Fátima Falcão1, Carla Lopes2, Erica Viegas3, Rita Perez4, Isabel Aldir5, Helena Farinha6, António Carvalho4, Ana Mirco3, Susana Marques7, Tiago Bana E Costa7, Ana Cláudia Miranda8, Luís Lebre7, Paula Peixe7, Cristina Chagas7, Kamal Mansinho8, José Manuel Correia4. 1. Pharmacy and Therapeutics Committee. Centro Hospitalar de Lisboa Ocidental. Lisboa; Pharmacy Department. Centro Hospitalar de Lisboa Ocidental. Lisboa; Department of Pharmacy Practice. Faculty of Pharmacy. University of Lisbon. Lisboa. Portugal. 2. Pharmacy Department. Centro Hospitalar de Lisboa Ocidental. Lisboa. Portugal. 3. Pharmacy and Therapeutics Committee. Centro Hospitalar de Lisboa Ocidental. Lisboa. Pharmacy Department. Centro Hospitalar de Lisboa Ocidental. Lisboa. Department of Pharmacy Practice. Faculty of Pharmacy. University of Lisbon. Lisboa. Portugal. 4. Pharmacy and Therapeutics Committee. Centro Hospitalar de Lisboa Ocidental. Lisboa. Portugal. 5. Pharmacy and Therapeutics Committee. Centro Hospitalar de Lisboa Ocidental. Lisboa. Infecciology. Hospital de Egas Moniz. Centro Hospitalar de Lisboa Ocidental. Lisboa. Portugal. 6. Pharmacy and Therapeutics Committee. Centro Hospitalar de Lisboa Ocidental. Lisboa. Pharmacy Department. Centro Hospitalar de Lisboa Ocidental. Lisboa. Portugal. 7. Gastroenterology. Hospital de Egas Moniz. Centro Hospitalar de Lisboa Ocidental. Lisboa. Portugal. 8. Infecciology. Hospital de Egas Moniz. Centro Hospitalar de Lisboa Ocidental. Lisboa. Portugal.
Abstract
INTRODUCTION: In late 2014, Portugal implemented a national program for the treatment of patients with chronic hepatitis C with directacting antiviral agents. This program has made Portugal one of the first European countries to implement a structured measure of treatment to eliminate this serious public health problem. The aim of this study was to assess the effectiveness of direct-acting antiviral therapy in the treatment of patients with chronic hepatitis C virus infection. MATERIAL AND METHODS: A retrospective observational study was conducted at Centro Hospitalar de Lisboa Ocidental on the national online platform from December 2014 until February 2017 and included patients with hepatitis C virus infection who underwent treatment. The primary endpoint was sustained virologic response at least 12 weeks post treatment. Data was analyzed with the SPSS 17.0 program. RESULTS: During the study period, 820 patients completed therapy and achieved sufficient follow-up time to assess sustained virologic response with an overall response rate of 97.2% (n = 797) and a response rate of 98.0%, 99.5%, 90.9%, 95.1% and 94.2% for genotypes 1a, 1b, 2, 3 and 4, respectively. Data suggested that advanced fibrosis (F3/F4), human immunodeficiency virus co-infection and treatment failure with interferon and ribavirin were not negatively related with sustained virologic response in our population. Most patients (80.1%) completed treatment with ledipasvir/sofosbuvir ± ribavirin. The most common adverse events were fatigue and insomnia followed by headache and weight loss. DISCUSSION: Patients predominantly had genotype 1 infection which correlates with HCV distribution in Europe, but we found a major proportion in genotype 4 which can be explained by immigration from African countries. Our patients' ages ranging from 22 to 90 years, reflected a new approach with no upper age limit. Direct-acting antivirals regimens resulted in remarkably high SVR rates compared to interferon-based regimens, which were consistent with clinical trials data. CONCLUSION: Our data showed that direct-acting antiviral-based regimens are safe and have a high success rate in the treatment of patients with hepatitis C virus infection in a real-world setting.
INTRODUCTION: In late 2014, Portugal implemented a national program for the treatment of patients with chronic hepatitis C with directacting antiviral agents. This program has made Portugal one of the first European countries to implement a structured measure of treatment to eliminate this serious public health problem. The aim of this study was to assess the effectiveness of direct-acting antiviral therapy in the treatment of patients with chronic hepatitis C virus infection. MATERIAL AND METHODS: A retrospective observational study was conducted at Centro Hospitalar de Lisboa Ocidental on the national online platform from December 2014 until February 2017 and included patients with hepatitis C virus infection who underwent treatment. The primary endpoint was sustained virologic response at least 12 weeks post treatment. Data was analyzed with the SPSS 17.0 program. RESULTS: During the study period, 820 patients completed therapy and achieved sufficient follow-up time to assess sustained virologic response with an overall response rate of 97.2% (n = 797) and a response rate of 98.0%, 99.5%, 90.9%, 95.1% and 94.2% for genotypes 1a, 1b, 2, 3 and 4, respectively. Data suggested that advanced fibrosis (F3/F4), human immunodeficiency virus co-infection and treatment failure with interferon and ribavirin were not negatively related with sustained virologic response in our population. Most patients (80.1%) completed treatment with ledipasvir/sofosbuvir ± ribavirin. The most common adverse events were fatigue and insomnia followed by headache and weight loss. DISCUSSION: Patients predominantly had genotype 1 infection which correlates with HCV distribution in Europe, but we found a major proportion in genotype 4 which can be explained by immigration from African countries. Our patients' ages ranging from 22 to 90 years, reflected a new approach with no upper age limit. Direct-acting antivirals regimens resulted in remarkably high SVR rates compared to interferon-based regimens, which were consistent with clinical trials data. CONCLUSION: Our data showed that direct-acting antiviral-based regimens are safe and have a high success rate in the treatment of patients with hepatitis C virus infection in a real-world setting.
Entities:
Keywords:
Antiviral Agents/therapeutic use; Hepacivirus/drug effects; Hepatitis C/drug therapy; Portugal