Format

Send to

Choose Destination
Clin Infect Dis. 2016 Nov 15;63(10):1320-1324. Epub 2016 Aug 17.

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).

Author information

1
Center for Infectiology Berlin.
2
Center for Interdisciplinary Medicine Muenster.
3
Faculty of Medicine, Department of Surgery and Cancer, Imperial College London, United Kingdom.
4
Gastroenterology Practice, Herne.
5
Infektiologikum, Frankfurt.
6
Infectiology Center in Hamburg.
7
Center for HIV and Hepatogastroenterology, Duesseldorf.
8
Ambulanzzentrum Virushepatologie, University Medical Center Hamburg-Eppendorf and DZIF Partner Site, Hamburg.
9
Medical Department I, University Hospital, Bonn.
10
Klinische Arbeitsgemeinschaft AIDS, Bonn.
11
Gastroenterology Practice, Leverkusen, Germany.

Abstract

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.

KEYWORDS:

8 weeks; HIV coinfection; ledipasvir; short course treatment; sofosbuvir

PMID:
27535952
DOI:
10.1093/cid/ciw567
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Silverchair Information Systems
Loading ...
Support Center