Daclatasvir plus Asunaprevir dual therapy for chronic HCV genotype 1b infection: results of turkish early access program



Document title: Daclatasvir plus Asunaprevir dual therapy for chronic HCV genotype 1b infection: results of turkish early access program
Journal: Annals of hepatology
Database: PERIÓDICA
System number: 000406027
ISSN: 1665-2681
Authors: 1
2
3
4
5
6
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8
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10
Institutions: 1Hacettepe University, School of Medicine, Ankara. Turquía
2Karadeniz University, School of Medicine, Trabzon. Turquía
3Ege University, School of Medicine, Izmir. Turquía
4Gaziantep University, School of Medicine, Gaziantep. Turquía
5Yildirim Beyazit University, School of Medicine, Ankara. Turquía
6Ataturk Education and Research Hospital,, Department of Gastroenterology, Ankara. Turquía
7Mersin Government Hospital, Department of Gastroenterology, Mersin. Turquía
8Kocaeli University, School of Medicine, Kocaeli. Turquía
9Istanbul University, Cerrahpasa Medical School, Estambul. Turquía
10Ankara University, School of Medicine, Ankara. Turquía
Year:
Season: Ene-Feb
Volumen: 16
Number: 1
Pages: 71-76
Country: México
Language: Inglés
Document type: Estadística o encuesta
Approach: Caso clínico
English abstract Daclatasvir and asunaprevir dual therapy is approved for the treatment of HCV genotype 1b infection in several countries. Aim. To evaluate the efficacy and safety of daclatasvir and asunaprevir dual therapy in Turkish patients. Material and methods. Sixty-one patients with HCV genotype 1b were enrolled in the Turkish early access program. Most of the patients were in difficult-to-treat category. Patients were visited at each 4 week throughout the follow-up period. Laboratory findings and adverse events were recorded at each visit. Results. Fifty-seven of 61 enrolled patients completed 24 weeks of treatment. Two patients died as a result of underlying diseases at 12-14th weeks of treatment. Two patients stopped the treatment early as a consequence of virological breakthrough, and 2 patients had viral relapse at the post-treatment follow-up. Overall SVR12 rates were 90% (55/61) and 93.2% (55/59) according to intention-to-treat (ITT) and per protocol (PP) analysis respectively. In ITT analysis, SVR12 was achieved by 93% (13/14) in relapsers, 80% (12/15) in interferon-ineligible patients and 91% (20/22) in previous nonresponder patients. SVR12 rates were 86.5% and 91.4% in patients with cirrhosis according to ITT and PP analysis respectively. SVR12 was 95.8% in non-cirrhosis group in both analysis. Patients with previous protease inhibitor experience had an SVR12 of 87.5%. Common adverse events developed in 28.8% of patients. There were no treatment related severe adverse event or grade-4 laboratory abnormality. Conclusions. Daclatasvir and asunaprevir dual therapy is found to be effective and safe in difficult-to-treat Turkish patients with HCV genotype 1b infection
Disciplines: Medicina
Keyword: Gastroenterología,
Microbiología,
Terapéutica y rehabilitación,
Daclatasvir,
Hepatitis C,
Asunaprevir,
Efectividad
Keyword: Medicine,
Gastroenterology,
Microbiology,
Therapeutics and rehabilitation,
Daclatasvir,
Hepatitis C,
Asunaprevir,
Effectiveness
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