Sofosbuvir plus daclatasvir with or without ribavirin for chronic hepatitis C infection: Impact of drug concentration on viral load decay

Abstract Background Sofosbuvir (SOF) plus daclatasvir (DCV) with or without ribavirin is one of the currently recommended treatment option for chronic hepatitis C. Aims Our objectives were to identify factors associated with SOF/DCV plasma concentrations [C] variations and to evaluate their impact o...

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Bibliographic Details
Published in:Digestive and liver disease 2016-11, Vol.48 (11), p.1351-1356
Main Authors: Virlogeux, Victor, Choupeaux, Laure, Pradat, Pierre, Maynard, Marianne, Bailly, François, Scholtès, Caroline, Gagnieu, Marie-Claude, Zoulim, Fabien
Format: Article
Language:English
Subjects:
Aged
Antiviral Agents - blood
Antiviral Agents - therapeutic use
Cancer
Cirrhosis
Direct acting antiviral agents
Drug Monitoring
Drug Therapy, Combination
Female
France
Gastroenterology and Hepatology
Glomerular Filtration Rate
HCV
Hepacivirus
Hepatitis C, Chronic - complications
Hepatitis C, Chronic - drug therapy
Humans
Imidazoles - blood
Imidazoles - therapeutic use
Life Sciences
Linear Models
Liver Cirrhosis - epidemiology
Male
Middle Aged
Multivariate Analysis
Pharmacological monitoring
Retrospective Studies
Ribavirin - therapeutic use
Sofosbuvir - blood
Sofosbuvir - therapeutic use
Treatment Outcome
Viral Load
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Summary:Abstract Background Sofosbuvir (SOF) plus daclatasvir (DCV) with or without ribavirin is one of the currently recommended treatment option for chronic hepatitis C. Aims Our objectives were to identify factors associated with SOF/DCV plasma concentrations [C] variations and to evaluate their impact on viral kinetics. Methods 130 consecutive HCV patients initiating SOF/DCV therapy with or without ribavirin were enrolled. Clinical, biological, virological and pharmacological data were collected at baseline, at week 4, 8, 12, and 24 of therapy and 12 weeks after the end of therapy. Results Mean age was 57 years, 68% of patients were males, 69% were infected by HCV genotype 1 and cirrhosis was observed in 76% of patients. Multivariate analysis showed that higher SOF [C] and DCV [C] during treatment were associated with eGFR impairment and absence of cirrhosis. We found a significant correlation between the magnitude of HCV viral load decrease from day 0 to week 4 and a higher SOF [C] at week 4 ( p = 0.032) and a higher DCV [C] at week 8 ( p = 0.013). Conclusions Pharmacological monitoring showed significant associations between elevated SOF or DCV [C] and absence of cirrhosis, decreased eGFR and viral load decrease during the first month of treatment.
ISSN:1590-8658
1878-3562
DOI:10.1016/j.dld.2016.07.014