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 naive 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 log(10) 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. Published by Elsevier Ltd on behalf of Editrice Gastroenterologica Italiana S.r.l.
A simple rule to personalize standard dual therapy across all genotypes in naive chronic hepatitis C patients: The TT4 randomized trial / Simona, Francioso; Cristiana, Almerighi; Paolo, Forte; Franco, Bandiera; Lorenzo, Nosotti; Raffaella, Lionetti; Taliani, Gloria; Maria Rosaria, Piras; Maria Laura, Ponti; Giustino, Parruti; Francesco Di, Candilo; Silvia, Gentile; Paola, Piccolo; Angela, Salso; Francesca, Riccobelli; Sara, Renzi; Maria Antonella, Longo; Marzia, Montalbano; Salvatore, Zaru; Biliotti, Elisa; Francesco Di, Masi; Francesco, Santopaolo; Mario, Angelico. - In: DIGESTIVE AND LIVER DISEASE. - ISSN 1590-8658. - STAMPA. - 46:2(2014), pp. 164-169. [10.1016/j.dld.2013.10.002]
A simple rule to personalize standard dual therapy across all genotypes in naive chronic hepatitis C patients: The TT4 randomized trial
TALIANI, Gloria;BILIOTTI, ELISA;
2014
Abstract
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 naive 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 log(10) 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. Published by Elsevier Ltd on behalf of Editrice Gastroenterologica Italiana S.r.l.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.