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Peginterferon alfa-2B and Ribavirin for Liver Transplant Patients Yields 30% HCV SVR

April 26, 2010 (Vienna, Austria) — In the largest study of its kind to date, about one third of patients infected with hepatitis C virus (HCV) who underwent transplants and were treated with peginterferon alfa-2b and ribavirin achieved a sustained virologic response (SVR), researchers announced.

But about the same number of patients had to drop out of the study because of adverse events, the most common of which was severe anemia, according to the final results of the PROTECT study, presented here at the European Association for the Study of the Liver 45th Annual Meeting.

The long-running study was started approximately 4 years ago by Schering-Plough, which merged with Merck in November 2009.

These results come from a single-group, multicenter, open-label study conducted at 24 centers in the United States .

A total of 125 patients with a recurrent HCV infection after transplantation received peginterferon alfa-2b in weight-based doses, plus 400 to 1200 mg ribavirin a day, also based on weight, for up to 48 weeks. They were followed for another 24 weeks.

In the study's intent-to-treat analysis, incorporating data from patients who dropped out of the trial, 36 of 125 patients (29%) achieved SVR, Frederic Gordon, MD, a physician in the Department of Gastroenterology at the Burlington, Massachusetts–based Lahey Clinic, told meeting attendees.

Twenty-five of 105 (24%) patients with genotype 1 achieved SVR, whereas 11 of 20 (55%) with genotype 2 and 3 achieved SVR.

For those who actually completed the study, 55% percent achieved SVR.

Overall, 18% of patients relapsed — 19% in the genotype 1 group and 15% in the genotype 2 and 3 group.

The 83% of patients who had a rapid virologic response — undetectable HCV RNA after 4 weeks — achieved SVR. The 67% with a complete early virologic response — undetectable HCV RNA after 12 weeks — achieved SVR.

There were 38 patients (30%) who experienced adverse events leading to the discontinuation of treatment.

Anemia was foremost, leading 14 of the patients (11%) to withdraw from treatment. In all, 92 patients (74%) had anemia occur during treatment. Fatigue and headaches were reported in 71% and 62%, respectively.

The other adverse events leading to drop-out were neutropenia, leucopenia, thrombocytopenia, pneumonia, increased creatinine, and dyspnea. There were 2 events of each, except neutropenia, of which there were 3.

"With the use of [erythropoietin] growth factors, [anemia] may be a modifiable barrier to treatment of this population," Dr. Gordon said.

Andrew Burroughs, MD, senior physician of the Liver Transplant Program at the Royal Free and University Medical College in London , United Kingdom , who moderated the session, said the study is larger than others, but echoed previous results.

He said that a concern about the study was the selection of patients.

"The question I asked was, 'How did you select them?' " he said. Everyone "has viral recurrence. But some of them don't progress so would not need treatment."

He said further research is needed to evaluate that question.

"It really needs good observational studies but with very clear criteria for selection," he said, "or a randomized study, [in which] you have criteria for progression and then the group that is not initially randomized to treatment gets treatment subsequently, if they progress."

The study was funded by Schering-Plough. Dr. Gordon reports being was an investigator for the study. Dr. Burroughs has disclosed no relevant financial relationships.

European Association for the Study of the Liver (EASL) 45th Annual Meeting. Presented April 15, 2010.


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