Background and Aims: To maximize cost/efficay of boceprevirbasedtriple therapy (BOC) in patients with HCV-related advancedfibrosis/cirrhosis.Methods: ITT SVR12, safety and futility rules value were evaluatedin the multicenter national Italian and Spanish early access Name-Patient-Program which includes treatment-experienced patientswith HCVG1-related advanced fibrosis/cirrhosis (Metavir F3/4)treated with BOC in both countries.Results: 402 patients (mean age 55 years; range 22–75),316 (78.6%) G1b, 255 (63.4%) F4, 60 (30.9%) with oesophagealvarices, 137 (34.1%) relapsers, 95 (23.6%) partial and 168 (41.8%) nullresponders were enrolled. Platelets count <100,000 and albuminlevels <3.5 g/dl were present in 49 (12.2%) and 22 (6.3%) patients,respectively. 369 (91.8%) received at least 1 dose of BOC. Overall ITTSVR12 rates and according to prior response to P/R, fibrosis stageand TW8 HCV-RNA value to P/R/BOC are reported in the table.At multivariate analysis, the strongest predictors of SVR12 wereTW8 HCV-RNA undetectability (RR, 30.8; 95% CI, 8.7–108.7) andHCV-RNA detectable but <1000 IU/mL (RR, 9.1; 95% CI, 2.6–31.8)compared to those with HCV-RNA ≥1000 IU/mL.Two patients (0.5%) died from multi-organ failure, 13 (3.2%)developed hepatic decompensation, 41 (10.2%) had severe anemia(<8.5 g/dl) and 31 (7.7%) required at least one blood transfusion.Conclusions: In treatment-experienced patients with advancedfibrosis/cirrhosis, SVR12 attained by BOC was satisfactory. Mortality,life-threatening adverse events and severe anemia rates weresimilar to those reported in other real-practice studies. A TW8futility rule enables a safely discontinuation of BOC in patientswho are extremely unlikely to achieve SVR, thus optimizing theeffectiveness of treatment in this difficult-to-cure population.
|Numero di pagine||1|
|Stato di pubblicazione||Published - 2014|