Sofosbuvir and ledipasvir are associated with high sustained virologic response and improvement of health-related quality of life in East Asian patients with hepatitis C virus infection.
J Viral Hepat
; 25(12): 1429-1437, 2018 12.
Article
em En
| MEDLINE
| ID: mdl-29974665
ABSTRACT
Although HCV infection is highly prevalent in East Asia, these patients have been underrepresented in HRQL studies. Here, we assess HRQL in East Asian HCV patients treated with different anti-HCV regimens. Patients completed Short Form-36 (SF-36) before, during and after treatment. A total of 989 HCV patients were enrolled in two phase 3 clinical trials [China 60.2%, South Korea 22.4%, Taiwan 17.4%; genotype 1 55.3%, treatment-naïve 57.5%; cirrhosis 14.0%]. Patients received pegylated interferon, sofosbuvir and ribavirin (Peg-IFN + SOF + RBV; n = 130, genotypes 1, 6) or SOF + RBV (n = 475, all genotypes) or SOF and ledipasvir (LDV/SOF; n = 384, genotype 1). The SVR-12 rates were 94.6%, 96.2% and 99.2%, respectively (P = 0.005). During treatment, Peg-IFN + SOF + RBV-treated group experienced significant declines in most HRQL scores (by the end of treatment, mean decline up to -12.0 points, all P < 0.05). Patients on SOF + RBV had milder HRQL impairment (up to -5.8 points, P < 0.05 for 5 of 8 HRQL domains). In contrast, patients receiving IFN- and RBV-free regimen with LDV/SOF had their HRQL scores improve (mean up to +4.3 points, P < 0.0001 for 3 of 8 scales). In multivariate analysis, receiving Peg-IFN + SOF + RBV was consistently independently associated with HRQL impairment during treatment (ß -10.3 to -16.4) and after achieving SVR-12 (ß -4.4 to -9.1) (all P < 0.01). The results were reproduced in a subgroup of patients enrolled in China. We conclude that in East Asian patients with HCV, HRQL improved from baseline after treatment with LDV/SOF but not with Peg-IFN + RBV-containing or Peg-IFN-free RBV-containing regimens. The HRQL impairment associated with the use of Peg-IFN persists even after achieving sustained virologic clearance.
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Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Antivirais
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Qualidade de Vida
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Benzimidazóis
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Hepatite C Crônica
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Fluorenos
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Sofosbuvir
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Resposta Viral Sustentada
Tipo de estudo:
Clinical_trials
/
Risk_factors_studies
Limite:
Adult
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Aged
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Female
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Humans
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Male
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Middle aged
País/Região como assunto:
Asia
Idioma:
En
Ano de publicação:
2018
Tipo de documento:
Article