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Roferon-A (Interferon Alfa-2A (Recombinant)) - Summary

 
 



Alpha-interferons, including Interferon alfa-2a, cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy. In many, but not all cases, these disorders resolve after stopping Interferon alfa-2a therapy (see WARNINGS and ADVERSE REACTIONS).

 

ROFERON-A SUMMARY

ROFERON®-A
(Interferon alfa-2a, recombinant)

Roferon-A (Interferon alfa-2a, recombinant) is a sterile protein product for use by injection. Roferon-A is manufactured by recombinant DNA technology that employs a genetically engineered Escherichia coli bacterium containing DNA that codes for the human protein.

Roferon-A is indicated for the treatment of chronic hepatitis C and hairy cell leukemia in patients 18 years of age or older. In addition, it is indicated for chronic phase, Philadelphia chromosome (Ph) positive chronic myelogenous leukemia (CML) patients who are minimally pretreated (within 1 year of diagnosis).

FOR PATIENTS WITH CHRONIC HEPATITIS C: Roferon-A is indicated for use in patients with chronic hepatitis C diagnosed by HCV antibody and/or a history of exposure to hepatitis C who have compensated liver disease and are 18 years of age or older. A liver biopsy and a serum test for the presence of antibody to HCV should be performed to establish the diagnosis of chronic hepatitis C. Other causes of hepatitis, including hepatitis B, should be excluded prior to therapy with Roferon-A.


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NEWS HIGHLIGHTS

Published Studies Related to Roferon-A (Interferon Alfa-2A)

Antiviral activity of danoprevir (ITMN-191/RG7227) in combination with pegylated interferon alpha-2a and ribavirin in patients with hepatitis C. [2011.08.15]
BACKGROUND: Current therapy options for patients with chronic hepatitis C virus (HCV) infection genotype 1 are effective in <50%. Danoprevir (ITMN-191/RG7227) is a potent, selective, and orally active inhibitor of the HCV NS3/4A serine protease... CONCLUSIONS: Our study showed substantial antiviral efficacy of danoprevir in combination with pegylated interferon alpha-2a and ribavirin. Exploration of the safety and antiviral efficacy of danoprevir in longer clinical studies is warranted.

Randomised clinical trial: efficacy of peginterferon alfa-2a in HBeAg positive chronic hepatitis B patients with lamivudine resistance. [2011.08]
BACKGROUND: Previous studies suggested that a finite course of peginterferon alfa-2a may offer an alternative rescue therapy for patients with lamivudine resistance. However, because of the limitation of study design and small sample size, it is difficult to make definitive conclusion. AIM: To explore the role of peginterferon alfa-2a, in the rescue treatment of HBeAg-positive chronic hepatitis B patients with lamivudine resistance... CONCLUSIONS: Overall, the response to peginterferon alfa-2a among patients with lamivudine resistance was suboptimal. HBeAg seroconversion rate at week 72 by 48 weeks peginterferon alfa-2a treatment was higher than continuous adefovir therapy. Monitoring HBsAg levels can help to predict response to peginterferon alfa-2a. (c) 2011 Blackwell Publishing Ltd.

High-dose pegylated interferon-alpha and ribavirin in nonresponder hepatitis C patients and relationship with IL-28B genotype (SYREN trial). [2011.07]
BACKGROUND &#38; AIMS: In patients with chronic hepatitis C who failed to respond to standard therapy, high-dose pegylated interferon (IFN)-alpha and/or ribavirin could induce a stronger antiviral response and prevent treatment failure and HCV resistance when combined with direct-acting antivirals. The influence of genetic determinants in this context remains unknown... CONCLUSIONS: High-dose pegylated IFN-alpha with standard or high doses of ribavirin induces a potent antiviral response in a substantial number of patients who did not respond to standard therapy. The IL-28B genotype is an independent predictor of the antiviral response. High-dose pegylated IFN-alpha in combination with ribavirin and protease inhibitors appears as an attractive option for future study in this population. Copyright (c) 2011 AGA Institute. Published by Elsevier Inc. All rights reserved.

Twice-weekly pegylated interferon-alpha-2a and ribavirin results in superior viral kinetics in HIV/hepatitis C virus co-infected patients compared to standard therapy. [2011.06.01]
CONCLUSION: Our results, when confirmed in larger randomized clinical trials, may provide a novel therapeutic approach to improve SVR among HIV/HCV co-infected patients, especially African-American patients.

Coffee consumption is associated with response to peginterferon and ribavirin therapy in patients with chronic hepatitis C. [2011.06]
BACKGROUND &#38; AIMS: High-level coffee consumption has been associated with reduced progression of pre-existing liver diseases and lower risk of hepatocellular carcinoma. However, its relationship with therapy for hepatitis C virus infection has not been evaluated... CONCLUSIONS: High-level consumption of coffee (more than 3 cups per day) is an independent predictor of improved virologic response to peginterferon plus ribavirin in patients with hepatitis C. Copyright (c) 2011 AGA Institute. Published by Elsevier Inc. All rights reserved.

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Clinical Trials Related to Roferon-A (Interferon Alfa-2A)

Pegylated Interferon Alfa-2a Plus Low Dose Ribavirin for Treatment-Naïve Dialysis Patients With Chronic Hepatitis C [Recruiting]
Chronic hepatitis C virus (HCV) infection is common in dialysis patients. Interferon (IFN)-based treatment for chronic hepatitis C has been the mainstay therapy in immunocompetent patients. In dialysis patients, treatment with conventional or pegylated interferon has also received much attention recently. Two meta-analyses evaluating the efficacy and safety of conventional IFN alfa monotherapy showed that the sustained virologic response (SVR) rates were 37% and 33%, respectively; and the corresponding dropout rates were 17% and 29. 6%, respectively. The efficacy and safety of pegylated IFN alfa-2a and 2b in treating dialysis patients showed conflicting results, with a more favorable outcome of patients treated with pegylated IFN alfa-2a (135-180 μg/week: SVR 33-75%, well tolerated) than those treated with pegylated IFN alfa-2b (0. 5-1. 0 μg/week: SVR 12. 5%, poorly tolerated. Currently, IFN-based therapy to treatment HCV infection should be initiated in dialysis stages, because the use of IFN in RT patients harbors high risks of acute graft rejection,and have low response rates under the concomitant use of immunosuppressive agents.

Ribavirin, which has been used in combination with IFN to treat chronic hepatitis C in the general patients and achieve a higher SVR rate than IFN monotherapy, is considered contraindicated in dialysis patients with chronic hepatitis C due to the risk of severe hemolytic anemia. However, some pilot studies evaluating combined conventional IFN alfa plus low dose ribavirin (170-300 mg/day) showed SVR rates of 17%-66% after 24-48 weeks of treatment. In addition, a recent study including 6 patients with combination of pegylated IFN alfa plus low dose ribavirin also showed a SVR rate of 50%. In this study, treatment with pegylated IFN alfa-2a plus low dose ribavirin achieved a higher SVR rate that that with pegylated IFN alfa-2b plus low dose ribavirin (100% vs. 25%).

Based on the long-term favorable outcome in dialysis patients who eradicate HCV, and the superior response of pegylated IFN alfa-2a plus low dose ribavirin to pegylated IFN alfa-2b plus low dose ribavirin in treating dialysis patients with chronic hepatitis C, the aim of the study is to evaluate the efficacy and safety of pegylated IFN alfa-2a plus low dose ribavirin versus pegylated interferon alfa-2a alone in treatment naïve dialysis patients with chronic hepatitis C.

Ipilimumab or High-Dose Interferon Alfa-2b in Treating Patients With High-Risk Stage III or Stage IV Melanoma That Has Been Removed by Surgery [Recruiting]
This phase III clinical trial is studying ipilimumab or high-dose interferon alfa-2b in treating patients with high-risk stage III or stage IV melanoma that has been removed by surgery. Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of melanoma and other cancers. It is not yet known whether ipilimumab is more effective then interferon alfa-2b in treating patients with melanoma

Phase II Study of KW2871 Combined With High Dose Interferon-alpha2b in Patients With Metastatic Melanoma [Recruiting]
This study will evaluate the safety and effectiveness of the combination regimen of KW2871 and high dose Interferon-alfa2b (HDI) in patients with metastatic melanoma (skin cancer that has spread to other parts of the body).

KW2871 is an antibody that is made in a laboratory. Antibodies are part of the immune system. KW2871 attaches to the GD3 ganglioside (a molecule that is found on melanoma cells). This may help slow or stop the growth of melanoma tumors.

Interferon-alfa 2b is a man-made version of interferon. Interferons are among a number of substances produced by the immune system in response to the presence of enemy cells. Not only does it "interfere" with foreign invaders that may cause infection, but it can prevent the growth and spread of other diseased cells as well, including some types of cancer cells. Interferons have been shown to be effective against a variety of tumors.

Clinical Trial to Assess Safety and Efficacy of Combination Therapy: Hydroxychloroquine, Pegylated Interferon Alpha-2a and Ribavirin in Chronic Hepatitis C Subjects Non-responders to the Standard of Care Therapy. [Not yet recruiting]
The study is aimed to investigate the safety, tolerability and efficacy of a fixed dose combination therapy of: Hydroxychloroquine (HCQ), Pegylated Interferon Alpha-2a (PEG-IFN alpha-2a) and Ribavirin (RBV) in Chronic Hepatitis C Genotype 1 Infected adult subjects who failed to respond following a course of PEG-IFN and RBV Therapy.

Randomized Trial of Pegylated Interferon Alfa-2a Versus Hydroxyurea in Polycythemia Vera (PV) and Essential Thrombocythemia (ET) [Recruiting]
This research is looking at two conditions, Essential Thrombocythemia (ET) and Polycythemia Vera (PV). ET causes people to produce too many blood cells called platelets and PV causes too many platelets and red blood cells to be made. Platelets are particles which circulate in the blood stream and normally prevent bleeding and bruising. Having too many platelets in the blood increases the risk of developing blood clots, which can result in life threatening events like heart attacks and strokes. When the number of red blood cells is increased in PV this will slow the speed of blood flow in the body and increases the risk of developing blood clots.

The purpose of this study is to look at the effectiveness of giving participants who have been diagnosed with ET or PV one of two different study regimens over time. The study subject will be followed for their condition for about 5 years. The subject will be randomized into one of two study regimens, either Pegylated Interferon Alfa-2a (PEGASYS) or Aspirin and Hydroxyurea (also called Hydroxycarbamide). The subject must be newly diagnosed or already receiving treatment for either PV or ET. Each of the study drugs used in this study is already being used to treat subjects with ET or PV currently, but the investigators are unsure which study drug is better.

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Reports of Suspected Roferon-A (Interferon Alfa-2A) Side Effects

Anaemia (9)Pyrexia (7)Decreased Appetite (7)Diarrhoea (6)Gastrointestinal Perforation (5)Blood Alkaline Phosphatase Increased (5)Vomiting (5)Neoplasm Malignant (5)Leukopenia (5)Completed Suicide (4)more >>


Page last updated: 2011-12-09

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