Virologic response following combined ledipasvir and sofosbuvir administration in patients with HCV genotype 1 and...

Area of Science:

• Hepatology and Virology
• Infectious Diseases
• Antiviral Therapy

Background:

• An unmet need exists for interferon- and ribavirin-free treatments for chronic hepatitis C virus (HCV) infection in patients co-infected with human immunodeficiency virus (HIV).
• Ledipasvir and sofosbuvir is a fixed-dose combination therapy for HCV.
• This study evaluates this combination in treatment-naïve HCV/HIV co-infected patients.

Purpose of the Study:

• To evaluate the rates of sustained virologic response (SVR) and adverse events.
• To assess a 12-week treatment of ledipasvir and sofosbuvir.
• In previously untreated patients with HCV genotype 1 and HIV co-infection.

Main Methods:

• Open-label, single-center, phase 2b pilot study.
• Fifty treatment-naïve patients with HCV genotype 1 and HIV co-infection received ledipasvir (90 mg) and sofosbuvir (400 mg) daily for 12 weeks.
• Primary outcome: SVR 12 weeks post-treatment.

Main Results:

• 98% (49/50) of patients achieved SVR 12 weeks after treatment.
• One patient relapsed, with NS5A resistance-associated mutation identified.
• Most common adverse events: nasal congestion (16%) and myalgia (14%); no serious adverse events or discontinuations due to study drug.

Conclusions:

• Ledipasvir and sofosbuvir for 12 weeks demonstrated high SVR rates in HCV genotype 1/HIV co-infected patients.
• Further studies are needed in patients with cirrhosis and lower CD4 counts.
• This regimen offers a promising interferon- and ribavirin-free option for this population.