DDW 2013: Prior Non-responders Can Achieve Good SVR Rates with Boceprevir Triple Therapy

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People previously treated with interferon-based therapy can achieve good results when retreated with boceprevir (Victrelis) triple therapy, according to final results from the PROVIDE study presented at the Digestive Disease Week meeting (DDW 2013) last month in Orlando. Prior relapsers had the best response, but even 41% of prior null responders achieved a cure.

John Vierling from Baylor College of Medicine and colleagues reported final findings from the PROVIDE trial, which included patients from the pegylated interferon/ribavirin standard-of-care control arms in Phase 2 and 3 trials of boceprevir who were treated for at least 12 weeks.

This single-arm, open-label study enrolled 168 genotype 1 chronic hepatitis C patients. Two-thirds were men, more than 80% were white, the mean age was 52 years, 62% had harder-to-treat HCV subtype 1a, and 10% had liver cirrhosis. Categorized by previous treatment outcome, 17% were prior relapsers, 51% were partial responders, and 31% were prior null responders who experienced little or no decline in HCV RNA (< 2 log) with previous interferon-based therapy.

Participants were treated with 800 mg 3-time-daily boceprevir plus 1.5 mcg/kg/week pegylated interferon alfa-2b (PegIntron) and 600-1400 mg/day weight-based ribavirin for up to 44 weeks. People with more than 2 weeks since the end of prior treatment received a 4-week lead-in of pegylated interferon/ribavirin alone before adding boceprevir; 4 patients dropped out during the lead-in and never started triple therapy, leaving 164 who received at least 1 dose of boceprevir.

Results

o   Prior relapsers: 96%;

o   Prior partial responders: 67%;

o   Prior null responders: 41%.

"SVR rates with [boceprevir and pegylated interferon/ribavirin] were high in all patient subgroups, even among patients who were documented to be null responders to prior pegylated interferon/ribavirin treatment," the investigators concluded. "The safety profile was similar to that previously reported for [boceprevir and pegylated interferon/ribavirin]."

6/6/13

Reference

JM Vierling, FA Helmond, J Wahl, et al. Sustained Virologic Response (SVR) in Prior Peginterferon/Ribavirin (PR) Treatment Failures After Retreatment With Boceprevir (BOC) PR: Final Results of the Provide Study. Digestive Disease Week (DDW 2013). Orlando, May 18-21, 2013. Abstract 869c.