AASLD: HCV Outcomes Found Equivalent With Pegylated Interferons and Ribavirin
"BOSTON, Nov. 4 -- The pegylated interferons alpha-2a (Pegasys) and alpha-2b (PegIntron) are comparably effective and safe in combination with ribavirin (Rebetol) for hepatitis C viral infection, reported investigators here.
* Explain to patients who ask that this study found pegylated interferon in combination with weight-based dosing of ribavirin is effective at controlling or clearing hepatitis C viral infections.
* Explain that untreated HCV infections can lead to fibrosis, cirrhosis, liver failure and the need for transplant.
* This study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary as they have not yet been reviewed and published in a peer-reviewed publication.
Although there are no results from head-to-head trials pitting the two pegylagted interferons against each other in combination with ribavirin, a retrospective review showed them similar in efficacy in all patients with HCV infections, reported Ihab Hammoud, M.D., of the Henry Ford Hospital in Detroit, and colleagues.
There were also no significant differences in outcomes or in safety parameters among patients with HCV genotype 1, including those with a high viral load, the investigators reported at the American Association for the Study of Liver Diseases meeting.
The authors looked at all treatment naïve patients with HCV treated with a pegylated interferon and weight-based dose ribavirin at their center from 2001 through 2005. Patients with HCV and HIV or HBV co-infection and those who were on dialysis were excluded from the analysis.
"This was a relatively difficult to treat population," said Dr. Hammoud in an interview. "We had 40% African-American patients, 74% of patients had genotype 1 and 60% had a high viral load, but still we found no real differences between pegylated interferon alpha-2a or pegylated interferon alpha-2b when given with ribavirin with weight-based dosing."
Patients with the more treatment-refractory HCV genotype 1 received peginterferon 2a or 2b and weight-based dose ribavirin for 48 weeks. Patients with HCV genotype 2 or 3 received treatment for either 24 or 48 weeks.
The patients were evaluated for sustained viral responses at 24 weeks with polymerase chain reaction testing for HCV RNA.
A total of 259 patients were included in the analysis, 212 them receiving peginterferon alfa-2b and ribavirin and 47 given peginterferon alfa-2a with ribavirin.
There were no significant differences between the groups in gender, percentage of African-American patients, frequency of HCV genotype, HCV genotype with high viral load, percentage of patients weighing more than 105 kg (231 pounds) or ribavirin dosing.
In addition, on-treatment dose reductions of either peginterferon or ribavirin were similar for the two groups, at 8% for patients on peginterferon-2b and 2% for those on peginterferon-2a (P=NS).
The overall sustained viral response among patients in the 2b group was 38%, and in the 2a groups was 40% (P=NS). Among the patients with genotype 1, the sustained viral response was 23% for patients on 2b, and 26% for patients on 2a (P=NS).
Among patients with genotype 1 and a high viral load, the sustained viral response was 20% for patients on 2b, and 30% for patients on 2a (P=NS), and for those genotype 1 patients who weighed more than 105 kg, the SVR rates were nearly identical, at 20.7% and 20%, respectively (P=NS).
Safety parameters were also similar between the groups, Dr. Hammoud said.
He noted that the study was neither randomized nor controlled, and that the number of patients treated with peginterferon-2b was greater than that of patients treated with peginterfron-2a. The randomized IDEAL trial, conducted by Schering-Plough, maker of PegIntron, compared the two drugs head-to-head. Results are expected later this year or early in 2008."
What struck me was that there was no difference in patients weighing 230+ pounds. I only recently conceded that overweight patients would do better with Peg-Intron than with Pegasys but this study seems to suggest that is not the case. What's your take Jim - am I missing something here?