Home / Pharmaceuticals / Side Effects of Telaprevir

Side Effects of Telaprevir

Telaprevir is a newly approved antiviral drug used for the treatment of infection caused by the hepatitis C virus (HCV). Classified as a hepatitis C virus protease inhibitor, this drug (marketed as Incivek) gained FDA approval last May 23, 2011.

Considered as a direct acting antiviral drug, telaprevir is the second drug in its class to gain approval; boceprevir (Victelis) being ahead by one week to obtain the heads up from the FDA for the treatment of HCV infection.

By composition, telaprevir is a combination of peginterferon alfa and ribavirin. This drug is prescribed for adult patients with genotype 1 chronic hepatitis C infection with compensated liver disease, including cirrhosis, who have not received interferon-based treatment for their condition. This may also be given to patients who have previously shown inadequate response to interferon-based therapy, including those with prior null response, partial response as well as those who experience relapse.

Telaprevir has been associated with a number of side effects in some clinical trial patients. In well-controlled safety assessment clinical trials involving 1797 patients, the following side effects were noted to be the most common causes for treatment discontinuation: rash, anemia, fatigue, pruritus, diarrhea, hemorrhoids, discomfort in the anorectal area, anal pruritus, persistent abnormal taste (dysgeusia), nausea, and vomiting.

Abnormalities in laboratory readings were also seen in some patients receiving telaprevir. The peginterferon alfa and ribavirin combined formulation of telaprevir was associated with decreased total white blood cell (WBC) and leukocyte cell (a type of WBC) counts. Decrease in the number of platelets was also found in some patients treated with telaprevir. Of those who received telaprevir, 41 percent had shown increased levels of bilirubin (brownish yellow pigment found in the bile). The increase was steep during the first 1 to 2 weeks of treatment, became stable, then returned to baseline levels between the 12th and the 16th weeks. Another laboratory parameter found to be elevated in patients receiving telaprevir was uric acid. And about less than 1 percent of those patients had experienced clinical episodes of gout/gouty arthritis, although none of the cases were considered serious and none led to treatment discontinuation.

Three percent of the patients who received telaprevir experienced serious adverse reactions to the drug. The most common serious side effects noted in patients receiving telaprevir were skin disorders such as rash and/or pruritus and anemia. Out of the patients who received Incivek (telaprevir) combination treatment, 14 percent discontinued because of serious adverse reactions to the drug.

These were just the most commonly reported side effects in clinical trials hence; this article may not provide a complete list of all possible side effects of telaprevir. As the drug is made available to a lot of people with different conditions, other side effects may occur. Post-marketing surveillance of this drug may yield reports of other side effects. If this drug is included in your treatment, be sure to ask your doctor for all the possible side effects it may cause. And follow all your doctor’s orders regarding proper use of telaprevir to help minimize its side effects. Lastly, be alert for any side effect which you may experience while using this drug and call your doctor right away for immediate medical attention.