In recent years, there has been an increasing number of clinical trials for the treatment of nonalcoholic steatohepatitis (NASH). People living with human immunodeficiency virus (PLWH) are commonly excluded from these studies, usually due to concerns over drug-drug interactions associated with antiretroviral therapy. The Steatohepatitis in HIV Emerging Research Network, a group of international experts in hepatology and infectious diseases, discusses our current understanding on the interaction between human immunodeficiency virus 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 drug-drug interactions between antiretroviral therapy and aramchol, cenicriviroc, elafibranor, obeticholic acid and resmetirom (MGL-3196), which are currently in phase 3 trials for the treatment of NASH, are reviewed. A model for trial design to include PLWH is proposed, strongly advocating for the scientific community to include this group as a subpopulation within studies.

New Drugs for NASH and HIV Infection: Great Expectations for a Great Need / Guaraldi, G.; Maurice, J. B.; Marzolini, C.; Monteith, K.; Milic, J.; Tsochatzis, E.; Bhagani, S.; Morse, C. G.; Price, J. C.; Ingiliz, P.; Lemoine, M.; Sebastiani, G.. - In: HEPATOLOGY. - ISSN 1527-3350. - 71:5(2020), pp. 1831-1844. [10.1002/hep.31177]

New Drugs for NASH and HIV Infection: Great Expectations for a Great Need

Guaraldi G.;
2020

Abstract

In recent years, there has been an increasing number of clinical trials for the treatment of nonalcoholic steatohepatitis (NASH). People living with human immunodeficiency virus (PLWH) are commonly excluded from these studies, usually due to concerns over drug-drug interactions associated with antiretroviral therapy. The Steatohepatitis in HIV Emerging Research Network, a group of international experts in hepatology and infectious diseases, discusses our current understanding on the interaction between human immunodeficiency virus 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 drug-drug interactions between antiretroviral therapy and aramchol, cenicriviroc, elafibranor, obeticholic acid and resmetirom (MGL-3196), which are currently in phase 3 trials for the treatment of NASH, are reviewed. A model for trial design to include PLWH is proposed, strongly advocating for the scientific community to include this group as a subpopulation within studies.
2020
71
5
1831
1844
New Drugs for NASH and HIV Infection: Great Expectations for a Great Need / Guaraldi, G.; Maurice, J. B.; Marzolini, C.; Monteith, K.; Milic, J.; Tsochatzis, E.; Bhagani, S.; Morse, C. G.; Price, J. C.; Ingiliz, P.; Lemoine, M.; Sebastiani, G.. - In: HEPATOLOGY. - ISSN 1527-3350. - 71:5(2020), pp. 1831-1844. [10.1002/hep.31177]
Guaraldi, G.; Maurice, J. B.; Marzolini, C.; Monteith, K.; Milic, J.; Tsochatzis, E.; Bhagani, S.; Morse, C. G.; Price, J. C.; Ingiliz, P.; Lemoine, M...espandi
File in questo prodotto:
Non ci sono file associati a questo prodotto.
Pubblicazioni consigliate

Licenza Creative Commons
I metadati presenti in IRIS UNIMORE sono rilasciati con licenza Creative Commons CC0 1.0 Universal, mentre i file delle pubblicazioni sono rilasciati con licenza Attribuzione 4.0 Internazionale (CC BY 4.0), salvo diversa indicazione.
In caso di violazione di copyright, contattare Supporto Iris

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11380/1203163
Citazioni
  • ???jsp.display-item.citation.pmc??? 7
  • Scopus 19
  • ???jsp.display-item.citation.isi??? 16
social impact