Francioso, Simona and Almerighi, Cristiana and Forte, Paolo and Bandiera, Franco and Nosotti, Lorenzo and Lionetti, Raffaella and Taliani, Gloria and Piras, Maria Rosaria and Ponti, Maria Laura and Parruti, Giustino and Di Candilo, Francesco and Gentile, Silvia and Piccolo, Paola and Salso, Angela and Riccobelli, Francesca and Renzi, Sara and Longo, Maria Antonella and Montalbano, Marzia and Zaru, Salvatore and Biliotti, Elisa and Di Masi, Francesco and Santopaolo, Francesco and Angelico, Mario (2014) A Simple rule to personalize standard dual therapy across all genotypes in naive chronic hepatitis C patients: the TT4 randomized trial. Digestive and liver disease, Vol. 46 (2), p. 164-169. ISSN 1590-8658. eISSN 1878-3562. Article.
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Background: Rapid and early virological responses to peginterferon-alpha and ribavirin are predictive of sustained virological response (SVR) in hepatitis C virus (HCV) infection. We aimed at finding a simple rule to determine the shortest duration of dual therapy for all HCV genotypes, obtained by multiplying time to Initial Viral Response, IVR (first undetectable HCV-RNA) by 4 (Tailored Therapy-4, or TT4).
Method: 267 naïve HCV-infected patients with compensated liver disease were randomized (2:1) to the TT4 (n = 180) or current standard-of-care (SoC, n = 87) and received peginterferon-alpha plus ribavirin. Patients with HCV-RNA decrease ≤2 log10 at week 12 or detectable HCV-RNA at week 24 discontinued treatment.
Results: Both groups had comparable baseline characteristics, SVR rates were similar in the whole population (60.6% vs. 60.9%) and within each genotype subgroup (G1: 46.6% vs. 55.6%; G2: 90.2% vs. 94.4%; G3: 74.1% vs. 58.3%; G4: 45.8% vs. 33.3%). Relapse rate was higher in G1-TT4 than G1-SoC. Treatment duration in SVR patients was shorter in TT4 compared to SoC, both overall [25 ± 15 vs. 36 ± 12.1 weeks], and for subgroups: G1 [35.3 ± 16.7 vs. 47.3 ± 2.6 weeks], G2 [18.3 ± 7.5 vs. 24 ± 2.8 weeks], G3 [15.2 ± 8.7 vs. 22.8 ± 3 weeks] and G4 [26.9 ± 13 vs. 48 weeks].
Conclusions: In HCV-naive patients, TT4-rule treatment yields similar SVR rates compared to SoC but with shorter treatment duration and remarkable cost reduction.
|Uncontrolled Keywords:||HCV treatment, dual therapy, pegylated interferon, ribavirin, rapid viral response, response-guided therapy, individualized therapy|
|Copyright Holders:||Published by Elsevier Ltd on behalf of Editrice Gastroenterologica Italiana S.r.l.|
|Deposited On:||28 May 2014 09:44|
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