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Shorter HCV Treatment Shows Notable Success
It Also Lowers Costs and the Risk of Serious Side Effects
Two new randomized controlled trials show that treating Hepatitis C (HCV) with peginterferon and ribavirin for shorter durations can yield success rates similar to those from longer treatment lengths, with cost-savings and lower risk of serious side effects. Patients’ HCV-RNA levels after 4 weeks of treatment may be an important factor for determining the best treatment length. These findings are in the January issue of Hepatology, a journal published by John Wiley & Sons on behalf of the American Association for the Study of Liver Diseases (AASLD). The articles are also available online at Wiley Interscience at (http://wileyonlinelibrary.com/journal/hepatology).
HCV genotype is the single most important predictor of a patient’s outcome after treatment with peginterferon and ribavirin. Only about half of all patients with genotype 1 will achieve a sustained viral response, compared to 70 to 90 percent of patients with genotype 2 or 3. Regardless of HCV genotype, patients who respond quickly to the drugs are also more likely to be cured by them. Based on these differences, and because the therapy is costly and carries risks of serious side effects, researchers have been exploring ways to customize treatment for each patient.
Researchers led by Alessandra Mangia of Italy’s Istituto di Ricovero e Cura a Carattere Scientifico, Casa Sollievo Della Sofferenza, in San Giovanni Rotondo conducted a randomized controlled trial of patients with HCV genotype 1. They hypothesized that variable treatment duration based on the first measurement of undetectable HCV RNA would be as effective as standard 48-week treatment. They enrolled 696 patients, 237 of whom received standard HCV. The remaining 459 were treated for 24, 48, or 72 weeks, if HCV-RNA was undetectable at 4, 8, or 12 weeks, respectively.
Nearly 49 percent of patients receiving variable treatment based on detectable viral levels achieved a sustained viral response, compared to 45 percent of patients in the standard group. A majority of patients who showed a viral response at week 4 were cured by a 24-week therapy. However, for patients who did not show a response until week 12, 72 weeks of treatment was required for an approximately similar cure rate.
“In conclusion,” the authors report, “variable treatment duration ensures a sustained viral response rate similar to that of standard treatment duration, with potential significant reduction in cost and side effects.”
Meanwhile, researchers in Norway led by Olav Dalgard conducted a randomized controlled trial of 428 patients with HCV genotype 2 or 3 to assess the success rate of 14 weeks of treatment with peginterferon plus ribavirin. Patients who achieved a viral response after 4 weeks were randomly assigned to complete either 14 or 24 total weeks of treatment.
They found that 81 percent of patients in the 14-week treatment group achieved a sustained viral response, with 86 percent still cured at 24-weeks post-treatment. Nearly 91 percent of patients in the 24-week treatment group achieved a sustained viral response, with 93 percent still cured at 24-weeks post-treatment.
“We cannot formally claim that 14 weeks treatment is non-inferior to 24 weeks treatment,” the authors conclude, “However, the sustained viral response rate after 14 weeks treatment is high, and although longer treatment may give a slightly better sustained viral response rate, we believe considerable economical savings, good response to re-treatment and less side effects make it rational to treat patients with genotype 2 or 3 and rapid viral response for only 14 weeks.”
Both studies agree that customizing treatment lengths based on the patient response to therapy could lead to very good outcomes, with fewer harmful side effects, and lower costs.
“Individualized Treatment Duration for Hepatitis C Genotype 1 Patients: A Randomized Controlled Trial”
Mangia, Alessandra; Minerva, Nicola; Bacco, Donato; Cozzolongo, Raffaele; Ricci, Giovanni; Carretta, Vito; Vinelli, Francesco; Scotto, Gaetano; Montalto, Giuseppe; Romano, Mario; Cristofaro, Giuseppe; Mottala, Leonardo; Spirito, Fulvio; Andriulli, Angelo
Hepatology; January 2008
“Pegylated interferon alfa and ribavirin for 14 versus 24 weeks in patients with hepatitis C virus genotype 2 or 3 and rapid virological response”
Dalgard, Olav; Bjoro, Kristian; Ring-Larsen, Helmer; Bjornsson, Einar; Holberg-Petersen, Mona; Skovlund, Eva; Reichard, Olle; Bo, Sundelof; Myrvang, Bjorn; Ritland, Stale; Aril, Fryden; Hellum, Kjell; Florholmen, Jon; Verbaan, Hans
Hepatology; January 2008
MRI Techniques Evolving Towards Better Assessment of Liver Fibrosis
They could potentially replace liver biopsy
MRI imagery is emerging as a non-invasive way to determine the existence and extent of hepatic fibrosis. It could eventually help the development of pharmacologic strategies to combat the condition. These findings are in the January issue of Hepatology, a journal published by John Wiley & Sons on behalf of the American Association for the Study of Liver Diseases (AASLD). The article is also available online at Wiley Interscience (http://wileyonlinelibrary.com/journal/hepatology).
Currently, the best way to assess hepatic fibrosis is liver biopsy; however, it is an invasive procedure that can cause serious side effects. Researchers have been studying less invasive techniques, such as blood tests and imaging strategies like ultrasound, but so far, they have not proven sensitive enough to detect the various stages of fibrosis.
Over the past decade, a number of technological advances have been made in magnetic resonance (MR) imaging of the liver. Researchers led by Jayant Talwalkar of the Mayo Clinic, examined the current state of MR imaging and the studies that looked at its utility in detecting liver fibrosis.
They found that contrast-enhanced magnetic resonance imaging, magnetic resonance spectroscopy, and diffusion-weighted magnetic resonance imaging have shown promise for detecting hepatic fibrosis, though they require further refinement.
But the technology that is showing the greatest promise is magnetic resonance elastography, which quantitatively assesses tissue stiffness. Recent studies have shown that MR elastography has high sensitivity and specificity in detecting fibrosis stages. “As with other techniques, efforts to standardize the equipment and techniques used for MR elastography should be pursued to maximize diagnostic accuracy and facilitate comparison of results in different settings,” the authors suggest. “Reproducibility appears good from initial studies but requires additional study for verification.”
The authors emphasize that the design and conduct of high-quality diagnostic accuracy studies is essential for ongoing validation of these emerging non-invasive techniques for determining hepatic fibrosis. Most relevant studies to date have included small numbers of patients and lacked independent assessment, issues that should be addressed in future studies.
Once MRI techniques have become suitably advanced, patients will likely prefer them to liver biopsy. “While the number of patients screened for hepatic fibrosis may increase using MR imaging, proof will be required that early detection and intervention can reduce morbidity and resource utilization associated with the clinical sequelae of advanced disease,” the authors point out.
“The development of a reliable and valid non-invasive method to assess hepatic fibrosis could result in comparable or, perhaps, improved accuracy in terms of staging,” they conclude. “The emergence of MR imaging techniques (singly or in combination with other methods) could result in the performance of true functional hepatic imaging.”
“Magnetic Resonance Imaging of Hepatic Fibrosis: Emerging Clinical Applications”
Talwalkar, Jayant; Yin, Meng; Fidler, Jeff; Sanderson, Schuyler; Kamath, Patrick S.; Ehman, Richard
Hepatology; January 2008