
- Indication: Drugs for Treatment-naïve and treatment-experienced HCV patients
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing