title: A randomized trial of 24 versus 48 weeks of peginterferon α-2a in patients infected with chronic hepatitis C virus genotype 2 or low viral load genotype 1: a multicenter national study in Japan.
abstract: In a country such as Japan with the average age of patients with chronic hepatitis C treated with antivirals sometimes well above 60 years, the standard combination therapy is not well tolerated. In this randomized, prospective, controlled trial, we investigated the efficacy of 24-week peginterferon α monotherapy for easy-to-treat patients. A total of 132 patients chronically infected with hepatitis C virus (HCV) genotype 2 (n = 115) or low viral load HCV genotype 1 (<100 kIU/ml, n = 17) were treated with peginterferon α-2a (180 μg/week). Patients with a rapid virological response (RVR, HCV RNA negative or <500 IU/ml at week 4) were randomized for a total treatment duration of 24 (group A) or 48 (group B) weeks. Patients who did not show RVR (group C) were treated for 48 weeks. Sustained virological response (SVR) was assessed by qualitative reverse-transcription polymerase chain reaction. One hundred eight of 132 (82%) patients with RVR were randomized. SVR rates were 60% (group A), 79% (group B), and 27% (group C), respectively. Similar SVR rates were achieved in patients infected with HCV genotype 2 with low pretreatment viral load (<1000 kIU/ml) in group A (81%) and group B (79%) (P = 0.801), whereas in those with higher viral load (≥1000 kIU/ml), a lower SVR rate was identified in group A (26%) than in group B (67%) (P = 0.041). In conclusion, in patients infected with HCV genotype 2 and pretreatment viral load below 1000 kIU/ml who achieve RVR, 24-week treatment with peginterferon α-2a alone is clinically sufficient. Those who show no RVR or have higher baseline viral load, require alternative therapies.
authors: Yoshiaki
authors: Y
authors: Iwasaki
authors: Yasushi
authors: Y
authors: Shiratori
authors: Shuhei
authors: S
authors: Hige
authors: Shuhei
authors: S
authors: Nishiguchi
authors: Hitoshi
authors: H
authors: Takagi
authors: Morikazu
authors: M
authors: Onji
authors: Haruhiko
authors: H
authors: Yoshida
authors: Namiki
authors: N
authors: Izumi
authors: Yutaka
authors: Y
authors: Kohgo
authors: Kyosuke
authors: K
authors: Yamamoto
authors: Nobuhiro
authors: N
authors: Sato
authors: Akitaka
authors: A
authors: Shibuya
authors: Hidetsugu
authors: H
authors: Saito
authors: Michio
authors: M
authors: Sata
authors: Kazuyuki
authors: K
authors: Suzuki
authors: Shuichi
authors: S
authors: Kaneko
authors: Mitsuhiko
authors: M
authors: Moriyama
authors: Masao
authors: M
authors: Omata