Effect of fluvastatin on 24-week telaprevir-based combination therapy for hepatitis C virus genotype 1b-infected chronic hepatitis C.

Abstract

OBJECTIVES:

The addition of fluvastatin significantly improves sustained virological response (SVR) in pegylated interferon and ribavirin (peg-IFN/RBV) combination therapy for patients infected with the hepatitis C virus. However, the add-on effect on telaprevir-based triple combination therapy remains unknown. The aim of this study was to investigate the effect of fluvastatin on telaprevir-based combination therapy by conducting a prospective, open-label, randomized, controlled trial.

PATIENTS AND METHODS:

Among 124 genotype 1b-infected chronic hepatitis C patients recruited, 116 eligible patients were allocated randomly to two study arms; they received 12 weeks of telaprevir/peg-IFN/RBV, followed by 12 weeks of peg-IFN/RBV with or without 24 weeks of fluvastatin (fluvastatin group and control group, respectively). Treatment outcomes and adverse effects were compared between the two groups.

RESULTS:

There were 56 men and 60 women, median age 60 years (range, 28-71 years). Rapid virological response and end of treatment response rates were 87.9% (51/58) and 96.6% (56/58) in the control group and 75.9% (44/58) and 98.3% (57/58) in the fluvastatin group, respectively. SVR rates in the control group and the fluvastatin group were 84.5% (49/58) and 81.0% (47/58), respectively; there was no significant difference (P=0.806). Stratified analysis showed that no factors associated with the SVR rate were found between the two groups. No adverse events were associated with fluvastatin.

CONCLUSION:

In this trial, administration of fluvastatin with telaprevir/peg-IFN/RBV was a safe combination. However, fluvastatin had no add-on effect on 24-week telaprevir-based combination therapy for chronic hepatitis C genotype 1b-infected patients.

• Authors: Masanori Atsukawa, Akihito Tsubota, Noritomo Shimada, Chisa Kondo, Norio Itokawa, Ai Nakagawa, Takeshi Fukuda, Yoko Matsushita, Yoshiyuki Narahara, Yuji Osada, Hiroki Yamaguchi, Katsuhisa Nakatsuka, Katsuhiko Iwakiri, Chiaki Kawamoto, Choitsu Sakamoto
• Journal: European journal of gastroenterology & hepatology (Eur J Gastroenterol Hepatol) Vol. 26 Issue 7 Pg. 781-7 (Jul 2014) ISSN: 1473-5687 [Electronic] England
• PMID: 24732752 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Anticholesteremic Agents
• Antiviral Agents
• Fatty Acids, Monounsaturated
• Indoles
• Oligopeptides
• Fluvastatin
• telaprevir

Topics

• Adult
• Aged
• Anticholesteremic Agents (administration & dosage, adverse effects)
• Antiviral Agents (administration & dosage, adverse effects)
• Drug Therapy, Combination
• Fatty Acids, Monounsaturated (administration & dosage, adverse effects)
• Female
• Fluvastatin
• Genotype
• Hepacivirus (drug effects, genetics)
• Hepatitis C, Chronic (drug therapy, virology)
• Humans
• Indoles (administration & dosage, adverse effects)
• Male
• Medication Adherence
• Middle Aged
• Oligopeptides (administration & dosage, adverse effects)
• Prospective Studies
• Treatment Outcome