Managing Side Effects From New Hepatitis C Drugs

Serious Rashes

Severe rashes appeared to be more common among users of telaprevir than among people who used interferon and ribavirin. In about 5% of clinical trial participants, telaprevir-associated rash was severe. As with every drug, there are always cases of very severe skin reactions that could become life threatening if early symptoms go unrecognized and if use of the drug is not stopped.

The good news is that in the case of telaprevir only about 0.4% of participants developed a collection of severe rash and other symptoms called DRESS (drug reactions with eosinophilia and systemic symptoms) and TEN (toxic epidermal necrolysis) or Stevens-Johnson Syndrome (SJS). All severe reactions cleared once participants stopped taking telaprevir.

About DRESS

In general, cases of DRESS tend to occur several weeks after a person has started taking the offending drug. DRESS involves an immunologic reaction that can affect several parts of the body (liver, kidneys, lungs, heart), depending on the severity of the reaction.

There does not appear to be international consensus about all the signs and symptoms associated with DRESS. However, cases of DRESS have been associated with the following:

• fever (more than 38.5°C)
• rash
• swollen lymph nodes
• facial swelling
• higher-than-normal levels of liver enzymes in the blood
• eosinophilia -- an increase in the number of a type of white blood cell called eosinophils in blood and tissues

Due to the similarities between some symptoms of DRESS and infections, a delay in arriving at an accurate diagnosis sometimes occurs.

DRESS can cause severe complications when it affects internal organs (liver, kidneys, lungs, heart).

About SJS and TEN

SJS and TEN have similar symptoms. Prior to SJS occurring, patients may experience a flu-like illness with such symptoms as these:

• cough
• fever
• sore throat

A few days later the following can occur:

• swelling of the face and/or tongue
• painful skin
• raised itchy and red patches of skin
• a rapidly spreading red or purple skin rash
• blisters on the skin, particularly in the mouth, inside the nose and eyes
• the outer layers of the skin start to fall off

SJS and TEN can cause life-threatening complications, so if symptoms occur, contact your physician right away or go to the emergency department of a hospital.

Anal Problems

In placebo-controlled studies, anorectal problems were more common among telaprevir users (26%) than among people who received placebo (5%). Anorectal problems included the following:

• hemorrhoids
• anal itching
• anal discomfort
• rectal burning

Mostly these problems were of mild-to-moderate intensity and they cleared after the course of telaprevir treatment ceased.

Dr. Hézode recommends that patients who use telaprevir and who report these problems first have their physicians conduct an anal exam to assess the health of the affected area and rule out other possible causes of anal irritation. He recommends anal creams, corticosteroid creams and even local anaesthetic creams in cases of rectal burning.

References

1. Hézode C. Boceprevir and telaprevir for the treatment of chronic hepatitis C: safety management in clinical practice. Liver International. 2012 Feb;32 Suppl 1:32-8.
2. Cacoub P, Bourlière M, Lübbe J, et al. Dermatological side effects of hepatitis C and its treatment: patient management in the era of direct-acting antivirals. Journal of Hepatology. 2012 Feb;56(2):455-63.