Sofosbuvir

(Sovaldi®)

Sofosbuvir

Drug updated on 11/1/2024

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.

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Summary
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  • This summary is based on the review of 20 systematic review(s)/meta-analysis(es). [1-20]
  • Sofosbuvir/Velpatasvir (SOF/VEL) achieved high sustained virologic response at 12 weeks (SVR12) rates, exceeding 90% across various populations, including a 100% SVR12 in hepatitis C virus (HCV) genotype 2 (GT2) patients. In contrast, Sofosbuvir/Daclatasvir (SOF/DCV) demonstrated near 100% SVR12 rates in adolescents and GT3 patients.
  • Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) showed effectiveness as a salvage treatment in DAA-experienced patients, with pooled SVR12 rates between 93-96%, although effectiveness was lower in patients with genotype 3, cirrhosis, or prior SOF/VEL failure.
  • Glecaprevir/Pibrentasvir (GLE/PIB) consistently achieved SVR12 rates close to 100% across different populations, including pediatric and adolescent groups, and was notably effective for HCV GT2 patients.
  • Effectiveness varied significantly by population, with Pomalidomide-based regimens showing better outcomes in earlier treatment lines (2L population having an ORR of 87.2% and a CR rate of 29.7%), while non-cirrhotic patients generally experienced higher SVR rates compared to cirrhotic patients.
  • Common Adverse Events (AEs) for Sofosbuvir-based regimens included fatigue (14%) and headache (13.1%), while serious adverse events (SAEs) were rare, with pooled rates below 1% for most regimens, although slightly higher in patients with cirrhosis or genotype 3 receiving Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX).
  • Discontinuation rates due to adverse events were low (<1%), indicating a generally favorable safety profile across the studied regimens, including in pediatric populations where younger children experienced slightly higher AE rates.
  • Diabetic patients receiving SOF/VEL/VOX exhibited rare instances of grade 3 hyperglycemia, particularly among those with cirrhosis or genotype 3, underscoring the need for careful monitoring in this subgroup.
  • Age Groups: Sofosbuvir-based regimens, including SOF/VEL, SOF/DCV, and GLE/PIB, demonstrated high effectiveness with SVR12 rates often close to 100% in adolescents and children, although younger children exhibited slightly higher rates of adverse events.
  • Genotypes: In HCV genotype 2 (GT2) patients, SOF/VEL and GLE/PIB achieved 100% SVR12 rates, while SOF/VEL/VOX was less effective in genotype 3 (GT3) compared to other genotypes; GLE/PIB showed higher effectiveness in GT3 patients.
  • Cirrhosis: Non-cirrhotic patients had higher SVR rates than cirrhotic patients, who experienced lower SVR rates and increased adverse events, including instances of hyperglycemia.
  • Renal Impairment and Prior Treatment Experience: SOF-based regimens were effective and safe in patients with stage 4-5 chronic kidney disease (CKD) with recommended monitoring, and SOF/VEL/VOX was effective in DAA-experienced patients, though slightly lower efficacy was noted in those with prior SOF/VEL failure or GT3.

Product Monograph / Prescribing Information

Document TitleYearSource
Sovaldi (sofosbuvir) Prescribing Information.2020Gilead 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
Treatment Outcomes of Sofosbuvir/Velpatasvir/Voxilaprevir in Direct-Acting Antiviral-Experienced Hepatitis C Virus Patients: A Systematic Review and Meta-Analysis2023Viruses
The impact of sofosbuvir/velpatasvir/voxilaprevir treatment on serum hyperglycemia in hepatitis C virus infections: a systematic review and meta-analysis2023Annals of Medicine
Safety and efficacy of sofosbuvir-velpatasvir: A meta-analysis2022Medicine
Effectiveness and Safety of Sofosbuvir/Velpatasvir/Voxilaprevir as a Hepatitis C Virus Infection Salvage Therapy in the Real World: A Systematic Review and Meta-analysis2022Infectious Diseases and Therapy
Safety and efficacy of sofosbuvir-based medication regimens with and without ribavirin in hepatitis C patients: A systematic review and meta-analysis2022Journal of Clinical Pharmacy and Therapeutics
Cost-Effectiveness of Elbasvir/Grazoprevir for the Treatment of Chronic Hepatitis C: A Systematic Review2022Frontiers in Public Health
Sofosbuvir-based regimens for HCV in stage 4-stage 5 chronic kidney disease. A systematic review with meta-analysis2021Nefrologia
Effect of sofosbuvir-based DAAs on changes in lower-density lipoprotein in HCV patients: a systematic review and meta-analysis2021BMC Infectious Diseases
Efficacy and safety of ledipasvir/sofosbuvir for hepatitis C among drug users: a systematic review and meta-analysis2021Virology Journal
An updated systematic review and meta-analysis on efficacy of Sofosbuvir in treating hepatitis C-infected patients with advanced chronic kidney disease2021Plos One
Real-World Effectiveness of Direct-Acting Antiviral Regimens against Hepatitis C Virus (HCV) Genotype 3 Infection: A Systematic Review and Meta-Analysis2021Annals of Hepatology
Efficacy and safety of sofosbuvir in the treatment of hep C among patients on hemodialysis: a systematic review and meta-analysis2020Scientific Reports
Drug-Drug Interactions between Direct Oral Anticoagulants and Hepatitis C Direct-Acting Antiviral Agents: Looking for Evidence Through a Systematic Review2020Clinical Drug Investigation
Cutaneous Adverse Events in Newly Approved FDA Non-cancer Drugs: A Systematic Review2020Drugs in R&D
Systematic review with meta-analysis: effectiveness of direct-acting antiviral treatment for hepatitis C in patients with hepatocellular carcinoma2020Alimentary Pharmacology & Therapeutics
Systematic Review with Meta-Analysis: Efficacy and Safety of Direct-Acting Antivirals for Chronic Hepatitis C Genotypes 5 and 62019Biomed Research International