A regimen of boceprevir combined with pegylated interferon-ribavirin improved sustained virologic response in patients with hepatitis C and advanced fibrosis and cirrhosis, according to recent study results.
Using two phase 3, randomized double blind studies, researchers assessed the efficacy and safety of triple therapy — boceprevir (BOC) and peginterferon-ribavirin (PR) — among 178 treatment naive or unresponsive patients with HCV genotype 1 and advanced F3/F4 Metavir fibrosis scores. Patients assigned to three study arms received a 4-week lead-in of PR and then either 44 more weeks of PR plus placebo (PR48), PR in addition to BOC response-guided therapy (BOC/RGT), or PR plus BOC for 44 weeks (BOC/PR48).
Primary endpoint was sustained virologic response (SVR), defined as undetectable HCV-RNA levels, at week 24 of follow-up. Researchers found that HCV-RNA levels at weeks 4 and 8 were highly predictive of response, and no patients among the PR48 cohort with less than 1 log10 decline in HCV-RNA at week 4 achieved SVR. Conversely, patients in the BOC/RGT and BOC/PR48 arms reached SVR rates between 11% and 33% (for F3) and 10% and 14% (F4) when combining studies.
For (F3/F4) patients with a 1 or greater log10 decline at week 4, SVR rates for the BOC/PR48 arm were 77% and 87% in the two studies compared with 50% and 18% for PR48 patients. Fatigue and anemia were the most common adverse events in BOC/PR48 patients; neutropenia and thrombocytopenia were more common among cirrhotic patients than noncirrhotics.
“The results of these subgroup analyses suggest that BOC improves SVR rate in patients with advanced fibrosis/cirrhosis and that the longer treatment duration (4 weeks of PR plus 44 weeks of BOC plus PR) provides the greatest benefit to these patients,” the researchers concluded. “In this very difficult-to-treat subset of patients receiving triple therapy with BOC, the 4-week lead-in defines those in whom the addition of BOC results in low SVR rates.”
Disclosure: See the study for a full list of relevant disclosures.