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Efficacy and safety of the first domestic pegilated interferon alpha-2b «Pegaltevir» at chronic hepatitis C: pilot data of phase III clinical study

Abstract

Aim of investigation. Comparative assessment of efficacy and safety of Pegaltevir and PegIntron in within pattern of combined antiviral therapy in previously untreated patients with chronic hepatitis C.

Material and methods. Overall 140 patients with chronic hepatitis C, who received no antiviral therapy previously were included in original study. Patients were randomized in 4 groups. Groups differed in relation to received drug and hepatitis C virus genotype. All patients received 1,5 mkg per 1 kg body weight per week of Pegaltevir or PegIntron and 800–1400 mg of ribavirin per day. Preliminary estimation of drug efficacy was based on rates of rapid and early virologic response (RVR and EVR) achievement, dynamics of biochemical tests, dynamics of blood level of peginterferon alpha and neopterin. Safety features were estimated as well.

Results. Comparative analysis has demonstrated absence of statistically significant distinctions of RVR and РВО rates at application of two peginterferon alpha-2b drugs. There were no differences in frequency of achievement of serologic response, as well as safety in Pegaltevir and PegIntron groups. Dynamics of blood concentration of peginterferon alpha correlated to neopterin concentration both in Pegaltevir group and in PegIntron group.

Conclusions. Study results have shown high rates of RVR and РВО achievement, and acceptable safety profile of Pegaltevir, comparable with that of PegIntron at chronic hepatitis C in previously untreated patients.

About the Authors

V. T. Ivashkin
State educational government-financed institution of higher professional education «Sechenov First Moscow state medical university», Ministry of Healthcare of the Russian Federation
Russian Federation


Ye. N. Bessonova
Government healthcare institution «Sverdlovsk regional clinical hospital N 1»
Russian Federation


P. O. Bogomolov
LLC «Tsentrosoyuz Clinical hospital»
Russian Federation


N. I. Geyvandova
Stavropol region State government-financed healthcare institution «Stavropol regional clinical center of specialized medical care»
Russian Federation


K. V. Zhdanov
State military educational government-financed institution of higher professional education «Kirov military medical academy» Ministry of Defense of the Russian Federation
Russian Federation


M. V. Mayevskaya
State educational government-financed institution of higher professional education «Sechenov First Moscow state medical university», Ministry of Healthcare of the Russian Federation
Russian Federation


V. G. Morozov
LLC «Hepatologist» medical company
Russian Federation


V. D. Pasechnikov
State educational government-financed institution of higher professional education «Stavropol state medical university » Ministry of Healthcare of the Russian Federation
Russian Federation


I. Yu. Khomenko
Municipal health care institution «Semashko City hospital N 1
Russian Federation


A. V. Yagoda
Stavropol region State government-financed healthcare institution «Stavropol regional clinical center of specialized medical care»
Russian Federation


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Review

For citations:


Ivashkin V.T., Bessonova Ye.N., Bogomolov P.O., Geyvandova N.I., Zhdanov K.V., Mayevskaya M.V., Morozov V.G., Pasechnikov V.D., Khomenko I.Yu., Yagoda A.V. Efficacy and safety of the first domestic pegilated interferon alpha-2b «Pegaltevir» at chronic hepatitis C: pilot data of phase III clinical study. Russian Journal of Gastroenterology, Hepatology, Coloproctology. 2014;24(1):47-55. (In Russ.)

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ISSN 1382-4376 (Print)
ISSN 2658-6673 (Online)