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Hepatitis C Often Untreated and Outcomes Lag behind Trials in Clinical Practice: Presented at ACG

By Paula Moyer

HONOLULU, HI -- November 9, 2005 -- When patients with hepatitis C go on antiviral therapy, the likelihood of a response may be half of that seen in clinical trials, according to investigators who presented their findings here at the 70^th annual meeting of the American College of Gastroenterology (ACG).

The research was presented on November 2^nd by Ramsey C. Cheung, MD, Chief of Hepatology, Veterans Affairs Palo Alto Health Care System, and Associate Professor of Medicine, Stanford University Medical School, Stanford, California, United States.

"A lot of people with a diagnosis of hepatitis C are not being treated for multiple reasons," Dr. Cheung, MD, said in an email. "When we decide to treat a patient and when the patient decides to go on treatment, the probability of achieving a cure is important to both parties."

However, he added, his study showed that the response rate is much lower in clinical practice than has been seen in the registration trial. "It is important for the treating physician and the patient to know what the response rate is likely to be, not what has been reported in registration trial."

He noted that studies of patients with hepatitis C within the Veterans Affairs system showed that the sustained viral response rate was low. The investigative team conducted the current study to see if the same results would be seen in a community cohort.

The team reviewed several databases of selected sites within the Kaiser Permanente Northern California Health System, and identified 1470 patients with chronic hepatitis C who were seen within the system from 1999-2004. They obtained demographic information from administrative files on age, gender, and ethnicity and patients' laboratory records.

The system's pharmacy records held data on patients' treatment with interferon combined with ribavirin or pegylated interferon combined with ribavirin, along with information regarding the patients' use of erythropoetin (Procrit), filgrastim (Neupogen), antidepressants, and transfusions.

Results show that 246 (16.5%) underwent treatment; 65.3% of these patients were men. Data were completely evaluable for 242 patients; 119 of these were treated with interferon plus ribavirin, and 123 were treated with pegylated interferon plus ribavirin. Patients were an average of 47.1 years old (range 33.3-60.91).

The vast majority of treated patients (72.4%) had HCV genotype I, while 24% had HCV genotypes II and III, and 3.6% had HCCV genotypes IV-VI.

Patients were treated for an average of 29.2 weeks. A sustained virologic response occurred in 19.8% of treated patients, including 11.8% of those who received interferon plus ribavirin, and 27.6% of those treated with pegylated interferon plus ribavirin.

In clinical trials, sustained viral response rates have reached more than 70%, Dr. Cheung said.

Although the reasons for the gap are unclear, these findings may help physicians and patients have more realistic expectations of treatment, Dr. Cheung said.


[Presentation title: Practice Patterns and Treatment of Outcomes in the Management of Chronic Hepatitis C (CHC) Infection in a Large Managed Care Cohort. Abstract 785]

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