Interferon alfa-1b
Also known as: IFN-α1b, IFN‑α1b, Interferon alfa‑1b, Multiferon, Recombinant human interferon alpha-1b, rHuIFN-α1b, Sumiferon
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Summary
Interferon alfa-1b (IFN‑α1b) is a recombinant type I interferon approved for prescription use. It is administered by injection (intramuscular, intravenous, or subcutaneous) and has antiviral, immunomodulatory, and antiproliferative properties. Research has explored its role in chronic hepatitis B, COVID‑19 in infants, and as an adjunct in hepatocellular carcinoma and melanoma therapy.
Mechanism of Action
IFN‑α1b binds the interferon‑α/β receptor (IFNAR) on target cells, activating the JAK‑STAT signaling cascade. This induces transcription of interferon‑stimulated genes that confer antiviral activity, inhibit cell proliferation, and modulate immune responses. In tumor models, the pathway reduces angiogenic factors such as VEGF, lowers MMP2/TIMP2 ratios, and impairs neovascularization, contributing to anti‑tumor and anti‑metastatic effects.
What the Research Shows
Pre‑clinical mouse studies of hepatocellular carcinoma showed that high‑dose, long‑term IFN‑α1b reduced tumor volume, prevented lung metastasis, and extended survival, an effect linked to anti‑angiogenesis. In a separate mouse model, IFN‑α1b lowered microvessel density and MMP2/TIMP2 ratio, especially when combined with the herbal formula Songyou Yin. A case report described inhaled IFN‑α1b given to an infant with mild COVID‑19, where throat swabs stayed negative while anal swabs remained positive. Another case noted vitiligo emergence in a chronic hepatitis B patient receiving IFN‑α1b, suggesting autoimmune potential. A large Chinese real‑world cohort of advanced melanoma patients receiving PD‑1 plus IFN‑α1b (with or without tyrosine‑kinase inhibitors) reported increased immune‑related adverse events, particularly in triple‑therapy regimens, though most combinations were tolerated.
Reported Benefits
Animal data indicate IFN‑α1b can suppress tumor growth, limit metastasis, and inhibit angiogenesis in hepatocellular carcinoma models. Clinical observations suggest antiviral utility in mild SARS‑CoV‑2 infection and established use in chronic hepatitis B. When combined with PD‑1 inhibitors, IFN‑α1b may enhance immunotherapy, albeit with higher toxicity, offering a potential adjuvant strategy in melanoma.
Limitations of the Evidence
Human evidence is limited to case reports and observational cohorts; no large randomized trials confirm efficacy for cancer indications. The anti‑tumor benefits are derived mainly from mouse studies, which may not translate to patients. Safety concerns, especially autoimmune phenomena and heightened immune‑related adverse events in combination regimens, remain incompletely characterized.
Safety Considerations
Reported adverse effects include autoimmune skin depigmentation (vitiligo) and increased immune‑related adverse events when IFN‑α1b is combined with PD‑1 blockade, particularly with added tyrosine‑kinase inhibitors. Baseline hepatic or renal dysfunction and pre‑existing autoimmune disease may heighten risk. Standard interferon‑associated flu‑like symptoms are expected, though not detailed in the abstracts.
How It Is Administered
IFN‑α1b is supplied as a recombinant protein for injection via intramuscular, intravenous, or subcutaneous routes. In a pediatric COVID‑19 case, the drug was delivered by aerosolized atomization inhalation for ten days. Formulations are intended for clinical prescription use only.
Routes of Administration
Goals & Uses
- Chronic Hepatitis C treatmentAntiviralHigh
- Chronic Hepatitis B treatmentAntiviralHigh
- Antiviral therapy for chronic hepatitis BViral InfectionModerate
- Condylomata acuminataAntiviral / DermatologyModerate
- Hairy cell leukemiaOncologyModerate
- Chronic myelogenous leukemia (CML)OncologyModerate
- Adjuvant treatment of melanomaOncologyLow
- Antiviral therapy for chronic hepatitis CViral InfectionModerate
Contraindications
- Severe psychiatric disorders (e.g., severe depression, psychosis)PsychiatricHigh
- Severe autoimmune diseaseImmunologicalHigh
- PregnancyPopulationHighPotential fetal risk or insufficient safety data
- Severe renal or cardiac insufficiencyOrgan ImpairmentModerate
- Severe depression or psychiatric illnessPsychiatricModerate
- Autoimmune hepatitisHepatic / AutoimmuneHigh
- Decompensated liver diseaseHepatic ImpairmentHigh
- Hypersensitivity to interferon alfa or any componentImmunologicHigh
Adverse Effects
- Flu-like syndrome (fever, chills, myalgia, headache)SystemicCommon
- Neuropsychiatric effects (depression, irritability, suicidal ideation)PsychiatricCommon
- Injection site reactionsLocalCommon
- Elevated liver enzymes / hepatotoxicityHepaticUncommon
- Myelosuppression (neutropenia, thrombocytopenia, anemia)HematologicCommon
- DepressionPsychiatricUncommon
- Injection site reactionLocalCommonRedness, swelling, itching, bruising, or pain at the injection site
- Flu‑like syndrome (fever, chills, myalgia)SystemicCommon
- Leukopenia / neutropeniaHematologicUncommon
- Thyroid dysfunction (hypo- or hyperthyroidism)EndocrineUncommon
Drug Interactions
- Immunosuppressants (e.g., corticosteroids)Moderate
- Live vaccinesHigh
- Zidovudine (AZT)Moderate
- Immunosuppressants (e.g., cyclosporine)Moderate
- Theophylline / AminophyllineModerate
- RibavirinModerate
- ClozapineHigh
Population Constraints
- Renal impairmentOrgan ImpairmentRelative
- Pediatric patientsAgeRelative
- Patients with pre-existing psychiatric illnessPsychiatricRelative
- Patients with autoimmune diseaseAutoimmuneRelative
- Elderly patients (≥65 years)Age RelatedRelative
- Elderly (>75 years)GeriatricRelative
Regulatory Status
- CNApprovedApproved: chronic hepatitis B, chronic hepatitis CApproved by NMPA for antiviral therapy.
- European UnionApprovedApproved: chronic hepatitis B, chronic hepatitis C, melanoma (adjuvant)Marketing authorisation granted in several member states.
- United StatesUnapprovedNot FDA‑approved; available only via clinical trial or compassionate use.
- United KingdomUnknownNo independent MHRA approval identified for interferon alfa-1b specifically.
Not approved by the US FDA; approved in several EU member states, China, and Russia for hepatitis B/C and specific cancers. Marketing authorisations vary by indication.
Evidence & Sources
- Journal ArticleLowWang L, et al.2000-01-01T00:00:00.000000Z
- Journal ArticleLowLi J, et al.2020-01-01T00:00:00.000000Z
- Journal ArticleLowHu MF, Li YL, Zhuang L2010-01-01T00:00:00.000000Z
- Journal ArticleLowQiao Y, et al.2026-01-01T00:00:00.000000Z
- Journal ArticleLowHuang XY, et al.2010-01-01T00:00:00.000000Z
Frequently Asked Questions
What conditions has interferon alfa‑1b been studied for?
Research has examined IFN‑α1b in chronic hepatitis B, mild SARS‑CoV‑2 infection in infants, hepatocellular carcinoma (both as postoperative adjuvant and in combination with herbal therapy), and as an adjunct to PD‑1 immunotherapy in advanced melanoma.
Is interferon alfa‑1b approved for cancer treatment?
Current regulatory approvals list IFN‑α1b as a prescription antiviral agent. While pre‑clinical studies show anti‑tumor activity, there is no formal approval for cancer indications based on the available literature.
What are the main safety concerns with interferon alfa‑1b?
Potential adverse effects include flu‑like symptoms, autoimmune reactions such as vitiligo, and heightened immune‑related toxicities when combined with checkpoint inhibitors, especially in regimens that also contain tyrosine‑kinase inhibitors.
How is interferon alfa‑1b administered?
The drug is given by injection—intramuscular, intravenous, or subcutaneous. In a reported infant COVID‑19 case, it was delivered via aerosolized inhalation, but this route is not standard for routine prescribing.
Does interferon alfa‑1b improve outcomes after liver cancer surgery?
In mouse models, high‑dose IFN‑α1b reduced tumor recurrence, metastasis, and angiogenesis after hepatic resection, extending survival. Human clinical data are limited to pre‑clinical findings, so benefits in patients remain unproven.
What is Interferon alfa-1b?
Interferon alfa-1b (IFN‑α1b) is a recombinant type I interferon approved for prescription use. It is administered by injection (intramuscular, intravenous, or subcutaneous) and has antiviral, immunomodulatory, and antiproliferative properties. Research has explored its role in chronic hepatitis B, COVID‑19 in infants, and as an adjunct in hepatocellular carcinoma and melanoma therapy.
What is Interferon alfa-1b used for?
Interferon alfa-1b is educationally associated with: Chronic Hepatitis C treatment, Chronic Hepatitis B treatment, Antiviral therapy for chronic hepatitis B, Condylomata acuminata, Hairy cell leukemia, Chronic myelogenous leukemia (CML), Adjuvant treatment of melanoma, Antiviral therapy for chronic hepatitis C. Educational only — not medical advice.
How is Interferon alfa-1b administered?
Recorded routes of administration: Intramuscular, Intravenous, Subcutaneous.
What are the potential side effects of Interferon alfa-1b?
Reported adverse effects include: Flu-like syndrome (fever, chills, myalgia, headache), Neuropsychiatric effects (depression, irritability, suicidal ideation), Injection site reactions, Elevated liver enzymes / hepatotoxicity, Myelosuppression (neutropenia, thrombocytopenia, anemia), Depression, Injection site reaction, Flu‑like syndrome (fever, chills, myalgia), Leukopenia / neutropenia, Thyroid dysfunction (hypo- or hyperthyroidism). This list is not exhaustive — consult a qualified clinician.
Who should avoid Interferon alfa-1b?
Recorded contraindications: Severe psychiatric disorders (e.g., severe depression, psychosis), Severe autoimmune disease, Pregnancy, Severe renal or cardiac insufficiency, Severe depression or psychiatric illness, Autoimmune hepatitis, Decompensated liver disease, Hypersensitivity to interferon alfa or any component. Consult a qualified clinician before use.