Details

Autor(en) / Beteiligte

• Ingiliz, Patrick
• Christensen, Stefan
• Kimhofer, Torben
• Hueppe, Dietrich
• Lutz, Thomas
• Schewe, Knud
• Busch, Heiner
• Schmutz, Günther
• Wehmeyer, Malte H.
• Boesecke, Christoph
• Simon, Karl-Georg
• Berger, Florian
• Rockstroh, Jürgen K.
• zur Wiesch, Julian Schulze
• Baumgarten, Axel
• Mauss, Stefan

Titel

Sofosbuvir and Ledipasvir for 8 Weeks for the Treatment of Chronic Hepatitis C Virus (HCV) Infection in HCV-Monoinfected and HIV-HCV–Coinfected Individuals: Results From the German Hepatitis C Cohort (GECCO-01)

Ist Teil von

• Clinical infectious diseases, 2016-11, Vol.63 (10), p.1320-1324

Ort / Verlag

United States: Oxford University Press

Erscheinungsjahr

2016

Quelle

Oxford Journals 2020 Medicine

Beschreibungen/Notizen

• Background. Shortening the duration of treatment with HCV direct-acting antivirals (DAAs) leads to substantial cost reductions. According to the label, sofosbuvir and ledipasvir can be prescribed for 8 weeks (SL8) in noncirrhotic women or men with HCV genotype 1 and low viral loads. However, real-world data about the efficacy and safety of SL8 are largely missing. Methods. Interim results from an ongoing prospective, multicenter cohort of 9 treatment centers in Germany (GECCO). All patients started on treatment with HCV DAAs since January 2014 were included. This report describes safety and efficacy outcomes in 210 patients with HCV monoinfection and 35 with human immunodeficiency virus (HIV)–HCV coinfection given SL8 in a real-world setting. Results. Of 1353 patients included into the GECCO cohort until December 2015, a total of 1287 had complete data sets for this analysis; 337 (26.2%) fulfilled the criteria for SL8 according to the package insert, but only 193 (57.2%) were eventually treated for 8 weeks. Another 52 patients did not fulfill the criteria but were treated for 8 weeks. SL8 was generally well tolerated. The overall sustained virologic response rate 12 weeks after the end of treatment was 93.5% (186 of 199). The on-treatment response rate was 99.4% (159 of 160) in HCV-monoinfected and 96.4% (27 of 28) in HIV-HCV–coinfected patients. Ten patients were lost to follow-up. Conclusions. SL8 seems highly effective and safe in well-selected HCV-monoinfected and HIV-HCV–coinfected patients in a real-world setting.