By Liz Highleyman
Paul Feuerstadt and colleagues assessed the effectiveness of interferon-based therapy for previously untreated chronic hepatitis C patients who received treatment at either the private Faculty Practice of Albert Einstein College of Medicine or the attending physician-supervised liver clinic at Montefiore Medical Center, both in the Bronx, New York, between 2001 and 2006.
Randomized controlled trials of pegylated interferon plus ribavirin have yielded rates of sustained virological response (SVR) -- or continued undetectable HCV viral load 6 months after completion of therapy -- ranging from about 50% to 60% for all genotypes combined, the study authors noted as background. But treatment results in actual clinical practice may not be as good.
The analysis initially included 2370 outpatients with chronic hepatitis C; a subset of 255 previously untreated HIV negative individuals started therapy. In the treated group, 60% were men, the mean age was 50 years, and most (68%) had hard-to-treat HCV genotype 1.
The treated population included a large proportion of what the authors called "minorities" (though this term is inaccurate in New York and many other large U.S. cities), including 58% Hispanics and 20% African-Americans -- groups that have been shown to respond less well to interferon-based therapy in prior studies.
Each patient had his or her care supervised by a single experienced physician under conditions of everyday clinical practice, and appropriate supporting resources were made available to all. Aggressive side effects management was employed at both sites. The authors suggested that these resources were at least equal in quality and accessibility to those available to patients treated in non-hospital-based private practices.
Results
| - About half the treated patients (51%) completed therapy.
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| - In an intent-to-treat analysis, 14% of genotype 1 patients and 37% of genotype 2 or 3 patients achieved SVR.
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| - 63% of Hispanic patients, 17% of whites, and 8% of African-Americans (all genotypes combined) achieved SVR.
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| - The overall SVR rate was significantly higher in the faculty practice than in the liver clinic in the intent-to-treat analysis (27% vs 15%, respectively).
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| - This was no longer the case, however, in a per-protocol or as-treated analysis (46% vs 34%, respectively).
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| - Looking at the total 1656 HIV negative treatment-naive patients in the initial group, only 3.3% ultimately achieved SVR.
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"Current hepatitis C therapies may sometimes be unavailable to, inappropriate for, and ineffective in United States urban patients," the investigators concluded.
"Treatment with pegylated interferon and ribavirin was less effective in this population than is implied by multinational Phase III controlled trials," they continued. "New strategies are needed to care for such patients."
Division of Gastroenterology, Division of Abdominal Organ Transplantation, and Division of Hepatology, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY.
6/4/10
Reference
P Feuerstadt, AL Bunim, H Garcia, and others. Effectiveness of hepatitis C treatment with pegylated interferon and ribavirin in urban minority patients. Hepatology 51(4): 1137-1143 (Abstract). April 2010.
Source: www.hivandhepatitis.com
