Hepatology and Liver Transplantation Unit, Department of Experimental Medicine and Surgery, Tor Vergata University, Rome, Italy.
Hepatology and Liver Transplantation Unit, Department of Experimental Medicine and Surgery, Tor Vergata University, Rome, Italy.
Dig Liver Dis. 2014 Feb;46(2):164-9. doi: 10.1016/j.dld.2013.10.002. Epub 2013 Nov 13.
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).
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 ≤2log10 at week 12 or detectable HCV-RNA at week 24 discontinued treatment.
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].
In HCV-naive patients, TT4-rule treatment yields similar SVR rates compared to SoC but with shorter treatment duration and remarkable cost reduction.
聚乙二醇干扰素-α和利巴韦林的快速早期病毒学应答可预测丙型肝炎病毒（HCV）感染的持续病毒学应答（SVR）。我们旨在寻找一种简单的规则，以确定所有 HCV 基因型的双重治疗最短持续时间，方法是将初始病毒学应答（IVR，首次不可检测的 HCV-RNA）时间乘以 4（量身定制的治疗-4，或 TT4）。
267 例初治 HCV 感染代偿性肝病患者被随机（2:1）分为 TT4（n=180）或当前标准治疗（SoC，n=87），并接受聚乙二醇干扰素-α加利巴韦林治疗。第 12 周 HCV-RNA 下降≤2log10 或第 24 周可检测到 HCV-RNA 的患者停止治疗。
两组基线特征具有可比性，全人群 SVR 率相似（60.6%比 60.9%），各基因型亚组相似（G1：46.6%比 55.6%；G2：90.2%比 94.4%；G3：74.1%比 58.3%；G4：45.8%比 33.3%）。G1-TT4 组比 G1-SoC 组复发率更高。与 SoC 相比，TT4 组 SVR 患者的治疗时间更短，总疗程为[25±15 比 36±12.1 周]，亚组分别为：G1 [35.3±16.7 比 47.3±2.6 周]，G2 [18.3±7.5 比 24±2.8 周]，G3 [15.2±8.7 比 22.8±3 周]和 G4 [26.9±13 比 48 周]。
在 HCV 初治患者中，TT4 规则治疗与 SoC 相比可获得相似的 SVR 率，但治疗时间更短，成本显著降低。
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