Review article: safety and tolerability of direct-acting anti-viral agents in the new era of hepatitis C therapy

Alimentary Pharmacology & Therapeutics
D Banerjee, K R Reddy

Abstract

Direct-acting anti-virals (DAAs) licensed to treat chronic HCV infection have revolutionised treatment algorithms by drastically mitigating side effects while enhancing efficacy relative to interferon-based therapy. To review adverse events (AEs) uniquely associated with DAA therapy across a broad spectrum of patient populations. Searches of PubMed and FDA surveillance studies were undertaken to complete an exhaustive review. Search terms included 'DAAs', 'safety', and 'tolerability'. While DAAs are remarkably well tolerated, they are accompanied by unique AEs. Simeprevir, an NS3/4A protease inhibitor, has been known, albeit infrequently, to cause mild hyperbilirubinemia and photosensitivity reactions; and paritaprevir boosted with ritonavir causes bilirubin and ALT elevations. Asunaprevir, another protease inhibitor, infrequently causes elevated transaminase levels. NS5A and NS5B inhibitors are well tolerated, although sofosbuvir is contraindicated in patients with severe renal impairment. Ribavirin co-administered in certain treatment regimens has been associated with cough, rash and haemolytic anaemia. With the impending reality of a more tolerable interferon-sparing regimen, the future of DAA therapy offers shorter treatmen...Continue Reading

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