Ippolito, G; Zumla, A; Lanini, S; (2018) Is there sufficient evidence to repeal three decades of clinical research on chronic hepatitis C? Clinical Microbiology and Infection , 24 (4) pp. 328-331. 10.1016/j.cmi.2018.01.001.

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Text Zumla 2. Ippolito G Is there sufficient evdidence HCV_DAA_Cochrane_CMI (2).pdf - Accepted Version Download (115kB) | Preview

Abstract

Introduction A recently published systematic review on the treatment of chronic hepatitis C (CHC) with direct-acting antivirals (DAAs) performed by the Cochrane Collaboration has reached highly controversial conclusions [1,2]. The authors included 138 randomized controlled trials (RCTs) with no restriction on disease stage or type of DAA combination. They concluded that there was no evidence to either confirm or reject the premise that DAAs had any clinical effect, and they also stated that sustained virologic response (SVR) was an unreliable surrogate marker to assess clinical efficacy. We differ on both these counts. These results are in discordance with current international guidelines (https://www.hcvguidelines.org/) [3], the opinion of the of scientific societies for the study of liver diseases in Europe [4] and in America (https://www.aasld.org/about-aasld/press-room/aasld-expresses-concern-cochrane-review-daas), and the endorsement of the World Health Organization, which states that DAAs may eliminate hepatitis C virus (HCV) by 2030 (http://apps.who.int/iris/bitstream/10665/246177/1/WHO-HIV-2016.06-eng.pdf?ua=1; http://www.who.int/hepatitis/news-events/direct-acting-antiviral-cure-hepatitis-c/en/) [5]. The Cochrane Collaboration's results reflect an underestimation of the actual value of observational evidence in the context of the current knowledge of CHC clinical management [6,7].

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