Interferon alfa-n3
Also known as: alfa-n3, Alferon N, human leukocyte interferon alpha, n-alpha interferon
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Summary
Interferon alfa‑n3 is a naturally derived human type I interferon supplied for injection and approved as a prescription drug. Clinical investigations have examined its antiviral activity against early HIV‑1 infection, chronic hepatitis C virus, and its use as an adjuvant after surgical removal of anal condyloma. The agent is administered in unit‑based doses several times weekly.
Mechanism of Action
Interferon alfa‑n3 binds the interferon‑α/β receptor (IFNAR) on target cells, activating the JAK‑STAT signaling cascade. This induces transcription of interferon‑stimulated genes, including 2′‑5′‑oligoadenylate synthetase, which degrades viral RNA and creates an antiviral state that limits replication of diverse viruses such as HIV‑1 and HCV.
What the Research Shows
Early‑stage HIV‑1 trials (n=20) showed interferon alfa‑n3 was safe, well tolerated, and produced dose‑related antiviral activity with CD4 stabilization for over 20 months; neuropsychiatric effects were minimal. In a randomized hepatitis C study (n=77), 10 MU three times weekly yielded 59% undetectable HCV RNA at therapy end, with 24% sustained virologic response after follow‑up. A subsequent trial demonstrated that concurrent ribavirin plus interferon alfa‑n3 improved ALT normalization and viral clearance compared with sequential or monotherapy. A prospective anal condyloma trial (n=43) reported fewer recurrences when intralesional interferon was added to surgery (12% vs 39%). Pharmacokinetic work in healthy volunteers indicated that subcutaneous and intramuscular routes increase serum exposure and 2‑5‑A synthetase activity relative to intravenous dosing, with only mild flu‑like symptoms reported.
Reported Benefits
Evidence from small trials suggests interferon alfa‑n3 can induce antiviral effects against HIV‑1, stabilizing CD4 counts, and against HCV, achieving dose‑dependent viral clearance, especially when combined with ribavirin. Intralesional administration after anal condyloma excision appears to lower recurrence rates. Across studies, the drug was generally well tolerated, supporting its potential as an adjunct antiviral or adjuvant therapy.
Limitations of the Evidence
The clinical data are limited to modestly sized, often early‑phase studies with short to medium follow‑up. HIV investigations involved only asymptomatic patients; hepatitis C results derive from a single randomized trial with limited sustained response, and combination therapy benefits were modest. The anal condyloma study lacked long‑term outcomes. No large, multicenter phase III trials have confirmed efficacy, and the approved indication of the product is not detailed in the available literature.
Safety Considerations
Across studies, interferon alfa‑n3 was associated primarily with mild to moderate flu‑like symptoms (fever, myalgia, fatigue) and minimal laboratory toxicity. Neuropsychiatric side effects were rare, and no neutralizing antibodies developed. When combined with ribavirin, mild hemolytic anemia occurred. Overall tolerability was good, but clinicians should monitor for flu‑like reactions, hepatic enzymes, and, in combination regimens, hematologic changes.
How It Is Administered
Interferon alfa‑n3 is provided as a sterile aqueous solution for injection. It can be given intramuscularly, subcutaneously, intravenously, or intralesionally (e.g., into the anal canal). Clinical protocols have used unit‑based doses ranging from 1 to 10 million units three times weekly, typically administered as separate injections.
Routes of Administration
Goals & Uses
- ImmunomodulationImmunologyModerate
- Treatment of condylomata acuminata (genital warts)Antiviral / DermatologyHigh
- Antiviral activity against HPVAntiviralHigh
Contraindications
- Hypersensitivity to mouse immunoglobulinAllergy / ImmunologyHigh
- Autoimmune diseaseImmuneModerateMay worsen or interact with immune-mediated disease
- Severe psychiatric disorders (pre-existing)PsychiatricHigh
- Hypersensitivity to human interferon alfa or any product componentAllergy / ImmunologyHigh
- Hypersensitivity to egg protein or neomycinAllergyHigh
Adverse Effects
- Flu-like symptoms (fever, chills, myalgia, headache)SystemicCommon
- Fatigue / malaiseSystemicCommon
- Injection site reactions (pain, burning)LocalCommon
- Depression / neuropsychiatric effectsPsychiatric / NeurologicalUncommon
- Elevated liver enzymesHepaticUncommonIncrease in AST/ALT or other hepatic markers
- Leukopenia / neutropeniaHematologicUncommon
Drug Interactions
- Myelosuppressive agentsModerate
- CNS depressants / psychotropic agentsModerate
- TheophyllineModerate
Population Constraints
- PregnancyReproductive SafetyRelative
- Pediatric patients (<18 years)AgeAbsolute
- Severe hepatic or renal impairmentOrgan ImpairmentRelative
- Immunocompromised patientsImmunologicRelative
Regulatory Status
- European UnionUnknownNot widely approved as a distinct product in EU; other interferon alfa products are used
- United StatesApprovedApproved: Refractory or recurring external condylomata acuminata (genital warts) in adults ≥18 yearsFDA-approved since 1989; marketed as Alferon N Injection by Hemispherx Biopharma; availability has been sporadic
- United KingdomUnknownNo specific MHRA approval identified for interferon alfa-n3 as a distinct product
FDA-approved in 1989 for intralesional treatment of refractory or recurring external condylomata acuminata in patients 18 years of age or older. Manufactured by Interferon Sciences / Hemispherx Biopharma. Supply and availability have been intermittent.
Evidence & Sources
- Journal ArticleModerateMapou RL, et al.1996-01-01T00:00:00.000000Z
- Journal ArticleModerateSkillman DR, et al.1996-01-01T00:00:00.000000Z
- Journal ArticleModerateSimon DM, et al.1997-01-01T00:00:00.000000Z
- Journal ArticleModerateFleshner PR, Freilich MI1994-01-01T00:00:00.000000Z
- Journal ArticleModerateSostegni R, et al.1998-01-01T00:00:00.000000Z
- Journal ArticleModerateSturgill MG, et al.2000-01-01T00:00:00.000000Z
Frequently Asked Questions
How does interferon alfa‑n3 differ from other interferon‑alpha products?
Interferon alfa‑n3 is a natural mixture isolated from human leukocytes that contains multiple interferon‑alpha species, whereas many commercial products are recombinant single‑species molecules. This broader composition may elicit a wider range of antiviral genes, but direct comparative data are limited.
What conditions has interferon alfa‑n3 been studied for?
Clinical research has evaluated interferon alfa‑n3 in early HIV‑1 infection, chronic hepatitis C virus infection (both as monotherapy and with ribavirin), and as an adjuvant after surgical treatment of anal condyloma. Pharmacokinetic studies have also examined its systemic exposure via different injection routes.
What are the most common side effects?
The predominant adverse effects are flu‑like symptoms such as fever, chills, myalgia, and fatigue, reported in all healthy volunteers studied. Laboratory abnormalities are minimal, but when combined with ribavirin, mild hemolytic anemia can occur. Serious neuropsychiatric events were rare in the reported trials.
Is interferon alfa‑n3 effective as a single agent for hepatitis C?
Monotherapy showed a dose‑dependent reduction in HCV RNA, with the highest dose (10 MU) achieving 59% viral clearance at treatment end, but only 24% maintained undetectable RNA after follow‑up. Thus, while active, sustained virologic response is limited without additional agents.
How is interferon alfa‑n3 administered?
The drug is supplied for injection and can be given intramuscularly, subcutaneously, intravenously, or directly into lesions (intralesional). Clinical studies have used three‑times‑weekly dosing schedules, typically expressed in million‑unit quantities per injection.
What is Interferon alfa-n3?
Interferon alfa‑n3 is a naturally derived human type I interferon supplied for injection and approved as a prescription drug. Clinical investigations have examined its antiviral activity against early HIV‑1 infection, chronic hepatitis C virus, and its use as an adjuvant after surgical removal of anal condyloma. The agent is administered in unit‑based doses several times weekly.
What is Interferon alfa-n3 used for?
Interferon alfa-n3 is educationally associated with: Immunomodulation, Treatment of condylomata acuminata (genital warts), Antiviral activity against HPV. Educational only — not medical advice.
How is Interferon alfa-n3 administered?
Recorded routes of administration: Intralesional.
What are the potential side effects of Interferon alfa-n3?
Reported adverse effects include: Flu-like symptoms (fever, chills, myalgia, headache), Fatigue / malaise, Injection site reactions (pain, burning), Depression / neuropsychiatric effects, Elevated liver enzymes, Leukopenia / neutropenia. This list is not exhaustive — consult a qualified clinician.
Who should avoid Interferon alfa-n3?
Recorded contraindications: Hypersensitivity to mouse immunoglobulin, Autoimmune disease, Severe psychiatric disorders (pre-existing), Hypersensitivity to human interferon alfa or any product component, Hypersensitivity to egg protein or neomycin. Consult a qualified clinician before use.