Daclatasvir and asunaprevir improves health-related quality of life in Japanese patients infected with hepatitis C virus

Abstract

Aims: Interferon-free direct-acting antiviral agent (DAA) regimens for chronic hepatitis C virus (HCV) patients have improved their health-related quality of life (HRQOL). Currently, there are no published data assessing the impact of DAAs regimens without sofosbuvir on HRQOL. The aim of this study was to investigate the improvement of HRQOL in Japanese HCV patients treated with a protease inhibitor and a nonstructural protein 5A inhibitor.

Methods and results: A total of 123 Japanese genotype 1b HCV patients receiving daclatasvir (DCV) and asunaprevir (ASV) for 24 weeks were enrolled. HRQOL was assessed using the Japanese version of the Chronic Liver Disease Questionnaire (CLDQ) at baseline; weeks 4, 12, and 24; and post-24 weeks. Changes in CLDQ scores were calculated by subtracting the CLDQ score at each time point from the baseline value. Improvement in the mean change of the Japanese version of the CLDQ score became statistically significant as early as week 4 after the initiation of treatment (+9.3%; P < 0.0001) and was sustained during and after DCV/ASV treatment. The changes of CLDQ at posttreatment week 24 in patients with sustained virological responses (SVR) were significantly higher than those in patients without SVR (0.4% and -4.1%, respectively; P < 0.05).

Conclusions: This study of DCV/ASV treatment for Japanese HCV patients in a clinical setting demonstrated that HRQOL can improve as early as at the initiation of treatment and can continue during and after treatment, regardless of the classes of DAAs regimens and race. Moreover, SVR are needed to continue HRQOL improvement.

Keywords: asunaprevir; chronic liver disease questionnaire; daclatasvir; health‐related quality of life; hepatitis C virus.

Figure 1

Early changes of the Japanese version of the CLDQ for HCV patients receiving antiviral treatment with DCV/ASV. We calculated the mean changes in the CLDQ transformed to a 0–100% scale from each patient's baseline value to treatment week 4. Comparing the CLDQ score at the onset of treatment and at week 4, overall CLDQ scores and all individual domains show significant improvement after the initiation of treatment. Asterisks show significant differences from the baseline (P < 0.05 by paired t‐test). AS, abdominal symptoms; FA, fatigue; SS, systemic symptoms; AC, activity; EF, emotional function; WO, worry.

Figure 2

Course of the Japanese version of the CLDQ during 24 weeks of treatment with DCV/ASV. We calculated the mean changes in the CLDQ transformed to a 0–100% scale from each patient's baseline to treatment weeks 4, 12, and 24 (end of treatment). Improvements of overall CLDQ scores and all individual domains were sustained through treatment with DCV/ASV for 24 weeks. AS, abdominal symptoms; FA, fatigue; SS, systemic symptoms; AC, activity; EF, emotional function; WO, worry.

Figure 3

Influence of the virological response on the changes in the Japanese version of the CLDQ following treatment. We calculated the mean changes in the CLDQ transformed to a 0–100% scare from each patient's baseline to the end of treatment (treatment week 24) and posttreatment week 24. Comparing the CLDQ scores at the end of treatment with those at posttreatment week 24, there is no significant difference in the overall CLDQ score or the individual domains. However, there was a tendency for decreases of CLDQ scores in the FA, SS, AC, and EF domains (a). We calculated the mean changes in the CLDQ transformed 0–100% scale from each patient's end‐of‐treatment score to posttreatment week 24. Comparing the virological responses, the changes of the CLDQ scores from treatment week 24 to posttreatment week 24 differed significantly between SVR and non‐SVR patients (b). The mean ALT level at posttreatment week 24 and the change in MCP‐1/CCL2 levels from each patient's baseline value to posttreatment week 24 did not differ significantly between SVR and non‐SVR patients (c, d). AS, abdominal symptoms; FA, fatigue; SS, systemic symptoms; AC, activity; EF, emotional function; WO, worry; MCP‐1/CCL2, monocyte chemotactic protein 1/chemokine (C‐C motif) ligand 2.