Berlin—A new study found that adding 20 mg daily of fluvastatin to pegylated interferon-ribavirin (PegIFN-ribavirin) significantly increased the likelihood that patients with chronic hepatitis C virus (HCV) infection will have early and sustained virologic responses. The findings add to a growing body of evidence that shows statins have an important place in the treatment of chronic HCV infection.

“These data, as well as preliminary findings from an ongoing trial I am helping conduct, support the addition of fluvastatin to peginterferon and ribavirin for treating some hepatitis C patients,” commented Ted Bader, MD, director of liver diseases at the University of Oklahoma Health Sciences Center, in Norman, who was not involved in the current study.

Since a study that was published in 2008 showed fluvastatin monotherapy reduced HCV loads in 31 infected patients, interest in the potential use of the drug for this indication has increased (Bader T et al. Am J Gastroenterol 2008;103:1383-1389).

To further explore the drug’s use in treating HCV, Eugen Georgescu, MD, PhD, and colleagues compared viral loads and liver function between 104 patients with HCV who were randomly assigned to receive PegIFN-ribavirin plus fluvastatin 20 mg once daily and 105 patients with HCV given PegIFN-ribavirin plus a placebo, both for 48 weeks. None of the subjects had used statin medications within the year before study onset and all were followed for 24 weeks. Fifty subjects had metabolic syndrome.

Dr. Georgescu, who presented the findings at the 46th annual meeting of the European Association for the Study of the Liver (abstract 2922), said that viral loads at study onset were similar in both groups: 3.79±0.29 106 IU/mL for placebo versus 3.47±0.26 106 IU/mL for the fluvastatin group. After 12 weeks of treatment, mean HCV loads decreased to 0.33±0.04 106 IU/mL in the placebo group and 0.21±0.03 106 IU/mL in the fluvastatin group. The reduction in viral loads was significantly greater in the treatment group (94.53%) than in the placebo group (91.74%) compared with baseline (P=0.031).

Moreover, 76% of statin recipients experienced an early virologic response after 12 weeks of treatment, in contrast to 62% of patients in the placebo group (P=0.049). Viral suppression persisted at 72 weeks in significantly more patients who received fluvastatin compared with placebo recipients (63% vs. 50%, respectively; P=0.05).

The added efficacy of fluvastatin held regardless of metabolic syndrome status; 85% of fluvastatin and 71% of placebo recipients without metabolic syndrome had an early virologic response, and 74% and 58% of the same groups showed a sustained response at 72 weeks (P<0.05 for both).

The researchers said that although fluvastatin use resulted in statistically significant improvements, the changes were relatively modest.

“Nevertheless, our results justify further research to confirm statins as an adjuvant therapy in chronic hepatitis C and to understand the mechanisms underlying its synergistic effects with PegIFN-ribavirin therapy,” concluded Dr. Georgescu, professor in the Department of Internal Medicine/Gastroenterology, Filantropia Municipal Hospital, in Craiova, Romania.

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