An unexpected adverse effect: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide–induced cholestasis

The morbidity and mortality of people living with HIV (PLWH) has decreased markedly after the introduction of highly effective antiretroviral therapy (ART). The safety profile of drugs used for HIV has improved over time, and nowadays, co-formulated combinations with excellent tolerability are available. One of the most commonly used is elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (EVG/COBI/FTC/TAF) due to its effectiveness in viral suppression and good tolerability [1-2]. PLWH are at greater risk of suffering hepatobiliary complications, not only caused by opportunistic infections or AIDS cholangiopathy related to advanced immunosuppression but also due to drug-induced hepatotoxicity, use of alcohol or other substances, coinfections with hepatitis virus or liver steatosis [3]. This article describes a case of a patient who developed a severe increase in cholestasis parameters after starting EVG/COBI/FTC/TAF regimen, probably related to integrase strand transfer inhibitor (InSTI). Liver enzyme elevation during InSTI-based therapy is an unusual finding. To our knowledge, this is the first report in the literature of EVG/COBI/FTC/TAF-associated cholestasis. The article tries to generate knowledge in order to strengthen pharmacovigilance of this adverse effect and reviews the available data on cholestasis in PLWH.