CONCLUSION: Reassessment of strategies for hepatitis C diagnosis especially in ... L. Hepatitis C therapy in non-genotype 1 patients: the near future. Journal of ...
Poster Session mine the independent predictors of MRU-associated costs. Interaction effects of variables-covariates were investigated with logistic and linear regression models; costs comparison with Wilcoxon rank sum test. RESULTS: Severe liver fibrosis, first-order interaction between sustained virologic response at week 12 (SVR12) and gender (female) as well as second-order interaction between age (older), severe liver fibrosis and treatment with telaprevir/PegIFN/R triple therapy were identified as the strongest set of predictors for total MRU-related costs. Differences in MRU-related costs between female and male patients who attained SVR12 stem mainly from hospitalisations with median (interquartile ranges) costs of £423 (0) and £258 (0), respectively (p < 0.001). No significant difference in median and mean ( standard deviation) MRU-related costs was observed between telaprevir (£642 1349) and simeprevir (£602 1260), although hospitalisation costs are higher in the telaprevir arm. CONCLUSION: Reassessment of strategies for hepatitis C diagnosis especially in elderly and female patients could limit CHC-related complications and associated costs, especially when progressing to liver failure. In treatment-experienced patients, factors other than the choice of protease inhibitor seemed to have a much stronger influence on costs over the short term. However, treatment effects can have substantial cost consequences in the long term when patient’s age increases and liver function deteriorates.
HEPATITIS C VIRUS: PRACTICAL MANAGEMENT STRATEGIES P11 The use of silymarin in chronic hepatitis C infection: an updated systematic review and meta-analysis I Cua and M Oliman St. Luke’s Medical Center, Quezon City, Philippines BACKGROUND: The current standard of care for hepatitis C
virus (HCV) infection is expensive and associated with low success rates (1). Silymarin can inhibit HCV replication and has anti-inflammatory and immunomodulatory actions in vitro (2, 3). Clinical studies to evaluate this potential have inconsistent results or had low methodological qualities (4). The objective of this study is to assess the effects of silymarin in patients with chronic HCV infection using meta-analyses of available randomized controlled trials (RCTs) with good methodological quality. MATERIALS AND METHODS: Manual and electronic searches through The Cochrane Central Register of Controlled Trials, MEDLINE, and PUBMED were done. RCTs with a quality scale of A-B using the Quality Scale for Meta-analytic Reviews, that performed in vivo evaluation of
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the effects of silymarin in adults with HCV infection, were included. Each study was independently appraised by 2 reviewers with regards to methods of minimizing selection bias, performance bias, exclusion bias, and detection bias. Disagreements and discrepancies were discussed and resolved accordingly. Data were analyzed using RevMan 5, and the Forest plots generated were interpreted accordingly. Chi-square test was used to test for heterogeneity and a p-value of 0.05 was considered significant. RESULTS: 13 RCTs were identified. Of these, 6 were excluded, 2 could not be retrieved, and 1 lacked data on HCV patients. 4 studies were included in the review. Oral silymarin preparations did not show statistically significant benefits in achieving SVR, decreasing viral load, and improvement of other liver parameters in patients with chronic HCV infection. CONCLUSIONS: Presently available robust in vivo data have not shown that oral preparations of silymarin alone may induce SVR in patients with chronic HCV infection. It has also not been shown to significantly affect HCV viral loads, as well as other liver parameters. REFERENCES
1. Wartelle-Bladou C, Le Folgoc G, Bourlie‘re M, Lecomte L. Hepatitis C therapy in non-genotype 1 patients: the near future. Journal of Viral Hepatitis 2012;19:525–536. 2. Ashfaq UA, Javed T, Rehman S, Nawaz Z, Riazuddin S. Inhibition of HCV 3a core gene through Silymarin and its fractions. Virology Journal 2011;8:153. 3. Morishima C, Shuhart MC, Wang CC, et al. Silymarin inhibits in vitro T cell proliferation and cytokine production in hepatitis C virus infection. Gastroenterology 2010;138 (2):671. 4. Mayer KE, Myers RP, Lee SS. Silymarin treatment of viral hepatitis: a systematic review. Journal of Viral Hepatitis 2005;12:559–567.
P12 Factors associated with triple therapy discontinuation due to adverse effects among patients with hepatitis C genotype 1 chronic infection N Miotto, L Pisoni Zanaga, E Sellan, L Goncales, L Mendes, M Lazarini, R Stucchi, F Lopes Goncales Jr and A Gonzalez Vigani State University of Campinas – UNICAMP, Campinas, Brazil BACKGROUND: Different regimens for the treatment of hep-
atitis C virus (HCV) infection exist. Triple therapy (TT) with peginterferon (PEG-IFN), ribavirin (RBV), and first-generation protease inhibitors (PIs), telaprevir (TVR) or boceprevir (BOC) is a treatment option in many countries but is associated with higher rates of adverse effects (AE) and
© 2014 The Authors Journal of Viral Hepatitis © 2014 Blackwell Publishing Ltd, Vol 21 (Suppl. S2), October 2014, 21–48
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Poster Session
AE-related treatment discontinuation when compared to PEG-IFN plus RBV (1–3). The purpose of the study is to determinate the rate of PI discontinuation among patients with hepatitis C virus (HCV) genotype 1 chronic infection receiving TT due to AE and its associated factors. METHODS: We included patients with chronic HCV genotype 1 who initiated TT treatment at a Brazilian university hospital between August 2012 and December 2014. We prospectively collected data from medical records and evaluated it by EpiInfo 6.0. SUMMARY OF RESULTS: Of 113 enrolled patients, 101 (89%) were Caucasians and 86 (76%) male. The median age was 52 years-old, 54 (48%) had cirrhosis, 20 (18%) were diabetic. Forty-nine (83%) were previously treated with PEG-IFN and RBV. Seventy patients (62%) received TVR and 43 (38%) received BOC as the PI for their regimens. Overall treatment discontinuation rate due to AE was 13%. Twentyone (19%) patients developed AE that led to PI discontinuation. These included anaemia (33%), rash (14%), anorectal disorders (14%), infection (10%), vomiting (10%), bleeding (5%), cranial nerve palsies (5%), thrombocytopenia (5%) and decompensation of liver function (5%). Considering those who interrupted and those who maintained PI, severe AE rate was 76% and 13%, respectively. Multivariate analysis revealed that cirrhosis (OR 5.51, p = 0.03) and median RNI >1,17 (OR 4.83, p = 0.02) at beginning of the treatment were associated with discontinuation of PI use due to AE. CONCLUSION: Triple therapy discontinuation rate due do AE was similar to previous studies (1–4). Rash, anaemia and anorectal pathologies are known to be more intense and frequent in TT (7), and in this study were the main AE related with discontinuation of PI. Adverse effects management should be precocious and aggressive for those patients presenting predicting factors for PI discontinuation. REFERENCES
1. McHutchison JG, Manns MP, Muir AJ, et al. Telaprevir for previously treated chronic HCV infection. N Engl J Med 2010;362(14):1292–303. 2. Poordad F, McCone J Jr, Bacon BR, et al. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med 2011;364(13):1195–206. 3. Hezode C, Fontaine H, Dorival C, et al. Triple therapy in treatment-experienced patients with HCV-cirrhosis in a multicentre cohort of the French Early Access Programme (ANRS CO20-CUPIC) – NCT01514890. J Hepatol 2013;59 (3):434–41. 4. Colombo M, Fernandez I, Abdurakhmanov D, et al. Safety and on-treatment efficacy of telaprevir: the early access programme for patients with advanced hepatitis. Gut 2014;63(7):1150–8.
P13 Triple therapy with boceprevir in treatmentexperienced patients with HCV in a third-level hospital in Mexico J Mata-Marı´n1, B Manjarrez-Tellez1, A ChaparroS anchez1, G Huerta-Garcıa2, J DomınguezHermosillo1 and J Gayt an-Martınez1 1Hospital de Infectologıa, Mexico City, Mexico, 2Hospital de Pediatrıa, Siglo XXI, Mexico City, Mexico PURPOSE OF THE STUDY: Few Latin American people have
been included in phase III trials of pegylated interferon/ ribavirin with boceprevir. We reported a safety and efficacy analysis in a cohort HCV treatment-experienced patients in an early access programme in Mexico. METHODS: This is an open-labeled observational study including HCV treatment-experienced adults at the Hospital de Infectologıa ‘La Raza’ in Mexico City. Patients were eligible if they were chronically infected with HCV genotype 1, who did not achieve SVR after a prior course of IFNbased therapy, including relapsers, partial and null responders and whom started triple therapy with BOC plus PegIFN alfa-2a or alfa-2b/RBV. SUMMARY OF RESULTS: 30 patients with BOC containing triple therapy and data up to at least week 24 of follow up were included; 6 (28%) were diagnosed with cirrhosis. Median age was 51 years old (IQR 44–58); 15 (50%) were men, 21 (66%) were genotype 1b. According to previous treatment response, 9 (30%) were null responders, 9 (30%) partial responders and 12 (40%) relapsers. All patients were treated with a lead-in phase. Among patients with evaluable data at each time point, 8 (26%) were with SVR12. Eight (26%) patients had therapy failure; 3 (10%) had futility rules; 1 (3%) relapsed and 4 (13%) withdrawal treatment associated with adverse events; 14 (46%) patients were undetectable at week 24, but they are still under treatment. Median baseline haemoglobin was 15.6 g/dL (IQR 13.8–16.7), at week 12, 11.2 g/dL (10.2– 12.4) p < 0.001, and at week 24, 10.6 (9.4–11.3) p < 0.001. CONCLUSION: Real-world experience with boceprevir plus PegIFN alfa-2a or alfa2b/RBV in Latin American people in terms of effectiveness is consistent with the results of those real-life published data in other countries.
© 2014 The Authors Journal of Viral Hepatitis © 2014 Blackwell Publishing Ltd, Vol 21 (Suppl. S2), October 2014, 21–48
