Health-related quality of Life in patients with chronic hepatitis C receiving Sofosbuvir-based treatment, with and without Interferon: a prospective observational study in Egypt

Abstract

BackgroundThe Egyptian government introduced the first directly acting antivirals (DAAs) into Egypt through the government funded National Treatment Program. As yet, there has been no investigation into the effects of these new DAAs therapies on patient reported outcomes (PROs). This study aimed to (1) assess the PROs (health-related quality of life (HRQoL), mental health and perceived social support) of HCV patients receiving DAAs therapy prior, during and at the end of therapy; (2) evaluate PROs of Interferon-free (dual) users versus Interferon-containing (triple) users cross the three different time periods; and (3) identify the predictors of HRQoL of DAAs therapy users cross the three different time periods.MethodsA prospective observational design was used. Patients with chronic HCV undergoing treatment following the Egyptian National Guidelines at one of the national treatment centers were approached. Data collection occurred in the period from February to October 2015. Data was collected at three time points: (1) baseline (time 0: T0), before initiating therapy); (2) 5/6 weeks after initiation of therapy (time 1 of therapy: T1) and at the end of the therapy (Time 2: T2). Four PROs questionnaires were utilized for data collection: (1) Multidimensional Scale of Perceived Social Support (MSPSS), (2) The Depression Anxiety Stress Scales (DASS-21), (3) the Liver Disease Symptom Index-2.0 (LDSI-2.0) for testing disease specific HRQoL and (4) the Center for Adherence Support Evaluation (CASE) Index, alongside the background data sheet.ResultsSixty-two patients participated. There was a change in HRQoL, symptom experience and mental health across the three different time periods. HRQoL was impaired more after starting the course of therapy (T1) than at baseline (T0) and end of therapy (T2), z ≥ -2.04, p ≤ .04. Also, symptom experience deteriorated more during the treatment period than at the baseline, Z ≥ -1.97, p ≤ .04. Anxiety and stress were significantly higher during the treatment period than at the end of treatment. Perceived social support was significantly higher during the treatment period than at baseline and end of therapy, Z ≥ -2.27, p ≤ .023. During the course of therapy, triple users were more likely to report poorer HRQoL and anxiety than dual users (p ≤ .04). By the end of therapy, the two arms of therapy had no significant differences in any of the PROs.At baseline, the predictor model significantly (p = .000) explained 37.5% of the variation in the HRQoL prior to therapy. Depression was the main variable that contributed to (41.3%) predicting change in HRQoL prior to therapy. During therapy, the model significantly (p = .000) explained 76% of the variation in the HRQoL-T1. Stress-T1, body mass index (BMI)-T1 and HRQoL-T0 significantly and respectively predicted 44.4, 46.5 and 31.1% of the variation in HRQoL-T1. At the end of therapy, the model significantly (p = .000) predicted 80.5% of the variation in the HRQoL-T2. HRQoL-T1 and anxiety-T2 significantly predicted 72.3 and 61.6% of the variation ...

Impact of successful treatment with direct-acting antiviral agents on health-related quality of life in chronic hepatitis C patients

“…Two possible shortcomings of our study need to be considered. First, the population size, although similar or greater than that of other observational studies [ 35 , 14 , 57 ] was not large enough to obtain conclusive results in some subanalyses. In any case, the patients included accounted for 78% of the patients who received treatment successfully during the study period.…”

“…Middle age, baseline anxiety-depression, advanced fibrosis and cirrhosis were found to be the most consistent predictors of HRQoL improvements after SVR. Precisely, those factors have been previously associated with impairment in HRQoL among chronic hepatitis C patients [ 4 , 29 , 48 ] and appear to be key determinants for HRQoL deterioration prior to therapy [ 14 ]. The high prevalence of depression and anxiety in HCV patients before treatment initiation [ 49 ] would reinforce the need for psychosocial screening, even more when considering that a greater HRQoL improvement may occurs in those patients after SVR.…”

“…Antiviral therapies can eradicate the HCV resulting in improvements in liver histology, morbidity, mortality and enhancing HRQoL because of symptoms´ alleviation [ 14 ]. A combination of pegylated interferon (peg-IFN) and ribavirin (RBV) has long been the standard treatment for chronic hepatitis C, with limited efficacy and significant adverse effects [ 15 ].…”

Lived Experience with Cirrhosis of Liver Patient at a University Hospital: A Qualitative Study

“…The actual causes of cirrhosis of liver can't be identified yet [14]. However, most of the studies reported that chronic hepatitis B and hepatitis C infection are the causes of more than half of all cases of liver cirrhosis [1] [2] [4] [15]- [20].…”

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

“…Thereby reducing HRQOL during treatment (12,13). On the other hand, IFN-free DAAs have been reported to have little impact on HRQOL and side effects during treatment (14)(15)(16)(17) The purpose of this study was to evaluate HRQOL on the clinical course of patients with chronic hepatitis C (CHC) receiving DCV/ASV therapy using the Short Form-36 (SF-36) and comparison between younger (<70) and elderly (≥70) patients.…”