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Safety and efficacy of daclatasvir in the management of patients with chronic hepatitis C.

ABSTRACT: Daclatasvir (Daklinza™), a new oral direct-acting antiviral, is an inhibitor of hepatitis C virus NS5A protein and has recently been approved in the United States, Europe and Japan in chronic hepatitis C. It shows potent pangenotypic activity and moderately high genetic barrier to resistance improving the sustained virological response (SVR) rates. In COMMAND phase 2 trials, daclatasvir demonstrated high SVR rates in HCV genotype 1-4 chronically infected patients treated with peginterferon-a (pegIFN?) plus ribavirin (RBV). Furthermore, it produced even higher response rates in all-oral combination with sofosbuvir, an interferon-free regimen, with or without ribavirin, in patients with advanced liver disease, HCV/HIV coinfection, liver transplantation in ALLY studies and other real-world studies. This narrative review provides information on the pharmacological properties, role, efficacy and safety of daclatasvir-containing regimens in chronic hepatitis C patients. Daclatasvir administered once-daily in combination with sofosbuvir is an effective 12-week treatment in adult patients with chronic hepatitis C and is generally safe and well tolerated.

SUBMITTER: Manolakopoulos S

PROVIDER: S-EPMC4923813 | biostudies-literature | 2016 Jul-Sep

REPOSITORIES: biostudies-literature

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Safety and efficacy of daclatasvir in the management of patients with chronic hepatitis C.

Manolakopoulos Spilios S Zacharakis George G Zissis Miltiadis M Giannakopoulos Vassilis V

Annals of gastroenterology 20160511 3

Daclatasvir (Daklinza™), a new oral direct-acting antiviral, is an inhibitor of hepatitis C virus NS5A protein and has recently been approved in the United States, Europe and Japan in chronic hepatitis C. It shows potent pangenotypic activity and moderately high genetic barrier to resistance improving the sustained virological response (SVR) rates. In COMMAND phase 2 trials, daclatasvir demonstrated high SVR rates in HCV genotype 1-4 chronically infected patients treated with peginterferon-a (pe ...[more]

PMID: 27366028

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Project description:Background:Chronic hepatitis, mainly B or C, increases the risk of hepatocellular carcinoma and remains an emerging issue in the globe. China has high rates of liver cancer incidence and mortality in the world. To address such challenges, adequate management of chronic hepatitis is required. Self-management education is one alternative for improving the hepatitis patients' knowledge of the disease, mental health, and clinical management.This study aimed to examine the quality of life (QOL), psychological effects, and behavioral changes of a self-management program which allows continuity of care for chronic hepatitis B and C patients. Method:In a six-month, randomized controlled trial, we invited 73 chronic hepatitis B/C inpatients to receive (i) two face-to-face education sessions provided by a nurse during hospitalization, and monthly telephone counseling at home after discharge; (ii) or usual care treatment (control group). The primary endpoint (patients' QOL) and secondary outcomes (including self-efficacy, depression symptoms, perceived cognition of illness and behavioral changes) were assessed. In addition, we conducted qualitative data analysis to facilitate the evaluation of the interventions. Results:Sixty (82.2%) out of 73 eligible patients with chronic hepatitis B/C (aged 34.9?±?8.9?years) participated in the study. The intervention group (n?=?30) significantly improved on outcomes including QOL, self-efficacy, perceived cognition of illness, and behavioral changes, whereas the control group significantly decreased their healthy behaviors. In terms of behavioral changes, alcohol avoidance, dietary adherence, and stress management also improved in the intervention group. However, there were no significant improvements in symptoms of depression. Most participants (80%) in the intervention group stated that they benefited from the program. Conclusions:This program contributed to patients' acquisition of self-management skills to cope with their illnesses, and significantly improved their QOL. This program serves as a reminder for nurses who care for patients with chronic viral hepatitis to acquire these skills as it would help them address the daily needs of their patients. Trial registration:UMIN000025378. Registered December 23, 2016.

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Safety and efficacy of daclatasvir in the management of patients with chronic hepatitis C.

Publications

Safety and efficacy of daclatasvir in the management of patients with chronic hepatitis C.

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