Reuters Health Information (2010-03-26): Hepatitis C therapies less effective in urban minority patients
Hepatitis C therapies less effective in urban minority patients
Last Updated: 2010-03-26 15:40:07 -0400 (Reuters Health)
NEW YORK (Reuters Health) - Pegylated interferon and ribavirin appear to be less effective against hepatitis C virus (HCV) in urban minority patients than clinical trial results would suggest, according to a report in the April issue of Hepatology.
In randomized controlled trials, pegylated interferon and ribavirin produce sustained viral response (SVR) rates of 54% to 63%, the report indicates. But in the present study of minority patients in New York City, the SVR rate ranged from 15% to 46%, depending on the analysis and the site of care.
From 2001 to 2006, researchers from the Albert Einstein College of Medicine in the Bronx evaluated 1656 HIV-negative patients with treatment-na�ve HCV infection to determine their eligibility for therapy. Eventually, 255 patients received at least one dose of interferon and ribavirin.
Most patients (58%) were Hispanic, 20% were African American, 9% Caucasian, and 13% of other ethnicities. Roughly two-thirds (68%) had HCV genotype 1; the remainder had type 2 or 3. All had at least one liver biopsy. Their mean age was 50, and 60% were male.
On intention-to-treat analysis, the SVR rates were 27% for patients seen in the authors' private practice offices and 15% for patients treated in the clinic (p = 0.01). On per-protocol analysis, however, the corresponding rates were not significantly different: 46% and 34%.
When all 1656 possible treatment patients were considered, just 3.3% ultimately achieved SVR, the report indicates. The authors consider this "the most disturbing finding" of the study.
"A major reason for this result is that 84.6% of our patients did not meet the general treatment requirements, which were based on widely used criteria to determine eligibility for HCV therapy," they write, adding that they are presently studying "why urban patients often fail to meet treatment eligibility requirements."
They also emphasize that patients received care from the same physicians and ancillary support teams whether they were treated in the faculty practice offices or in the clinic, using the same protocols and the same "aggressive approach" to side effects.
"Practitioners need to know not only the efficacy of combination therapy as demonstrated in phase III registration trials, but also its effectiveness...in patients like their own receiving ordinary clinical care," said senior author Dr. John F. Reinus in a statement.
He added, "The overall SVR rate in our patients was one-third to less than one-half that predicted on the basis of registration trials....We conclude that new strategies are needed to care for such patients."