Victrelis™ (boceprevir) and Hepatitis C

Are there any other warnings one should know regarding Victrelis™ combination therapy?

UPDATE: As of January 2015 Merck announced it will discontinue selling Victrelis in the United States by the end of the year.

• Pregnancy – Ribavirin may cause birth defects and/or death of the unborn baby. Pregnancy must be avoided in female patients as well as female partners of male patients. It is recommended that at least two forms of contraception be used during treatment and for at least 6 months after the completion of treatment since systemic hormonal contraceptives (birth control pills, vaginal rings, implants, or injections) may not be as effective for women taking Victrelis™. Recommended alternative contraception options include intrauterine devices (IUD) and barrier methods. If the female patient or female partner of the male patient should get pregnant during treatment or within 6 months of completing treatment, she should contact her healthcare provider right away.
• Anemia – while anemia has been reported with peginterferon alfa and ribavirin therapy, adding Victrelis™ is associated with an additional decrease in hemoglobin concentrations.
• Neutropenia (lowered neutrophils – type of white blood cell that surrounds and destroys bacteria) – In Phase 2 and 3 clinical trials, 7% of subjects receiving the combination of Victrelis™ with PegIntron/Rebetol had neutrophil counts of less than 0.5 x 109/L compared to 4% of subjects receiving PegIntron/Rebetol alone. Three subjects experienced severe or life-threatening infections associated with neutropenia, compared to two subjects receiving the combination of Victrelis™/PegIntron/Rebetol.
• Drug Interactions – see “When is Victrelis™ contraindicated?” for more information.
• Laboratory Tests – HCV-RNA levels should be consistently monitored at weeks 4, 8, 12 and 24 of treatment, as well as at the end of treatment, during treatment follow up as well as additional tests as indicated. It is recommended that a sensitive, real-time, reverse-transcription polymerase chain reaction (RT-PCR) assay for monitoring be used.Additionally, a complete blood count must be conducted prior to initiating Victrelis™ combination therapy. These complete blood counts should be consistently obtained at weeks 4, 8 and 12 of treatment and should be monitored at other points as is clinically appropriate.

  Due to the risk of birth defects and/or fetal death, the report of a negative pregnancy test should be obtained immediately before the start of therapy and performed routinely every month during treatment until at least 6 months after treatment has concluded.

• Breastfeeding – It is not known whether Victrelis™ is excreted into human breast milk. Due to the potential for adverse reactions from the drug in breastfeeding infants, a decision must be made whether one should discontinue breastfeeding or discontinue Victrelis™ combination treatment.

Last Updated: January 2015