Although HCV infection is highly prevalent in East Asia, these patients have been underrepresented in HRQL studies. Here, we assess HRQL in East Asian HCV patients treated with different anti-HCV regimens. Patients completed Short Form-36 (SF-36) before, during and after treatment. A total of 989 HCV patients were enrolled in two phase 3 clinical trials [China: 60.2%, South Korea: 22.4%, Taiwan: 17.4%; genotype 1: 55.3%, treatment-naïve: 57.5%; cirrhosis: 14.0%]. Patients received pegylated interferon, sofosbuvir and ribavirin (Peg-IFN + SOF + RBV; n = 130, genotypes 1, 6) or SOF + RBV (n = 475, all genotypes) or SOF and ledipasvir (LDV/SOF; n = 384, genotype 1). The SVR-12 rates were 94.6%, 96.2% and 99.2%, respectively (P = 0.005). During treatment, Peg-IFN + SOF + RBV-treated group experienced significant declines in most HRQL scores (by the end of treatment, mean decline up to −12.0 points, all P < 0.05). Patients on SOF + RBV had milder HRQL impairment (up to −5.8 points, P < 0.05 for 5 of 8 HRQL domains). In contrast, patients receiving IFN- and RBV-free regimen with LDV/SOF had their HRQL scores improve (mean up to +4.3 points, P < 0.0001 for 3 of 8 scales). In multivariate analysis, receiving Peg-IFN + SOF + RBV was consistently independently associated with HRQL impairment during treatment (β: −10.3 to −16.4) and after achieving SVR-12 (β: −4.4 to −9.1) (all P < 0.01). The results were reproduced in a subgroup of patients enrolled in China. We conclude that in East Asian patients with HCV, HRQL improved from baseline after treatment with LDV/SOF but not with Peg-IFN + RBV-containing or Peg-IFN-free RBV-containing regimens. The HRQL impairment associated with the use of Peg-IFN persists even after achieving sustained virologic clearance.
Bibliographical noteFunding Information:
This study was funded by Gilead Sciences.
All Science Journal Classification (ASJC) codes
- Infectious Diseases