Undetectable HCV-RNA at treatment-week 8 results in high-sustained virological response in HCV G1 treatment-experienced patients with advanced liver disease: the International Italian/Spanish Boceprevir/Peginterferon/Ribavirin Name Patients Program
Articolo
Data di Pubblicazione:
2014
Citazione:
Undetectable HCV-RNA at treatment-week 8 results in high-sustained virological response in HCV G1 treatment-experienced patients with advanced liver disease: the International Italian/Spanish Boceprevir/Peginterferon/Ribavirin Name Patients Program / Bruno, S; Bollani, S; Zignego, A L; Pascasio, J M; Magni, C; Ciancio, A; Caremani, M; Mangia, A; Marenco, S; Piovesan, S; Chemello, L; Babudieri, S; Moretti, A; Gea, F; Colletta, C; Perez-Alvarez, R; Forns, X; Larrubia, J R; Arenas, J; Crespo, J; Calvaruso, V; Ceccherini Silberstein, F; Maisonneuve, P; Craxì, A; Calleja, J L. - In: JOURNAL OF VIRAL HEPATITIS. - ISSN 1352-0504. - 22:5(2014), pp. 469-480. [10.1111/jvh.12342]
Abstract:
In many countries, first-generation protease inhibitors
(PIs)/peginterferon/ribavirin (P/R) still represent the only treatment option for
HCV-infected patients. Subjects with advanced disease and previous failure to P/R
urgently need therapy, but they are under-represented in clinical trials. All
treatment-experienced F3/4 Metavir patients who received boceprevir (BOC)+P/R in
the Italian-Spanish Name Patient Program have been included in this study.
Multivariate logistic regression analysis (MLR) was used to identify baseline and
on-treatment predictors of SVR and adverse events (AEs). Four hundred and sixteen
patients, mean age 57.7 (range 25-78 years), 70% males, 69.5% (289/416) F4, 14%
(41/289) Child-Pugh class A6, 24% (70/289) with varices and 42% (173/416) prior
null responders to P/R, were analysed. Overall, SVR rate (all 381 patients who
received one dose of BOC) was 49%, (58% in F3, 45% in F4, 61% in relapsers, 51%
in partial, 38% in null responders, and 72% in subjects with undetectable HCV-RNA
at treatment-week (TW)8. Among patients with TW8 HCV-RNA ≥ 1000 IU/L, SVR was 8%
(negative predictive value = 92%). Death occurred in 3 (0.8%) patients, while
decompensation and infections were observed in 2.9% and 11%, respectively. At
MLR, SVR predictors were TW4 HCV-RNA ≥ 1log10 -decline from baseline,
undetectable TW8 HCV-RNA, prior relapse, albumin levels ≥3.5 g/dL and platelet
counts ≥100 000/μL. Metavir F4, Child-Pugh A6, albumin, platelets, age and female
gender were associated with serious and haematological AEs. Among
treatment-experienced patients with advanced liver disease eligible for IFN-based
therapy, TW8 HCV-RNA characterised the subset with either high or poor likelihood
of achieving SVR. Using TW8 HCV-RNA as a futility rule, BOC/P/R appears to have a
favourable benefit-risk profile.
(PIs)/peginterferon/ribavirin (P/R) still represent the only treatment option for
HCV-infected patients. Subjects with advanced disease and previous failure to P/R
urgently need therapy, but they are under-represented in clinical trials. All
treatment-experienced F3/4 Metavir patients who received boceprevir (BOC)+P/R in
the Italian-Spanish Name Patient Program have been included in this study.
Multivariate logistic regression analysis (MLR) was used to identify baseline and
on-treatment predictors of SVR and adverse events (AEs). Four hundred and sixteen
patients, mean age 57.7 (range 25-78 years), 70% males, 69.5% (289/416) F4, 14%
(41/289) Child-Pugh class A6, 24% (70/289) with varices and 42% (173/416) prior
null responders to P/R, were analysed. Overall, SVR rate (all 381 patients who
received one dose of BOC) was 49%, (58% in F3, 45% in F4, 61% in relapsers, 51%
in partial, 38% in null responders, and 72% in subjects with undetectable HCV-RNA
at treatment-week (TW)8. Among patients with TW8 HCV-RNA ≥ 1000 IU/L, SVR was 8%
(negative predictive value = 92%). Death occurred in 3 (0.8%) patients, while
decompensation and infections were observed in 2.9% and 11%, respectively. At
MLR, SVR predictors were TW4 HCV-RNA ≥ 1log10 -decline from baseline,
undetectable TW8 HCV-RNA, prior relapse, albumin levels ≥3.5 g/dL and platelet
counts ≥100 000/μL. Metavir F4, Child-Pugh A6, albumin, platelets, age and female
gender were associated with serious and haematological AEs. Among
treatment-experienced patients with advanced liver disease eligible for IFN-based
therapy, TW8 HCV-RNA characterised the subset with either high or poor likelihood
of achieving SVR. Using TW8 HCV-RNA as a futility rule, BOC/P/R appears to have a
favourable benefit-risk profile.
Tipologia CRIS:
1.1 Articolo in rivista
Elenco autori:
Bruno, S; Bollani, S; Zignego, A L; Pascasio, J M; Magni, C; Ciancio, A; Caremani, M; Mangia, A; Marenco, S; Piovesan, S; Chemello, L; Babudieri, S; Moretti, A; Gea, F; Colletta, C; Perez-Alvarez, R; Forns, X; Larrubia, J R; Arenas, J; Crespo, J; Calvaruso, V; Ceccherini Silberstein, F; Maisonneuve, P; Craxì, A; Calleja, J L
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