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Sofosbuvir and Ledipasvir for 8 weeks for the treatment of chronic hepatitis C virus infection in HCV-mono-infected and HIV-HCV co-infected individuals – Results from the German hepatitis C cohort (GECCO-01).

Sofosbuvir and Ledipasvir for 8 weeks for the treatment of chronic hepatitis C virus infection in HCV-mono-infected and HIV-HCV co-infected individuals – Results from the German hepatitis C cohort (GECCO-01).
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Ingiliz P, Christensen S, Kimhofer T, Hueppe D, Lutz T, Schewe K, Busch H, Schmutz G, Wehmeyer MH, Boesecke C, Simon KG, Berger F, Rockstroh JK, Schulze Zur Wiesch J, Baumgarten A, Mauss S,


Ingiliz P, Christensen S, Kimhofer T, Hueppe D, Lutz T, Schewe K, Busch H, Schmutz G, Wehmeyer MH, Boesecke C, Simon KG, Berger F, Rockstroh JK, Schulze Zur Wiesch J, Baumgarten A, Mauss S, (click to view)

Ingiliz P, Christensen S, Kimhofer T, Hueppe D, Lutz T, Schewe K, Busch H, Schmutz G, Wehmeyer MH, Boesecke C, Simon KG, Berger F, Rockstroh JK, Schulze Zur Wiesch J, Baumgarten A, Mauss S,

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Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 2016 8 17() pii

Abstract
BACKGROUND
 Shortening the duration of treatment with HCV direct-acting antivirals (HCV-DAAs) leads to substantial cost reductions. According to the label, sofosbuvir and ledipasvir can be prescribed for 8 weeks (SL8) in non-cirrhotic, HCV genotype-1 women or men with low viral load. However, real-world data about the efficacy and safety of SL8 are largely missing.

METHODS
 Interim results from an ongoing prospective, multicenter cohort of nine treatment centers in Germany (GECCO). All patients started on HCV-DAAs since January 2014 are included. The present study describes safety and efficacy outcomes in 210 HCV mono- and 35 HIV-HCV-coinfected individuals treated with sofosbuvir and ledipasvir for 8 weeks in a real-world setting.

RESULTS
 1353 patients were included into the GECCO cohort until December 2015 and 1287 had complete datasets for this analysis: 337 (26.2%) fulfilled the criteria for an 8-week treatment as per package insert, but only 193 (57.2%) were eventually treated for 8 weeks. An additional 52 patients who did not fulfill the criteria for SL8 but were treated for 8 weeks. SL8 was generally well tolerated. The overall sustained virologic response rates 12 weeks after the end of treatment (SVR12) was 93.5% (186/199). The on-treatment response rate was 99.4% (159/160) in HCV-monoinfected patients and 96.4% (27/28) in HIV-HCV coinfected patients. Ten patients were lost-to-follow-up.

CONCLUSION
 Short treatment with 8 weeks of sofosbuvir and ledipasvir seems highly effective and safe in well-selected HCV mono- and HIV-HCV-coinfected patients in a real-world setting.

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