HCV Therapy Fails in Many Urban Patients

HCV Therapy Fails in Many Urban Patients

MedPage Today

Published: March 29, 2010


Action Points


* Explain to interested patients that this study suggests that many patients in U.S. cities, particularly those who belong to ethnic minorities, may not do as well as expected with the standard treatment for hepatitis C.


The standard treatment for hepatitis C -- highly effective in clinical trials -- may be unavailable, inappropriate, or ineffective in urban U.S. patients, researchers said.


In clinical trials, treatment with pegylated interferon and ribavirin yielded sustained viral response rates between 54% and 63%, according to John Reinus, MD, and colleagues at Montefiore Medical Center and the Albert Einstein College of Medicine in New York City.


But in an urban population, with many members of ethnic minorities, sustained viral response rates were between 14% and 37%, Reinus and colleagues reported in the April issue of Hepatology.


Moreover, the vast majority of those screened -- 84.6% -- did not meet the general requirements for treatment with interferon and ribavirin, the researchers said.


The study confirms that members of ethnic minorities -- usually under-represented in clinical trials -- do not fare as well as expected with treatment in the real world, Reinus said in a statement.


Physicians, he said, "need to know not only the efficacy of combination therapy as demonstrated in phase III registration trials, but also its effectiveness: the outcome of treatment in patients like their own receiving ordinary clinical care."


Reinus and colleagues looked at outcomes in 2,134 treatment-naive patients with hepatitis C seen from 2001 through 2006 in the faculty practice of the Albert Einstein College of Medicine or the attending-supervised Montefiore Medical Center Liver Clinic.


In either setting, the researchers said, patients had the same access to treating physicians and similar support by ancillary services. In addition, the approach to side-effect management was aggressive in both settings.


Of the screened patients, the researchers found, 478 had HIV and 1,401 did not meet the general treatment requirements, leaving an intent-to-treat population of 255 who got at least one dose of interferon and ribavirin.


More than half of those of the study cohort (149 patients) were Hispanic, followed by 52 African Americans, 31 classified as "other," and 23 Caucasians.


Only 51% of the study group completed the therapy and returned six months later for follow-up laboratory testing, while 26% either lost insurance and were unable to obtain medications or simply didn't return. Another 23% stopped prematurely because of side effects.


Of the 131 patients who completed therapy and were tested six months later, 54 patients achieved a sustained viral response. That amounts to 41.2% of the per-protocol population, but only 21.2% of the intent-to-treat cohort.


The researchers found that 68% of the intent-to-treat cohort had genotype 1 of hepatitis C -- regarded as more difficult to treat -- while the rest had either genotype 2 or 3.


More patients with genotypes 2 and 3 achieved a sustained viral response (37% versus 14%) with the difference significant at P<0.001, they reported.


Among patients with a sustained viral response, 63% were Hispanic, 8% were African American, and 17% were Caucasian, Reinus and colleagues reported.


With the exception of African Americans, those rates were less than expected, Reinus and colleagues said.


"Almost all patients treated in this urban medical center, with the exception of African Americans, had substantially worse than predicted outcomes regardless of care environment," they said.


"The overall (sustained viral response) rate in our patients was one-third to less than one-half that predicted on the basis of registration trials," Reinus said.


The difference "does not appear to be accounted for by other factors, including patient demographics and features of infection," he said, adding that he and colleagues "conclude that new strategies are needed to care for such patients."