Triple Therapy Has Poor Safety in Cirrhotic Hepatitis C
December 12, 2012
French researchers reported that a combination of three therapies was effective in producing high virologic response rates in hepatitis C patients with compensated cirrhosis. However, some patients had to discontinue the treatment regimen because of severe complications, such as hard-to-manage anemia.
The regimen used in the multi-site trial combined a protease inhibitor -- telaprevir (Incivek) or boceprevir (Victrelis) -- with pegylated interferon alfa-2a or 2b in combination with ribavirin (PEG-IFN/RBV) for patients with cirrhosis who had not responded to prior therapy. Cristophe Hézode, MD, reported virologic response rates of 92 percent for study participants taking telaprevir and 77 percent for those taking boceprevir. Because of the risk of adverse events, Hézode recommended that clinicians use caution in using the regimen with "treatment-experienced cirrhotic patients with platelet counts of 100,000/mm3 or serum albumin levels below 35 g/L."
Participants in the study had been treated before for chronic hepatitis C, but they had relapsed or only partially responded to prior treatment. After 16 weeks of receiving one of two regimens, 45 percent of those who received telaprevir had "at least one serious adverse event," and there were five deaths. Complications included infections, hepatic decompensation, asthenia, and renal failure. Of the study participants receiving boceprevir, 32.7 percent experienced one or more serious adverse event, and one died. Hézode listed infections, hepatic decompensation, and asthenia as complications from boceprivir. None of the patients taking boceprevir experienced renal failure.
The risks for severe complications included low platelet counts and a serum albumin level below 35 g/L. Patients at risk for severe anemia were females, persons 65 or older, women with hemoglobin 12g/dL or lower, and men with hemoglobin 13gd/L or lower. Hézode said persons without these predictors could receive the regimen, but they should be "cautiously and carefully monitored."
The study was presented at the 2012 annual meeting of the American Association for the Study of Liver Diseases.
Family Practice News
12.11.2012; Neil Osterweil
This article was provided by U.S. Centers for Disease Control and Prevention. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update. Visit the CDC's website to find out more about their activities, publications and services.
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