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Late HCC onset after DAAs therapy in patients with SVR: a type D ADR that requires a longer follow-up?
  1. Antonella Nappi1,
  2. Alessandro Perrella2,
  3. Luca Rinaldi3,
  4. Antonio Izzi4,
  5. Rodolfo Punzi4,
  6. Luigi Elio Adinolfi3,
  7. Costanza Sbeglia2,
  8. Pasquale Bellopede2,
  9. Adelaide Maddaloni2,
  10. Nunzia Papa1,
  11. Micaela Spatarella1
  1. 1 HospitalPharmacy - Pharmacovigilance Unit, Ospedali dei Colli, P.O. D.Cotugno, Naples, Italy
  2. 2 VII Unit InfectiousDiseaseand Immunology, Ospedali dei Colli P.O. D.Cotugno, Naples, Italy
  3. 3 Gastroenterology Unit, Università degli Studi della Campania "LuigiVanvitelli", Naples, italy
  4. 4 AORN Ospedali dei Colli, Napoli, Italy
  1. Correspondence to Dr Antonella Nappi, AORN Ospedali dei Colli, P.O. D.Cotugno, Via Quagliariello 54, Naples, Italy; antonella.nappi{at}; Dr Alessandro Perrella; alessandro.perrella{at}

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The new antivirals for the treatment of hepatitis C virus (HCV) are characterised by short duration with an increased sustained virological response (SVR), a reduced follow-up with a significant impact on HCV natural history and health public burden. However they still lack substantial data on long-term disease evolution in real life.1 More recently Yin et al showed that real-life SVR was similar to clinical study with a reduction in health costs.2 However, despite the noteworthy results on the virus, the long-term outcome, possible related adverse drug reaction (ADR) and their impact on healthcare cost are still controversial, even when achieving SVR3 particularly in regards to hepatocellular carcinoma (HCC). At the beginning of 2015, we started to assess the presence of any kind of ADR of these new DAAs …

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  • Contributors AN, NP and MS were involved in ADR reporting and pharmacovigilance follow-up of the patients. AP, AN and LR were involved in study design and writing and reviewing the paper. AP, LR CS, RP, PB, AI and AM were engaged in patients' follow-up and enrolment.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; internally peer reviewed.