Beyond phase 3 registration trials: defining safety for triple therapy with protease inhibitors in cirrhosis
| العنوان: | Beyond phase 3 registration trials: defining safety for triple therapy with protease inhibitors in cirrhosis |
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| المؤلفون: | Peter Ferenci, G Dusheiko |
| المصدر: | Gut |
| بيانات النشر: | BMJ, 2013. |
| سنة النشر: | 2013 |
| مصطلحات موضوعية: | Liver Cirrhosis, Male, INTERFERON, medicine.medical_specialty, Cirrhosis, Interferon alpha-2, Antiviral Agents, Polyethylene Glycols, Telaprevir, chemistry.chemical_compound, Internal medicine, Boceprevir, Ribavirin, Humans, Medicine, Protease inhibitor (pharmacology), ANEMIA, Hepatology, business.industry, Gastroenterology, Interferon-alpha, Hepatitis C, Hepatitis C, Chronic, medicine.disease, Recombinant Proteins, Surgery, Clinical trial, chemistry, HEPATITIS C, Portal hypertension, Female, business, Oligopeptides, medicine.drug |
| الوصف: | Background and aim Severe adverse events (AEs) compromise the outcome of direct antiviral agent-based treatment in patients with advanced liver fibrosis due to HCV infection. HEP3002 is an ongoing multinational programme to evaluate safety and efficacy of telaprevir (TVR) plus pegylated-interferon-α (PEG-IFNα) and ribavirin (RBV) in patients with advanced liver fibrosis caused by HCV genotype 1 (HCV-1). Methods 1782 patients with HCV-1 and bridging fibrosis or compensated cirrhosis were prospectively recruited from 16 countries worldwide, and treated with 12 weeks of TVR plus PEG-IFN/RBV, followed by 12 or 36 weeks of PEG-IFN and RBV (PR) alone dependent on virological response to treatment and previous response type. Results 1587 patients completed 12 weeks of triple therapy and 4 weeks of PR tail (53% cirrhosis, 22% HCV-1a). By week 12, HCV RNA was undetectable in 85% of naives, 88% of relapsers, 80% of partial responders and 72% of null responders. Overall, 931 patients (59%) developed grade 1–4 anaemia (grade 3/4 in 31%), 630 (40%) dose reduced RBV, 332 (21%) received erythropoietin and 157 (10%) were transfused. Age and female gender were the strongest predictors of anaemia. 64 patients (4%) developed a grade 3/4 rash. Discontinuation of TVR due to AEs was necessary in 193 patients (12%). Seven patients died (0.4%, six had cirrhosis). Conclusions In compensated patients with advanced fibrosis due to HCV-1, triple therapy with TVR led to satisfactory rates of safety, tolerability and on-treatment virological response with adequate managements of AEs. |
| تدمد: | 1468-3288 0017-5749 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::17555cd5d9ea9edadea8493cd6d4a08cTest https://doi.org/10.1136/gutjnl-2013-306480Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....17555cd5d9ea9edadea8493cd6d4a08c |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 14683288 00175749 |
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