Publications (2)9.27 Total impact
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Article: Assessment of hepatitis C virus-RNA clearance under combination therapy for hepatitis C virus genotype 1: performance of the transcription-mediated amplification assay.
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ABSTRACT: Monitoring of HCV-RNA in blood during antiviral therapy is performed mostly by commercially available reverse transcription polymerase chain reaction-based (RT-PCR) assays, with a lower detection limit of 30-50 IU/mL of HCV-RNA. Use of different tests in the pivotal trials of combination therapy has generated some discordance, in terms of predictive value of the early virological response (EVR). To evaluate whether the use of a more sensitive test, as a qualitative assay based on transcription mediated amplification (TMA) with a lower detection limit of 5-10 IU/mL of HCV-RNA, may obtain a better prediction of EVR and of the ultimate virological outcome, we retrospectively evaluated serial samples from 108 naïve patients with HCV genotype 1 chronic hepatitis, treated with pegylated alpha2b interferon plus ribavirin for 48 weeks and with a 24 weeks stopping rule. Serum samples of patients, obtained during treatment at weeks 4, 12, 24 and 48 and after treatment at week 24, were evaluated by TMA. Comparison of the RT-PCR and TMA assays for the qualitative detection of HCV-RNA showed no significant differences in performance when these tests were used at the end of the treatment period for assessing patients without an on-treatment virological response and those who eventually obtain a sustained virological response. Our results show instead that the use of TMA assay to detect HCV-RNA at 12 and 24 weeks of the combination therapy is more effective than RT-PCR in identifying patients with the highest probability of sustained HCV-RNA clearance.Journal of Viral Hepatitis 02/2008; 15(1):66-70. · 4.09 Impact Factor -
Article: Occult HBV infection and suppression of HCV replication in the early phase of combination therapy for chronic hepatitis C.
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ABSTRACT: Occult HBV infection in subjects with chronic hepatitis C is related to more severe disease outcome. It has been suggested that it might reduce sensitivity to antiviral treatment. To assess in HBsAg negative subjects with chronic hepatitis C any effect of the presence of HBV genomes in the liver on the early kinetics of HCV-RNA under PEG-IFN plus ribavirin. Twenty-two anti-HCV and HCV-RNA positive subjects, with biopsy-proven chronic hepatitis C (M/F 15/7; 50 +/- 8.6 years, 16 genotype 1b) were given PEG-IFN alpha 2b 1.0 microg qw plus ribavirin (800 to 1,200 mg daily according to body weight) for an intended 52 week period. Early virological response was assessed over the first 4 weeks of therapy by quantifying HCV-RNA. Occult HBV infection was assessed by testing for HBV-DNA in the liver before therapy. HBV genomes were found in the liver of 7 of 22 (31.4%) patients, unrelated to anti-HBc status. Kinetics of HCV-RNA during the first 4 weeks of antiviral treatment was unaffected by occult HBV infection, both in terms of absolute reduction of viral load and of number of cases with a reduction of > or = 2 log10 on treatment. Occult HBV infection does not affect the early phase of response to combination therapy. Further follow-up of patients into the maintenance phase of antiviral treatment and after stopping it will clarify if and when occult HBV has a role in reducing sustained virological response.Journal of biological regulators and homeostatic agents 17(2):172-5. · 5.18 Impact Factor
