Sofosbuvir/Ledipasvir plus Ribavirin 24W — Competitive Intelligence Brief

Sofosbuvir/Ledipasvir plus Ribavirin 24W (Sofosbuvir/Ledipasvir plus Ribavirin 24W) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Direct-acting antiviral (DAA) combination. Area: Virology/Hepatology.

phase 3 Direct-acting antiviral (DAA) combination HCV NS5B polymerase, HCV NS5A protein Virology/Hepatology Small molecule

Target snapshot

Sofosbuvir/Ledipasvir plus Ribavirin 24W (Sofosbuvir/Ledipasvir plus Ribavirin 24W) — Iran Hepatitis Network. Sofosbuvir inhibits HCV NS5B polymerase while ledipasvir inhibits HCV NS5A protein, and ribavirin enhances viral clearance through multiple mechanisms to achieve sustained virologic response in hepatitis C.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Sofosbuvir/Ledipasvir plus Ribavirin 24W TARGET	Sofosbuvir/Ledipasvir plus Ribavirin 24W	Iran Hepatitis Network	phase 3	Direct-acting antiviral (DAA) combination	HCV NS5B polymerase, HCV NS5A protein
Sofosbuvir/Velpatasvir/Voxilaprevir	Sofosbuvir/Velpatasvir/Voxilaprevir	Peking University People's Hospital	marketed	Direct-acting antiviral (DAA) combination; NS5B polymerase inhibitor + NS5A inhibitor + NS3/4A protease inhibitor	HCV NS5B polymerase, HCV NS5A protein, HCV NS3/4A protease
Sofosbuvir/Velpatasvir + Ribavirin	Sofosbuvir/Velpatasvir + Ribavirin	Peking University People's Hospital	marketed	Direct-acting antiviral (DAA) combination	HCV NS5B polymerase, HCV NS5A protein
Sofosbuvir/Ledipasvir plus Ribavirin 12W	Sofosbuvir/Ledipasvir plus Ribavirin 12W	Iran Hepatitis Network	phase 3	Direct-acting antiviral	HCV NS5B polymerase, HCV NS5A protein
Administration of DAA-based treatment	Administration of DAA-based treatment	Ain Shams University	phase 3	Direct-acting antiviral (DAA) combination	HCV NS3/4A protease, HCV NS5B polymerase, HCV NS5A protein (depending on specific DAA regimen)
Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]	Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]	Ohio State University	marketed	Direct-acting antiviral (DAA) combination	HCV NS5B polymerase and NS5A protein
ABT450r-ABT267-ABT333 +/- Ribavirin	ABT450r-ABT267-ABT333 +/- Ribavirin	Ottawa Hospital Research Institute	marketed	Direct-acting antiviral (DAA) combination	HCV NS3/4A protease, NS5A protein, NS5B polymerase

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Direct-acting antiviral (DAA) combination class)

1. Massachusetts General Hospital · 3 drugs in this class
2. Egyptian Liver Hospital · 3 drugs in this class
3. Hannover Medical School · 2 drugs in this class
4. University of Maryland, Baltimore · 2 drugs in this class
5. Iran Hepatitis Network · 2 drugs in this class
6. Partners in Health · 2 drugs in this class
7. HaEmek Medical Center, Israel · 1 drug in this class
8. Almaza Military Fever Hospital · 1 drug in this class
9. Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba · 1 drug in this class
10. Federal University of São Paulo · 1 drug in this class