October 22, 2014
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Decreased hemoglobin levels did not impact SVR rate in patients treated for HCV genotype 1

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PHILADELPHIA — Decreased hemoglobin levels were well-managed in patients with hepatitis C virus infection receiving a three direct-acting antiviral regimen with or without ribavirin and did not affect response to treatment, according to data presented at the ACG Annual Scientific Meeting.

Vinod Rustgi, MD, of Metropolitan Research, Fairfax, Virginia, and colleagues analyzed pooled data from treatment naïve and treatment-experienced patients with HCV genotype 1a or 1b (n=910) enrolled in the PEARL-II (n=186), III (n=419) and IV (305) phase 3 trials undergoing treatment with a three direct-acting antiviral (3D) regimen. Patients were assigned ABT-450/ritonavir/ombitasvir (150 mg/100 mg/25 mg once daily) and dasabuvir (250 mg twice daily) with (n=724) or without ribavirin (RBV; n=186) for 12 weeks. Hemoglobin levels were evaluated at baseline, throughout therapy and follow-up to determine any decreases and effects on treatment.

Vinod Rustgi

A grade 2 hemoglobin decrease occurred in 23 patients while receiving the 3D with RBV regimen; a grade 3 decrease occurred in 2 of these patients. All these patients had normal hemoglobin levels at baseline. None of the patients receiving treatment with the 3D without RBV regimen experienced a grade 2 or 3 hemoglobin decrease. No grade 4 hemoglobin decreases were observed in any of the patients.

RBV dose was reduced in the 23 patients who experienced hemoglobin decrease. All of these patients achieved a sustained virologic response at 12 weeks (SVR12). No patients discontinued treatment due to hemoglobin decrease or anemia. However, one patient underwent blood transfusion for a grade 3 decrease.

“The 3D regimen was well-tolerated with and without ribavirin in treatment-naïve and treatment-experienced patients,” Rustgi said during the presentation. “Clinically significant decreases in hemoglobin were uncommon. SVR12 rates were not impacted by RBV dose modification.”

For more information:

Rustgi V. Abstract 33. Presented at: Annual ACG Scientific Meeting, Oct. 17-22, 2014; Philadelphia, PA.

Disclosure: The research was funded by AbbVie. See the abstract for a full list of relevant financial disclosures.