A simple rule to personalize standard dual therapy across all genotypes in naive chronic hepatitis C patients: The TT4 randomized trial

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• 作者：Simona Francioso ; Cristiana Almerighi ; Paolo Forte ; Franco B ; iera ; Lorenzo Nosotti ; Raffaella Lionetti ; Gloria Taliani ; Maria Rosaria Piras ; Maria Laura Ponti ; Giustino Parruti ; Francesco Di C ; ilo ; Silvia Gentile ; Paola Piccolo ; Angela Salso ; Francesca Riccobelli ; Sara Renzi ; Maria Antonella Longo ; Marzia Montalbano ; Salvatore Zaru ; Elisa Biliotti ; Francesco Di Masi ; et al.
• 关键词：HCV treatment ; Dual therapy ; Pegylated interferon ; Ribavirin ; Rapid viral response ; Response-guided therapy ; Individualized therapy
• 刊名：Digestive and Liver Disease
• 出版年：February, 2014
• 年：2014
• 卷：46
• 期：2
• 页码：164-169
• 全文大小：737 K

文摘

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 na茂ve 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 鈮? 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 卤 15 vs. 36 卤 12.1 weeks], and for subgroups: G1 [35.3 卤 16.7 vs. 47.3 卤 2.6 weeks], G2 [18.3 卤 7.5 vs. 24 卤 2.8 weeks], G3 [15.2 卤 8.7 vs. 22.8 卤 3 weeks] and G4 [26.9 卤 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.