Provided by Healio
July 5, 2013
Sustained virologic response to a regimen of three antivirals and ribavirin was highly prevalent with or without a ribavirin dose reduction among patients with chronic HCV in a study presented at the International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention in Kuala Lumpur, Malaysia.
Researchers evaluated 247 noncirrhotic patients with chronic HCV genotype 1, including 159 treatment-naive patients and 88 who were nonresponsive to previous interferon-based therapy. Patients were assigned 12 or 24 weeks of treatment with a combination of three direct-acting antivirals (DAA): HCV protease inhibitor ABT-450/r; NS5A inhibitor ABT-267, and non-nucleoside NS5B inhibitor ABT-333, along with weight-based ribavirin (RBV).
Four patients discontinued treatment due to adverse treatment-related events, and one patient experienced arthralgia considered potentially related to the regimen. Hemoglobin levels below 10 g/dL were measured in 16 patients during therapy, with one patient indicating levels below 8.5 g/dL.
RBV dose reductions were required due to toxicity in 27 cases, including 21 treatment-naive patients and six prior null responders. The most frequent adverse event requiring RBV reduction was anemia, which occurred in 16 cases. Other events resulting in dose reduction included diarrhea, fatigue, dizziness and increased creatinine levels.
After 12 weeks post-treatment, sustained virologic response (SVR) was observed in all participants who required an RBV reduction, as well as 93.5% of treatment-naive patients and 92.7% prior null responders who did not receive a dose reduction.
“RBV dose reductions were required less frequently with this peginterferon-free regimen than in previously reported studies of subjects receiving peginterferon-containing regimens,” the researchers wrote. “High SVR12 rates (100%) were achieved among subjects requiring RBV dose reduction.”
For more information:
Cohen D. TUAB0103: Safety of Ribavirin-Containing Regimens of ABT-450/r, ABT-333 and ABT-267 for the Treatment of HCV Genotype 1 Infection and Efficacy in Subjects with Ribavirin Dose Reductions. Presented at: IAS Conference on HIV Pathogenesis, Treatment and Prevention; June 30-July 03, 2013; Kuala Lumpur, Malaysia.