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J Viral Hepat. 2017 Apr;24(4):304-311. doi: 10.1111/jvh.12648. Epub 2016 Dec 9.

Effectiveness and safety of sofosbuvir-based regimens plus an NS5A inhibitor for patients with HCV genotype 3 infection and cirrhosis. Results of a multicenter real-life cohort.

Author information

1
Gastroenterology, Hospital Universitario Fundación Alcorcón, Madrid, Spain.
2
Liver Unit, Internal Medicine Department, Vall d'Hebron Hospital, Barcelona, Spain.
3
Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain.
4
Digestive Diseases Service, Hospital 12 Octubre, Madrid.
5
Hospital General Universitario Gregorio Marañón, Madrid, Spain.
6
Hospital Universitario La Princesa, Madrid, Spain.
7
Gastroenterology and Hepatology Unit, Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain.
8
Gastroenterology and Hepatology Department, Hospital Universitario Ramón y Cajal, IRYCIS, Madrid, Spain.
9
Hospital Universitario La Paz, Madrid, Spain.
10
Liver Unit, Hospital Universitario Puerta de Hierro-Majadahonda, IDIPHIM, CIBERehd, Majadahonda, Madrid, Spain.
11
Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain.
12
Liver Section, Gastroenterology Department, Hospital del Mar, Universitat Autònoma de Barcelona, IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain.
13
Hospital Universitario Donostia, Donostia, Spain.
14
Hospital Universitario Clínico San Carlos, Madrid, Spain.
15
Hospital Universitari de Bellvitge, IDIBELL, Barcelona, Spain.
16
Hospital Universitario de A Coruña, A Coruña, Spain.
17
Hospital Virgen de Valme, and Institute of Biomedicine of Seville, Spain.
18
H. U. de Gran Canaria Dr. Negrín, Gran Canaria, Spain.
19
H. U. Virgen del Rocío, Seville, Spain.
20
Hepatology Unit, Digestive Medicine Service, Hospital Universitari i Politècnic La Fe, Valencia, Spain.
21
H. U. San Cecilio, Granada, Spain.
22
Hospital Universitario de Burgos, Burgos, Spain.
23
C. H. U. de Albacete, Albacete, Spain.
24
Liver Unit, Hospital Clínic, Instituto de Investigaciones Biomédicas August Pi i Sunyer (IDIBAPS), Barcelona, Spain.
25
Department of Gastroenterology, Complejo Hospitalario Universitario de Pontevedra and IISGS, Pontevedra, Spain.
26
Hospital Reina Sofia, Córdoba, Spain.

Abstract

Patients with HCV genotype 3 (GT3) infection and cirrhosis are currently the most difficult to cure. We report our experience with sofosbuvir+daclatasvir (SOF+DCV) or sofosbuvir/ledipasvir (SOF/LDV), with or without ribavirin (RBV) in clinical practice in this population. This was a multicenter observational study including cirrhotic patients infected by HCV GT3, treated with sofosbuvir plus an NS5A inhibitor (May 2014-October 2015). In total, 208 patients were included: 98 (47%) treatment-experienced, 42 (20%) decompensated and 55 (27%) MELD score >10. In 131 (63%), treatment was SOF+DCV and in 77 (37%), SOF/LDV. Overall, 86% received RBV. RBV addition and extension to 24 weeks was higher in the SOF/LDV group (95% vs 80%, P=.002 and 83% vs 72%, P=.044, respectively). A higher percentage of decompensated patients were treated with DCV than LDV (25% vs 12%, P=.013). Overall, SVR12 was 93.8% (195/208): 94% with SOF+DCV and 93.5% with SOF/LDV. SVR12 was achieved in 90.5% of decompensated patients. Eleven treatment failures: 10 relapses and one breakthrough. RBV addition did not improve SVR (RR: 1.08; P=.919). The single factor associated with failure to achieve SVR was platelet count <75×10E9/mL (RR: 3.50, P=.019). In patients with MELD <10, type of NS5A inhibitor did not impact on SVR12 (94% vs 97%; adjusted RR: 0.49). Thirteen patients (6.3%) had serious adverse events, including three deaths (1.4%) and one therapy discontinuation (0.5%), higher in decompensated patients (16.7% vs 3.6%, P<.006). In patients with GT3 infection and cirrhosis, SVR12 rates were high with both SOF+DCV and SOF/LDV, with few serious adverse events.

KEYWORDS:

SVR12; cirrhosis; daclatasvir; genotype 3; hepatitis C; ledipasvir; observational study; real-world cohort; sofosbuvir

PMID:
27935168
DOI:
10.1111/jvh.12648
[Indexed for MEDLINE]

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