Meloxicam as an adjuvant to peginterferon-α-2a and ribavirin treatment for genotype 1 chronic hepatitis C: A randomized trial.

Abstract

AIM:

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).

CONCLUSION:

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.

• Authors: Tatehiro Kagawa, Sei-Ichiro Kojima, Koichi Shiraishi, Shunji Hirose, Yoshitaka Arase, Shinji Takashimizu, Norihito Watanabe, Naruhiko Nagata, Makoto Numata, Hirokazu Shiozawa, Yasuhiro Nishizaki, Mayu Toki, Teruji Sugita, Kijuro Nomura, Takashi Sakaguchi, Kazuhiro Atsukawa, Hiroto Tajima, Yoshihiro Tei, Tsutomu Inomoto, Tetsuya Mine
• Journal: Hepatology research : the official journal of the Japan Society of Hepatology (Hepatol Res) Vol. 43 Issue 9 Pg. 925-32 (Sep 2013) ISSN: 1386-6346 [Print] Netherlands
• PMID: 23356876 (Publication Type: Journal Article)
• Copyright: © 2012 The Japan Society of Hepatology.