Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis

Area of Science:

• Hepatology
• Virology
• Infectious Diseases

Background:

• Hepatitis C virus (HCV) infection is a significant global health concern.
• High rates of sustained virologic response (SVR) have been achieved with 12-week regimens of sofosbuvir and ledipasvir.
• This study investigated the efficacy of an 8-week treatment duration.

Purpose of the Study:

• To evaluate the noninferiority of an 8-week ledipasvir-sofosbuvir regimen compared to a 12-week regimen for HCV genotype 1.
• To assess the impact of adding ribavirin to the 8-week regimen.

Main Methods:

• Phase 3, open-label, randomized study involving 647 treatment-naive patients with HCV genotype 1 and no cirrhosis.
• Patients received either 8 weeks of ledipasvir-sofosbuvir, 8 weeks of ledipasvir-sofosbuvir plus ribavirin, or 12 weeks of ledipasvir-sofosbuvir.
• Primary endpoint: SVR at 12 weeks post-therapy.

Main Results:

• SVR rates were 94% for 8 weeks of ledipasvir-sofosbuvir, 93% for 8 weeks with ribavirin, and 95% for 12 weeks.
• The 8-week ledipasvir-sofosbuvir regimen demonstrated noninferiority to the 12-week regimen.
• Adverse events were more frequent with ribavirin; no patients on 8-week ledipasvir-sofosbuvir alone discontinued due to adverse events.

Conclusions:

• Eight weeks of ledipasvir-sofosbuvir is effective for previously untreated patients with HCV genotype 1 without cirrhosis.
• Adding ribavirin or extending treatment to 12 weeks did not provide additional benefit.
• The 8-week regimen offers a potentially shorter and well-tolerated treatment option.