Health-related quality of life on the clinical course of patients with chronic hepatitis C receiving daclatasvir/asunaprevir therapy: A prospective observational study comparing younger (<70) and elderly (≥70) patients

Abstract

Abstract. Interferon-free direct acting antiviral agent regimens for chronic hepatitis C (CHC) have been developed. These regimens have shown a high rate of sustained virologic response (SVR), and a reduction in side effects during treatment is also anticipated. However, the impact of the regimens on health-related quality of life (HRQOL) and side effects during treatment is not fully understood. The purpose of the present study was to evaluate HRQOL in the clinical course of patients with CHC receiving daclatasvir/asunaprevir (DCV/ASV) therapy using the Short Form-36 (SF-36) method. Twenty-eight patients with CHC receiving DCV/ASV therapy were analyzed in the present study, and HRQOL was measured by SF-36. Patients were asked to fill out the SF-36 prior to therapy (baseline), following 12 weeks of therapy, at the end of treatment and at SVR week 24 (SVR24) to evaluate HRQOL. Laboratory data were also investigated during the same period, and associations between these results and SF-36 were investigated. Aspartate aminotransferase, alanine aminotransferase, serum albumin, α-fetoprotein, platelet counts and Fibrosis (Fib)-4 index were all significantly improved at each time point when compared with baseline. With regard to alterations in HRQOL during therapy, the ≥70-year-old group displayed a significantly greater improvement in physical functioning during the period between baseline and 12 weeks when compared with the <70-year-old group. In the analysis of the SF-36 differences within each group, general health improved significantly in the ≥70-year-old group, as well as albumin levels. In addition, Fib-4-index significantly improved at all time points (12 and 24 weeks, and SVR24) when compared with baseline in the ≥70-year-old group. Therefore, DCV/ASV therapy may improve HRQOL and hepatic functional reserve, particularly in elderly patients. IntroductionHepatitis C virus (HCV) was discovered by Choo et al in the United States in 1989 (1). It revealed that over 90% of cases diagnosed previously as non-A non-B hepatitis is caused by HCV. There are an estimated 170 million HCV-infected patients worldwide (2-4). It is estimated that 15-30% of such patients will develop serious complications, including liver cirrhosis, end-stage liver disease and hepatocellular carcinoma (5). HCV-infected patients have mortality rate of 5.0 deaths/100,000 population in 2013 (6).Recently, direct acting antiviral agents (DAAs) were developed and advanced interferon (IFN)-free treatment. As a result, a high rate of sustained virologic response (SVR) has shown, and a reduction of side effects during treatment is also anticipated. DAAs selectively inhibit HCV proteins such as nonstructural protein NS 3/4A protease, NS5A, NS5B polymerase (7,8). New DAA combination therapies such as sofosbuvir plus ledipasvir and ombitasvir/paritaprevir/ritonavir have also recently been approved in Japan (9-11). Previous studies have shown that HCV-infected patients treated with IFN-containing DAAs experience a significant health-related quality of life ...

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