What is the recommended treatment duration for a patient with Hepatitis C (HCV) using velpatasvir (NS5A inhibitor) and sofosbuvir (NS5B polymerase inhibitor)?

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Treatment Duration for Hepatitis C with Sofosbuvir/Velpatasvir

The standard treatment duration for sofosbuvir/velpatasvir is 12 weeks for most patients with chronic hepatitis C, regardless of genotype, treatment history, or presence of compensated cirrhosis. 1, 2, 3

Treatment Duration by Patient Population

Treatment-Naïve and Treatment-Experienced Patients WITHOUT Cirrhosis

  • 12 weeks of sofosbuvir/velpatasvir is the recommended duration for all HCV genotypes (1-6) 1, 2, 3
  • This applies equally to treatment-naïve and treatment-experienced patients 1, 3
  • The FDA label explicitly states this as the standard regimen 3

Treatment-Naïve and Treatment-Experienced Patients WITH Compensated Cirrhosis (Child-Pugh A)

  • 12 weeks of sofosbuvir/velpatasvir remains the standard duration 1, 2, 3
  • For genotype 3 with compensated cirrhosis, consider adding ribavirin for 12 weeks OR extending to 24 weeks without ribavirin, particularly in treatment-experienced patients 1
  • The ASTRAL-3 trial showed SVR12 rates of 93% in treatment-naïve and 89% in treatment-experienced genotype 3 patients with cirrhosis using 12 weeks of sofosbuvir/velpatasvir 1

Patients WITH Decompensated Cirrhosis (Child-Pugh B or C)

  • 12 weeks of sofosbuvir/velpatasvir PLUS weight-based ribavirin (1,000 mg if <75 kg or 1,200 mg if ≥75 kg) 1, 3
  • The ASTRAL-4 study demonstrated SVR12 rates of 94% with this 12-week combination in decompensated cirrhosis 1, 4
  • Protease inhibitors are contraindicated in decompensated cirrhosis 1

Genotype-Specific Considerations

Genotype 1a

  • 12 weeks of sofosbuvir/velpatasvir achieves 100% SVR in previously treated patients and 99% in treatment-naïve patients 1
  • The 8-week regimen with sofosbuvir/velpatasvir/voxilaprevir showed inferior results (92% SVR) compared to 12 weeks of sofosbuvir/velpatasvir (99% SVR) and is NOT recommended 1, 5

Genotype 2

  • 12 weeks of sofosbuvir/velpatasvir achieves 99% SVR 6
  • This is superior to the older regimen of sofosbuvir plus ribavirin 6

Genotype 3

  • Without cirrhosis: 12 weeks of sofosbuvir/velpatasvir achieves 95-98% SVR 1, 6
  • With compensated cirrhosis: 12 weeks of sofosbuvir/velpatasvir plus ribavirin OR 12 weeks of sofosbuvir/velpatasvir/voxilaprevir 1
  • Patients with NS5A Y93H resistance-associated substitution should receive ribavirin addition 1

Genotypes 4,5, and 6

  • 12 weeks of sofosbuvir/velpatasvir for all patients with or without cirrhosis 1, 3
  • SVR rates of 97-100% have been demonstrated 1

Special Populations

HIV/HCV Coinfection

  • Same duration as HCV monoinfection: 12 weeks of sofosbuvir/velpatasvir 2, 3
  • No adjustment needed for HIV coinfection 2

Liver Transplant Recipients

  • 12 weeks of sofosbuvir/velpatasvir for treatment-naïve and treatment-experienced recipients without cirrhosis or with compensated cirrhosis 3

Renal Impairment (Including End-Stage Renal Disease on Dialysis)

  • 12 weeks of sofosbuvir/velpatasvir using standard dosing 3
  • No dose adjustment required 3

Critical Warnings About Shorter Duration

Do not use 8-week regimens with sofosbuvir/velpatasvir alone - the POLARIS-2 trial definitively showed that 8 weeks of sofosbuvir/velpatasvir/voxilaprevir failed to meet noninferiority compared to 12 weeks of sofosbuvir/velpatasvir, with particularly poor results in genotype 1a (92% vs 99% SVR) 1, 5. The virologic relapse rates were 8% in non-cirrhotic and 10% in cirrhotic patients with the 8-week regimen 1.

Monitoring Requirements

  • HCV RNA at 12 weeks post-treatment to confirm SVR12 (sustained virologic response = cure) 2, 7
  • Baseline HCV genotype and viral load determination 2
  • Assessment for cirrhosis using FIB-4 score, transient elastography, or other non-invasive methods 2
  • Test for hepatitis B (HBsAg and anti-HBc) before starting treatment due to risk of HBV reactivation 3

Common Pitfalls to Avoid

  • Never shorten treatment to less than 12 weeks with sofosbuvir/velpatasvir alone, regardless of viral load or cirrhosis status 1, 3, 5
  • Do not use sofosbuvir/velpatasvir without ribavirin in decompensated cirrhosis - this significantly reduces SVR rates 1, 3, 4
  • Avoid coadministration with amiodarone due to risk of serious symptomatic bradycardia 3
  • For genotype 3 with cirrhosis, the standard 12-week sofosbuvir/velpatasvir regimen without ribavirin may have suboptimal efficacy (89% SVR in treatment-experienced patients); strongly consider adding ribavirin 1

References

1
Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

2
Guideline

Management of Chronic Hepatitis C

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

6
Research

Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.

The New England journal of medicine, 2015

7
Guideline

First-Line Treatment for Chronic Viral Hepatitis C

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

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Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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