Sofosbuvir and Velpatasvir for HCV in Patients with Decompensated Cirrhosis

Area of Science:

• Hepatology
• Virology
• Clinical Pharmacology

Background:

• Aging hepatitis C virus (HCV) infected population leads to increased decompensated cirrhosis cases.
• Decompensated cirrhosis poses significant challenges in HCV treatment efficacy and patient management.

Purpose of the Study:

• To evaluate the efficacy and safety of sofosbuvir-velpatasvir regimens in patients with HCV and decompensated cirrhosis.
• To determine optimal treatment duration and the role of ribavirin in this patient population.

Main Methods:

• Phase 3, open-label study of 267 patients with HCV genotypes 1-6 and Child-Pugh-Turcotte class B cirrhosis.
• Randomized assignment to 12 weeks of sofosbuvir-velpatasvir, 12 weeks of sofosbuvir-velpatasvir plus ribavirin, or 24 weeks of sofosbuvir-velpatasvir.
• Primary endpoint: sustained virologic response (SVR) at 12 weeks post-therapy.

Main Results:

• High SVR rates observed across all treatment arms: 83% (12-week SOF-VEL), 94% (12-week SOF-VEL+RBV), and 86% (24-week SOF-VEL).
• No significant differences in SVR rates among the three groups.
• Adverse events were generally mild; anemia was more frequent with ribavirin.

Conclusions:

• Sofosbuvir-velpatasvir-based regimens are highly effective for HCV patients with decompensated cirrhosis.
• Both 12-week and 24-week treatment durations demonstrated high SVR rates.
• Treatment with or without ribavirin for 12 weeks is a viable option for this challenging patient group.