New Approach to Managing Hepatitis C-Related Anemia

New study findings suggest reducing the ribavirin dose should be the primary approach for managing anemia associated with peginterferon, ribavirin (RBV), and boveprevir therapy in patients with chronic hepatitis C. In a randomized, open-label study, researchers from the Texas Liver Institute at the University of Texas Health Center in San Antonio analyzed the effects of two anemia-management strategies—ribavirin dose reduction and erythropoietin (EPO) treatment—on patients’ sustained virologic response (SVR).

The researchers found a less than 1% difference between the two groups, and also determined that SVR rates were much lower among those receiving less than half of the total ribavirin dose during the entire treatment period, in comparison to those who received a greater proportion of the total dosage. Conducted between December 2009 and October 2011, the study compared the two regimens in 500 of 687 previously untreated patients with chronic HCV genotype-1 infections, who became anemic during treatment with three drugs: peginterferon alfa-2b at a dose of 1.5 mcg/kg per week; ribavirin at a dose of 600 mg to 1,400 mg per day, depending on weight; and boveprevir at a dose of 800 mg 3 times daily. The study included an algorithm for managing boceprevir-related anemia, based on the results of this study as well as other clinical studies.

The authors’ proposed algorithm, which has different hemoglobin monitoring recommendations for those with and without advanced fibrosis and cirrhosis, recommends that the primary intervention for managing anemia should be to reduce the RBV dosage. However, “secondary interventions, such as administration of EPO, red cell transfusions, and reducing the dosage of peginterferon can be considered” if hemoglobin levels remain below 10 g/dL, according to the authors’ report. “It is important,” the report continued, “that the patient receives at least 50% of the total milligrams of RBV calculated from the initial RBV dosage (mg/d) and the assigned duration” defined by the response-guided therapy algorithm.

This study of anemia management in hepatitis C is “the first to demonstrate in a randomized, controlled fashion that reducing ribavirin when anemia is present is an effective and safer intervention than using erythropoietin,” says Fred Poordad, MD, vice president of academic and clinical affairs at The Texas Liver Institute, clinical professor of medicine at The University of Texas Health Science Center, and lead study author. “This allows for a simpler management paradigm, since a secondary medication can be avoided,” says Poordad. “It also allows for cost savings, since EPO is an expensive medication,” he adds, noting that, while the findings were demonstrated with boceprevir, “the concept can be applied to any ribavirin-based therapy, such as emerging therapies, expected in 2014, with sofosubuvir and simeprevir.” The study was originally published in the November issue of Gastroenterology.

—Mark McGraw

Reference

Poordad F, Lawitz E, et al. Effects of Ribavirin Dose Reduction vs. Erythropoietin for Boceprevir-Related Anemia in Patients With Chronic Hepatitis C Virus Genotype 1 Infection—A Randomized Trial. Gastroenterology. 2013.