New drugs for non-alcoholic steatohepatitis and HIV infection: great expectations with a great absent?
AbstractIn recent years, there has been an increasing number of clinical trials for the treatment of non-alcoholic steatohepatitis (NASH). People living with HIV (PLWH) are commonly excluded from these studies, usually due to concerns over drug-drug interactions (DDI) associated with antiretroviral therapy (ART). The Steatohepatitis in HIV Emerging Research (SHIVER) Network, a group of international experts in hepatology and infectious diseases, discusses our current understanding on the interaction between HIV and NASH, and the issues related to the inclusion of PLWH in NASH clinical trials. Recent trials addressing NASH treatment in PLWH are discussed. The risk of DDI between ART and aramchol, cenicriviroc, elafibranor, obeticholic acid and resmetirom (MGL-3196), which are currently in phase III trials for the treatment of NASH, are reviewed. Finally, a model for trial design to include PLWH is proposed, strongly advocating for the scientific community to include this group as a sub-population within studies.