Abstract
Background
Therapy with sofosbuvir–ledipasvir (SOF–LDV) has been very effective in chronic HCV genotype-1 in clinical trials and several real-world cohorts. However, the safety and efficacy data of SOF–LDV for HCV genotype-6 is quite limited.
Methods
This open-label, clinical experience evaluated the safety and efficacy of SOF–LDV with or without ribavirin (RBV) for 12–24 weeks in patients with HCV genotype-1 (n=356) and genotype-6 (n=175) in Vietnam between September 2015 and May 2017.
Results
Among 539 patients evaluated for therapy, 531 patients completed treatment with either SOF–LDV for 12 weeks (n=284); SOF–LDV + RBV for 12 weeks (n=109); SOF–LDV for 24 weeks (n=36); or SOF–LDV + RBV for 24 weeks (n=102). 45% were male with a mean age of 56.3 (range 20–87) years. The mean HCV RNA was 4,370,000 IU/ml and 72.7% had high viral load of >800,000 IU/ml. 17.3% failed prior interferon-based therapy and 52.5% had advanced fibrosis (F3–4) as noted by transient elastography. The overall sustained virological response (SVR12) rate was 99.6% (529/531). Virological relapses occurred in two patients with genotype-1 in the SOF–LDV for 12 weeks and SOF–LDV + RBV for 24 weeks treatment groups. There was no significant difference in demographic data and treatment outcomes between patients with genotype-1 versus 6. Adverse events were mild with all SOF–LDV regimens, but appeared to be more common with 24-week treatment groups.
Conclusions
SOF–LDV with or without RBV was highly effective and safe in Vietnamese patients with HCV genotype-1 and 6.