Abstract | BACKGROUND AND AIM: Although the anti-hepatitis C virus (HCV) effect of statins in vitro and clinical efficacy of fluvastatin combined with Pegylated interferon (PEG-IFN)/ ribavirin therapy for chronic hepatitis C (CHC) have been reported, the details of clinical presentation are largely unknown. We focused on viral relapse that influences treatment outcome, and performed a post-hoc analysis by using data from a randomized controlled trial. METHODS: Thirty-four patients in the fluvastatin group and 33 patients in the non- fluvastatin group who achieved virological response (complete early virological response [cEVR] or late virological response [LVR]) with PEG-IFN/ ribavirin therapy were subjected to this analysis. Factors contributing to viral relapse were identified by using multiple logistic regression analysis. RESULTS: Relapse rate in patients with cEVR was significantly lower in the fluvastatin group (2 of 23, 8.7%) than in the non- fluvastatin group (9 of 26, 34.6%; P = 0.042). The use of fluvastatin decreased relapse rate in patients with LVR (27.3% vs 57.1%), though not significantly. Overall, relapse rate was significantly lower in the fluvastatin group (14.7%; 5 of 34) than in the non- fluvastatin group (39.4%; 13 of 33; P = 0.027). Multivariate analysis identified absence of fluvastatin (P = 0.027, odds ratio [OR] = 3.98, 95% confidence interval [CI] = 1.05-15.11) and low total ribavirin dose (P = 0.002, OR = 2.41, 95% CI = 1.38-4.19) as independent factors contributing to relapse. CONCLUSION: The concomitant addition of fluvastatin significantly suppressed viral relapse, resulting in the improvement of sustained virological response rate, in PEG-IFN/ ribavirin therapy for CHC patients with HCV genotype 1b and high viral load.
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Authors | Masanori Atsukawa, Akihito Tsubota, Chisa Kondo, Norio Itokawa, Yoshiyuki Narahara, Katsuhisa Nakatsuka, Satomi Hashimoto, Takeshi Fukuda, Yoko Matsushita, Hideko Kidokoro, Tamaki Kobayashi, Hidenori Kanazawa, Choitsu Sakamoto |
Journal | Journal of gastroenterology and hepatology
(J Gastroenterol Hepatol)
Vol. 28
Issue 1
Pg. 51-6
(Jan 2013)
ISSN: 1440-1746 [Electronic] Australia |
PMID | 22989264
(Publication Type: Journal Article, Randomized Controlled Trial)
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Copyright | © 2012 Journal of Gastroenterology and Hepatology Foundation and Wiley Publishing Asia Pty Ltd. |
Chemical References |
- Antiviral Agents
- Fatty Acids, Monounsaturated
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Indoles
- Interferon alpha-2
- Interferon-alpha
- RNA, Viral
- Recombinant Proteins
- Polyethylene Glycols
- Ribavirin
- Fluvastatin
- peginterferon alfa-2b
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Antiviral Agents
(therapeutic use)
- Confidence Intervals
- Drug Therapy, Combination
- Fatty Acids, Monounsaturated
(therapeutic use)
- Female
- Fluvastatin
- Hepacivirus
(genetics)
- Hepatitis C, Chronic
(blood, drug therapy)
- Humans
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
(therapeutic use)
- Indoles
(therapeutic use)
- Interferon alpha-2
- Interferon-alpha
(therapeutic use)
- Logistic Models
- Male
- Middle Aged
- Multivariate Analysis
- Odds Ratio
- Polyethylene Glycols
(therapeutic use)
- RNA, Viral
(blood)
- Recombinant Proteins
(therapeutic use)
- Recurrence
- Ribavirin
(therapeutic use)
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