Mangia Alessandra, Santoro Rosanna, Minerva Nicola, Ricci Giovanni L, Carretta Vito, Persico Marcello, Vinelli Francesco, Scotto Gaetano, Bacca Donato, Annese Mauro, Romano Mario, Zechini Franco, Sogari Fernando, Spirito Fulvio, Andriulli Angelo
Gastroenterology Unit, IRCCS Casa Sollievo della Sofferenza Hospital, San Giovanni Rotondo, Italy.
N Engl J Med. 2005 Jun 23;352(25):2609-17. doi: 10.1056/NEJMoa042608.
We hypothesized that in patients with hepatitis C virus (HCV) genotype 2 or 3 in whom HCV RNA is not detectable after 4 weeks of therapy, 12 weeks of treatment is as effective as 24 weeks.
A total of 283 patients were randomly assigned to a standard 24-week regimen of peginterferon alfa-2b at a dose of 1.0 mug per kilogram weekly plus ribavirin at a dose of 1000 mg or 1200 mg daily, on the basis of body weight. Of these, 70 patients were assigned to the 24-week regimen (standard-duration group) and 213 patients to a variable regimen (variable-duration group) of 12 or 24 weeks, depending on whether tests for HCV RNA were negative or positive at week 4. The primary end point was HCV that was not detectable by polymerase-chain-reaction (PCR) assay 24 weeks after the completion of therapy.
In the standard-duration group, 45 (64 percent) patients had HCV that was not detectable by PCR assay at week 4, as compared with 133 (62 percent) in the variable-duration group (difference [the rate in the standard-duration group minus that in the variable-duration group], 2 percent; 95 percent confidence interval, -11 to 15 percent). Fifty-three patients (76 percent) in the standard-duration group and 164 patients (77 percent) in the variable-duration group had a sustained virologic response (difference, -1 percent; 95 percent confidence interval, -13 to 10 percent). Fewer patients in the variable-duration group receiving the 12-week regimen had adverse events and withdrew than in the group receiving the 24-week regimen (P=0.045). The rate of relapse (defined as HCV not detectable at the end of treatment but detectable at the end of follow-up) was 3.6 percent in the standard-duration group and 8.9 percent in the variable-duration group (P=0.16). Overall, the rate of sustained virologic response was 80 percent among patients with HCV genotype 2 and 66 percent among those with genotype 3 (P<0.001).
A shorter course of therapy over 12 weeks with peginterferon alfa-2b and ribavirin is as effective as a 24-week course for patients with HCV genotype 2 or 3 who have a response to treatment at 4 weeks.
我们推测，对于丙型肝炎病毒（HCV）基因2型或3型且治疗4周后HCV RNA检测不到的患者，12周的治疗与24周的治疗效果相同。
总共283例患者被随机分配至标准的24周治疗方案，即聚乙二醇化干扰素α-2b，剂量为每周每千克体重1.0μg，加用利巴韦林，根据体重每日剂量为1000mg或1200mg。其中，70例患者被分配至24周治疗方案组（标准疗程组），213例患者被分配至可变疗程组（可变疗程组），疗程为12周或24周，这取决于第4周时HCV RNA检测结果为阴性还是阳性。主要终点是治疗结束24周后聚合酶链反应（PCR）检测不到HCV。
在标准疗程组中，45例（64%）患者在第4周时PCR检测不到HCV，而可变疗程组为133例（62%）（差异[标准疗程组的率减去可变疗程组的率]，2%；95%置信区间，-11%至15%）。标准疗程组53例（76%）患者和可变疗程组164例（77%）患者获得持续病毒学应答（差异，-1%；95%置信区间，-13%至10%）。与接受24周疗程的组相比，接受12周疗程的可变疗程组中出现不良事件并退出治疗的患者较少（P = 0.045）。复发率（定义为治疗结束时HCV检测不到但随访结束时可检测到）在标准疗程组为3.6%，在可变疗程组为8.9%（P = 0.16）。总体而言，HCV基因2型患者的持续病毒学应答率为80%，基因3型患者为66%（P < 0.001）。
对于HCV基因2型或3型且在4周时有治疗反应的患者，聚乙二醇化干扰素α-2b和利巴韦林12周的较短疗程与24周疗程效果相同。
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