Trial reportPloS one2013
Eligibility and safety of triple therapy for hepatitis C: lessons learned from the first experience in a real world setting.
Trial report in PloS one, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
40 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Treatment for hepatitis C virus-associated mixed cryoglobulinaemia.The Cochrane database of systematic reviews · 2018Pooled it
- Trial
- Trial
- Trial
- Trial
- PEG-IFN alpha but not ribavirin alters NK cell phenotype and function in patients with chronic hepatitis C.PloS one · 2014Trial
- Integrated Care Models for Hepatitis C: Lessons From Southeast Asia and Sub-Saharan Africa.Open forum infectious diseases · 2025Article
- Breakthroughs in hepatitis C research: from discovery to cure.Nature reviews. Gastroenterology & hepatology · 2022Review
- Review
- Design and Synthesis of Novel Bis-Imidazolyl Phenyl Butadiyne Derivatives as HCV NS5A Inhibitors.Pharmaceuticals (Basel, Switzerland) · 2022Article
- Targeting the RdRp of Emerging RNA Viruses: The Structure-Based Drug Design Challenge.Molecules (Basel, Switzerland) · 2020Review
- Frequency of Potential Drug-Drug Interactions in the Changing Field of HCV Therapy.Open forum infectious diseases · 2020Article
- Hepatitis C models of care: approaches to elimination.Canadian liver journal · 2020Review
- Economic study of the value of expanding HCV treatment capacity in Germany.BMJ open gastroenterology · 2017Article
- Efficacy and safety of sofosbuvir-based therapies in patients with advanced liver disease in a real-life cohort.Hepatic medicine : evidence and research · 2017Article
- Lower response to simeprevir and sofosbuvir in HCV genotype 1 in routine practice compared with clinical trials.BMJ open gastroenterology · 2016Article
- Outcomes and Costs of Treating Hepatitis C Patients in the Era of First Generation Protease Inhibitors - Results from the PAN Study.PloS one · 2016Article
- Pretreatment Predictors of Response to PegIFN-RBV Therapy in Egyptian Patients with HCV Genotype 4.PloS one · 2016Article
- Hepatitis C virus treatment in the real world: optimising treatment and access to therapies.Gut · 2015Review
- Treatment patterns, health care resource utilization, and costs in U.S. patients diagnosed with chronic hepatitis C infection who received telaprevir or boceprevir.Journal of managed care & specialty pharmacy · 2015Article
Corrections and comments
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Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundHCV protease inhibitors (PIs) boceprevir and telaprevir in combination with PEG-Interferon alfa and Ribavirin (P/R) is the new standard of care in the treatment of chronic HCV genotype 1 (GT1) infection. However, not every HCV GT1 infected patient is eligible for P/R/PI therapy. Furthermore phase III studies did not necessarily reflect real world as patients with advanced liver disease or comorbidities were underrepresented. The aim of our study was to analyze the eligibility and safety of P/R/PI treatment in a real world setting of a tertiary referral center.
methodsAll consecutive HCV GT1 infected patients who were referred to our hepatitis treatment unit between June and November 2011 were included. Patients were evaluated for P/R/PI according to their individual risk/benefit ratio based on 4 factors: Treatment-associated safety concerns, chance for SVR, treatment urgency and nonmedical patient related reasons. On treatment data were analyzed until week 12.
results208 patients were included (F3/F4 64%, mean platelet count 169/nl, 40% treatment-naïve). Treatment was not initiated in 103 patients most frequently due to safety concerns. 19 patients were treated in phase II/III trials or by local centers and a triple therapy concept was initiated at our unit in 86 patients. Hospitalization was required in 16 patients; one patient died due to a gastrointestinal infection possibly related to treatment. A platelet count of <110/nl was associated with hospitalization as well as treatment failure. Overall, 128 patients were either not eligible for therapy or experienced a treatment failure at week 12.
conclusionsP/R/PI therapies are complex, time-consuming and sometimes dangerous in a real world setting, especially in patients with advanced liver disease. A careful patient selection plays a crucial role to improve safety of PI based therapies. A significant number of patients are not eligible for P/R/PI, emphasizing the need for alternative therapeutic options.
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