Hepatitis C Drug Labeling Update
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Adding boceprevir (Victrelis) to combination therapy has been a major breakthrough in Hepatitis C treatment, dramatically boosting the odds of recovering from this prevalent and persistent viral infection of the liver. On the positive side, boceprevir helps boost the likelihood of combination therapy eliminating Hepatitis C from 50 percent up to 75 percent. However, boceprevir remains a potent drug with its fair share of side effects. Confirming this understanding, the U.S. Food and Drug Administration (FDA) mandated an addendum to boceprevir’s warning label in early November 2012. If you are currently taking boceprevir or are planning to do so, make sure you are aware of this drug’s newly recognized list of cautions.
About Victrelis
Approved by the FDA in the spring of 2011, Victrelis is a protease inhibitor intended for use with the medicines peg-interferon alfa and ribavirin to treat chronic Hepatitis C genotype 1 infection in adults with stable liver disease who:
- have not been treated before
- have failed previous treatment
This oral medication can help many people achieve a sustained virologic response (the standard goal of treatment equating to a Hepatitis C cure). Unfortunately, Victrelis can also cause serious side effects.
More About SVR
Sustained virologic response, or SVR, is the achievement of clearing the Hepatitis C virus from the blood stream. An SVR can only be declared if Hepatitis C cannot be detected in the blood six months after the end of treatment.
However, achieving SVR is not a guarantee that Hepatitis C won’t return:
- There is no such thing yet as life-long immunity to this virus; as such, another exposure to viral particles can easily result in re-infection.
- Although not terribly common, there have been cases where Hepatitis C returns after someone achieves SVR.
- Because the Hepatitis C virus has been found in tissues outside of the liver and blood, the potential exists for it to hide elsewhere for an extended period of time before reappearing.
Nonetheless, achieving SVR is the closest measurement we currently have to evaluate Hepatitis C treatment effectiveness. In addition, a growing number of studies are demonstrating that achieving SVR or even just enduring Hepatitis C combination therapy bode well for reducing the risk of future liver health complications.
Victrelis Side Effects
As is the case with any powerful medication, Victrelis is accompanied by a long list of potentially severe side effects. A summary of its side effects include:
- Birth defects or death of an unborn baby
- Severe anemia or other blood problems, because Victrelis can affect bone marrow and cause low red blood cell and low white blood cell counts
- Tiredness or fatigue
- Nausea
- Headache
- Change in taste
- Interactions with other medicines
Victrelis Safety Update
Familiar to most boceprevir-prescribing physicians, the side effects listed above are far from a complete list. Addressing the potential for an allergic reaction and other adverse effects, Victrelis’ label was updated by the FDA.
Clinically described as a risk of serious hypersensitivity, people taking Victrelis as part of triple antiviral therapy for Hepatitis C are at risk of the following allergic reaction symptoms:
- Itching
- Hives
- Facial, tongue or throat swelling
- Difficulty breathing or swallowing
Because an allergic reaction that progresses to difficulty breathing is serious, those who experience hypersensitivity symptoms are urged to seek prompt medical attention.
In addition, several more potential adverse reactions were added to this medication’s insert. They include several gastrointestinal and skin disorders:
- Mouth ulceration
- Stomatitis
- Angioedema
- Drug rash with eosinophilia and systemic symptoms (DRESS) syndrome
- Exfoliative rash
- Exfoliative dermatitis
- Stevens-Johnson syndrome
- Toxic skin eruption
- Toxicoderma
Since all of the issues described above are far from subtle, they would be recognized right away. Thus, anyone noticing the signs of an allergic reaction or one of the gastrointestinal or skin problems listed on the new label would likely consult his or her physician immediately anyway – regardless of the drug’s new package insert.
It is natural to want to avoid a drug with a long list of cautions. However, any drug that is strong enough to help wipe out the notoriously difficult-to-treat Hepatitis C is bound to have some unwanted systemic effects. Since the benefits gained from SVR are worth a few side effects, this new labeling protocol is not expected to turn physicians away from including boceprevir in their Hepatitis C regimens. Instead, the FDA’s intervention in Victrelis’ labeling helps make those involved in fighting Hepatitis C more educated, aware and prepared for the hurdles that could possibly come their way.
References:
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm301204.htm, Victrelis (boceprevir) label change reflects drug-drug interaction information with HIV protease inhibitors, Retrieved November 6, 2012, US Food and Drug Administration, 2012.
http://hivandhepatitis.com/hepatitis-c/hepatitis-c-topics/hcv-treatment/3850-boceprevir-label-information-updated-to-include-acute-hypersensitivity-risk, Boceprevir Label Information Updated to Include Acute Hypersensitivity Risk, Retrieved November 6, 2012, US Food and Drug Administration, 2012.
http://www.victrelis.com/boceprevir/victrelis/consumer/hepatitis-c-treatment.jsp, Victrelis (boceprevir), Retrieved November 9, 2012, Merck & Co., Inc., 2012.
