Sofosbuvir
Antivirals For Treatment Of Hcv Infections
Sold as Vosevi · Harvoni · Sovaldi · Epclusa
- Drug class
- Antivirals For Treatment Of Hcv Infections
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 4
- Products on record
- 21
- FDA reports (12 mo)
- 381
Overview
Plain-language summary, compiled from the cited regulatory records
Sofosbuvir is an antiviral medication used to treat chronic hepatitis C virus (HCV) infection in adults [1]. It belongs to a class of drugs known as antivirals for the treatment of HCV infections [1].
VOSEVI, a brand name for sofosbuvir, is indicated for patients with chronic HCV infection who do not have cirrhosis or have compensated cirrhosis (Child-Pugh A) [1]. This medication is approved for individuals with HCV genotypes 1, 2, 3, 4, 5, or 6 who have previously received treatment with an HCV regimen that included an NS5A inhibitor [1]. It is also indicated for genotype 1a or 3 infections in patients previously treated with a sofosbuvir-based regimen that did not include an NS5A inhibitor [1].
In the past 12 months, there have been 381 adverse event reports associated with this active ingredient [2]. The most frequently reported adverse events include drug ineffectiveness, hepatitis C, death, fatigue, and treatment failure [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 12 | April 24, 2026 |
| EU European Union | EMA | 4 | January 9, 2026 |
| CA Canada | Health Canada | 4 | March 22, 2025 |
| US United States | FDA | 1 | July 14, 2025 |
GBUnited Kingdom· MHRA
12 products
Uses
1).
How to take
EUEuropean Union· EMA
4 products
Uses
1). 1.
How to take
CACanada· Health Canada
4 products
Uses
SOVALDI is indicated for the treatment of genotype 1, 2, 3, or 4 chronic hepatitis C virus (CHC) infection as a component of a combination antiviral treatment regimen. The following points should be considered when initiating treatment with SOVALDI: SOVALDI must not be administered as monotherapy (see 7 WARNINGS AND PRECAUTIONS, General).
Treatment regimen and duration are dependent on both viral genotype and patient population (see 4 DOSAGE AND ADMINISTRATION). Treatment response varies based on baseline host and viral factors. Patients Awaiting Liver Transplantation Efficacy with SOVALDI + ribavirin (RBV) regimen has been established in patients with HCV genotype 1, 2, 3 or 4 infection awaiting liver transplantation with hepatocellular carcinoma (HCC) meeting Milan criteria (see 4 DOSAGE AND ADMINISTRATION and 14 CLINICAL TRIALS).
Patients Co-infected with Human Immunodeficiency Virus (HIV-1) Efficacy with SOVALDI + RBV regimen has been established in treatment-naïve CHC patients with HCV genotype 1 and in CHC patients with HCV genotype 2 or 3 regardless of treatment experience.
USUnited States· FDA
1 product
Uses
2) and Clinical Studies (14) ]: genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor. genotype 1a or 3 infection and have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor.
Additional benefit of VOSEVI over sofosbuvir/velpatasvir was not shown in adults with genotype 1b, 2, 4, 5, or 6 infection previously treated with sofosbuvir without an NS5A inhibitor. 2 , 14 ): genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor.
genotype 1a or 3 infection and have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor. Additional benefit of VOSEVI over sofosbuvir/velpatasvir was not shown in adults with genotype 1b, 2, 4, 5, or 6 infection previously treated with sofosbuvir without an NS5A inhibitor.
Drug interactions
Known interactions involving Sofosbuvir. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PLGB119720057 · revised May 2, 2025
- [2]European Medicines Agency · EMEA/H/C/003850 · revised January 9, 2026
- [3]Health Canada (DPD) · 02418355 · revised March 22, 2025
- [4]FDA DailyMed · 17ffc094-8ca7-45… · revised July 14, 2025 [PDF]
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.