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Table 153-4

Indications and Recommendations for Antiviral Therapy of Chronic Hepatitis Ca

Standard Indications for Therapya

AASLD and EASL 2015 Guidelines recommend treatment for all with advanced fibrosis and differ regarding therapy for those with earlier stage fibrosis as follows:

AASLD

  • Treatment is recommended for all pts with chronic HCV infection, except those with short life expectancies owing to comorbid conditions.
  • Immediate treatment is assigned the highest priority for those pts with advanced fibrosis (Metavir stage F3), those with compensated cirrhosis (Metavir stage F4), liver transplant recipients, and pts with severe extrahepatic hepatitis C.

EASL

  • All treatment-naïve and treatment-experienced pts with compensated and decompensated liver disease.
  • Treatment should be prioritized for pts with significant fibrosis (METAVIR score F3 or F4)
  • In pts with less severe disease, the indication for and timing of therapy can be individualized.
Antiviral Therapy Management Decisions Made on an Individual Basis

Children (age <18 years)—protease inhibitors not recommended.

Age >70 (in protease inhibitor trials, telaprevir trials included pts age 18-70; boceprevir trials included pts >18 years of age [no upper age cutoff])

Mild hepatitis on liver biopsy

Persons with severe renal insufficiency (require reduced doses of PEG IFN and ribavirin)

Concurrent HIV treated similarly, but with extra attention to interactions.

Long-Term Maintenance Therapy Recommended: None
Long-Term Maintenance Therapy in Nonresponders: Not Recommended
Antiviral Therapy Not Recommended

Decompensated cirrhosis (contraindicated with IFN based regimens)

Pregnancy (teratogenicity of ribavirin, unknown effects DAAs)

Contraindications to use of antiviral medications

Therapeutic Regimens

TREATMENT-NAÏVE

Genotype 1a:

  • Daclatasvir 60 mg and sofosbuvir 400 mg daily for 12 (no cirrhosis) or 24 weeks +/- weight-based ribavirin (cirrhosis)
  • Ledipasvir 90 mg and sofosbuvir 400 mg daily for 12 weeks
  • Daily paritaprevir 150mg and ritonavir 100mg/ombitasvir 25mg + twice daily dasabuvir 250mg + weight-based ribavirin for 12 (no cirrhosis) or 24 weeks (cirrhosis)
  • Simepravir 150 mg and sofosbuvir 400 mg daily for 12 weeks (no cirrhosis) or 24 weeks (cirrhosis without q80K mutation) +/- weight-based ribavirin

Genotype 1b:

  • Same as genotype 1a with the exception of daily paritaprevir 150 mg/ritonavir 100mg/ombitasvir 25 mg + twice daily dasabuvir 250 mg is used without ribavirin

Genotype 2:

  • Daclatasvir 60 mg and sofosbuvir 400 mg daily for 12 weeks in pts who cannot tolerate ribavirin
  • Sofosbuvir 400 mg daily + weight-based ribavirin for 12 weeks in noncirrhotic pts, 16 weeks if cirrhotic.

Genotype 3:

  • Daclatasvir 60 mg and sofosbuvir 400 mg daily for 12 weeks (no cirrhosis) or 24 weeks +/- weight-based ribavirin (cirrhosis).
  • Sofosbuvir 400 mg daily and weight-based ribavirin + weekly PEG-IFN for IFN eligible pts
  • Alternative: sofosbuvir 400 mg daily and weight-based ribavirin for 24 weeks

Genotype 4:

  • Ledipasvir 90 mg and sofosbuvir 400 mg daily for 12 weeks
  • Daily paritaprevir 150mg/ritonavir 100mg/ombitasvir 25mg + weight-based ribavirin for 12 weeks
  • Sofosbuvir 400 mg daily + weight-based ribavirin for 24 weeks
  • Alternative: sofosbuvir 400 mg daily + weight-based ribavirin + weekly PEG-IFN for 12 weeks

Genotype 5 and 6:

  • Ledipasvir 90 mg/sofosbuvir 400 mg daily for 12 weeks
  • Alternative: sofosbuvir 400 mg + weight-based ribavirin + weekly PEG-IFN for 12 weeks

TREATMENT-EXPERIENCED

For the latest guidelines:

Features Associated with Reduced Responsiveness

Genotype and subtype

Treatment experience

Extent of fibrosis

aRecommendations for the treatment of hepatitis C are rapidly evolving and new recommendations continue to supplant those listed in this table. Before making any therapeutic decisions, the most recent guidelines should be reviewed which can be found at the website locations provided within the table.

Abbreviations: AASLD, American Society for the Study of Liver Diseases; ALT, alanine aminotransferase; DAA, directly acting antivirals; EASL, European Association for the Study of the Liver; HCV, hepatitis C virus; IFN, interferon; PEG IFN, pegylated interferon; IU, international units (1 IU/mL is equivalent to ~2.5 copies/mL).