Patients with chronic hepatitis C and compensated cirrhosis experienced higher rates of sustained virologic response with the addition of boceprevir to therapy with pegylated interferon and ribavirin in a study presented at the International Liver Congress in Amsterdam.
Researchers performed a meta-analysis of five phase 3 studies assessing the efficacy of boceprevir, peginterferon and ribavirin. After undergoing 4 weeks of lead-in therapy with peginterferon and ribavirin (P/R), 2,415 patients with chronic hepatitis C received either P/R alone or boceprevir plus P/R (BOC/P/R) for 24, 32 or 44 weeks. The cohort included 2,074 patients with stage 0-2 fibrosis (F0-2; including 1,638 BOC/P/R and 436 P/R recipients), 129 with stage 3 (F3; 107 BOC/P/R; 22 P/R) and 212 with stage 4 (F4; 180 BOC/P/R; 32 P/R) based on Metavir scores from liver biopsies.
Investigators calculated pooled estimates of sustained virologic response (SVR) of 66% among BOC/P/R recipients vs. 28% of P/R recipients with F0-2; 54% and 26%, respectively, of those with F3; and 55% and 17%, respectively, of those with F4. Multivariate analysis indicated that male sex (OR=2.23; P=.0141), HCV RNA levels of 800,000 IU/mL or less at baseline (OR=2.55; P=.0383), a decline of 1 log10 or more in HCV RNA levels after lead-in therapy (OR=2.64; P=.0053) and undetectable RNA levels after 4 weeks of BOC/P/R (OR=10.57; P<.0001) were independently predictive of SVR among patients with F3 or F4.
More than half of BOC/P/R recipients developed anemia (53% of F0-2, 56% of F3 and 63% of F4 patients). Serious adverse events occurred in 12% of those with F0-2 and F3 and 18% of F4 patients in the BOC/P/R group.
“Based on an overall favorable benefit-risk profile, BOC/P/R can be safely and effectively used in compensated cirrhotic patients,” the researchers concluded. “Efficacy is particularly high in cirrhotic patients achieving undetectable HCV-RNA at [treatment week 8]. Viral response at [week 8] is especially informative in deciding to continue or discontinue treatment.”
For more information:
Vierling JM. #1430: Safety and Efficacy of Boceprevir/Peginterferon/Ribavirin (BOC/P/R) Combination Therapy for Chronic HCV G1 Patients with Compensated Cirrhosis: A Meta-Analysis of Five Phase 3 Clinical Trials. Presented at: The International Liver Congress 2013; April 24-28, Amsterdam.