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Sofosbuvir and Velpatasvir
Sofosbuvir and Velpatasvir is a Direct-acting antiviral (DAA) combination Small molecule drug developed by Hannover Medical School. It is currently FDA-approved for Chronic hepatitis C virus infection (genotypes 1-6), Hepatitis C virus infection in patients with compensated cirrhosis. Also known as: Epclusa 400 mg/100 mg film-coated tablets, Sofosvel.
Sofosbuvir and velpatasvir are direct-acting antivirals that inhibit hepatitis C virus NS5B polymerase and NS5A protein, blocking viral replication.
Sofosbuvir and Velpatasvir are small molecule inhibitors of the Nonstructural protein 5A, a protein involved in the replication of the Hepatitis C Virus. They are used to treat conditions such as Hepatitis C, Chronic Hepatitis C, and Hepatitis C Virus Infection, among others.
At a glance
| Generic name | Sofosbuvir and Velpatasvir |
|---|---|
| Also known as | Epclusa 400 mg/100 mg film-coated tablets, Sofosvel |
| Sponsor | Hannover Medical School |
| Drug class | Direct-acting antiviral (DAA) combination |
| Target | HCV NS5B polymerase and NS5A protein |
| Modality | Small molecule |
| Therapeutic area | Virology / Hepatology |
| Phase | FDA-approved |
Mechanism of action
Sofosbuvir is a nucleotide analog inhibitor of the HCV NS5B RNA-dependent RNA polymerase, essential for viral replication. Velpatasvir inhibits the NS5A protein, which plays a critical role in HCV replication and assembly. Together, this combination targets two distinct viral proteins to achieve potent suppression of hepatitis C virus across multiple genotypes.
Approved indications
- Chronic hepatitis C virus infection (genotypes 1-6)
- Hepatitis C virus infection in patients with compensated cirrhosis
Common side effects
- Headache
- Fatigue
- Nausea
- Diarrhea
Key clinical trials
- People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents (PHASE4)
- A Trial of Transplanting Hepatitis C Kidneys Into Hepatitis C-Negative Kidney Recipients (PHASE2)
- Implementing Low-Barrier HCV Treatment in a Jail Setting (PHASE4)
- Prophylaxis With Direct-acting Antivirals for Kidney Transplantation From HCV-Infected Donors to Uninfected Recipients (NA)
- Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy (PHASE4)
- Transplant of Redeemed Organs by Judicious Administration of New Direct-Acting Antivirals for Hepatitis-C Heart Recipients (PHASE2)
- C-Forward: Efficacy and Safety of BEM/RZR vs SOF/VEL in Subjects With Chronic HCV (PHASE3)
- Expanding the Pool in Orthotopic Heart Transplantation (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:
- Sofosbuvir and Velpatasvir CI brief — competitive landscape report
- Sofosbuvir and Velpatasvir updates RSS · CI watch RSS
- Hannover Medical School portfolio CI
Frequently asked questions about Sofosbuvir and Velpatasvir
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Related
- Drug class: All Direct-acting antiviral (DAA) combination drugs
- Target: All drugs targeting HCV NS5B polymerase and NS5A protein
- Manufacturer: Hannover Medical School — full pipeline
- Therapeutic area: All drugs in Virology / Hepatology
- Indication: Drugs for Chronic hepatitis C virus infection (genotypes 1-6)
- Indication: Drugs for Hepatitis C virus infection in patients with compensated cirrhosis
- Also known as: Epclusa 400 mg/100 mg film-coated tablets, Sofosvel
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing