Direct-acting antiviral drugs for chronic hepatitis C and risk of major vascular events: a systematic review

Eleonora Tamborini Permunian, Lorenzo Gervaso, Victor Gerdes, Lorenzo Moja, Luigina Guasti, Alessandro Squizzato

Research output: Contribution to journalReview articlepeer-review

Abstract

Direct-acting antiviral drugs (DAAs) were recently approved for treating hepatitis C virus-related chronic hepatitis. As advanced chronic liver disease may predispose patients to thrombotic events, it is still uncertain whether DAAs may influence the actual risk of major arterial and venous thrombotic events. We performed a systematic review to assess the incidence of major vascular events in patients receiving DAAs for HCV chronic hepatitis during phase-III randomized controlled trials (RCTs). Two reviewers identified studies through Pubmed database until October 2015. Reporting and incidence of any vascular events were compared with reporting and incidence of major bleeding, anemia (a prespecified safety outcome) and headache (a common non-prespecified safety outcome). 33 RCTs, encompassing 14,764 patients, were included. Only 13 (39%) and 4 (12%) RCTs provide data on any arterial or venous events, respectively. Occurrence of anemia and headache is reported in all studies. Crude unweighted rate of major arterial events is 0.16% (95% CI 0.10–0.24) of the total included population and 0.47% in those 13 RCTs reporting data. Crude unweighted rate of major venous events is 0.03% of the total included population (95% CI 0.01–0.08) and 0.22% in those four RCTs reporting data. Crude unweighted rate of major bleeding is 0.07% (95% CI 0.03–0.1). Incidence of thrombotic events in HCV patients receiving DAAs may be low, but an incorrect estimation cannot be excluded.

Original languageEnglish
Pages (from-to)775-790
Number of pages16
JournalInternal and Emergency Medicine
Volume13
Issue number5
DOIs
Publication statusPublished - Aug 1 2018
Externally publishedYes

Keywords

  • Chronic hepatitis
  • Direct-acting antiviral drugs
  • Myocardial infarction
  • Underreporting
  • Venous thromboembolism

ASJC Scopus subject areas

  • Internal Medicine
  • Emergency Medicine

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