The purpose of this study is to evaluate the safety and efficacy of a locally produced 40KD pegylated interferon alpha-2a (Pegaferon) in patients with hepatitis C. 100 patients will be treated using standard guidelines for hepatitis C. Response to treatment and side effects will be recorded.

Start Date01 Dec 2007

Sponsor / Collaborator

Tehran University of Medical Sciences

100 Clinical Results associated with Peginterferon alfa-2a(Pooyesh Darou)

100 Translational Medicine associated with Peginterferon alfa-2a(Pooyesh Darou)

100 Patents (Medical) associated with Peginterferon alfa-2a(Pooyesh Darou)

Literatures (Medical) associated with Peginterferon alfa-2a(Pooyesh Darou)

01 Jan 2015·World Journal of GastroenterologyQ3 · MEDICINE

Interferon-λ polymorphisms and response to pegylated interferon in Iranian hepatitis C patients

Q3 · MEDICINE

Article

Author: Keshvari, Maryam ; Haj-Sheykholeslami, Arghavan ; Mohammadzadehparjikolaei, Fatemeh ; Hemmati, Khalil ; Pouryasin, Ali ; Sharafi, Heidar

AIMTo evaluate the efficacy of pegylated interferon in Iranian chronic hepatitis C patients in relation to interferon-λ (IFNL) polymorphisms.METHODSThis study enrolled patients with chronic hepatitis C referred to the Tehran Blood Transfusion Hepatitis Clinic in 2011. Patients were included in the study if they had no concomitant hepatic illness, were negative for human immunodeficiency virus antibodies, and had no prior history of treatment with any type of pegylated interferon. Patients were treated with 180 μg pegylated interferon alpha-2a (Pegaferon(®)) weekly and 800-1200 mg ribavirin daily for 24 or 48 wk depending on weight and hepatitis C virus (HCV) genotype. Blood samples were collected from patients to obtain DNA for determination of IFNL rs12979860 and rs8099917 polymorphisms. The virologic response in patients was then evaluated and compared between the different IFNL genotypes.RESULTSA total of 152 patients with a mean age of 41.9 ± 10.0 years were included in the study, of which 141/152 were men (92.8%). The most frequent HCV genotype was type-1, infecting 93/152 (61.2%) patients. Sustained virologic response (SVR) was achieved in 81.9% of patients with HCV genotype-1 and 91.1% of patients with HCV genotype-3. Treatment success was achieved in 91.2% (52/57) of patients with the IFNL rs12979860 CC genotype and 82.1% (78/95) in those with other genotypes. Similar treatment response rates were also observed in patients with rs8099917 TT (39/45; 86.7%) and non-TT (61/68; 89.7%) genotypes. Univariate analyses identified the following factors which influenced treatment response for inclusion in a multivariate analysis: age, HCV RNA level, stage of liver fibrosis, rs12979860 CC genotype, and aspartate transaminase level. A logistic regression analysis revealed that only the rs12979860 CC genotype was significantly associated with achievement of SVR (OR = 6.2; 95%CI: 1.2-31.9; P = 0.03).CONCLUSIONThe rs12979860 CC genotype was associated with SVR in patients receiving pegylated interferon plus ribavirin, however, the SVR rate in other rs12979860 genotypes was also relatively high.

01 Sep 2011·Middle East journal of digestive diseases

Pegaferon in hepatitis C: Results of a Multicenter Study.

Article

Author: Zamani, Farhad ; Shahzamani, Kiana ; Jabbari, Hossain ; Zamini, Hedye ; Sheikholeslami, Arghavan ; Sharfi, Amir Houshang ; Malekzadeh, Reza ; Fakharzadeh, Elham ; Hatami, Khadijeh ; Merat, Shahin

BACKGROUND Chronic hepatitis C (CHC) is a major contributor to cirrhosis and hepatocellular carcinoma and major global public health problem that causes mortality in both developed and developing countries.For the past decade, treatment with pegylated interferon (peg interferon α) and ribavirin (RBV) has been associated with rates of sustained virologic response of ≤ 66% among patients with hepatitis C virus (HCV) infection. In this study, we report the response rate of Iranian treatment-naïve CHC patients to Pegaferon, a locally developed pegylated interferon-α2a (PEG-IFNα2a). METHODS Patients diagnosed with CHC who referred to two university based outpatient clinics in Tehran from December 2007 to May 2011 were enrolled in a single-group, open-labeled experimental design. Eligible patients were above 15 years of age and had HCV infection with evidence of chronic hepatitis. Exclusion criteria included the presence of a debilitating disease, decompensated cirrhosis or refusal to participate in the study. Patients were treated with 180μg Pegaferon weekly in addition to 800-1200 mg daily, weight-based RBV for 24 or 48 weeks depending on genotype. Viral response and adverse effects were recorded. RESULTS A total of 216 patients were enrolled in the study of which 83.3% were male and 16.7% were female. In 93 (43.1%) patients, the HCV RNA viral load was ≥ 800,000 IU/ml before starting treatment. "As-treated analysis" indicated that a total of 168 (77.8%) patients achieved sustained viral response (SVR, undetectable plasma HCV RNA 24 weeks after the last planned dose of study treatment). CONCLUSION This study, with a larger number of participants, confirms the results of a previous study by the authors that Pegaferon, a PEG-IFNα 2a locally produced in Iran, is effective in treatment-naïve CHC patients.

Reports of Biochemistry and Molecular Biology

The Relationship Between HCV-NS5A Gene Mutations and Resistance to Combination Therapy in Patients with HCV- Genotype 1-B

Article

Author: Valibeik, Ali ; Marzban, Abdolrazagh ; Lashgarian, Hamed Esmaeil ; Karkhane, Maryam ; Shahzamani, Kiana

BACKGROUNDHepatitis C virus (HCV) is one of the major causes of chronic liver disease, as it holds a significant role in developing liver cirrhosis and hepatocellular carcinoma. Combination therapy with Pegaferon and Ribavirin leads to viral clearance of only 50% of patients. During the host antiviral response, protein kinase R (PKR) interacts with eukaryotic translation initiation factor 2 alpha (eIF2α), that leads to the inhibition of viral protein synthesis. The viral NS5A protein appears to interfere with this antiviral action, evading the host immune response. However, mutations in the NS5A gene have been observed to render HCV more susceptible to treatment. The aim of this study was to determine the mutations present in the IFN Sensitivity Determining Region (ISDR) and NS5A-PKRbinding domain regions in chronic HCV infected patients before and after therapy.METHODSViral RNA was isolated from the plasma of 52 chronic HCV infected patients before and after treatment. RT-Nested PCR reaction was used to reverse transcription and amplification of target fragment using the specific primers.RESULTSSequence analysis revealed no relationship between NS5A mutations and response to treatment. No significant difference was found between the mutations before and 3 months after treatment among responders and non-responders.CONCLUSIONThis study showed that the number of mutations in NS5A did not significantly differ between the patients who responded to treatment and the patients that did not. Therefore, sequencing of these regions does not appear to be a suitable tool for predicting treatment outcomes.

100 Deals associated with Peginterferon alfa-2a(Pooyesh Darou)

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KEGG	Wiki	ATC	Drug Bank
D02747	-	L03AB11	-

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Indication	Country/Location	Organization	Date
Hepatitis B	IR	Pooyesh Darou Biopharmaceuticals Co.	01 Jan 2008
Hepatitis C	IR	Pooyesh Darou Biopharmaceuticals Co.	01 Jan 2008

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