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• W2894900564 abstract "Potential conflict of interest: Nothing to report. To the Editor: A commentary1 has criticized our systematic review regarding the use of direct‐acting agents (DAAs) in chronic hepatitis C.2 The following represents our major disagreements. Sustained virological response (SVR) is a nonvalidated surrogate outcome. The principles of evidence‐based medicine require that it be validated in randomized clinical trials (RCTs) by showing parallel benefits in clinical outcomes.3 This has never been accomplished. One RCT comparing pegylated interferon to no treatment in patients failing prior treatment found that more treated patients had SVRs (albeit a small percentage) but also died more often4; in this scenario, the surrogate failed to validate. We do agree that the RCTs to date were of relatively short duration and not designed to assess long‐term clinical outcomes, but no short‐term clinical benefits were observed. The cited “mounting evidence” consisted of observational studies (which are always limited by confounding). A comparison of treated and untreated patients cannot account for the reason(s) why treatment was or was not offered; untreated patients are often sicker. Patients who develop SVRs are at lower risk of progression,5 so comparing them to untreated participants adds selection bias. Comparing patients who do and do not develop SVRs shows that the SVR is a good prognostic sign, but this cannot provide any insight into treatment because all of the participants were treated. The six cited uncontrolled observational studies describing the use of DAAs for patients with decompensated liver disease (with or without transplantation) described many patients who had further episodes of liver failure; in the absence of untreated control groups, it is impossible to put these studies into perspective. Even alleged improvement may only represent better general care or natural history. The absence of blinding and the effects of marketing and bias make it impossible to assess quality of life. Because patients with SVRs may have hepatitis C virus RNA in peripheral blood mononuclear cells,5 transmission is still a theoretical possibility. It is ethical to call for RCTs to provide a scientific basis for the use of scarce resources. It may be unethical to expect health care systems to shift scarce resources from other interventions, particularly those with better evidence, to implement DAA therapy that has only been shown to improve surrogate outcomes and never been shown to improve morbidity or mortality." @default.
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• W2894900564 date "2019-04-12" @default.
• W2894900564 modified "2023-09-26" @default.
• W2894900564 title "Letter to Editor: Response to AASLD Editorial/Message from the President" @default.
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• W2894900564 doi "https://doi.org/10.1002/hep.30298" @default.
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