ABSTRACT
BACKGROUND: Sustained virological response rates of up to 52% have been obtained with peginterferon alpha2a (40 kDa) plus ribavirin in patients suffering from chronic hepatitis C genotype 1 in randomized-controlled trials. AIM: To assess early virological response and its clinical utility in predicting an sustained virological response in patients suffering from chronic hepatitis C genotype 1 in routine clinical practice in Spain. METHODS: Treatment-naïve patients received pegylated interferon alpha2a (40 kDa) 180 microg/week plus ribavirin 1000/1200 mg/day for 48 weeks, and were followed for a further 24 weeks. Overall, 475 patients received at least one dose of medication and were included in the efficacy population. RESULTS: The overall sustained virological response rate was 48%. Of those with week 12 virological data, 83% had an early virological response. The negative predictive value of an early virological response was 93%. CONCLUSION: If sustained virological response is the goal, a treatment-decision based on a 12-week evaluation during routine clinical practice is feasible.
Subject(s)
Antiviral Agents/therapeutic use , Hepatitis C, Chronic/drug therapy , Interferon-alpha/therapeutic use , Polyethylene Glycols/therapeutic use , Ribavirin/therapeutic use , Adult , Antiviral Agents/pharmacokinetics , Drug Therapy, Combination , Female , Hepatitis C, Chronic/virology , Humans , Interferon alpha-2 , Interferon-alpha/pharmacokinetics , Male , Middle Aged , Polyethylene Glycols/pharmacokinetics , Recombinant Proteins , Ribavirin/pharmacokinetics , Treatment OutcomeABSTRACT
OBJECTIVES: To assess the usefulness of HELISAL in the diagnosis of Helicobacter pylori infection by comparing it with ELISA, JATROX and histopathologic findings. EXPERIMENTAL DESIGN: Randomized prospective study. PATIENTS: Sixty-one patients, thirty-three males and twenty-eight females, 18-73 years old, submitted to esophagogastroduodenoscopy. RESULTS: The sensitivity of HELISAL when compared to ELISA test was 60.8%, the specificity 73.3%, the positive predictive value 87.5%, the negative predictive value 37.9%, and the kappa index 0.26. When compared to histopathologic test: sensitivity 60.9%, specificity 65%, positive predictive value 78.1%, negative predictive value 44.7%, kappa 0.28. When compared to JATROX, sensitivity 57.7%, specificity 62.5%, positive predictive value 81.2%, negative predictive value 34.4%, kappa 0.21. CONCLUSION: The sensitivity of HELISAL test is lower than that of other compared tests, and the negative predictive value is very low. The specificity and the positive predictive value are higher than the sensitivity. The kappa index shows a very low concordance.
