ORLANDO, Fla. — Therapy with boceprevir in addition to pegylated interferon and ribavirin led to high sustained virologic response rates in patients with hepatitis C who failed previous interferon-based treatment in a study presented at Digestive Disease Week.
In the single-arm, open-label, multicenter roll-over PROVIDE study, researchers randomly assigned 168 patients with chronic HCV genotype 1 to 800 mg boceprevir three times daily, in addition to a standard dose of peginterferon alfa-2a and weight-based ribavirin (PR), for up to 44 weeks. All participants had been in control arms of prior phase 2 and 3 boceprevir studies and had experienced relapse or null or partial response to PR (51% partial responders, 31% null responders and 17% relapse responders, with 1% not classifiable).
Patients enrolled more than 2 weeks after their previous therapy also received a 4-week lead-in with PR alone (n=156). Four patients discontinued treatment during this period, leaving 164 boceprevir recipients for analysis.
Sustained virologic response (SVR) at 24 weeks occurred in 41% of null responders, 67% of partial responders and 96% of relapsers in final analysis, for an overall SVR rate of 65%. Relapse occurred in 13% of null responders, 15% of partial responders and no relapsers (11% average rate). Most patients who experienced SVR were men, not of black race, and had viral loads of 800,000 IU/mL or lower upon initiation. SVR rates were similar among those with HCV genotype 1a and 1b, and poorer among patients with platelet counts less than 200,000.
Commonly reported adverse events included anemia (49% of cases), dysgeusia (35%) and neutropenia (23%), and the safety profile was similar to previous studies. Eight percent of the cohort discontinued treatment because of adverse events.
“Overall, the data of this final analysis led to the conclusion that boceprevir combined with peginterferon/ribavirin therapy is efficacious in subjects with all three categories of nonresponse: relapsers, partial responders; and, most importantly, null responders,” researcher John M. Vierling, MD, professor of medicine and surgery, director of Baylor Liver Health and chief of hepatology at Baylor College of Medicine in Houston, said.
Disclosure: The researchers report numerous financial disclosures.
For more information:
Vierling JM. 869c: Sustained Virologic Response (SVR) in Prior PegInterferon/Ribavirin (PR) Treatment Failures After Retreatment With Boceprevir (BOC) and PR: Final Results of the PROVIDE Study. Presented at: Digestive Disease Week 2013; May 18-21, Orlando, Fla.