Treatment of chronic hepatitis C virus (HCV) infection with ledipasvir/sofosbuvir (LDV/SOF) for 8 weeks may be equally as effective at achieving remission as longer-term (12-week) treatment, according to research recently published in the Journal of Hepatology.
Researchers compared several cohorts of patients registered in the German National Hepatitis C Registry who had previously received either 8 or 12 weeks of oral LDV/SOF: Intention-to-Treat Group 1 (ITT1, the safety population), who had received either 8 weeks (n=968) or 12 weeks (n=1,415) of oral LDV/SOF; Intention-to-Treat Group 2 (ITT2, the effectiveness population) either 8 weeks (n=877) or 12 weeks (n=1,275) of oral LDV/SOF and also completed follow-up; and the per protocol analysis group (PP, total N=2066; n=835 for 8-week treatment, n=1231 for 12-week treatment).
More than 84% (2,034/2,404) of the safety population (ITT1) and 98% (2,029/2,066) of the per protocol (PP) population achieved sustained HCV virological response at week 12.
The researchers identified high cure rates for noncirrhotic patients receiving 8-week treatment with oral LCV/SOF alone (98.3%) and their 12-week counterparts (98.1%) in the PP analysis group. For cirrhotic patients, the rates were lower, with 90.5% achieving remission but relapse occurred more frequently (9.5% vs 1.2%) compared with noncirrhotic patients.
The research team found that following the inclusion criteria laid out in the European Summary of Product Characteristics for 8-week oral LDV/SOF achieved the best results; these criteria included patients who were treatment naive and noncirrhotic, with HCV genotype 1.
These findings indicate that 8-week treatment for patients matching these criteria is effective and can both decrease costs and potentially increase adherence compared with 12-week treatment.
Buggisch P, Vermehren J, Mauss S, et al. Real-world effectiveness of 8-week treatment with ledipasvir/sofosbuvir in chronic hepatitis C [published online November 11, 2017]. J Hepatol. doi:10.1016/j.jhep.2017.11.009