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Treatment for Hepatitis C Virus Infection in Adults: Comparative Effectiveness

Slide: 25 of 34

Key U.S. Food and Drug Administration-Issued Information on Medications Used To Treat Hepatitis C Virus Infection (1 of 2)

Some medications used to treat hepatitis C carry boxed warnings for potential serious adverse effects that might occur with their use. These boxed warnings have been issued by the U.S. Food and Drug Administration. The medications that carry such warnings include:

Pegylated interferon (alfa-2a or alfa-2b) carries boxed warnings for risk of fatal or life-threatening:

  • Neuropsychiatric disorders
  • Autoimmune disorders
  • Ischemic disorders
  • Infectious disorders

Ribavirin carries boxed warnings for:

  • The lack of efficacy of ribavirin monotherapy in patients with chronic hepatitis C virus infection
  • Risk of myocardial infarctions resulting from ribavirin-associated hemolytic anemia
  • Contraindication in pregnant women and in the male partners of pregnant women who are pregnant. Extreme care must be taken to avoid pregnancy during ribavirin therapy in female patients and for 6 months after completion of ribavirin therapy in the female partners of male patients because significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to the drug.