Effectiveness of hepatitis C drug can now be determined sooner

By Joe Kuttenkuler

RICHMOND, Va. – Patients being treated for the hepatitis C virus – a blood-borne disease that attacks the liver – now can learn earlier than ever before if they are likely to benefit from an investigational drug therapy. The findings are based on analysis of data from a Phase-3 study of pegylated interferon alfa-2a (Pegasys), a longer acting form of the medication interferon. The report was presented today (Nov.12) in Dallas, TX at the annual meeting of the American Association for the Study of Liver Disease.

According to the data, how patients respond after 12 weeks of treatment to pegylated interferon alfa-2a, combined with the anti-viral drug ribavirin, is a good indicator of how likely they are to respond to the medication long-term. Until now physicians had to wait six months before they could determine initial treatment results.

Sixty-four percent of patients who showed a marked decrease in the presence of the hepatitis C virus at week 12 were more likely to have a long-term sustained virologic response. At the same time, 98 percent of patients who had little or no response to treatment by the 12th week failed to exhibit a SVR at the conclusion of treatment. The data also shows patients who achieve a SVR rarely experience a recurrence of the hepatitis C virus.

"Being able to determine early on whether a treatment is going to effective ultimately will enable physicians to provide a better quality of care to their patients," said Mitchell Shiffman, M.D., chief of hepatology and professor of medicine at Virginia Commonwealth University’s Medical College of Virginia Hospitals.

Treatment for hepatitis C generally involves a year-long regimen of interferon – the only known medication for treating the virus. But because the side effects from the drug can be severe, including flu-like symptoms, depression, dizziness and nausea, patients are often reluctant to commit to taking the drug for such a long period of time.

"Committing to one year of therapy is difficult for many patients," said Shiffman. "When patients hear the initial phase of treatment is now only three months long, and then we evaluate how they are doing, it becomes a more reasonable time frame for them. If the drug is working, we continue with it. If not, we stop and look for other options."

The potency of pegylated interferon alfa-2a is the primary factor in being able to determine the drug’s early effectiveness, according to Shiffman. "Its ability to drive down the levels of the virus in some patients so quickly after initiating treatment has enabled us to better predict the drugs long-term effectiveness."

Standard interferon therapy must be administered by injection three times a week and leaves the body in six hours. Pegylated interferon is injected only once a week and remains in the body for up to a week because the body absorbs it more slowly. The long-acting properties of pegylated interferon alfa-2a result in constant viral suppression, while at the same time, stimulate the immune system to attack it.

Chronic hepatitis C affects an estimated 3 million Americans and is the most common cause of liver disease. Left untreated, the virus can lead to cirrhosis, liver cancer and, in some cases, necessitate a liver transplant.

VCU is one of about 40 sites worldwide studying pegylated interferon alfa-2a. The drug, manufactured by Hoffmann-La Roche Inc., is awaiting approval from the U.S. Food and Drug Administration.