MONDAY, Aug. 9 (HealthDay News) -- The addition of boceprevir, an NS3 protease inhibitor, to the standard regimen of peginterferon alfa-2b and ribavirin for patients with treatment-naive genotype 1 chronic hepatitis C infection can nearly double the sustained virological response (SVR) rate, according to a study published online Aug. 9 in The Lancet.
In part one of the trial, Paul Y. Kwo, M.D., of the Indiana University School of Medicine in Indianapolis, and colleagues randomized 520 treatment-naive patients with genotype 1 hepatitis C virus infection to receive peginterferon alfa-2b (1.5 µg/kg) plus ribavirin (800 to 1,400 mg daily) for 48 weeks (PR48); peginterferon alfa-2b and ribavirin daily for four weeks, followed by peginterferon alfa-2b, ribavirin, and boceprevir (800 mg) three times daily for 24 weeks (PR4/PRB24) or 44 weeks (PR4/PRB44); or peginterferon alfa-2b, ribavirin, and boceprevir three times daily for 28 weeks (PRB28) or 48 weeks (PRB48). In part two of the study, 75 patients were randomized to receive either PRB48 or low-dose ribavirin (400 to 1,000 mg) plus peginterferon alfa-2b and boceprevir three times a day for 48 weeks (low-dose PRB48).
The researchers found that patients in the four groups receiving boceprevir experienced higher SVR rates than the control group (54 percent for PRB28, 56 percent for PR4/PRB24, 67 percent for PRB48, and 75 percent for PR4/PRB44, compared to 38 percent for the PR48 control group). However, patients in the boceprevir groups experienced higher rates of anemia (55 versus 34 percent) and dysgeusia (27 versus 9 percent) compared to the control group. The researchers also found that low-dose ribavirin was linked to a higher rate of viral breakthrough (27 percent), and the rate of relapse (22 percent) was found to be similar to that of the control group (24 percent).
"In patients with untreated genotype 1 chronic hepatitis C infection, the addition of the direct-acting antiviral agent boceprevir to standard treatment with peginterferon and ribavirin after a four-week lead-in seems to have the potential to double the sustained response rate compared with that recorded with standard treatment alone," the authors write.
The study was funded by Merck. Several authors disclosed financial ties to Merck and other pharmaceutical and/or medical device companies.
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