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Evaluation of the effi cacy and safety of the use of asunaprevir in combination with daclatasvir in patients with chronic hepatitis С: a prospective cohort study

https://doi.org/10.21886/2219-8075-2017-8-4-74-81

Abstract

Objective: to give assessment of the effi cacy and safety of using asunaprevir in combination with daclatasvir in patients with chronic hepatitis C (HCV) with severe fi brosis and cirrhosis. Materials and methods: a prospective cohort clinical trial involved 50 patients with HCV (including 30 patients with compensated cirrhosis of the liver, class A in Child-Pugh), caused by genotype 1b. All patients received asunaprevir in a dose of 100 mg twice a day in combination with daclatasvir 60 mg once a day. Th e duration of the treatment course was 24 weeks. Th e effi cacy criterion was the undetectable level of HCV RNA 24 weeks aft er the end of antiviral therapy (SVR24). Results: at the end of the 4th week of treatment, aviremia was achieved in 92% of patients. Th e incidence of SVR24 in previously untreated patients was 90%, in the group of patients who did not respond to previous therapy with pegylated interferon-interferon with ribavirin- 86.9%. Conclusion: Th e combination of asunaprevir with daclatasvir is highly eff ective and provides a sustained virologic response in 86-90% of cases. A low incidence of adverse events (8%) demonstrates a favorable safety profi le of this treatment regimen.

About the Authors

Elena B. Romanova
NA Semashko the city hospital number 1
Russian Federation
PhD, associate professor, doctor of infectious diseases department No.4
Competing Interests:

Авторы заявляют об отсутствии конфликта интересов.



Yuri M. Ambalov
Rostov State Medical University
Russian Federation
PhD, Professor, Head of the Department infectious diseases Rostov State Medical University


Dmitry V. Sizyakin
NA Semashko the city hospital number 1
Russian Federation
PhD, Professor, chief physician of the NA Semashko city hospital number 1


Irina Y. Khomenko
NA Semashko the city hospital number 1
Russian Federation
Candidate of Medical Sciences, Head of infectious diseases department No.4


Oleg I. Khomenko
NA Semashko the city hospital number 1
Russian Federation
Candidate of Medical Sciences, doctor of infectious diseases department No.4


Karina R. Titiryan
Rostov State Medical University
Candidate of Medical Sciences, Teaching Assistant, Department of infection diseases


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Review

For citations:


Romanova E.B., Ambalov Yu.M., Sizyakin D.V., Khomenko I.Y., Khomenko O.I., Titiryan K.R. Evaluation of the effi cacy and safety of the use of asunaprevir in combination with daclatasvir in patients with chronic hepatitis С: a prospective cohort study. Medical Herald of the South of Russia. 2017;8(4):74-81. (In Russ.) https://doi.org/10.21886/2219-8075-2017-8-4-74-81

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ISSN 2219-8075 (Print)
ISSN 2618-7876 (Online)