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Daclatasvir + Sofosbuvir
Daclatasvir and sofosbuvir work together to inhibit hepatitis C virus (HCV) replication by blocking the NS5A protein and the NS5B RNA polymerase, respectively.
Daclatasvir and sofosbuvir work together to inhibit hepatitis C virus (HCV) replication by blocking the NS5A protein and the NS5B RNA polymerase, respectively. Used for Chronic hepatitis C virus (HCV) infection, all genotypes.
At a glance
| Generic name | Daclatasvir + Sofosbuvir |
|---|---|
| Also known as | Solvaldi, Daklinza |
| Sponsor | Federal University of São Paulo |
| Drug class | Direct-acting antiviral (DAA) combination |
| Target | HCV NS5A protein and HCV NS5B RNA-dependent RNA polymerase |
| Modality | Small molecule |
| Therapeutic area | Virology / Hepatology |
| Phase | FDA-approved |
Mechanism of action
Daclatasvir 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, blocking viral RNA synthesis. Together, this combination directly targets two essential HCV replication enzymes, achieving high cure rates across multiple HCV genotypes.
Approved indications
- Chronic hepatitis C virus (HCV) infection, all genotypes
Common side effects
- Fatigue
- Headache
- Nausea
- Diarrhea
- Insomnia
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:
- Daclatasvir + Sofosbuvir CI brief — competitive landscape report
- Daclatasvir + Sofosbuvir updates RSS · CI watch RSS
- Federal University of São Paulo portfolio CI