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EMA-approvedaka Roferon-A

Interferon alfa-2aComplete Research Guide (2026)

Last updated 2026-06-30

TL;DR

Interferon alfa-2a (also known as Roferon-A) is a peptide catalogued under Immune (IFN-α). Neutral reference entry; EU status: EU-approved prescription medicine.

What is Interferon alfa-2a?

Interferon alfa-2a (brand name Roferon-A) is a recombinant interferon-alpha, a single-species cytokine produced in E. coli that reproduces a naturally occurring human immune protein. It is an FDA-approved prescription biologic, historically indicated for hairy-cell leukemia, AIDS-related Kaposi sarcoma, chronic-phase Philadelphia-chromosome-positive chronic myelogenous leukemia (CML), and chronic hepatitis C.

Evidence is drawn from human randomized and controlled clinical trials, though for chronic hepatitis C it has been largely superseded by direct-acting antivirals, and Roferon-A itself was withdrawn from several markets. This is a regulated therapeutic agent, not a research chemical or wellness supplement.

How does Interferon alfa-2a work?

Interferon alfa-2a binds the type I interferon receptor (IFNAR) and activates the JAK-STAT pathway, inducing interferon-stimulated genes that produce antiviral, antiproliferative, and immunomodulatory effects.

These actions enhance immune-cell cytotoxicity and directly slow proliferation of malignant and virus-infected cells.

What does the research say about Interferon alfa-2a?

  • Induces hematologic remission in hairy-cell leukemia, the observation that established interferon-alpha as an effective therapy for the disease. [1]
  • Prolongs survival and increases cytogenetic response versus conventional chemotherapy in chronic-phase CML in a randomized trial (pre-tyrosine-kinase-inhibitor era). [2]
  • Produces tumor responses in AIDS-related Kaposi sarcoma in controlled clinical trial settings. [3]

Clinical research & studies

The references below are the primary sources cited throughout this guide. Each links directly to PubMed or the regulator. Where evidence is preclinical (animal or in-vitro), that is stated rather than implied.

  • [1] Alpha interferon for induction of remission in hairy-cell leukemiaQuesada JR et al., New England Journal of Medicine 1984. (Clinical trial)
  • [2] Interferon alfa-2a as compared with conventional chemotherapy for the treatment of chronic myeloid leukemiaItalian Cooperative Study Group on Chronic Myeloid Leukemia, New England Journal of Medicine 1994. (Randomized controlled trial)
  • [3] Interferon-alpha 2a in the treatment of acquired immunodeficiency syndrome-related Kaposi's sarcomaEvans LM et al., Journal of Immunotherapy 1991. (Controlled clinical trial)
  • [4] Reinforced regimen of interferon alfa-2a reduces the incidence of cirrhosis in patients with chronic hepatitis C: a multicentre randomised trial. Multicentre GER-CYT-04 GroupDegos F et al., Journal of Hepatology 1998. (Randomized controlled trial)
  • [5] Therapy of hepatitis C: interferon alfa-2a trialsLee WM et al., Hepatology 1997. (Meta-analysis / review)
  • [6] The role of interferon in the treatment of hairy cell leukemiaRatain MJ et al., Seminars in Oncology 1986. (Review)

Dosing context

This is not medical advice or a usage recommendation. Dosing figures are reported research context only, cited from the published literature.

Dosing was individualized by indication and given by subcutaneous or intramuscular injection under oncology or hepatology supervision, with regimens differing markedly between hairy-cell leukemia, CML, Kaposi sarcoma, and hepatitis C.

This information is historical context only and not a dosing recommendation; interferon alfa-2a is a prescription biologic requiring physician management.

Side effects & safety profile

Interferon-alpha products carry an FDA boxed warning that they may cause or aggravate fatal or life-threatening neuropsychiatric (including depression and suicidal ideation), autoimmune, ischemic, and infectious disorders, with mandatory close monitoring and discontinuation in patients with persistently severe signs.

Nearly all patients experience a flu-like syndrome (fever, chills, myalgia, fatigue, headache), and dose-limiting cytopenias (neutropenia, thrombocytopenia), elevated liver enzymes, and thyroid dysfunction are common.

It is contraindicated in autoimmune hepatitis and decompensated liver disease and must be used only under specialist supervision. This is not a self-administered wellness compound.

Stacking & combinations

In its approved eras it was combined with other agents (for example ribavirin for hepatitis C or zidovudine in Kaposi sarcoma) only within supervised medical regimens, never as an unmonitored stack.

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Frequently asked questions

Yes. It was FDA-approved as Roferon-A for hairy-cell leukemia, AIDS-related Kaposi sarcoma, chronic-phase Philadelphia-chromosome-positive CML, and chronic hepatitis C. It is a prescription biologic, and Roferon-A has since been withdrawn from various markets.

References

  1. [1] Alpha interferon for induction of remission in hairy-cell leukemiaQuesada JR et al., New England Journal of Medicine 1984. PMID: 6689734. View sourceStudy: Clinical trialAlpha interferon induced hematologic remissions in patients with hairy-cell leukemia, establishing interferon as effective therapy.
  2. [2] Interferon alfa-2a as compared with conventional chemotherapy for the treatment of chronic myeloid leukemiaItalian Cooperative Study Group on Chronic Myeloid Leukemia, New England Journal of Medicine 1994. PMID: 8114834. View sourceStudy: Randomized controlled trialInterferon alfa-2a prolonged survival and increased cytogenetic responses compared with conventional chemotherapy in chronic-phase CML.
  3. [3] Interferon-alpha 2a in the treatment of acquired immunodeficiency syndrome-related Kaposi's sarcomaEvans LM et al., Journal of Immunotherapy 1991. PMID: 1826454. View sourceStudy: Controlled clinical trialInterferon-alpha 2a produced antitumor responses in patients with AIDS-related Kaposi sarcoma.
  4. [4] Reinforced regimen of interferon alfa-2a reduces the incidence of cirrhosis in patients with chronic hepatitis C: a multicentre randomised trial. Multicentre GER-CYT-04 GroupDegos F et al., Journal of Hepatology 1998. PMID: 9722203. View sourceStudy: Randomized controlled trialA reinforced interferon alfa-2a regimen lowered the incidence of cirrhosis in chronic hepatitis C patients.
  5. [5] Therapy of hepatitis C: interferon alfa-2a trialsLee WM et al., Hepatology 1997. PMID: 9305671. View sourceStudy: Meta-analysis / reviewPooled analysis of interferon alfa-2a trials showed modest sustained virologic response rates in chronic hepatitis C, informing dose and duration.
  6. [6] The role of interferon in the treatment of hairy cell leukemiaRatain MJ et al., Seminars in Oncology 1986. PMID: 3532332. View sourceStudy: ReviewReviewed interferon-alpha as a highly active treatment for hairy-cell leukemia, summarizing response rates and toxicity.
This article is for educational and research purposes only. Peptides discussed here are not approved for human consumption by the FDA, EMA, or equivalent regulators outside of specific clinical contexts. Always consult a licensed medical professional before any therapeutic use.