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Only partial improvement in health‐related quality of life after treatment of chronic hepatitis C virus infection with direct acting antivirals in a real‐world setting—results from the German Hepatitis C‐Registry (DHC‐R)
Author(s) -
Ohlendorf Valerie,
Schäfer Arne,
Christensen Stefan,
Heyne Renate,
Naumann Uwe,
Link Ralph,
Herold Christoph,
Schiffelholz Willibold,
Günther Rainer,
Cornberg Markus,
Serfert Yvonne,
Maasoumy Benjamin,
Wedemeyer Heiner,
Kraus Michael R.
Publication year - 2021
Publication title -
journal of viral hepatitis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.329
H-Index - 100
eISSN - 1365-2893
pISSN - 1352-0504
DOI - 10.1111/jvh.13546
Subject(s) - medicine , minimal clinically important difference , quality of life (healthcare) , generalizability theory , hepatitis c , hepatitis c virus , clinical trial , population , randomized controlled trial , immunology , virus , statistics , nursing , mathematics , environmental health
Improvement of health‐related quality of life (HRQoL) is frequently reported as a benefit when treating hepatitis C virus infection (HCV) with direct acting antivirals (DAA). As most of the available data were obtained from clinical trials, limited generalizability to the real‐world population might exist. This study aimed to investigate the impact of DAA therapy on changes in HRQoL in a real‐world setting. HRQoL of 1180 participants of the German Hepatitis C‐Registry was assessed by Short‐Form 36 (SF‐36) questionnaires. Scores at post‐treatment weeks 12–24 (FU12/24) were compared to baseline (BL). Changes of ≥2.5 in mental and physical component summary scores (MCS and PCS) were defined as a minimal clinical important difference (MCID). Potential predictors of HRQoL changes were analysed. Overall, a statistically significant increase in HRQoL after DAA therapy was observed, that was robust among various subgroups. However, roughly half of all patients failed to achieve a clinically important improvement in MCS and PCS. Low MCS ( p < .001, OR = 0.925) and PCS ( p < .001, OR = 0.899) BL levels were identified as predictors for achieving a clinically important improvement. In contrast, presence of fatigue ( p = .023, OR = 1.518), increased GPT levels ( p = .005, OR = 0.626) and RBV containing therapy regimens ( p = .001, OR = 1.692) were associated with a clinically important decline in HRQoL after DAA therapy. In conclusion, DAA treatment is associated with an overall increase of HRQoL in HCV‐infected patients. Nevertheless, roughly half of the patients fail to achieve a clinically important improvement. Especially patients with a low HRQoL seem to benefit most from the modern therapeutic options.