Impact of added fluvastatin to standard-of-care treatment on sustained virological response in naïve chronic hepatitis C Patients infected with genotypes 1 and 3.

OBJECTIVES: The combination of pegylated interferon-α and ribavirin is a standard-of-care (SOC) treatment for chronic hepatitis C (CHC), and it achieves a sustained virological response (SVR) in 41-52% of genotype 1 and in 73-79% of genotype 3 patients. In a few clinical trials, the combination of fluvastatin and SOC increased the SVR in genotype 1 patients. METHODS: This prospective study enrolled 179 naïve CHC patients. In the fluvastatin group patients received the combination of SOC and fluvastatin 80 mg daily; historical controls matching the study group in genotype, age and gender were treated with the SOC treatment only. RESULTS: On-treatment viral responses as well as the SVR did not differ significantly between the two groups, except for the genotype 1 patients with a high viral load presenting a significantly higher SVR rate in the fluvastatin group (75%) compared to the control group (41%; p = 0.024). Multivariate logistic regression identified hepatitis C virus (HCV) genotype 3 infection (p < 0.001), age ≤40 years (p < 0.001), liver steatosis <5% (p < 0.01) and low viral load (p < 0.001) as independent predictors of an SVR. CONCLUSION: A combination of fluvastatin and SOC significantly improved the SVR in naïve CHC patients infected with HCV genotype 1 and high viral load, but it did not improve the SVR in patients infected with HCV genotype 3.

Efficacy of chronic hepatitis C therapy with interferon alpha (IFN-alpha) in Slovenia.

BACKGROUND/AIMS: Eighty Slovene patients with chronic hepatitis C were included in a prospective study conducted in the period 1997-1998 with the purpose to establish the efficacy of interferon alpha therapy. The average age of the patients was 39 years. In more than half of the patients (52%) the mode and time of onset of the infection were unknown. Two thirds of the patients were males. The plasma viral load exceeded 2 x 10(6) copies/mL in only three patients and in more than half of the cases (54%) HCV genotype 1b was present. METHODOLOGY: The 18-month treatment with 3 MU interferon alpha three times a week was concluded in 53 patients and, after doubling the initial dose of interferon alpha from 3 MU to 6 MU, in 5 patients. In 11 patients, the treatment was discontinued prematurely, after six months, due to therapeutic failure (despite doubling the initial dose of interferon alpha Eleven patients withdrew from the treatment: six of them due to side effects and five due to personal reasons. RESULTS: Complete response to therapy with disappearance of HCV from the blood was observed in 34 patients (49%), while in 24 the response to therapy was partial, i.e., the biochemical tests showed normalization of values but viremia persisted. There was a significant relation between the therapeutic response and those patients with the genotype 3 (p = 0.01). After three months of follow-up, complete therapeutic response was still observed in 19 patients (28%), most of them with genotype 3. Despite persistent viremia there was no progression of liver inflammation in eight partial responders, as evidenced by liver rebiopsy. Thus, it was confirmed that treatment is justified in these patients. CONCLUSIONS: During the continuation of the follow-up period we shall record further course of the disease and make an attempt in a subsequent study to improve the efficacy of the treatment by introducing a combination of interferon alpha and ribavirin into therapy.

Comparative evaluation of three commercial assays for quantitative measurement of hepatitis B virus DNA in serum samples.

BACKGROUND/AIMS: Quantitative determination of HBV DNA in serum samples is indispensable for predicting disease progression and for monitoring the antiviral treatment in patients with chronic HBV infection. METHODOLOGY: Three commercial assays for quantification of HBV DNA: Digene Hybrid-Capture HBV DNA Assay, Bayer Quantiplex HBV DNA Assay and Roche Amplicor HBV Monitor Test were comparatively evaluated under the routine conditions of diagnostic virology laboratory, using 61 serum samples obtained from 55 Slovenian patients with chronic hepatitis B. RESULTS: HBV DNA was detected by Amplicor, Quantiplex and Hybrid-Capture in 38 (62.3%), 34 (55.7%) and 27 (44.3%) samples, respectively. The sensitivity of Amplicor and Quantiplex assays did not differ significantly (p = 0.13), while both Amplicor and Quantiplex assays were found to be significantly more sensitive than Hybrid-Capture (p = 0.003 and p = 0.02, respectively). For a given sample, the highest correlation was observed between HBV DNA loads determined by Quantiplex and Hybrid-Capture assays (r = 0.85, p < 0.0001). CONCLUSIONS: Amplicor HBV Monitor Test seems to be the most sensitive assay for the detection of HBV DNA in serum samples and can be clinically used for monitoring patients with chronic HBV infection.