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Ledipasvir/sofosbuvir in chronic hepatitis C: a guide to its use in the EU

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Abstract

A single-tablet regimen of ledipasvir and sofosbuvir (ledipasvir/sofosbuvir; Harvoni®) was recently approved in the EU. The phase 3 ION trials included treatment-naïve (ION-1 and -3) or treatment-experienced (ION-2) patients with chronic hepatitis C virus (HCV) genotype 1 infection; ≈20 % of patients in ION-1 and -2 had cirrhosis, whereas none of the patients in ION-3 had cirrhosis. In ION-1, a 12-week regimen of ledipasvir/sofosbuvir achieved high rates of sustained virological response 12 weeks’ post-treatment (SVR12) in treatment-naïve patients, with no additional benefit conferred by the addition of ribavirin or extending the treatment duration to 24 weeks. An 8-week regimen also achieved high SVR12 rates in patients with a baseline HCV RNA level of <6 million IU/mL in ION-3. High SVR12 rates were seen in treatment-experienced patients who received ledipasvir/sofosbuvir for 12 or 24 weeks in ION-2. Data also support the use of ledipasvir/sofosbuvir in chronic HCV genotype 4 infection, in HCV and HIV co-infection and, in combination with ribavirin, in patients with chronic HCV genotype 1 or 4 infection who have decompensated cirrhosis or are liver transplant recipients and in chronic HCV genotype 3 infection. Oral ledipasvir/sofosbuvir was generally well tolerated.

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Acknowledgments

The review was updated from Drugs 2015;75(6):675–85 [28] and was reviewed by: S. Saluja, Saran Ashram Hospital, Dayalbagh, Agra, India; R. B. Shah, Department of Pharmacology, GMERS Medical College and Hospital, Gandhinagar, Gujarat, India. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on the manuscript. Changes resulting from comments received were made by the authors on the basis of scientific and editorial merit.

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    Gillian M. Keating

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Correspondence to Gillian M. Keating.

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The preparation of this review was not supported by any external funding.

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Gillian M. Keating is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.

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Keating, G.M. Ledipasvir/sofosbuvir in chronic hepatitis C: a guide to its use in the EU. Drugs Ther Perspect 31, 289–295 (2015). https://doi.org/10.1007/s40267-015-0232-y

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