1 Department of Surgical, Medical, Dental and Morphological Sciences, University of Modena and Reggio Emilia, Italy.
2 Hepatology Unit, Department of Surgery and Cancer, Imperial College London, UK.
3 Division of Infectious Diseases & Hospital Epidemiology, University Hospital Basel, Basel, Switzerland.
4 Coalition des organismes communautaires québécois, de lutte contre le sida (COCQ-SIDA), Montreal, QC, Canada.
5 UCL Institute for Liver and Digestive Health, Royal Free Hospital, University College London, UK.
6 Royal Free London, NHS Foundation Trust, London, UK.
7 Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC, 27157, USA.
8 Department of Medicine, University of California, San Francisco, 94143, USA.
9 Center for Infectiology, Berlin, Germany.
10 Department of Gastroenterology and Hepatology, Charité University Medical Center, Berlin, Germany.
11 Department of Surgery and Cancer, St Mary's Hospital, Imperial College London, Liver Unit, UK.
12 Division of Gastroenterology and Hepatology and Division of Infectious Diseases, McGill University Health Centre, Royal Victoria Hospital - Site Glen.
In 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.