In the June 2007 Journal of Hepatology, Italian
researchers presented data from a trial that included 42 currently non-cirrhotic
patients who had received liver transplants due to HCV-related cirrhosis 12 to
96 months earlier. Participants were randomly assigned to receive either 180 mcg/week
pegylated
interferon alfa-2a (Pegasys) monotherapy or else Pegasys
plus ribavirin (up to the maximum tolerated dose) for 48 weeks.
Results
• In an intention-to-treat
analysis, early virological response (EVR, defined as at least a 2-log decrease
in HCV RNA at week 12) occurred in 76% of patients in the monotherapy arm and
71% of those in the combination therapy group.
• 38% and 33%, respectively,
achieved sustained virological response
(SVR, defined as undetectable HCV RNA 24 weeks after completion of therapy).
• EVR had positive predictive
values for SVR of 50% and 47%, respectively.
•
The negative predictive value was 100% in both groups (i.e., no one who failed
to achieve EVR went on to achieve SVR).
•
6 patients in the monotherapy group and 7 in the combination therapy group discontinued
treatment prematurely.
•
Pegasys doses were reduced in 7 and 8 subjects, respectively.
•
The average daily dose of ribavirin was 435 mg/day.
Conclusion
The
authors concluded that Pegasys, with or without ribavirin, induces SVR in one-third
of transplant recipients with recurrent hepatitis C. "The low SVR rate is
mainly due to inability to sustain full doses of antivirals and lack of the booster
effect of ribavirin," they wrote.
07/10/07
Reference M
Angelico, A Petrolati, R Lionetti, and others. A randomized study on Peg-interferon
alfa-2a with or without ribavirin in liver transplant recipients with recurrent
hepatitis C. Journal of Hepatology 46(6): 1009-1017.
