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

• Published in: Hepatology research Vol. 43; no. 9; pp. 925 - 932
• Main Authors: Kagawa, Tatehiro, Kojima, Sei-ichiro, Shiraishi, Koichi, Hirose, Shunji, Arase, Yoshitaka, Takashimizu, Shinji, Watanabe, Norihito, Nagata, Naruhiko, Numata, Makoto, Shiozawa, Hirokazu, Nishizaki, Yasuhiro, Toki, Mayu, Sugita, Teruji, Nomura, Kijuro, Sakaguchi, Takashi, Atsukawa, Kazuhiro, Tajima, Hiroto, Tei, Yoshihiro, Inomoto, Tsutomu, Mine, Tetsuya
• Format: Journal Article
• Language: English
• Published: Netherlands Blackwell Publishing Ltd 01-09-2013
• Subjects: adjuvant; chronic hepatitis C; cyclooxygenase-2 inhibitor; interferon; meloxicam; neutropenia; neutropenia; meloxicam; interferon; adjuvant; chronic hepatitis C; cyclooxygenase-2 inhibitor
• ISSN: 1386-6346; 1872-034X
• DOI: 10.1111/hepr.12046

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.