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Ledipasvir-Sofosbuvir Plus Ribavirin in Treatment-Naive Patients With Hepatitis C Virus Genotype 3 Infection: An
Jordan J Feld1, Alnoor Ramji2, Stephen D Shafran3
1Toronto Centre for Liver Disease, University of Toronto, Ontario.
Summary
Treatment with ledipasvir-sofosbuvir and ribavirin achieved a high sustained virologic response (SVR12) in treatment-naive patients with genotype 3 hepatitis C virus (HCV). This regimen demonstrated good tolerability and efficacy, particularly in patients without cirrhosis.
Area of Science:
- Hepatology
- Virology
- Clinical Trials
Background:
- Genotype 3 hepatitis C virus (HCV) infection is associated with more rapid disease progression.
- Genotype 3 HCV is less responsive to current direct-acting antiviral therapies.
- Ledipasvir and sofosbuvir are direct-acting antivirals used in HCV treatment.
Purpose of the Study:
- To evaluate the safety, tolerability, and efficacy of ledipasvir and sofosbuvir plus ribavirin.
- To assess treatment outcomes in patients with genotype 3 HCV infection.
- To determine sustained virologic response rates at 12 weeks post-treatment (SVR12).
Main Methods:
- An open-label, multicenter trial (NCT02413593) enrolled treatment-naive patients with genotype 3 HCV.
- All patients received 12 weeks of ledipasvir-sofosbuvir (90 mg/400 mg) plus weight-based ribavirin.
- Sustained virologic response 12 weeks after treatment (SVR12) was the primary endpoint.
Main Results:
- 99 of 111 (89%) patients achieved SVR12.
- Patients without cirrhosis had a higher SVR12 rate (94%) compared to those with compensated cirrhosis (79%).
- Common adverse events included fatigue (51%), headache (36%), and nausea (23%). No treatment-emergent resistance mutations were observed.
Conclusions:
- 12 weeks of ledipasvir-sofosbuvir plus ribavirin is effective in treatment-naive patients with genotype 3 HCV.
- The regimen demonstrated a high SVR rate, especially in patients without cirrhosis.
- The treatment was generally safe and well-tolerated.
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