Article ; Online: The end-of-treatment ribavirin concentration predicts hepatitis C virus relapse.
2013 Volume 35, Issue 6, Page(s) 791–795
Abstract: ... rates in patients infected with hepatitis C virus (HCV). In this study, we performed an analysis ...
| Abstract | Background: The optimization of combination therapy with ribavirin (RBV) and pegylated interferon alpha has substantially improved sustained virologic response (SVR) rates and lowered virologic relapse rates in patients infected with hepatitis C virus (HCV). In this study, we performed an analysis of the relationship between the end-of-treatment plasma RBV concentration and virologic relapse. Methods: Thirty-four patients with HCV treated with pegylated interferon/RBV and with an end-of-treatment response were assayed for plasma RBV concentration using liquid chromatography assay coupled to tandem mass-spectrometric detection on the last day of the treatment. Clinical data and the concentration of RBV were compared between patients classified as either relapsers or nonrelapsers. Results: Eleven patients (32.4%) relapsed and 23 patients (67.6%) achieved an SVR. The mean plasma RBV concentration on the last day of treatment was 1380 ± 312 ng/mL for relapsers and 2278 ± 569 ng/mL for SVR patients (P < 0.0001). A receiver operating characteristic analysis showed that a threshold of 1960 ng/mL was associated with the greatest sensitivity and specificity (100% and 83%, respectively, with an area under the curve of 0.94; P < 0.0001) for discriminating between patients who relapsed and those who did not. A univariate logistic regression analysis indicated that a plasma RBV concentration of <1960 ng/mL at the end of the treatment was strongly associated with relapse (odds ratio, 55; 95% confidence interval, 7.24-∞; P = 0.0001) independently of age, body weight, RBV dose, baseline viral load, the interleukin-28B genotype, and response to previous courses of treatment. Conclusions: Our study results highlight the relevance of measuring plasma RBV concentrations during and at the end of HCV treatment, with a view to avoiding virologic relapse. |
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| MeSH term(s) | Adult ; Antiviral Agents/administration & dosage ; Antiviral Agents/blood ; Antiviral Agents/therapeutic use ; Area Under Curve ; Chromatography, Liquid/methods ; Drug Therapy, Combination ; Female ; Hepatitis C, Chronic/drug therapy ; Humans ; Interferon-alpha/administration & dosage ; Interferon-alpha/therapeutic use ; Logistic Models ; Male ; Middle Aged ; Polyethylene Glycols/administration & dosage ; Polyethylene Glycols/therapeutic use ; Recombinant Proteins/administration & dosage ; Recombinant Proteins/therapeutic use ; Recurrence ; Retrospective Studies ; Ribavirin/administration & dosage ; Ribavirin/blood ; Ribavirin/therapeutic use ; Sensitivity and Specificity ; Tandem Mass Spectrometry/methods ; Time Factors ; Treatment Outcome |
| Chemical Substances | Antiviral Agents ; Interferon-alpha ; Recombinant Proteins ; Polyethylene Glycols (30IQX730WE) ; Ribavirin (49717AWG6K) ; peginterferon alfa-2b (G8RGG88B68) ; peginterferon alfa-2a (Q46947FE7K) |
| Language | English |
| Publishing date | 2013-12 |
| Publishing country | United States |
| Document type | Journal Article |
| ZDB-ID | 424443-6 |
| ISSN | 1536-3694 ; 0163-4356 |
| ISSN (online) | 1536-3694 |
| ISSN | 0163-4356 |
| DOI | 10.1097/FTD.0b013e3182966dee |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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