Background/aims: Ledipasvir/sofosbuvir (LDV/SOF) combination is administered for 12 to 24 weeks to treat hepatitis C virus (HCV); guidelines recommend 8 weeks treatment duration for HCV genotype (GT) 1 infection based on the patient's baseline characteristics. Data on treating HCV GT4 with LDV/SOF are limited. In this prospective cohort study, the efficacy and safety of 8 weeks treatment duration with LDV/SOF was evaluated in HCV GT4 patients in Saudi Arabia.
Patients and methods: Treatment-naïve, non-cirrhotic HCV GT4 patients received LDV/SOF for 8 weeks. HCV RNA levels and laboratory evaluations were recorded at baseline and at Weeks 4, 8, and 20. The primary endpoint was sustained virologic response 12 weeks after the end of the treatment (SVR12). Safety data were also recorded.
Results: Forty-five patients with a mean age of 43.9 ± 17.2 years participated, of whom 57.8% were male. Mean log10HCV RNA was 6.26 ± 6.32 IU/mL and most (91.1%) had baseline HCV RNA levels <6 million IU/mL. The most frequent comorbidities were hypertension and diabetes mellitus (20.0% each). Concomitant medication was taken by 18 patients (40.0%), of whom two took proton pump inhibitors. Overall, SVR12 was 97.8% (95% confidence interval [CI]: 88.2%-99.9%); one patient (2.2%) relapsed post treatment. No serious adverse events or discontinuations were reported. Eighteen patients (44.4%) had 38 adverse events related to LDV/SOF; the most frequent was headache.
Conclusions: An 8-week regimen of LDV/SOF was well tolerated and efficacious in this treatment-naïve, non-cirrhotic HCV GT4-infected population. This study provides valuable information on a short treatment regimen for HCV GT4 infection in a real-world setting.
Keywords: Duration; genotype 4; hepatitis C; ledipasvir; sofosbuvir.