New Hepatitis C Drug Telaprevir Helps Cure the Disease

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What do you get when you add the new hepatitis C drug, telaprevir, to standard therapy? How about a 75 percent cure rate, according to the results of the ADVANCE trial which appear in the New England Journal of Medicine.

Badly needed: a cure for hepatitis C

Telaprevir (Incivek, by Vertex Pharmaceuticals) is one of two drugs recently approved (May 23, 2011) by the Food and Drug Administration (FDA) for treatment of hepatitis C only in conjunction with standard therapy, which is pegylated-interferon and ribavirin. Both telaprevir and the other new drug, boceprevir (Victrelis), are protease inhibitors, a class of drugs used to treat HIV.

Telaprevir works against hepatitis C virus (HCV) genotype 1, which is responsible for about 75 percent of hepatitis C cases in the United States and is the main genotype in other places throughout the world. More than 3 million people in the United States have chronic HCV infection, a disease characterized by persistent inflammation of the liver, which can result in liver damage, liver failure, or cirrhosis.

According to Dr. Ira J. Jacobson, chief of the Divisin of Gastroenterology and Hepatology and the Vincent Astor Distinguished Professor of Medicine at New York Presbyterian Hospital/Weill Cornell Medical Center, who led the international team of researchers in the ADVANCE trial, telaprevir, along with boceprevir, “is the first of a coming wave of new treatments that will help the medical community eradicate hepatitis C infection in a majority of patients.”

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The ADVANCE trial involved 1,088 untreated individuals with HCV genotype 1 who were assigned to one of three treatment arms: 48 weeks of standard therapy, or telaprevir combined with standard therapy for 8 or 12 weeks, followed by standard therapy alone for an additional 16 or 36 weeks, respectively.

The addition of telaprevir to standard therapy cured HCV in 75 percent of patients who received the combination for 12 weeks and 69 percent of those treated for 8 weeks compared with 44 percent of patients treated with standard therapy only.

In addition, about 90 percent of a subgroup of patients were cured: the nearly 60 percent of patients treated with telaprevir who had undetectable levels of virus at weeks 4 and 12 of treatment and who were eligible to receive a total of 24 weeks of treatment. Another subgroup of patients—African-Americans—responded well to telaprevir, with 62 percent achieving a viral cure compared with 25 percent who received standard therapy only.

The addition of telaprevir to standard therapy significantly improves efficacy but also adds side effects. Standard therapy is associated with anorexia, cough, depression fatigue, hair loss, headache, muscle aches, and nausea. Anemia is a side effect of ribavirin, and telaprevir may cause more frequent and severe anemia. Rash is also a side effect of telaprevir, and some patients experience itching around the anus or rectum.

The additional burden of side effects from adding telaprevir is outweighed by the improved efficacy it provides, noted Dr. Jacobson. “Our most cherished goal” is to cure hepatitis C using “a cocktail of fast-acting and well-tolerated drugs,” he said, adding that “many lives will be saved.”

SOURCES:
Jacobson IM et al. New England Journal of Medicine 2011 Jun 23; 364:2405-16
Ward RP et al. American Family Physician 2004; 69: 1429-36
Weill Cornell Medical College release June 23, 2011

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