Delving into the Latest Updates on Peginterferon alfa-2b biosimilar(Virchow Group) with Synapse

Overview

Basic Info

Drug Type

Interferons, Biosimilar

Synonyms

PEG-Inferon, Peginterferon alpha-2b biosimilar, VIPEG

Target

IFNAR

Mechanism

IFNAR agonists(Interferon alpha/beta receptor agonists), Immunostimulants, Innate antiviral immune response inducers

Therapeutic Areas

Infectious DiseasesDigestive System Disorders

Active Indication

Hepatitis BHepatitis CHepatitis, Chronic

Inactive Indication-

Originator Organization

Virchow Group

Active Organization

Virchow Group

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date-

Regulation-

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Gene Sequence

Sequence Code 26333714

The sequence is quoted from: *****

In this 24 week, non-randomized, observational, prospective study, 55 patients with chronic hepatitis C were treated with PegIFN-α-2a plus ribavirin (Group 1), and 26 patients were treated with PegIFN-α-2b plus ribavirin (Group 2). All patients underwent assessment using the Hospital Anxiety and Depression Scale (HADS) at the baseline and at weeks 4, 12 and 24. Patients with depression scores (HADS-D) ≥ 8 and anxiety scores (HADS-A) ≥ 8 were defined as having depression and anxiety, respectively. The factors that were associated with depression and anxiety during the 24 week antiviral treatment were determined.

RESULTS:

During the 24 week antiviral treatment, the proportion of patients with depression significantly increased over time in both groups (Group 1: p = 0.048; Group 2: p = 0.044). The proportion of patients with anxiety did not significantly change during the follow-up period in either group. Incidences of depression or anxiety did not differ significantly between Group 1 and Group 2. A history of alcohol use disorder was an independent predictor of depression at week 12 (p < 0.001) and week 24 (p < 0.001), and a poor virological response to treatment was associated with depression at week 24 (p = 0.029). Patients who had more physical comorbidities were more likely to suffer from anxiety at week 12 (p = 0.038).

CONCLUSIONS:

This study did not identify significant differences in depression or anxiety between in patients with chronic hepatitis C who underwent a 24 week antiviral treatment regimen with PegIFN-α-2a plus ribavirin and those who underwent a regiment with PegIFN-α-2b plus ribavirin. Future research with larger samples and a randomized, controlled design are required to verify the findings in this study.

TRIAL REGISTRATION:

This clinical study has been registered at ClinicalTrials.gov. (Trial registration: NCT02943330 ).

01 Jul 2011·JOURNAL OF GASTROENTEROLOGY

Antiviral effects of peginterferon alpha-2b and ribavirin following 24-week monotherapy of telaprevir in Japanese hepatitis C patients.

Article

Author: Chayama, Kazuaki ; Kuwata, Yasuaki ; Ohmura, Takumi ; Ozeki, Itaru ; Sato, Takahiro ; Kamiya, Naohiro ; Akaike, Jun ; Toyota, Joji ; Karino, Yoshiyasu ; Yamada, Ichimaro ; Arakawa, Tomohiro ; Kumada, Hiromitsu

BACKGROUND/AIMS:

Anemia is commonly observed as a side effect in a treatment with protease inhibitors combined with peginterferon alpha and ribavirin for hepatitis C virus infection. This study assessed the safety, tolerability, viral kinetics, and selection of variants in telaprevir monotherapy for 24 weeks, and outcomes of the off-study treatment with peginterferon alpha-2b and ribavirin among Japanese female patients at a median age of 54 years who were difficult to treat with the standard therapy (peginterferon alpha-2b and ribavirin) alone in Japan.

METHODS:

Four treatment-naïve patients with chronic hepatitis C virus subtype 1b infection received telaprevir (750 mg every 8 h) alone for 24 weeks. All patients then started the off-study treatment with peginterferon alpha-2b and ribavirin. Safety, tolerability, hepatitis C virus RNA levels, and emergence of telaprevir-resistant variants were monitored.

RESULTS:

During the 24 weeks of telaprevir monotherapy, there was no discontinuation due to adverse events, but 2 patients stopped the intake at weeks 6 and 15 because of viral breakthrough. Emergence of telaprevir-resistant variants was observed in 3 patients who showed viral breakthrough. These variants were eliminated by the off-study treatment, and sustained virological response was achieved in all patients.

CONCLUSIONS:

Anemia was manageable by carefully adjusting the ribavirin dosage in the standard therapy that followed telaprevir monotherapy. This sequential regimen seems to be safer and more tolerable than the triple combination of telaprevir, peginterferon alpha, and ribavirin, especially among elderly females with low baseline hemoglobin.

01 Feb 2010·PHARMAZIE

Prediction models for feverishness developed during interferon therapy of chronic hepatitis C patients.

Article

Author: Ishii, K ; Dai, Y ; Motege, E ; Uesawa, Y ; Mohri, K

Pegylated interferon (peginterferon) and ribavirin combination therapy is used extensively for therapy of chronic hepatitis C. Most patients that receive this therapy are known to develop influenza-like symptoms with fever and headache. Therefore, we attempted to construct a multiple-regression model to predict the intensity of feverishness from the profiles of such patients. A retrospective survey of the medical charts of patients with chronic hepatitis C that have been on peginterferon-alpha-2b and ribavirin combination therapy was performed. Body temperatures of patients at 8.5 h after receiving interferon injection on day one of therapy were the objective variables. Patients' profiles such as sex, age, and blood test results before the injection were defined as explanatory variables. Genetic algorism with leave-one-out cross-validation as selection pressure was applied in the selection of variables. The final model for prediction was determined by bootstrap validation. As a result, a significant multiple-regression model including sex, BUN, and leukocyte count as descriptors was constructed. The prediction of patients with severe fever in the model equation is of some help regarding the proper use of antipyretics in interferon therapy.

100 Deals associated with Peginterferon alfa-2b biosimilar(Virchow Group)

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