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4CPS-284 Binary logistic regression analysis to evaluate the influence of different basal factors on the effectiveness of ledipasvir/sofosbuvir
  1. JC del Río Valencia,
  2. R Asensi Diez,
  3. R Tamayo Bermejo,
  4. I Muñoz Castillo
  1. Hospital Regional Universitario Malaga, Servicio Farmacia, Malaga, Spain


Background Chronic hepatitis C treatment has changed with the direct-acting antivirals (DAAs) for the hepatitis C virus (HCV) with high levels of safety and effectiveness. Available data from clinical trials reveal that baseline factors at the beginning of treatment can influence treatment results: viral genotype, baseline viral load, degree of fibrosis and previous treatments.

Purpose To assess the influence of different variables on the effectiveness of Sofosbuvir(SOF)/Ledipasvir(LDV) in HCV-patients.

Material and methods Retrospective-observational study. Study period: April 2015–February 2016. Inclusion-criteria: Patients with HCV infection treated with SOF/LDV,12 weeks. Exclusion-criteria: Patients with no data. Outcomes collected: Demographics: age/sex. Clinical data: basal-viral-load (VL), sustained-virological-response at week 12 (SVR12), defined as HCV-RNA titres lower than 15I U/mL 12 weeks after end of treatment. METAVIR-score: F0-F4. Liver-transplant, HCV-genotype (G), HIV-coinfection, previous treatments for HCV. Logistic regressions were used to identify independent clinical and demographic predictors of treatment failure. Analyses were performed by SPSS.v17. All associations were tested at a significance level of 0.05.

Results 124 patients were included (65.6% men); mean age, 56.67±10.07 years. Naive (60.7%), 25.4% HIV-coinfected; 14.8% liver-transplant patients; genotypes: 9.68% G1; 23.38% G1a; 37.10% G1b; 12.90% G3; 16.94% G4. 63.9% patients had VL>800 000 UI/ml. Adherence to DDAs: 100%. Fibrosis-degree: 6.6% F1, 26.2% F2, 33.6% F3 and 33.6% F4.

Global SVR12 was 91.67% and all patients with HCV G1a, G1b, G4 achieved SVR12. Only one pre-treated-non-cirrhotic HCV G1 patients relapsed. The lowest SVR12 were obtained for G3 (43.75%) (7/16). None of the variables analyzed significantly influenced on SVR12, except G(p=0.001). Most of relapses occurred in G3.

Conclusion Variables analyzed didn’t influence on SVR12 matching the results of Kouris et al. 2018. However, we observed G influenced on SVR12 . It has been observed LDV is less active against G3 in-vitro (Gane et al. 2015).

References and/or acknowledgements Kouris G, Hydery T, Greenwood BC, et al. Effectiveness of Ledipasvir/Sofosbuvir and Predictors of Treatment Failure in Members with Hepatitis C Genotype-1 Infection: A Retrospective Cohort Study in a Medicaid Population. J Manag care Spec Pharm July 2018;24(7):591–7.

Gane EJ, Hyland RH, An D, et al. Efficacy of ledipasvir and sofosbuvir, with or without ribavirin, for 12 weeks in patients with HCV genotype-3 or 6 infection. Gastroenterology November 2015;149(6):1454–1461.e1.

Conflict of Interest No conflict of interest.

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