Predictors of adverse drug reactions associated with ribavirin in direct‐acting antiviral therapies for chronic hepatitis C
| Autor: | Priscilla Garcia de Oliveira Monteiro, Sabrina Calil-Elias, Gabriel da Silva Duarte, Camille Nigri Cursino, Renan Moritz Varnier Rodrigues de Almeida, Analúcia Rampazzo Xavier, Fabíola Giordani, Tassita Bezz Quintanilha Vieira, Verônica de Carvalho Crisante |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
Adult
Male Simeprevir medicine.medical_specialty Pyrrolidines Daclatasvir Sofosbuvir Epidemiology Anemia Antiviral Agents 030226 pharmacology & pharmacy 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Risk Factors Internal medicine Ribavirin Product Surveillance Postmarketing medicine Humans Pharmacology (medical) Longitudinal Studies Prospective Studies 030212 general & internal medicine Prospective cohort study Fatigue Aged Aged 80 and over business.industry Headache Imidazoles Valine Hepatitis C Chronic Middle Aged Pharmacoepidemiology medicine.disease chemistry Drug Therapy Combination Female Carbamates business Brazil Adverse drug reaction medicine.drug |
| Zdroj: | Pharmacoepidemiology and Drug Safety. 28:1601-1608 |
| ISSN: | 1099-1557 1053-8569 |
| DOI: | 10.1002/pds.4904 |
| Popis: | PURPOSE To identify factors associated with the development of adverse drug reactions (ADR) in ribavirin therapeutic regimens. METHODS A multicenter, prospective study was conducted in three public health hospitals in Rio de Janeiro between November 2015 and March 2018. Inclusion criteria were defined by patient follow-up at pharmaceutical consultation at the time of drug dispensing as those who used sofosbuvir in combination with simeprevir, daclatasvir, and/or ribavirin. All patients were invited to participate in the study during the first interview. Adverse drug reactions were reported according to the treatment regimen and frequency of occurrence. Statistical analysis was used to compare adverse reactions between treatments and their associated factors. RESULTS A total of 405 patients were included in the study (mean age 59.6 ± 9.6 years); 61.0% were female, 88.1% were infected with genotype 1, and 65.4% were cirrhotic. The most prescribed treatment was the combination of sofosbuvir, daclatasvir, and ribavirin (55.3%). The majority of patients reported at least one ADR during treatment (83.2%), of which fatigue, anemia, and headache were the most common. Being female (OR = 1.86, [1.08-3.20]) and use of ribavirin (OR: 2.39; 95% CI [1.38-4.13]) were predictors for the development of ADR, which was also associated with development of anemia (OR: 10.28; 95% CI: [5.78-18.30]). Treatment efficacy was 98.1%. CONCLUSIONS Direct-acting antiviral has been shown to be safe and effective. Therefore, use of ribavirin is questionable due to associated adverse reactions and similar efficacy to other treatments. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Plný text