International Journal of Clinical Pharmacy

, Volume 39, Issue 6, pp 1304–1311 | Cite as

Adverse effects of direct acting antiviral-based regimens in chronic hepatitis C patients: a Brazilian experience

  • Thalia Medeiros
  • Camila de Morais Salviato
  • Natalia Fonseca do Rosário
  • Geórgia do Nascimento Saraiva
  • Eliane Bordalo Cathalá Esberard
  • Jorge Reis Almeida
  • Analúcia Rampazzo Xavier
  • Andrea Alice da SilvaEmail author
Research Article


Background Direct-acting antivirals (DAA) are currently used for the treatment of chronic hepatitis C (HCV). However, few studies describe the adverse effects (AE) associated with DAA therapy in “real-word” cohorts. Aim To evaluate AE in Brazilian chronic HCV patients after DAA-therapy. Setting A reference center for hepatitis treatment in Rio de Janeiro, Brazil. Methods An observational “real-world” study was conducted with 102 chronic HCV patients undergoing DAA therapy for 12 or 24 weeks. The self-reported AE were correlated with cirrhosis status, genotype, age, current therapeutic schemes and comorbidities. Serious AE were also investigated. Main outcome measure Frequency of AE during DAA therapy. Results Overall, mean ± SD age was 60.9 ± 9.4 years, 67% were females, HCV-genotype 1 was the most prevalent (81%) and 74% were cirrhotic. Moreover, all patients reached sustained virological response. About 90% of patients reported at least one AE associated with current treatment, with a mean of 2.7 symptoms per patient. The most frequently reported AE were fatigue (43%), headache (42%), neuropsychiatric symptoms (30%) and nausea (26%). Furthermore, hemoglobin < 12 mg/dL was the most frequent (38%) laboratory abnormality observed. Neuropsychiatric symptoms were the only AE significantly different in treatment-experienced group when compared to naïve patients (41.7 vs. 12.5, P = 0.002). The higher frequency of AE did not correlate with the presence of previous treatment, cirrhosis, genotype, age, current therapeutic schemes with DAA or comorbidities. Conclusion DAA-based therapeutic regimens demonstrated safety in a Brazilian “real-world” cohort of chronic hepatitis C patients.


Adverse effects Brazil Chronic hepatitis C Direct-acting antiviral Sofosbuvir 



Adverse effects


Direct-acting antivirals




End of treatment


Hepatitis C virus




Pegylated interferon




Serious adverse effects






Sustained virological response



The authors thank to the Unidade de Pesquisa Clínica and the Serviço de Patologia Clínica (UFF) by technical support.


Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES): T. Medeiros, N.F. Rosário, G.N. Saraiva are students fellow.

Fundação Carlos Chagas Filho de Amparo à Pesquisa do Estado do Rio de Janeiro/FAPERJ (JCNE/E-26/102.173/2013): A.A. Silva is a research fellow.

Conflicts of interest

The authors declare that they have no conflicts of interest.


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Copyright information

© Springer International Publishing AG 2017

Authors and Affiliations

  • Thalia Medeiros
    • 1
  • Camila de Morais Salviato
    • 1
  • Natalia Fonseca do Rosário
    • 1
  • Geórgia do Nascimento Saraiva
    • 1
  • Eliane Bordalo Cathalá Esberard
    • 3
  • Jorge Reis Almeida
    • 1
  • Analúcia Rampazzo Xavier
    • 1
    • 2
  • Andrea Alice da Silva
    • 1
    • 2
    Email author
  1. 1.Laboratório Multiusuário de Apoio à Pesquisa em Nefrologia e Ciências Médicas, Departamento de Medicina Clínica, Faculdade de MedicinaUniversidade Federal FluminenseRio de JaneiroBrazil
  2. 2.Departamento de Patologia, Faculdade de MedicinaUniversidade Federal FluminenseRio de JaneiroBrazil
  3. 3.Centro de Referência de Tratamento em Hepatites/HUAP, Serviço de Gastroenterologia, Departamento de Medicina Clínica, Faculdade de MedicinaUFFRio de JaneiroBrazil

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