Thursday, January 24, 2013

One in Six Chronic Hepatitis C Patients May Have a Contraindication to Standard Treatment

One in Six Chronic Hepatitis C Patients May Have a Contraindication to Standard Treatment

By Will Boggs, MD
NEW YORK (Reuters Health) Jan 21 - About one in six of the estimated 5 million U.S. patients with chronic hepatitis C (HCV) has a contraindication to standard treatment with pegylated interferon and ribavirin, researchers say.

"When we designed the study, we expected that the rate of these contraindications would be higher than we discovered," Dr. Andrew H. Talal from the State University of New York, Buffalo, told Reuters Health by email. "The fact that the majority of the contraindications are reversible or readily treatable was another surprising aspect."

The study, published online January 7 in Alimentary Pharmacology & Therapeutics, was funded in part by Genentech Inc. and F. Hoffmann-La Roche Ltd; some of the authors are employees of Genentech.

Dr. Talal and colleagues used data from the General Electric Centricity electronic medical record dataset to determine how many people with HCV in the general population would be ineligible for therapy with pegylated interferon plus ribavirin because of medical and psychiatric problems.
Previous research from VA Medical Centers suggested that just over two-thirds (67.8%) of veterans referred for HCV treatment were ineligible according to standardized HCV treatment criteria; only 11.8% of those diagnosed with HCV between 1999 and 2003 received a prescription for antiviral therapy.

In this study, which included 45,690 patients diagnosed with HCV between 2004 and 2009, 7,903 (17.3%) had contraindications to therapy. Most (6,928, 87.6%) had only one contraindication.
Patients with contraindications were more likely to be younger, female, white, not currently married, and receiving Medicaid or Medicare health coverage than those without contraindications to treatment.

The most common contraindications were bipolar disorders (6.5%), anemia (5.9%), and pregnancy (1.9%).

"As such," the researchers note, "many contraindications observed in the current analysis are relative (and/or modifiable) or transient and therefore many patients could potentially benefit from current pegylated interferon-containing triple therapies or future pegylated interferon- or ribavirin-free regimens."

In contrast, conditions common in the general population (myocardial infarction, acute coronary syndromes, and depression) were usually not identified as contraindications.

"I think that the main message is that the vast majority of contraindications to pegylated interferon/ribavirin are reversible or potentially modifiable before treatment," Dr. Talal said. "Therefore, physicians need to very carefully assess the severity of contraindications and their potential treatment prior to deeming an individual ineligible for HCV treatment."

"The fact that the contraindications are higher in special populations, such as that found in the VA, is another important aspect of the work," Dr. Talal said. "I think that these findings should encourage physicians to search, especially for those contraindications that are the most prevalent, and to seek to modify them if the physician believes that they might interfere with a patient's ability to tolerate treatment."
"These findings should encourage further research to determine why patients have been reluctant to pursue HCV therapy," Dr. Talal added. "We know that a large percentage of those who know that they are HCV infected have elected not to proceed with HCV therapy for various reasons and we now know, as a result of this research, that contraindications to therapy are not as important an obstacle as we might have expected previously."

"Therefore," Dr. Talal concluded, "I think that additional interventions will need to be pursued to educate patients and providers on the importance of HCV treatment and to determine the additional reasons why a large percentage of those who are infected have not yet been treated."


Aliment Pharmacol Ther 2013.

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