In a phase 2a clinical trial, treatment with beclabuvir and a combination of pegylated interferon alfa-2a and ribavirin was well tolerated among patients with hepatitis C virus genotype 1 infection, according to study data.
Researchers, including Eric J. Lawitz, MD, of The Texas Liver Institute, University of Texas Health Science Center, San Antonio, randomly assigned 39 treatment-naive patients with HCV genotype 1 infection to 75 mg (n=13) or 150 mg (n=13) beclabuvir (formerly BMS-791325, Bristol-Myers Squibb) plus 180 mcg of PEG-IFN a-2a with weight-based ribavirin (RBV) or 1,200 mg of just PEG-IFN a-2a/RBV (n=23) per day for 48 weeks. Twenty-nine patients completed the study.
Overall, 76.9% of patients who received 75 mg beclabuvir (n=10) achieved rapid virologic response at 4 and 12 weeks of treatment compared with 38.5% of patients receiving 150 mg and 0% of patients receiving PEG-IFN a-2a/RBV alone. More patients in the 75-mg group achieved a sustained virologic response at 12 and 24 weeks (69.2% for both) compared with patients who received 150 mg (46.2%, 38.5%) and patients receiving placebo (38.5% for both). Three patients who received 150 mg experienced virologic breakthrough while undergoing treatment.
In all three treatment groups, the most common adverse events that led to dose reduction were anemia and neutropenia. Other common adverse events experienced among the cohorts were headache, fatigue, nausea, irritability, decreased appetite, depression and insomnia, most of which were related to PEG-IFN a-2a/RBV, according to the research.
“These data show that beclabuvir is effective and well tolerated in combination with PEG-IFN/RBV for the treatment of chronic HCV genotype 1, and support the use of beclabuvir in all-oral regimens,” the researchers concluded.
Disclosure: The study was funded by Bristol-Myers Squibb. See the study for a full list of researchers’ relevant financial disclosures.
Reposted from Healio on January 10, 2015: www.healio.com/hepatology/hepatitis-c/news/online/%7B0e0180fc-5825-491d-9f2c-acb74f58cc74%7D/beclabuvir-with-peg-ifn-a-2aribavirin-safely-treated-hcv