Infergen

Name: Infergen

Dosing & Uses

Dosage Forms & Strengths

injectable solution

  • 9mcg/0.3mL
  • 15mcg/0.5mL

Chronic Hepatitis C

This product was discontinued in September 2013

9 mcg SC 3 times/week for 24 wk

Retreatment: Allow 48 hr between doses

If severe toxicity occurs: Reduce to 7.5 mcg SC 3 times/week or discontinue

Monitor: Hgb, WBC, Plt, LFTs, creatinine, thyroid

Combination use with ribavirin

  • Retreatment: 15 mcg SC with ribavirin qDay for up to 48 weeks
  • <75 kg: ribavirin 1 g PO divided q12hr
  • ≥75 kg: ribavirin 1.2 g PO divided q12hr
  • Monitor: Hgb, WBC, Plt, LFTs, creatinine, thyroid

Renal Impairment

CrCl <50 mL/min: Avoid combination therapy with ribavirin in hepatitis C treatment

Hepatic Impairment

Moderate-to-severe (Child-Pugh Class B and C): Contraindicated

Other Indications & Uses

Off-label: Hairy-cell leukemia (in combination with G-CSF)

Safety and efficacy not established

Adverse Effects

>10%

Headache (~80%)

Fatigue (~70%)

Fever (~60%)

Rigors (~60%)

Myalgia (~55%)

Body pain (~50%)

Arthralgia (~45%)

Back pain (29-42%)

Granulocytopenia (23-42%)

Abd pain (24-41%)

Nausea (30-40%)

Insomnia (24-39%)

Pharyngitis (17-34%)

Nervousness (16-31%)

URI (16-31%)

Leukopenia (15-28%)

Limb pain (13-26%)

Diarrhea (~25%)

Cough (12-22%)

Dyspepsia (12-21%)

Anorexia (~20%)

Depression (~20%)

Inj site erythema (~20%)

Anxiety (19%)

Thrombocytopenia (19%)

Alopecia (14%)

Pruritus (14%)

Skeletal pain (14%)

Rash (13%)

Rhinitis (13%)

Chest pain (5-13%)

Hot flushes (4-13%)

Vomiting (12%)

Inj site pain (8-11%)

Asthenia (~10%)

1-10% (selected)

Abnormal LFTs

Amnesia

Constipation

Dysmenorrhea

Libido decrease

Bronchitis

Epistaxis

Hypertension

Palpitations

Vaginitis

Frequency Not Defined

Vision loss or retinopathy

Pregnancy & Lactation

Pregnancy Category: C (interferon monotherapy); X (combination with ribavirin)

Lactation: not known if excreted in breast milk, use caution

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Clinical pharmacology

Mechanism of Action

Interferon alfacon-1 is an inducer of the innate antiviral immune response.

Pharmacodynamics

Interferons induce pleiotropic biologic responses which include antiviral, antiproliferative, and immunomodulatory effects, regulation of cell surface major histocompatibility antigen (HLA class I and class II) expression and regulation of cytokine expression.

Analysis of INFERGEN-induced cellular products (induction of 2'5' OAS and ß-2 microglobulin) after treatment in these subjects revealed a statistically significant, dose-related increase in the area under the curve (AUC) for the levels of 2'5' OAS or ß-2 microglobulin induced over time. Concentrations of 2'5' OAS were maximal at 24 hours after dosing, while serum levels of ß-2 microglobulin appeared to reach a maximum 24 to 36 hours after dosing. The dose-response relationships observed for 2'5' OAS and ß-2 microglobulin were indicative of biological activity after subcutaneous injection administration of 1 mcg to 9 mcg INFERGEN.

Pharmacokinetics

The pharmacokinetic properties of INFERGEN have not been evaluated in patients with chronic hepatitis C. Pharmacokinetic profiles were evaluated in normal, healthy volunteer subjects after subcutaneous injection of 1 mcg, 3 mcg, or 9 mcg INFERGEN. Plasma levels of INFERGEN after subcutaneous injection administration of any dose were too low to be detected by either enzyme-linked immunosorbent assay (ELISA) or by inhibition of viral cytopathic effect.

Renal Dysfunction

Patients with creatinine clearance < 50 mL/min should not be treated with ribavirin [see WARNINGS AND PRECAUTIONS: Renal Impairment; Ribavirin Labeling].

Microbiology

Mechanism of Action

Interferon alfacon-1 is a recombinant hybrid protein based on the consensus amino acid sequence of naturally occurring human type-I interferon alphas. Type-I interferons are a family of small protein molecules with molecular weights of 15,000 to 21,000 daltons that are produced and secreted by cells in response to viral infections or to various synthetic and biological inducers. Interferons do not act directly on the virus but bind to the interferon cell-surface receptor leading to the production of several interferon-stimulated gene products. Interferons induce pleiotropic biologic responses which include antiviral, antiproliferative, and immunomodulatory effects, regulation of cell surface major histocompatibility antigen (HLA class I and class II) expression and regulation of cytokine expression.

Antiviral Activity in Cell Culture

The antiviral activity of INFERGEN, alone or in combination with ribavirin, against HCV or HCV-derived replicons in cell culture has not been determined.

Resistance

HCV genotypes show wide variability in their response to interferon/ribavirin based therapies. Genetic changes associated with the variable response have not been identified. It has been reported that certain regions of the HCV genome, especially a region in the NS5B protein called IFN-sensitive determining region, may play a role in determination of a patient's response to interferon treatment.

Cross-resistance

The homology between interferon alfacon-1 and other type-I interferons, and the clinical responses for the different HCV genotypes are consistent with cross-resistance.

Animal Toxicology and/or Pharmacology

Animal Toxicology

In preclinical toxicology studies in golden Syrian hamsters and rhesus monkeys, administration of INFERGEN at doses of up to 100 mcg/kg/day was associated with decreased body weight, decreased food consumption, and bone marrow suppression. High-dose chronic exposure at doses of 10 mcg/kg/day to 100 mcg/kg/day (50-fold to 500-fold higher than the maximum clinical dose given daily) in rhesus monkeys was not tolerated for greater than 1 month, due to the development of vascular leak syndrome.

Clinical Studies

Initial Treatment with INFERGEN Monotherapy

The efficacy of INFERGEN monotherapy compared to recombinant human interferon alfa-2b (IFN α-2b) was evaluated in a randomized, double-blind clinical trial involving 704 subjects previously untreated with interferon alpha. Subjects were 18 years or older, had compensated liver disease, tested positive for HCV RNA, and had elevated serum alanine aminotransferase (ALT) averaging greater than 1.5 times the upper limit of normal. Staging of chronic liver disease was confirmed by a liver biopsy taken within 1 year prior to enrollment.

Subjects were treated with INFERGEN 3 mcg (n = 232), 9 mcg (n = 232), or IFN α-2b 3 million international units (MIU) (n = 240), each administered three times per week for 24 weeks and were observed for 24 weeks after the end of treatment. Efficacy was determined by measurement of serum ALT and HCV RNA levels, and changes in liver histology. Serum HCV RNA was assessed using a research-based quantitative reverse transcriptase polymerase chain reaction (RT-PCR) assay with a lower limit of sensitivity of 100 copies/mL. Liver histology was assessed by comparing the histology activity index (HAI) score of pretreatment and post treatment biopsy specimens. Histologic improvement was defined as having at least a 2-unit decrease in the Knodell HAI score.

Response rates at the end of the observation period are included in Table 6.

Table 6: End of Observation Response Rates

  INFERGEN 9 mcg
n = 232
IFN α-2b 3 MIUa
n = 240
Normalized ALT 17% 17%
HCV RNA negative 9% 8%
Histologic improvement 68% 65%
a 3 MIU IFN α-2b is equivalent to approximately 15 mcg IFN α-2b.

The 3 mcg INFERGEN dosage arm was substantially less effective with only 3% of subjects achieving end of observation responses.

Subsequent Treatment with INFERGEN Monotherapy

Subsequent treatment with INFERGEN 15 mcg monotherapy for either 24 or 48 weeks was evaluated in an open-label clinical trial of 208 subjects who had failed initial interferon monotherapy. Of the subjects, 64% had failed to normalize ALT during initial treatment (ALT non-responder) and 36% achieved normal ALT levels during initial treatment, but had return of elevated ALT levels during post treatment observation (ALT relapse). Subjects were assessed for normalization of ALT and HCV RNA reduction to ≤ 100 copies/mL at the end of 24 weeks of observation following discontinuation of therapy. Response rates are included in Table 7.

Table 7: End of Observation Response Rates

  All Subjects Prior ALT Nonresponders Prior ALT Relapsers
24 Weeks
(n =107)
48 Weeks
(n = 101)
24 Weeks
(n = 74)
48 Weeks
(n = 59)
24 Weeks
(n = 33)
48 Weeks
(n = 42)
Normalized ALT 13% 19% 7% 7% 27% 36%
HCV RNA < 100 copies/mL 9% 22% 4% 12% 21% 36%

Subsequent Treatment with Combination INFERGEN/Ribavirin

This study (DIRECT Trial/ IRHC-001 and IRHC-002) was a randomized, open-label, multi-center, US-based study comparing the safety and efficacy of two doses of INFERGEN (9 mcg or 15 mcg) administered daily plus ribavirin (1000 mg or 1200 mg weight based dosed) administered daily for 48 weeks to subjects who were nonresponders to previous pegylated interferon plus ribavirin (PegIFN/ribavirin) therapy. Prior non-response was defined as a < 2 log10 decline in viral load (VL) while undergoing at least 12 weeks of previous Peg-IFN/ribavirin therapy with ≥ 80% adherence or a detectable VL at end-of-treatment after completing at least 24 weeks of therapy. Study subjects had a mean age of 50 yrs, 70% were male, mean weight of 89 kg, 19% were African Americans, 65% were Caucasians, 66% had high VL ( ≥ 850,000 IU/mL), 95% were infected with genotype 1, 54% had evidence of bridging fibrosis, 25% had evidence of cirrhosis on biopsy, and 50% had steatosis. Approximately, 80% of the subjects were null responders ( < 2 log10 drop in viral load during their previous Peg-IFN/ribavirin therapy). The median washout period between previous treatment and day 1 of INFERGEN therapy was 448 days (15 months) and 506 days (16.8 months) for the 9 mcg and 15 mcg groups, respectively. The use of hematopoietic growth factors was not permitted in the DIRECT Trial.

In study IRHC-001, 515 subjects were randomized to INFERGEN 9 mcg plus ribavirin (n=171), INFERGEN 15 mcg plus ribavirin (n=172), or no treatment (n=172). In study IRHC-002, 144 subjects in the no treatment arm of study IRHC-001 were re-randomized to either INFERGEN 9 mcg plus ribavirin (n=74) or INFERGEN 15 mcg plus ribavirin (n=70).

Subjects were treated for up to 48 weeks. The primary endpoint was sustained virological response (SVR), defined as undetectable HCV RNA 24 weeks after the end of treatment using a sensitive qualitative assay (TMA LOD < 10 IU/mL). None of the subjects in the no-treatment arm of study IRHC-001 achieved an SVR.

Combined SVR results from IRHC-001 and IRHC-002 according to baseline characteristics are shown in Table 8. Based on these results, INFERGEN 15 mcg is the recommended starting dose.

Table 8: SVR Rates for Subjects Retreated with INFERGEN/ribavirin

  INFERGEN 9 mcg/ribavirin INFERGEN 15 mcg/ribavirin
Overall SVR 5% (13/245) 9% (21/242)
Genotype 1 4% (10/231) 6% (15/233)
-F0-3 5% (9/181) 7% (12/167)
-F4 2% (1/50) 5% (3/66)
Other Genotypes 21% (3/14) 67% (6/9)
-F0-3 27% (3/11) 75% (6/8)
-F4 0% (0/3) 0% (0/1)
HCV RNA < 850,000 IU/mL 13% (10/77) 14% (11/78)
HCV RNA ≥ 850,000 IU/mL 2% (3/168) 6% (10/163)
Caucasian 6% (10/158) 10% (16/158)
African American 4% (2/52) 5% (2/42)
Other race 3% (1/35) 7% (3/42)

Inform MD

Before taking Infergen, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

  • are allergic to Infergen or to any of its ingredients
  • have diabetes
  • have autoimmune diseases
  • have depression
  • have heart disease
  • have hyperthyroidism
  • have hypothyroidism
  • have idiopathic pulmonary fibrosis
  • have cystic fibrosis
  • have Crohn's disease
  • have any eye conditions
  • are pregnant or plan to become pregnant
  • are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Infergen Usage

Take Infergen exactly as prescribed.

  • This medication is available in an injectable form to be given directly under the skin (subcutaneously), typically three times per week for 24 weeks. At least 48 hours should elapse between doses of Infergen
  • Do not reduce the dosage of Infergen prior to medical consultation
  • If self-injection is determined to be appropriate by your physician, instructions on appropriate use will be given to you by a healthcare professional

Administer Infergen exactly as instructed by your physician. You may refer to the following instructions for aditional information:

Initial Preparation

Assemble the supplies you will need for your injection:

  • A vial of Infergen
  • One sterile disposable syringe and needle
  • Several alcohol swabs
  • A puncture-proof container to dispose of the needle and syringe when you are done

Make sure you have the right syringe to use with Infergen. It is important to use a syringe that is marked in tenths of millimeters (mLs), for example, 0.1 mL. Your healthcare provider may refer to a mL as a cc (1 mL = 1 cc). Failure to use the right syringe can lead to a mistake in dosage. You may receive too little or too much Infergen.

Check the date on the vial of Infergen and make sure that the date has not passed and look at the liquid inside the vial.

Do not use Infergen if:

  • The liquid is cloudy
  • The liquid is not clear and colorless
  • The liquid has particles
  • The expiration date has passed

Selecting The Injection Site

Find a clean, comfortable, well-lit place and remove a vial of Infergen from the refrigerator and allow it to reach room temperature.

Wash your hands thoroughly with soap and water.

Pick a site for your injection:

  • Back of the upper arms (if someone is giving you the injection)
  • Upper stomach area (abdomen), except for the belly button (navel) and waist areas
  • Upper thighs

You should change the site for injection each time you inject to avoid soreness at any one site.

Clean the injection site with an alcohol swab. Use circular motions from the inside to the outside. Keep the used alcohol swab nearby.

Preparing the Dose

  1. Remove the colored cap from the vial, exposing the rubber stopper.
  2. Clean the rubber stopper with a new alcohol swab, and then cover the stopper with the swab
  3. Remove the syringe and needle from their packages. If either package looks like there have been opened or damaged, do not use the syringe or needle; dispose of it in the puncture-proof disposal container.
  4. Remove the needle cover and pull the plunger back and draw air into the syringe. The amount of air you draw into the syringe should be the same amount as the dose of medicine your healthcare provider has prescribed.
  5. Remove the alcohol wipe from the top of the vial and insert the needle straight through the center of the rubber stopper.
  6. Push the plunger of the syringe down to inject the air into the air space above the liquid in the vial. The air injected into the vial will allow Infergen to be easily withdrawn from the vial into the syringe.
  7. Keeping the needle in the vial, turn the vial upside down and make sure that the tip of the needle is in the liquid.
  8. Slowly pull the plunger back and let the medicine enter the syringe, filling it to the line that equals the dose your healthcare provider prescribed.
  9. Keeping the needle in the vial, check for air bubbles in the syringe. Air bubbles are harmless but can reduce the dose you should be receiving. To remove the air bubbles, gently tap the syringe with your fingers until the bubbles rise to the needle-end of the syringe barrel. Then push the plunger in to force the air out of the syringe.
  10. Make sure the tip of the needle is in the liquid and slowly pull back on the plunger until the liquid in the syringe reaches the mark that correctly matches the amount of your dose.
  11. Take the needle out of the vial and hold the syringe needle facing up in the hand that you will use to inject yourself. Do not lay the syringe down or allow the needle to touch anything.

Injecting The Dose

  1. After the needle is in, let go of the skin. Pull the plunger back slightly. If blood appears, do not inject Infergen, because the needle has entered a blood vessel. Withdraw the syringe and discard it. Prepare a new syringe and inject at a new site. Repeat this procedure at the second site, checking for blood before injecting.
  2. Hold the syringe the way you would hold a pencil and insert the needle either straight up and down (90 degree angle) or at a slight angle (45 degree angle) to the skin.
  3. Use the other hand to pinch a fold of skin at the site you cleaned for an injection.
  4. If no blood appears, slowly push down on the plunger all the way, until all the medicine is gone from the syringe.
  5. Pull the needle out of the skin at the same angle you put it in and place an alcohol swab over the injection site, then press for several seconds.
  6. Promptly place the needle and syringe in the puncture-proof disposal container. Never reuse the syringe or needle. Do not recap the needle.

Disposal

  • Dispose of syringes and needles as directed by your healthcare provider or pharmacist. There may be special state and local laws.
  • Place all used needles, needle covers, and syringes in a special container called a “Sharps Container” or a hard plastic container‚ or a metal container with a plastic lid. Do not use glass or clear plastic containers‚ or any container that will allow the needles to stick through them.
  • Always keep the container out of the reach of children.
  • Do not recycle containers or throw full containers into the household trash.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Infergen at the same time.

What happens if i miss a dose (infergen)?

Use the missed dose as soon as you remember, and then call your doctor to ask when you should use your next dose. Do not go back to your regular dosing schedule without talking to your doctor. Do not use extra medicine to make up the missed dose.

Indications and Usage for Infergen

Chronic Hepatitis C

Infergen® (interferon alfacon-1) is indicated for treatment of chronic hepatitis C in patients 18 years of age or older with compensated liver disease. This indication is based on clinical trials conducted using Infergen as monotherapy prior to the time that combination treatment was the standard of care and on a single trial evaluating Infergen in combination with ribavirin in patients who failed to respond to previous treatment with a pegylated interferon and ribavirin.

The following points should be considered when initiating treatment with Infergen:

• Use of monotherapy with an interferon such as Infergen for the treatment of hepatitis C is not recommended unless a patient is unable to take ribavirin. • The safety and efficacy of the combination of Infergen/ribavirin in treatment-naïve patients or in patients co-infected with HBV or HIV-1 have not been evaluated. • Patients with the following characteristics are less likely to benefit from retreatment with combination therapy: response of <1 log10 drop HCV RNA on previous treatment, Genotype 1, high viral load (>850,000 IU/mL), African American race, and/or presence of cirrhosis. • No safety and efficacy data are available for treatment of longer than one year.

Dosage Forms and Strengths

Infergen is provided in single-use vials containing:

• 9 mcg/0.3 mL Infergen in sterile, clear, colorless, preservative-free liquid • 15 mcg/0.5 mL Infergen in sterile, clear, colorless, preservative-free liquid

Clinical Studies

Initial Treatment with Infergen Monotherapy

The efficacy of Infergen monotherapy compared to recombinant human interferon alfa-2b (IFN α-2b) was evaluated in a randomized, double-blind clinical trial involving 704 subjects previously untreated with interferon alpha. Subjects were 18 years or older, had compensated liver disease, tested positive for HCV RNA, and had elevated serum alanine aminotransferase (ALT) averaging greater than 1.5 times the upper limit of normal. Staging of chronic liver disease was confirmed by a liver biopsy taken within 1 year prior to enrollment.

Subjects were treated with Infergen 3 mcg (n = 232), 9 mcg (n = 232), or IFN α-2b 3 million international units (MIU) (n = 240), each administered three times per week for 24 weeks and were observed for 24 weeks after the end of treatment. Efficacy was determined by measurement of serum ALT and HCV RNA levels, and changes in liver histology. Serum HCV RNA was assessed using a research-based quantitative reverse transcriptase polymerase chain reaction (RT-PCR) assay with a lower limit of sensitivity of 100 copies/mL. Liver histology was assessed by comparing the histology activity index (HAI) score of pretreatment and post treatment biopsy specimens. Histologic improvement was defined as having at least a 2-unit decrease in the Knodell HAI score.

Response rates at the end of the observation period are included in Table 6.

Table 6. End of Observation Response Rates
a 3 MIU IFN α-2b is equivalent to approximately 15 mcg IFN α-2b.

Infergen
9 mcg
n = 232

IFN  α-2b
3 MIUa
n = 240

Normalized ALT

17%

17%

HCV RNA negative

9%

8%

Histologic improvement

68%

65%

The 3 mcg Infergen dosage arm was substantially less effective with only 3% of subjects achieving end of observation responses.

Subsequent Treatment with Infergen Monotherapy

Subsequent treatment with Infergen 15 mcg monotherapy for either 24 or 48 weeks was evaluated in an open-label clinical trial of 208 subjects who had failed initial interferon monotherapy. Of the subjects, 64% had failed to normalize ALT during initial treatment (ALT non-responder) and 36% achieved normal ALT levels during initial treatment, but had return of elevated ALT levels during post treatment observation (ALT relapse). Subjects were assessed for normalization of ALT and HCV RNA reduction to ≤ 100 copies/mL at the end of 24 weeks of observation following discontinuation of therapy. Response rates are included in Table 7.

Table 7. End of Observation Response Rates

All Subjects

Prior ALT Nonresponders   

Prior ALT Relapsers

24 Weeks  
(n =107)

48 Weeks  
(n = 101)

24 Weeks  
(n = 74)

48 Weeks
(n = 59)

24 Weeks  
(n = 33)

48 Weeks
(n = 42)

Normalized ALT

13%

19%

7%

7%

27%

36%

HCV RNA <100 copies/mL

9%

22%

4%

12%

21%

36%

Subsequent Treatment with Combination Infergen/Ribavirin

This study (DIRECT Trial/ IRHC-001 and IRHC-002) was a randomized, open-label, multi-center, US-based study comparing the safety and efficacy of two doses of  Infergen (9 mcg or 15 mcg) administered daily plus ribavirin (1000 mg or 1200 mg weight based dosed) administered daily for 48 weeks to subjects who were nonresponders to previous pegylated interferon plus ribavirin (Peg-IFN/ribavirin) therapy. Prior non-response was defined as a < 2 log10 decline in viral load (VL) while undergoing at least 12 weeks of previous Peg-IFN/ribavirin therapy with ≥ 80% adherence or a detectable VL at end-of-treatment after completing at least 24 weeks of therapy. Study subjects had a mean age of 50 yrs, 70% were male, mean weight of 89 kg, 19% were African Americans, 65% were Caucasians, 66% had high VL (≥ 850,000 IU/mL), 95% were infected with genotype 1, 54% had evidence of bridging fibrosis, 25% had evidence of cirrhosis on biopsy, and 50% had steatosis. Approximately, 80% of the subjects were null responders (< 2 log10 drop in viral load during their previous Peg-IFN/ribavirin therapy). The median washout period between previous treatment and day 1 of Infergen therapy was 448 days (15 months) and 506 days (16.8 months) for the 9 mcg and 15 mcg groups, respectively. The use of hematopoietic growth factors was not permitted in the DIRECT Trial.

In study IRHC-001, 515 subjects were randomized to Infergen 9 mcg plus ribavirin (n=171), Infergen 15 mcg plus ribavirin (n=172), or no treatment (n=172). In study IRHC-002, 144 subjects in the no treatment arm of study IRHC-001 were re-randomized to either Infergen 9 mcg plus ribavirin (n=74) or Infergen 15 mcg plus ribavirin (n=70).

Subjects were treated for up to 48 weeks. The primary endpoint was sustained virological response (SVR), defined as undetectable HCV RNA 24 weeks after the end of treatment using a sensitive qualitative assay (TMA LOD <10 IU/mL). None of the subjects in the no-treatment arm of study IRHC-001 achieved an SVR.

Combined SVR results from IRHC-001 and IRHC-002 according to baseline characteristics are shown in Table 8. Based on these results, Infergen 15 mcg is the recommended starting dose.

Table 8. SVR Rates for Subjects Retreated with Infergen/ribavirin

Infergen 9 mcg/ribavirin   

Infergen 15 mcg/ribavirin

Overall SVR

5% (13/245)

9% (21/242)

Genotype 1

4% (10/231)

6% (15/233)

  - F0-3

5% (9/181)

7% (12/167)

  - F4

2% (1/50)

5% (3/66)

Other Genotypes

21% (3/14)

67% (6/9)

  - F0-3

27% (3/11)

75% (6/8)

  - F4

0% (0/3)

0% (0/1)

HCV RNA <850,000 IU/mL

13% (10/77)

14% (11/78)

HCV RNA ≥850,000 IU/mL

2% (3/168)

6% (10/163)

Caucasian

6% (10/158)

10% (16/158)

African American

4% (2/52)

5% (2/42)

Other race

3% (1/35)

7% (3/42)

How Supplied/Storage and Handling

Use only one vial per dose; do not re-enter the vial. Discard unused portions. Do not save unused drug for later administration.

Single-use, preservative-free vials containing 9 mcg (0.3 mL) of interferon alfacon-1 are available in dispensing packs of 6 vials (NDC 66435-202-09).

Single-use, preservative-free vials containing 15 mcg (0.5 mL) of interferon alfacon-1 are available in dispensing packs of 6 vials (NDC 66435-201-15).

Infergen should be stored in the refrigerator at 2 °C to 8 °C (36 °F to 46 °F). Do not freeze. Avoid vigorous shaking and exposure to direct sunlight

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