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

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Abstract

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.

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Abbreviations

AE:

Adverse effects

DAA:

Direct-acting antivirals

DCV:

Daclatasvir

EoT:

End of treatment

HCV:

Hepatitis C virus

IFN:

Interferon

Peg-IFN:

Pegylated interferon

RBV:

Ribavirin

SAE:

Serious adverse effects

SMV:

Simeprevir

SOF:

Sofosbuvir

SVR:

Sustained virological response

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Acknowledgements

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

Funding

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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    Authors and Affiliations

    1. Laboratório Multiusuário de Apoio à Pesquisa em Nefrologia e Ciências Médicas, Departamento de Medicina Clínica, Faculdade de Medicina, Universidade Federal Fluminense, Rio de Janeiro, Brazil

      Thalia Medeiros, Camila de Morais Salviato, Natalia Fonseca do Rosário, Geórgia do Nascimento Saraiva, Jorge Reis Almeida, Analúcia Rampazzo Xavier & Andrea Alice da Silva

    2. Departamento de Patologia, Faculdade de Medicina, Universidade Federal Fluminense, Rio de Janeiro, Brazil

      Analúcia Rampazzo Xavier & Andrea Alice da Silva

    3. Centro de Referência de Tratamento em Hepatites/HUAP, Serviço de Gastroenterologia, Departamento de Medicina Clínica, Faculdade de Medicina, UFF, Rio de Janeiro, Brazil

      Eliane Bordalo Cathalá Esberard

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    1. Thalia Medeiros
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    Correspondence to Andrea Alice da Silva.

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    Medeiros, T., Salviato, C.M., do Rosário, N.F. et al. Adverse effects of direct acting antiviral-based regimens in chronic hepatitis C patients: a Brazilian experience. Int J Clin Pharm 39, 1304–1311 (2017). https://doi.org/10.1007/s11096-017-0552-1

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