Meloxicam as an adjuvant to peginterferon-α-2a and ribavirin treatment for genotype 1 chronic hepatitis C: A randomized trial.
OBJECTIVE
In this multicenter, randomized trial, we evaluated the effectiveness of meloxicam - a non-steroidal anti-inflammatory drug - as an adjuvant for enhancing antiviral efficacy and preventing neutropenia during the treatment of patients with genotype 1 chronic hepatitis C using peginterferon and ribavirin.


METHODS
A total of 60 patients were randomly assigned, in a 1:1 ratio, to either the meloxicam or the control group after stratification by neutrophil count. Both groups received weekly peginterferon-α-2a (180 μg) and a weight-based dose of ribavirin for 48 weeks. The meloxicam group received meloxicam (10 mg/day) for the first 8 weeks after initiation of treatment.


RESULTS
Through intent-to-treat analysis, we found that the sustained virological response rate in the meloxicam group (19/30, 63.3%) was significantly higher than in the control group (11/30, 36.7%, P < 0.05). The relapse rate was more than twice as high (45%) in the control group than in the meloxicam group (19.0%); however, this difference was not statistically significant. The rate of neutrophil decrease, calculated by dividing the lowest value observed during the first 8 weeks by pretreatment count, was significantly smaller in the meloxicam group (55.1 ± 14.3%) than in the control group (62.3 ± 9.6%, P < 0.05).


CONCLUSIONS
Meloxicam enhanced antiviral efficacy and reduced the decline in neutrophil counts for the peginterferon and ribavirin treatment of genotype 1 chronic hepatitis C. This drug could be a reasonable adjuvant for the treatment of patients with chronic hepatitis C. The present study including a small number of patients warrants larger clinical trials.
Division of Gastroenterology, Department of Internal Medicine, Tokai University School of Medicine, Isehara.
Tatehiro
T
Kagawa
Sei-Ichiro
S
Kojima
Koichi
K
Shiraishi
Shunji
S
Hirose
Yoshitaka
Y
Arase
Shinji
S
Takashimizu
Norihito
N
Watanabe
Naruhiko
N
Nagata
Makoto
M
Numata
Hirokazu
H
Shiozawa
Yasuhiro
Y
Nishizaki
Mayu
M
Toki
Teruji
T
Sugita
Kijuro
K
Nomura
Takashi
T
Sakaguchi
Kazuhiro
K
Atsukawa
Hiroto
H
Tajima
Yoshihiro
Y
Tei
Tsutomu
T
Inomoto
Tetsuya
T
Mine
adjuvant; chronic hepatitis C; cyclooxygenase-2 inhibitor; interferon; meloxicam; neutropenia