Sofosbuvir and velpatasvir

(Epclusa®)

Sofosbuvir and velpatasvir

Drug updated on 12/11/2024

Dosage FormTablet (oral; sofosbuvir/velpatasvir: 400 mg/100 mg, 200 mg/50 mg); Pellet (oral; sofosbuvir/velpatasvir: 200 mg/50 mg, 150 mg/37.5 mg)
Drug ClassHepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitors and HCV NS5A inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adult and pediatric patients 3 years of age and older with chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis
  • Indicated for the treatment of adult and pediatric patients 3 years of age and older with chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection with decompensated cirrhosis in combination with ribavirin.

Latest News

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Summary
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  • This summary is based on the review of 10 systematic review(s)/meta-analysis(es). [1-10]
  • Virological Failure and Resistance-Associated Substitutions (RAS): Sofosbuvir/velpatasvir exhibited virological failure rates comparable to other direct-acting antiviral (DAA) regimens, with a high prevalence of RAS at 78%. Similar RAS rates were observed in other regimens, including sofosbuvir/daclatasvir (81%) and glecaprevir/pibrentasvir (79%), while retreatment with sofosbuvir/velpatasvir/voxilaprevir showed an even higher RAS prevalence of 93%.
  • Sustained Virological Response (SVR12) Across Populations: In genotype 2 (GT2) patients, sofosbuvir/velpatasvir and glecaprevir/pibrentasvir achieved a 100% SVR12 rate. Among pediatric and adolescent patients, sofosbuvir/velpatasvir achieved SVR12 rates of 95% in adolescents, 93% in older children, and 83% in young children. For end-stage renal disease (ESRD) patients, the SVR12 rate with sofosbuvir/velpatasvir was 97.69%, and for decompensated cirrhotic patients, it reached 91%, outperforming other sofosbuvir-based regimens such as sofosbuvir/ledipasvir (86.3%) and sofosbuvir/daclatasvir (82.4%).
  • Kidney Transplant Recipients and Other Genotypes: Kidney transplant recipients treated with sofosbuvir/velpatasvir achieved complete viral eradication at 12 weeks post-treatment. Additionally, genotype 3 patients treated with sofosbuvir/velpatasvir achieved an SVR12 rate of 95.08%, underscoring the regimen's efficacy across different genotypes.
  • Common and Serious Adverse Events (AEs): Fatigue (14%) and headache (13.1%) were the most common adverse events associated with sofosbuvir/velpatasvir. Serious adverse events (SAEs) and deaths were uncommon overall, though grade 3 hyperglycemia occurred in 2.1% of diabetic patients treated with sofosbuvir/velpatasvir/voxilaprevir.
  • Pediatric and Special Populations: Younger children experienced higher rates of adverse events (72%) compared to adolescents (50%) and older children (53%). Among end-stage renal disease (ESRD) patients, no serious adverse events were reported with sofosbuvir/velpatasvir. In decompensated cirrhotic patients, adding ribavirin to sofosbuvir-based regimens led to a notable increase in adverse event frequency.

Product Monograph / Prescribing Information

Document TitleYearSource
Epclusa (sofosbuvir and velpatasvir) Prescribing Information.2022Gilead Sciences, Inc., Foster City, CA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Prevalence of Drug Resistance Associated Substitutions in Persons With Chronic Hepatitis C Infection and Virological Failure Following Initial or Re-treatment With Pan-genotypic Direct-Acting Antivirals: A Systematic Review and Meta-analysis2024Clinical Infectious Diseases
Efficacy and safety of direct-acting antiviral regimen for patients with hepatitis C virus genotype 2: a systematic review and meta-analysis2024BMC Gastroenterology
Efficacy and safety of DAA in children and adolescents with chronic HCV infection: A systematic review and meta-analysis2024Liver 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-analysis2023Frontiers in Public Health
The impact of sofosbuvir/velpatasvir/voxilaprevir treatment on serum hyperglycemia in hepatitis C virus infections: a systematic review and meta-analysis2023Annals of Medicine
Efficacy and Safety of Sofosbuvir-based Regimens in Hepatitis C Patients With Decompensated Cirrhosis: A Systematic Review and Meta-analysis2023Journal of Clinical and Translational Hepatology
Transplant of Kidneys From Hepatitis C Virus-Positive Donors To Hepatitis C Virus-Negative Recipients: A Retrospective Study and Systematic Review2022Experimental and Clinical Transplantation
Safety and efficacy of sofosbuvir-velpatasvir: A meta-analysis2022Medicine
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-analysis2022Nephrology
Real-World Effectiveness of Direct-Acting Antiviral Regimens against Hepatitis C Virus (HCV) Genotype 3 Infection: A Systematic Review and Meta-Analysis2021Annals of Hepatology

Clinical Practice Guidelines