Sofosbuvir-ledipasvir with or without ribavirin for chronic hepatitis C genotypes 1 and 6: real-world experience in Vietnam

2017 Antiviral Therapy In Press;

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 during September 2015 and May 2017. RESULTS: Among 539 patients evaluated for therapy, 531 patients completed treatment with either (I) SOF-LDV for 12 weeks (n=284); (II) SOF-LDV + RBV for 12 weeks (n=109); (III) SOF-LDV for 24 weeks (n=36); or (IV) SOF-LDV + RBV for 24 weeks (n=102). Forty-five percent 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 2 patients with genotype 1 in the treatment groups (I) and (IV). 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.

Pubmed : 29303482