Not Achieving Sustained Viral Eradication of Hepatitis C Virus After Treatment Leads to Worsening of Patient-Reported Outcomes.
BACKGROUND: The causative relationship between clearance of infection and long-term health-related quality of life (HRQL) improvements in patients with hepatitis C virus (HCV) has been generally accepted. The aim is to assess long-term HRQL trends in HCV patients who did not achieve sustained virologic response (SVR) after treatment with direct-acting antivirals. METHODS: HCV patients who completed treatment in clinical trials and did not achieve SVR were enrolled in a long-term registry (#NCT01457768). HRQL scores were prospectively collected using Short Form-36 instrument (SF-36; 8 HRQL domains and 2 summary scores). RESULTS: 242 patients were included: 54±8 years, 85% male, 38% cirrhosis. Before treatment, patients' HRQL scores were similar to the general population norms (all one-sided p>0.05) followed by significant decreases by the end of treatment (-3.4 to -6.2 points, p<0.05 for 5/8 HRQL domains and Mental Summary). By the time subjects entered the registry, all but one mean HRQL scores had returned to pre-treatment levels (p>0.05). During subsequent periods in the registry, patients experienced further HRQL decrements: up to -9.2 points, p<0.05 for all HRQL domains, at week 24; up to -8.3 points, p<0.05 for 5/8 HRQL domains, at week 48. Although these HRQL decrements were observed regardless of cirrhosis status, they were more pronounced in patients with cirrhosis (p<0.05 for 3/8 HRQL domains). CONCLUSIONS: Patients who did not achieve SVR after treatment experience worsening of HRQL scores in long-term follow-up. Re-treatment of these patients will be important not only to improve their clinical outcomes but also their quality of life.
Younossi, ZM; Stepanova, M; Jacobson, I; Muir, AJ; Pol, S; Zeuzem, S; Younes, Z; Herring, R; Lawitz, E; Younossi, I; Racila, A
Pubmed Central ID
Electronic International Standard Serial Number (EISSN)
Digital Object Identifier (DOI)