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Gastroenterologie
a hepatologie

Gastroenterology and Hepatology

Gastroent Hepatol 2015; 69(5): 473–476. doi:10.14735/amgh2015473.

Ledipasvir/ sofosbuvir – rapid development of knowledge reduces treatment time

Petr Husa1

+ Affiliation

Summary

Ledipasvir and sofosbuvir in a fixed-dose single-tablet combination have a variety of therapeutic indications in patients infected with hepatitis C virus genotypes 1, 3, and 4. According to the current European Association for the Study of the Liver Guidelines, the duration of therapy with ledipasvir/sofosbuvir in combination with ribavirin is 12 weeks in cirrhotic patients infected with hepatitis C virus genotype 1 or 4. This recommendation includes patients with both compensated and decompensated liver cirrhosis, both pre- and post-liver transplantation. An extension of combination therapy to 24 weeks is indicated only in cirrhotic patients with negative predictive factors for the achievement of a sustained virologic response, especially with profound thrombocytopenia or when ribavirin is contraindicated or poorly tolerated. The last revision of the summary of product characteristics of Harvoni from June 2015 recommends 24 weeks of therapy with LDV/SOF alone in compensated cirrhosis and 24 weeks of ledipasvir/sofosbuvir in combination with ribavirin in decompensated cirrhosis in both pre- and post-transplantation patients. This contribution provides an analysis of this contradiction.

Keywords

HCV, chronic hepatitis C, ledipasvir, ribavirin, sofosbuvir, hepatitis C virus

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Literature

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2. European Association for Study of Liver. EASL recommendations on treatment of hepatitis C 2015. J Hepatol 2015; 63 (1): 199–236. doi: 10.1016/j.jhep.2015.03.025.
3. American Association for the Study of Liver Disease. HCV Guidance: Recommendations for testing, managing, and treating hepatitis C. Available from: www.hcvguidelines.org.
4. Souhrnu údajů o přípravku Harvoni [on- line]. Dostupné z: http: //www.ema.europa.eu/docs/cs_CZ/document_library/EPAR_ –_Product_Information/human/003850/ WC500177995.pdf.
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6. Bourlière M, Bronowicki JP, de Ledinghen V et al. Ledipasvir-sofosbuvir with or without ribavirin to treat patients with genotype 1 infection and cirrhosis non-responsive to previous protease-inhibitor therapy: a randomised, double-blind, phase 2 trial (SIRIUS). Lancet Infect Dis 2015; 15 (4): 397–404. doi: 10.1016/S1473-3099 (15) 70050-2.
7. Flamm SL, Everson GT, Charlton M et al. Ledipasvir/sofosbuvir with ribavirin for the treatment of HCV in patients with decompensated cirrhosis: preliminary results of a prospective, multicenrter study. 65th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD). Hepatology 2014; 60: 320A.
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9. Gane E, Manns MP, Forns X et al. 365 Ledipasvir/sofosbuvir with ribavirin is safe and efficacious in decompensated and post-liver transplantation patients with HCV infection: preliminary results of the prospective SOLAR2 trial. Gastroenterology 2015; 148 (4): S-978. doi: 10.1016/S0016-5085 (15) 33342-4.

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