Cure rates becoming the norm for patients with hepatitis C

Adding statins to usual therapy may lead to even greater treatment success, according to studies presented at Digestive Diseases Week 2007.

By Susan J. Landers — Posted June 18, 2007

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Medicine's quest for ever-elusive cures is relentless, but only rarely do victories occur. Such a moment is at hand for about half of patients with hepatitis C, said researchers at a recent meeting.

Treatment with pegylated interferon alone or with the antiviral drug ribavirin has been shown to eradicate the virus from many patients and to keep it at bay for several years, according to some long-running studies.

Results from one long-term follow-up study show that patients treated successfully had no detectable virus up to seven years later. Those findings were released at Digestive Disease Week 2007, an international gathering of thousands of physicians and researchers in gastroenterology, hepatology, endoscopy and gastrointestinal surgery. This year's meeting was held May 19-24 in Washington, D.C.

Hepatitis C infects more than 4 million people in this country and is one of the nation's most prominent causes of chronic liver disease. It accounts for about 15% of acute viral hepatitis, 60% to 70% of chronic hepatitis and up to 50% of cirrhosis, end-stage liver disease and liver cancer, according to the National Digestive Diseases Information Clearinghouse.

The fact that this disease is curable makes it important that patients be tested, identified and treated, said researchers. "The goal of therapy is cure and should not be anything else," said Dr. Jean-Michel Pawlotsky, professor of medicine at the University of Paris XII in Creteil, France. He delivered a "State of the Art Lecture on Hepatitis C" during DDW and noted that hepatitis C "is the only known viral infection that can be cured."

Dr. Pawlotsky's statements were echoed by Mitchell Shiffman, MD, professor of medicine at Virginia Commonwealth University School of Medicine in Richmond, where he also directs the Liver Transplant Program. Dr. Shiffman was one of the lead investigators in the follow-up study of nearly 1,000 patients treated with pegylated interferon alfa-2a and ribavirin. His data indicate that 99% of the patients at 40 study sites worldwide had no detectable virus for as long as seven years after treatment. "We have clearly demonstrated that we can cure hepatitis C with peginterferon and ribavirin," he said.

"The results are encouraging, because it is rare in the treatment of life-threatening viral diseases that we can tell patients they have a chance for a cure," he said in a statement.

The two drugs work together to suppress the virus and to stimulate the immune system to eradicate the virus from the body. Together they deliver a one-two punch, he added.

The study followed patients treated successfully for HCV for an average of four years. They were tested once yearly for the presence of the virus. Of the 997 patients in the study, 989 had undetectable viral levels.

Dr Pawlotsky noted in his presentation that patients with HCV genotype 1 seem to do best on a longer, 48-week course of therapy, while those with genotypes 2 and 3 may respond to a 24-week course of the combo medication. The dose and duration of treatment must be tailored to each patient, he said.

Although current therapies hold much promise, Dr. Pawlotsky said there are several more medications in development -- ones that target each step of the virus's lifecycle.

Another role for statins

Continued quest is necessary because, while half of patients are considered cured, another 2 million are not.

The interferon treatment regimen is also onerous, said Ted Bader, MD, associate professor in the division of digestive diseases at the University of Oklahoma, Oklahoma City. Side effects are similar to those from chemotherapy, and some patients have life-threatening reactions to the long-lasting and expensive treatment.

Dr. Bader and colleagues are exploring the role of statins in improving treatment responses. Their findings indicate that patients who take the cholesterol-lowering medications may experience improvements in some liver enzyme levels.

The use of statins for hepatitis C generally has not occurred because liver disease always has been considered a contraindication for the use of the popular medications, Dr. Bader said. But a small, 14-day trial conducted with permission from the Food and Drug Administration and the university's Institutional Review Board found that, rather than causing harm to hepatitis C-infected patients, statin use seemed to create no problems and even resulted in improved liver enzyme levels for a few patients.

Three patients with abnormal alanine transaminase liver enzyme levels experienced improvements after statin therapy, and nine patients who started with normal enzyme levels stayed normal. There also were no significant changes in total bilirubin that could indicate jaundice.

"Two remarkable observations were made, and data not only support the lack of harm in this situation, but seem to suggest a possible salutary effect that needs further study," he said.

In a retrospective study, Dr. Bader and colleagues also found that adding a statin to a regimen of pegylated interferon and ribavirin led to a greater sustained viral response for 63% of 30 patients considered cleared of the virus six months after therapy, as opposed to 37% of 104 patients who did not take a statin.

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Hepatitis C primer

  • An estimated 4.1 million Americans have antibodies to hepatitis C indicating an ongoing or previous infection with the virus.
  • Hepatitis C causes an estimated 10,000 to 12,000 U.S. deaths annually.
  • The disease varies in its course and outcome. Infected people may have no signs or symptoms of liver disease, while others may have high levels of the virus and ultimately develop cirrhosis and end-stage liver disease.
  • Among the most common risk factors are injecting drugs, even just once many years ago; having had a blood transfusion before June 1992 when sensitive tests for the disease were introduced; and receiving clotting factor concentrates before 1987.

Source: The National Digestive Diseases Information Clearinghouse

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