Ribavirin and Interferon Protocol for Hepatitis C

Aka: Ribavirin and Interferon Protocol for Hepatitis C, Hepatitis C Treatment with Interferon and Ribavirin

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II. Indications

  1. Previously used for treatment of Hepatitis C (replaced as of 2014)
  2. Included for completeness

III. Medications

  1. Interferon
    1. Replaced in most Hepatitis C protocols by other protocols as of 2014
    2. Interferon alfa-2a (preferred Interferon for all Genotypes)
      1. Pegylated Interferon Alfa-2A (Pegasys)
        1. Adult Dose: 180 mcg SQ per week
    3. Interferon Alfa-2B
      1. Interferon alfa-2a is preferred instead (see above)
      2. Pegylated Interferon Alfa-2B (PEG-Intron)
        1. Adult Dose: 1.5 mcg/kg per week
      3. Interferon Alfa-2B (Intron A)
        1. Dose: 3 Million Units SQ three times per week
        2. Administer with Ribavirin if not contraindicated
        3. Cost: $8000 per 24 week course
        4. Rebetron combines Ribavirin and Interferon Alfa-2B
    4. Adverse Effects
      1. See Interferon alfa
      2. Numerous potential life-threatening adverse effects
  2. Ribavirin (if not contraindicated)
    1. Genotype 2 or 3 (all weights)
      1. Take 400 mg orally twice daily
    2. Genotype 1a, 1b and 4
      1. Weight >75 kg (165 lb): 600 mg orally twice daily
      2. Weight <75 kg (165 lb): 400 mg qAM, 600 mg qPM
    3. Adverse effects
      1. Hemolytic Anemia
      2. Exacerbation of Coronary Artery Disease
      3. Highly Teratogenic
        1. Requires high efficacy, dual Contraception in women of child bearing age
        2. Includes women who are sexual partners of men on Ribavirin
        3. Contraception should be continued throughout therapy and for 6 months after

IV. Protocol

  1. Course
    1. Overall combined cost: $25,000 for 48 weeks
    2. Duration for up to 48 weeks
  2. Check Viral RNA load by PCR
  3. Initiate treatment at doses above
    1. Interferon
    2. Ribavirin
  4. Check Viral RNA load by PCR at 12 weeks
    1. Viral load High (<100 fold decrease)
      1. Stop treatment as unlikely to respond
    2. Viral load markedly lowered (>100 fold decrease)
      1. Continue antiviral course
  5. Antiviral Therapy Duration
    1. Genotype 1: 48 weeks
    2. Genotype 2 and 3: 24 weeks
  6. Check Viral RNA load by PCR at 24 weeks after therapy
    1. Virus detected: Relapse
    2. Virus not detected: 97% chance of cure

V. Monitoring

  1. Protocol
    1. Baseline labs
      1. Complete Blood Count (CBC) with Platelets
      2. Urine Pregnancy Test
      3. Thyroid Stimulating Hormone (TSH)
      4. Liver Function Tests (AST, ALT, Bilirubin)
    2. Repeat labs at 2 weeks, 4 weeks and then monthly
      1. Complete Blood Count (CBC) with Platelets
      2. Urine Pregnancy Test
      3. Liver Function Tests (AST, ALT, Bilirubin)
    3. Repeat TSH every 3 months
  2. Initial management of adverse blood counts
    1. Low Hemoglobin: Epogen 40,000 units SQ weekly
    2. Neutropenia: Consider G-CSF
  3. Response to labs refractory to Erythropoietin
    1. Indications to lower Ribavirin dose 200-400 mg/day
      1. Hemoglobin decreased <10 g/dl
      2. Hemoglobin drops >2 g/dl in one month if CAD
    2. Indications to lower PEG-Intron dose by 25-50%
      1. Hemoglobin drops >2 g/dl in one month if CAD
      2. WBC Count <1.5 x10^3/ul
      3. Neutrophil Count <0.75 x10^3/ul
      4. Platelet Count <50,000 to 80,000
    3. Indications to stop therapy
      1. Hemoglobin <8.5 g/dl
      2. Hemoglobin <12 g/dl after month on low dose if CAD
      3. WBC Count <1.0 x10^3/ul
      4. Neutrophil Count <0.5 x10^3/ul
      5. Platelet Count <25,000 to 50,000

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