Drug updated on 11/13/2023

Dosage FormTablet (oral; 200 mg, 400 mg); Pellets (oral; 150 mg, 200 mg)
Drug ClassHepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitors
Ongoing and
Completed Studies


  • For the treatment of adult patients with genotype 1, 2, 3 or 4 chronic HCV infection without cirrhosis or with compensated cirrhosis as a component of a combination antiviral treatment regimen.
  • For the treatment of pediatric patients 3 years of age and older with genotype 2 or 3 chronic HCV infection without cirrhosis or with compensated cirrhosis in combination with ribavirin.

Product Monograph / Prescribing Information

Document TitleYearSource
Sovaldi (sofosbuvir) Prescribing Information.2020Gilead Sciences, Inc., Foster City, CA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
The efficacy and safety of direct-acting antiviral regimens for end-stage renal disease patients with HCV infection: a systematic review and network meta-analysis. 2023Frontiers in Public Health
Treatment Outcomes of Sofosbuvir/Velpatasvir/Voxilaprevir in Direct-Acting Antiviral-Experienced Hepatitis C Virus Patients: A Systematic Review and Meta-Analysis. 2023Viruses
Effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir as a hepatitis C virus infection salvage therapy in the real world: a systematic review and meta-analysis.2022Infectious Diseases and Therapy
Sofosbuvir plus velpatasvir combination for the treatment of chronic hepatitis C in patients with end stage renal disease on renal replacement therapy: a systematic review and meta-analysis.2022Nephrology
Safety and efficacy of sofosbuvir-velpatasvir: a meta-analysis.2022Medicine
Safety and efficacy of sofosbuvir‐based medication regimens with and without ribavirin in hepatitis C patients: A systematic review and meta‐analysis. 2022Journal of Clinical Pharmacy and Therapeutics
Real-world effectiveness of direct-acting antiviral regimens against hepatitis C virus (HCV) genotype 3 infection: a systematic review and meta-analysis.2021Annals of Hepatology
Efficacy and safety of sofosbuvir in the treatment of hep C among patients on hemodialysis: a systematic review and meta‑analysis.2020Scientific Reports
Efficacy and safety of direct acting antiviral regimens for hepatitis C virus and human immunodeficiency virus co‐infection: systematic review and network meta‐analysis. 2020Journal of Gastroenterology and Hepatology
An updated systematic review and metaanalysis on efficacy of Sofosbuvir in treating hepatitis C-infected patients with advanced chronic kidney disease.2020PLoS One
Sofosbuvir-based regimen is safe and effective for hepatitis C infected patients with stage 4–5 chronic kidney disease: a systematic review and meta-analysis.2019Virology Journal
Sustained virologic response to direct-acting antiviral therapy in patients with chronic hepatitis C and hepatocellular carcinoma: a systematic review and meta-analysis. 2019Journal of Hepatology
Systematic review with meta‐analysis: effectiveness of direct-acting antiviral treatment for hepatitis C in patients with hepatocellular carcinoma.2019Alimentary Pharmacology and Therapeutics
A systematic review with meta-analysis: Is ribavirin necessary in sofosbuvir-based direct-acting antiviral therapies for patients with HCV recurrence after liver transplantation?2019International Journal of Infectious Diseases
Direct‐acting antiviral agents for liver transplant recipients with recurrent genotype 1 hepatitis C virus infection: Systematic review and meta‐analysis.2018Transplant Infectious Disease
Cardiac harms of sofosbuvir: Systematic review and meta-analysis. 2018Drug Safety
Real-world effectiveness of sofosbuvir plus ribavirin for chronic hepatitis C genotype 2 in Asia: a systematic review and meta-analysis.2018BMJ Open Gastroenterology

Clinical Practice Guidelines