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High efficacy and safety of triple therapy in HCV genotype 1 and moderate fibrosis: a multicenter study of clinical practice in Spain
- Source :
- Scopus-Elsevier, ResearcherID, Europe PubMed Central, Cristina Fernández Pérez, ANNALS OF HEPATOLOGY, r-IIS La Fe. Repositorio Institucional de Producción Científica del Instituto de Investigación Sanitaria La Fe, instname, Annals of Hepatology, Vol 14, Iss 4, Pp 477-486 (2015)
- Publication Year :
- 2015
-
Abstract
- Background and rational. Telaprevir-based therapy (TBT) has been extensively evaluated in clinical trials. So we designed a study to compare the efficacy and safety of TBT between patients with moderate fibrosis and those suffering from advanced fibrosis in clinical practice. A multicenter observational and ambispective study was conducted. It included 582 patients with chronic hepatitis C genotype 1, 214 with fibrosis F2, and 368 with F3/F4 (F3: 148; F4: 220). Results. The mean patient age was 55 years, 67% male. Type of prior response was 22% naive, 57% relapsers, and 21% partial/null responders, 69% had high viral load (> 800,000 IU/mL). HCV genotypes were 1a (19%), 1b (69%), and 1 (12%), respectively. Sixty-five percent were non-CC IL28B genotype. Week-12 sustained virologic response (SVR12) was significantly higher among F2-naive patients (78%) compared with F3/F4-naive patients (60%; p = 0.039) and among F2 non-responders (67%) compared with F3/F4 non-responders (42%; p = 0.014). SVR12 among relapsers was remarkably high in both groups (F2:89% vs. F3/F4:78%). Severe anemia and thrombocytopenia were more frequent among patients with F3/F4 than those with F2 (p < 0.01). Overall, 132 patients (22%) discontinued treatment: 58 due to adverse effects, 42 due to the stopping-rule, and 32 due to breakthrough. Premature discontinuation was more frequent among patients with F3/F4 (p = 0.028), especially due to breakthrough (p < 0.001). Conclusions. This multicenter study demonstrates high efficacy and an acceptable safety profile with regard to TBT in F2-patients in clinical practice.
- Subjects :
- Liver Cirrhosis
Male
Time Factors
Specialties of internal medicine
Hepacivirus
Gastroenterology
Severity of Illness Index
Telaprevir
Fibrosis
Risk Factors
Genotype
General Medicine
Middle Aged
Viral Load
Treatment Outcome
RC581-951
Hepatitis C genotype 1
RNA, Viral
Drug Therapy, Combination
Female
Telaprevir triple therapy
Moderate fibrosis
Viral load
Oligopeptides
medicine.drug
Adult
medicine.medical_specialty
Antiviral Agents
Safety and efficacy
Young Adult
Internal medicine
medicine
Humans
Adverse effect
Aged
Hepatology
business.industry
Interleukins
Hepatitis C, Chronic
medicine.disease
Surgery
Discontinuation
Clinical trial
Spain
Observational study
Interferons
business
Biomarkers
Subjects
Details
- ISSN :
- 16652681
- Volume :
- 14
- Issue :
- 4
- Database :
- OpenAIRE
- Journal :
- Annals of hepatology
- Accession number :
- edsair.doi.dedup.....57a8dee6b90da13a73c2bc86bde82ca9