Friday, February 15, 2013

Incident anemia improved response to peginterferon, ribavirin, boceprevir in HCV patients

Incident anemia improved response to peginterferon, ribavirin, boceprevir in HCV patients

Sulkowski MS. Hepatology. 2013;doi:10.1002/hep.26096.

February 15, 2013

Patients with chronic hepatitis C who developed anemia during treatment with pegylated interferon alfa-2b, ribavirin and boceprevir were more likely to experience sustained virologic response in a recent study.

As part of the Serine Protease Inhibitor Therapy 2 (SPRINT-2) Trial, 1,097 patients with chronic HCV genotype 1 randomly were assigned either peginterferon and ribavirin (PegIFN/RBV) with placebo or 800 mg boceprevir (BOC) three times a day for 44 weeks or response-guided PegIFN/RBV with BOC, following 4 weeks of lead-in therapy with PegIFN/RBV. Nearly all patients (n=1,080) had hemoglobin (Hb) levels measured during the study. Anemia (Hb below 10 g/dL) was managed with erythropoietin and/or RBV dose reduction.

Half of BOC recipients developed anemia during the study, compared with 31% of placebo recipients (P<.001). Severe anemia (Hb below 8.5 g/dL) occurred in 4% of placebo recipients and 7% BOC patients (P=.04). Patients who developed anemia had significantly lower Hb levels at baseline and estimated creatinine clearance and were more likely to use statins. Multivariate analysis indicated that baseline Hb was predictive of incident anemia (OR=0.58, 95% CI, 0.51-0.67) while low creatinine levels approached statistical significance (P=.0524).

Rates of SVR (72% vs. 58%) and response at end-of-treatment (81% vs. 67%) were higher among anemic patients than in nonanemic patients. SVR rates did not vary significantly based on anemia management method (range 70%-74%). Investigators noted that SVR rates were higher among anemic patients who experienced a maximum decline of more than 3 g/dL during treatment.

“The addition of BOC to PegIFN/RBV therapy is associated with greater risk of anemia compared with PegIFN/RBV alone,” the researchers wrote. “However, the SVR rate was higher in patients with incident anemia compared with those without anemia irrespective of the anemia management strategy. Additional studies are under way to further evaluate these strategies to management treatment-emergent anemia. Until such data is available, RBV dose reduction should remain the primary approach to anemia management during BOC [with PegIFN/RBV] therapy for treatment-naive patients.”

Disclosure: See the study for a full list of relevant disclosures.

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