Clinical

Epoetin alfa corrects HCV therapy-induced anemia

Last Updated: 2004-05-28 12:39:38 -0400 (Reuters Health)

NEW YORK (Reuters Health) - In a large trial of hepatitis C virus (HCV)-infected patients, epoetin alfa 40,000 units SC once weekly lessened HCV therapy-induced anemia, facilitated maintenance of ribavirin (RBV) dosing, and improved quality of life.

By making combination HCV therapy more tolerable and improving quality of life, treatment with epoetin alfa could improve adherence rates, which in turn may improve virologic response rates, study investigators suggest.

Standard treatment of HCV infected patients includes interferon alfa (IFN-alfa) in combination with RBV, both of which are known to lower hemoglobin (Hb) levels. When anemia results, RBV doses are often reduced or the drug is discontinued, which may compromise treatment success.

In a small "proof-of-principle" study, epoetin alfa 40,000 U once weekly effectively increased Hb levels and minimized the need for RBV dose reductions in anemic HCV-infected patients on combination HCV therapy. (see Reuters Health report December 24, 2003). These "promising results" motivated the researchers to conduct a larger trial, the results of which are reported this month in the journal Gastroenterology.

Dr. Nezam H. Afdhal from Beth Israel Deaconess Medical Center in Boston and colleagues randomly assigned 185 HCV-infected anemic patients (Hb less than or equal to 12 g/dL) on combination IFN-alpha/RBV therapy to once weekly epoetin alfa or matching placebo for 8 weeks. This double-blind phase was followed by an 8-week open label phase in which placebo-treated patients crossed over to epoetin.

At the end of the first 8 weeks, a significantly greater number of patients receiving epoetin than placebo maintained their RBV doses (88% vs 60%; p < 0.001). As expected, mean Hb levels increased significantly more in epoetin- than placebo-treated patients (2.2 vs 0.1 g/dL; p < 0.001).

"Similar results were demonstrated in patients who switched from placebo to epoetin alfa in the open-label phase," the authors report.

Treatment with epoetin alfa also led to "highly significant improvements" in various measures of quality of life including vitality, social functioning, and physical and emotional states. "These results are particularly notable and encouraging," the authors write, "because QOL in patients with chronic HCV infection is decreased compared with that of patients with other chronic conditions and that of healthy individuals."

Epoetin alfa was generally well tolerated; headache and nausea were the most commonly reported adverse effects.

Collectively, the responses to epoetin alfa demonstrated by the three study endpoints - RBV dose maintenance, Hb level, and QOL, "illustrate that a proactive approach to treating anemia in HCV-infected patients may impact treatment outcomes," Dr. Afdhal and colleagues write.

They suggest that future studies concentrate on the pharmacoeconomic benefits of epoetin alfa in HCV-infected patients on combination HCV therapy and its impact on virologic response rates.

Gastroenterol 2004;126:1302-1311.