Albinterferon Alfa-2B
Also known as: alb-interferon alfa-2b, albIFN alfa-2b, Albinterferon, Albinterferon alfa‑2b, Albuferon, IFN‑α2b‑albumin, IFN‑α2b‑albumin fusion, Joulferon, YFGN-IFN-alfa-2b
Source Albinterferon Alfa-2B at Peptiology
Save 10% with code PEPTI-BOSSRABBIT-10
Affiliate link: we earn a commission on purchases made through this link, at no extra cost to you.
Tapping Shop Now & Save 10% copies your 10% off code PEPTI-BOSSRABBIT-10 to your clipboard. Paste it at the Peptiology checkout to claim the discount.
Summary
Albinterferon alfa-2b is a recombinant fusion protein that links human albumin to interferon‑alpha‑2b, creating a long‑acting type I interferon. It has been investigated as part of combination therapy with ribavirin for chronic hepatitis C virus (HCV) infection, principally genotypes 2 and 3. Clinical trials compared it with standard weekly pegylated interferon, using dosing intervals of two or four weeks.
Mechanism of Action
The interferon‑alpha‑2b component binds the interferon‑α receptor (IFNAR) on target cells, activating the JAK‑STAT signaling cascade and inducing expression of antiviral genes that inhibit viral replication and modulate immune responses. Fusion to albumin markedly prolongs plasma half‑life (≈200 h), allowing sustained drug exposure and permitting dosing every two to four weeks instead of weekly injections.
What the Research Shows
Phase 2 studies in interferon‑naïve and prior‑non‑responder patients with HCV genotype 2/3 showed sustained virologic response (SVR) rates ranging from 61 % to 85 % with albinterferon doses of 900‑1500 µg given every two or four weeks, comparable to pegylated interferon‑α2a. A large phase 3 trial (933 patients) demonstrated non‑inferior SVR (≈80 %) for albinterferon 900 µg or 1200 µg q2 weeks versus pegylated interferon weekly. Pharmacokinetic modelling indicated high inter‑individual variability and limited exposure‑response relationships for efficacy and safety, prompting further dose‑optimization considerations.
Reported Benefits
Clinical data suggest albinterferon achieves SVR rates similar to weekly pegylated interferon in genotype 2/3 infection while requiring fewer injections, which may improve patient convenience and adherence. Some studies reported fewer reductions in neutrophil counts and hemoglobin, leading to fewer dose reductions of interferon or ribavirin. The prolonged half‑life enables flexible dosing intervals (2‑4 weeks) without a clear loss of antiviral potency.
Limitations of the Evidence
Development has been discontinued (withdrawn status), and evidence is limited to genotype 2/3; data for genotype 1 are sparse and derived from early phase 2 trials. Exposure‑response analyses did not reveal a consistent relationship between drug levels and SVR, leaving optimal dosing uncertain. Safety profiles were similar to standard interferon, with comparable rates of serious adverse events. Long‑term outcomes and real‑world effectiveness remain unstudied.
Safety Considerations
Adverse events mirrored those of conventional interferon therapy, including flu‑like symptoms, neutropenia, and anemia. Serious adverse events occurred in 4‑11 % of participants, and discontinuations due to adverse events ranged from 4.5 % (q4 weeks) to 14.3 % (q2 weeks) in early trials. Hematologic reductions (neutrophils, hemoglobin) were generally less frequent with the four‑week regimen. No increase in severe respiratory events was observed, but routine monitoring of blood counts and liver function is advised, as with other interferon‑based regimens.
How It Is Administered
Albinterferon alfa‑2b is administered by subcutaneous injection. Clinical studies evaluated doses of 900 µg, 1200 µg, and 1500 µg given either every two weeks or every four weeks, always in combination with oral ribavirin (typically 800 mg/day). The formulation is a sterile solution intended for single‑use injection.
Routes of Administration
Goals & Uses
- Reduced dosing frequency vs. standard interferonPharmacokinetic AdvantageModerate
- Chronic hepatitis C viral infectionAntiviral TherapyModerate
- Chronic hepatitis C infectionAntiviralModerate
- Chronic Hepatitis C treatment (genotype 1)Antiviral / HepatologyModerate
- Improved patient adherenceDosing ConvenienceModerate
- Chronic Hepatitis C treatment (genotypes 2/3)Antiviral / HepatologyModerate
Contraindications
- Hypersensitivity to interferon‑α or albuminAllergyHigh
- Severe hepatic impairment (Child‑Pugh C)Liver DiseaseHigh
- Hypersensitivity to interferon or albuminAllergyHigh
- Severe autoimmune diseaseImmunologicalModerate
- PregnancyPopulationHighPotential fetal risk or insufficient safety data
- Autoimmune hepatitisHepatic / AutoimmuneHigh
- Decompensated liver disease / Child-Pugh B or C cirrhosisHepaticHigh
- Severe psychiatric disorders (e.g., suicidal ideation)PsychiatricHigh
- Hypersensitivity to interferon alfa or albuminImmunologic / AllergicHigh
Adverse Effects
- Hematologic toxicity (neutropenia, thrombocytopenia, anemia)HematologicCommon
- Injection site reactionsLocalCommon
- Thyroid dysfunction (hypothyroidism or hyperthyroidism)EndocrineUncommon
- Flu‑like syndromeSystemicCommon
- NeutropeniaHematologicUncommonLow neutrophil count
- Flu-like symptoms (fever, chills, myalgia, fatigue)Systemic / ConstitutionalCommon
- Pulmonary adverse events (cough, dyspnea, interstitial pneumonitis)RespiratoryUncommon
- Depression and suicidal ideationPsychiatricUncommon
- Pulmonary hypertensionCardiovascular/pulmonaryRare
- DepressionPsychiatricCommon
- Flu‑like syndrome (fever, myalgia, fatigue)SystemicCommon
- Elevated liver enzymesHepaticUncommonIncrease in AST/ALT or other hepatic markers
- Neuropsychiatric effects (depression, irritability, insomnia)Psychiatric / NeurologicalCommon
Drug Interactions
- Theophylline / MethylxanthinesModerate
- RibavirinModerate
- CorticosteroidsLow
- ImmunosuppressantsModeratePotential interaction with immune pathways or infection risk
- Nucleoside analogues (e.g., zidovudine, didanosine)Moderate
Population Constraints
- Children (<18 years)AgeRelative
- Pediatric patients (<18 years)AgeRelative
- Elderly (>65 years)AgeRelative
- Pediatric patientsAgeRelative
- Patients with pre-existing pulmonary diseaseRespiratoryRelative
- Elderly patients (>65 years)AgeRelative
- Patients with pre-existing psychiatric conditionsPsychiatricRelative
- Pregnant womenReproductiveAbsolute
- Renal impairment (severe)RenalRelative
Regulatory Status
- European UnionInvestigationalNo marketing authorization granted.
- United StatesInvestigationalPhase III halted; never submitted for NDA.
- United KingdomInvestigationalNot approved by MHRA; clinical program terminated.
Phase III trials halted; not approved in US, EU, or other jurisdictions.
Evidence & Sources
- Journal ArticleModeratePianko S, et al.2012-01-01T00:00:00.000000Z
- Journal ArticleModerateBain VG, et al.2008-01-01T00:00:00.000000Z
- Journal ArticleModerateRustgi VK2009-01-01T00:00:00.000000Z
- Journal ArticleModerateRiggs MM, et al.2012-01-01T00:00:00.000000Z
- Journal ArticleModerateNelson DR, et al.2009-01-01T00:00:00.000000Z
- Journal ArticleModerateNelson DR, et al.2010-01-01T00:00:00.000000Z
Frequently Asked Questions
What type of hepatitis C infection has albinterferon been tested for?
All published trials focused on chronic HCV genotype 2 or 3 infection. Small phase 2 studies also included genotype 1 patients, but efficacy data for genotype 1 are limited.
How does the dosing schedule differ from standard interferon therapy?
Standard pegylated interferon is given weekly. Albinterferon’s albumin fusion extends its half‑life, allowing dosing every two weeks or every four weeks, reducing injection frequency.
Is albinterferon currently approved for clinical use?
No. The compound’s development was withdrawn, and it does not have regulatory approval for any indication.
What are the main safety concerns with albinterferon?
Safety is comparable to other interferons: flu‑like symptoms, neutropenia, anemia, and occasional serious adverse events. Hematologic monitoring is required, and dose reductions may be needed if blood counts fall.
What is Albinterferon Alfa-2B?
Albinterferon alfa-2b is a recombinant fusion protein that links human albumin to interferon‑alpha‑2b, creating a long‑acting type I interferon. It has been investigated as part of combination therapy with ribavirin for chronic hepatitis C virus (HCV) infection, principally genotypes 2 and 3. Clinical trials compared it with standard weekly pegylated interferon, using dosing intervals of two or four weeks.
What is Albinterferon Alfa-2B used for?
Albinterferon Alfa-2B is educationally associated with: Reduced dosing frequency vs. standard interferon, Chronic hepatitis C viral infection, Chronic hepatitis C infection, Chronic Hepatitis C treatment (genotype 1), Improved patient adherence, Chronic Hepatitis C treatment (genotypes 2/3). Educational only — not medical advice.
How is Albinterferon Alfa-2B administered?
Recorded routes of administration: Subcutaneous.
What are the potential side effects of Albinterferon Alfa-2B?
Reported adverse effects include: Hematologic toxicity (neutropenia, thrombocytopenia, anemia), Injection site reactions, Thyroid dysfunction (hypothyroidism or hyperthyroidism), Flu‑like syndrome, Neutropenia, Flu-like symptoms (fever, chills, myalgia, fatigue), Pulmonary adverse events (cough, dyspnea, interstitial pneumonitis), Depression and suicidal ideation, Pulmonary hypertension, Depression, Flu‑like syndrome (fever, myalgia, fatigue), Elevated liver enzymes, Neuropsychiatric effects (depression, irritability, insomnia). This list is not exhaustive — consult a qualified clinician.
Who should avoid Albinterferon Alfa-2B?
Recorded contraindications: Hypersensitivity to interferon‑α or albumin, Severe hepatic impairment (Child‑Pugh C), Hypersensitivity to interferon or albumin, Severe autoimmune disease, Pregnancy, Autoimmune hepatitis, Decompensated liver disease / Child-Pugh B or C cirrhosis, Severe psychiatric disorders (e.g., suicidal ideation), Hypersensitivity to interferon alfa or albumin. Consult a qualified clinician before use.