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Efficacy of Initial Treatment May Predict Long-Term Outcome in Chronic Hepatitis C Patients: Presented at AASLD

By Arushi Sinha

SAN FRANCISCO -- November 7, 2008 -- One of the challenges of treating patients diagnosed with chronic hepatitis C (HCV) is predicting long-term outcomes. New research presented at the Liver Meeting 2008, the 59th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) examined the probability of longer-term clinical outcomes based upon shorter-term response.

"We all want the earliest possible sustained response," explained Paul Kwo, MD, Indiana University School of Medicine, Indianapolis, Indiana, on November 4. Dr. Kwo was part of the Individualized Dosing Efficacy Versus Flat Dosing to Assess Optimal Pegylated Interferon Therapy (IDEAL) trial.

The researchers hypothesised that the reduction in HCV RNA load after 4 weeks of treatment, known as rapid virologic response (RVR), might function as a predictor of longer-term clinical outcome, or sustained virologic response (SVR).

The study enrolled a total of 3,070 patients to 48 weeks of treatment in 1 of 3 cohorts: group 1, pegylated interferon (PEG-IFN) alfa-2b 1.5 mcg/kg weekly; group 2, PEG-IFN alfa-2b 1 mcg/kg weekly plus ribavirin 800 to 1,400 mg/day; group 3, PEG-IFN alfa-2a 180 mcg weekly plus ribavirin 1,000 to 1,200 mg/day.

The cohort was 60% male, 71% white, an average age of 47.5 years, and had HCV RNA viral loads >600,000 IU/mL in 82% of patients.

Levels of HCV RNA were measured at weeks 2, 4, 12, 24, and 48, and compared against baseline levels.

Response to treatment was defined as a 2-log viral load decrease from baseline at 12 weeks or undetectable viral levels at 24 weeks.

Patients who did not respond discontinued the treatment.

At week 4, response to treatment was achieved in 23.8% of patients in group 1, 24.5% of patients in group 2, and 22.4% of patients in group 3.

Based on the trends seen, the researchers concluded that the change in viral load as measured by HCV RNA was predictive of SVR. They determined that patients with >3-log decrease in viral load had >61% chance of achieving SVR. Conversely, patients with a <1-log decrease in viral load had <5% chance of SVR.

The researchers suggested that monitoring HCV RNA levels is very important to determine a patient's chances of achieving SVR and that clinicians should incorporate this practice into their clinical decision making.

"What we are able to show is how fast the HCV load predicts the probability of sustained response," Dr. Kwo said.


[Presentation title: Probability of Sustained Virologic Response (SVR) Is Associated With the Magnitude of HCV RNA Reduction at Week 4 of Treatment With Peginterferon (PEG) Plus Ribavirin (RBV): Results of the IDEAL Trial. Abstract 1868]

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