Sofosbuvir

(Sovaldi®)

Sovaldi®

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Drug updated on 4/24/2024

Dosage FormTablet (oral; 200 mg, 400 mg); Pellets (oral; 150 mg, 200 mg)
Drug ClassHCV nucleotide analog NS5B polymerase inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated 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.
  • Indicated 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.

Summary
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  • Sofosbuvir (Sovaldi) is indicated for the treatment of adult and pediatric patients with chronic HCV infection. It shows high efficacy across various populations, including adults, adolescents, and children as young as 3 years. The drug maintains competitive SVR12 rates and a favorable safety profile compared to other pan-genotypic regimens like glecaprevir/pibrentasvir (GLE/PIB) and sofosbuvir/velpatasvir (SOF/VEL).
  • The information was derived from 22 systematic reviews/meta-analyses, providing extensive data on Sovaldi's safety, efficacy, and considerations for specific subgroups.
  • For patients with severe renal impairment or end-stage renal disease (ESRD), studies suggest that combinations like sofosbuvir/ledipasvir offer safe treatment options with high SVR rates, although patient response varies significantly, necessitating careful selection.
  • Treating experienced populations who have had prior exposure to DAAs, sofosbuvir/velpatasvir/voxilaprevir has proven highly efficacious while maintaining a good safety profile.
  • Patients suffering from decompensated cirrhosis can be effectively treated using SOF-based regimens, which showcase significant SVR rates. Among these treatments, sofosbuvir combined with velpatasvir±ribavirin achieved higher sustained virological responses, making it suitable for this fragile group.
  • Data indicates lower sustained virological response in hepatocellular carcinoma patients when treated by SOF-based therapies compared to non-HCC patients, emphasizing the need for early effective interventions in such cases.
  • A potential risk identified during the use of sofosbuvir-based treatments, particularly SOF/VEL/VOX, is grade 3 hyperglycemia, indicating that special attention should be paid to managing diabetes during HCV treatment among diabetic patients.
  • Sofosbuvir's adaptability across all HCV genotypes, particularly in combination with other agents, ensures its role as a cornerstone therapy for HCV. However, the incidence of adverse events points to the need for cautious monitoring and possibly dose adjustments in certain patient subsets.

Product Monograph / Prescribing Information

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

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Efficacy and safety of DAA in children and adolescents with chronic HCV infection: A systematic review and meta-analysis.2024Liver International
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
The impact of sofosbuvir/velpatasvir/voxilaprevir treatment on serum hyperglycemia in hepatitis C virus infections: a systematic review and meta-analysis.2023Annals of Medicine
Efficacy and safety of sofosbuvir-based regimens in hepatitis c patients with decompensated cirrhosis: a systematic review and meta-analysis.2023Journal of Clinical and Translational Hepatology
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
Effect of sofosbuvir-based DAAs on changes in lower-density lipoprotein in HCV patients: a systematic review and meta-analysis.2021BMC Infectious Diseases
Efficacy and safety of ledipasvir/sofosbuvir for hepatitis C among drug users: a systematic review and meta-analysis. 2021Virology Journal
An updated systematic review and meta-analysis on efficacy of Sofosbuvir in treating hepatitis C-infected patients with advanced chronic kidney disease.2021PLOS ONE
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
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
Systematic review with meta-analysis: efficacy and safety of direct-acting antivirals for chronic hepatitis c genotypes 5 and 6.2019BioMed Research International
Efficacy of 12-weeks velpatasvir plus sofosbuvir-based regimen in HCV-naive subjects with mild fibrosis: a meta-analysis.2019Acta Bio-medica
Systematic review with meta‐analysis: effectiveness of direct-acting antiviral treatment for hepatitis C in patients with hepatocellular carcinoma.2019Alimentary Pharmacology and Therapeutics

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