What types of adverse reactions were reported when taking Victrelis™? | Hepatitis Central

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Victrelis™ (boceprevir) and Hepatitis C

What types of adverse reactions were reported when taking Victrelis™?

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

In the clinical studies the most serious adverse reactions included anemia and neutropenia (lowered neutrophils – type of white blood cell that surrounds and destroys bacteria). The most commonly reported side effects were fatigue, anemia, nausea, headache, and alteration of taste (dysgeusia) when Victrelis™ was used in combination with PegIntron and Rebetol.

Of all subjects (whether previous treated or untreated) that received the Victrelis™/PegIntron/Rebetol combination therapy, additional adverse effects reported included diarrhea, vomiting, dry mouth, chills, asthenia (weakness), decreased appetite, arthralgia (joint pain), dizziness, insomnia, irritability, exertional dyspnea (breathlessness), alopecia (hairloss), dry skin and rash.

During the 4 week lead-in period with PegIntron/Rebetol 28 out of 1263 (approximately 2%) of the subjects experienced adverse reactions that lead to their discontinuing the treatment.

During the entire course of treatment, for those that were being treated with PegIntron/Rebetol alone, 12% discontinued treatment due to adverse reactions compared to 13% of those that were receiving the Victrelis™/PegIntrol/Rebetol combination. Merck reports that events resulting in discontinuation were similar to those seen in previous studies with PegIntron/Rebetol alone. They also report that only anemia and fatigue were reported as the events that led to discontinuation in greater than 1% of subjects in any of the test variants.

39% of subjects receiving the combination of Victrelis™ with PegIntron/Rebetol and 24% of subjects receiving PegIntron/Rebetol alone had adverse reactions, most commonly due to anemia, that led to dose modifications of any drug (primarily PegIntron and Rebetol dosages were modified).

Serious adverse events were reported in 11% of the subjects receiving the Victrelis™/PegIntron/Rebetol combination therapy, compared to 8% of subjects receiving PegIntron/Rebetol alone.

Last Updated: January 2015

Merck "Highlights of Prescribing Information - Victrelis" http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf. Retrieved May 18, 2011.

Merck "Medication Guide - Victrelis™" http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_mg.pdf. Retrieved May 18, 2011.

Merck "Patient Assistance Programs" http://www.merck.com/responsibility/pap-information.html. Retrieved May 23, 2011.

Neutropenia Support Association, Inc. "What is Neutropenia?" http://www.neutropenia.ca/. Retrieved May 19, 2011.

Victrelis http://victrelis.com/boceprevir/victrelis/consumer/index.jsp. Retrieved May 23, 2011.