Hepatotoxicity of contemporary antiretroviral drugs.
Journal
Current opinion in HIV and AIDS
ISSN: 1746-6318
Titre abrégé: Curr Opin HIV AIDS
Pays: United States
ID NLM: 101264945
Informations de publication
Date de publication:
01 11 2021
01 11 2021
Historique:
pubmed:
22
9
2021
medline:
25
2
2023
entrez:
21
9
2021
Statut:
ppublish
Résumé
To date, more than 30 antiretroviral drugs have been approved by the Food and Drug Administration for the treatment of HIV infection. As new drugs with better efficacy and safety profile become available for clinical practice, older drugs are either withdrawn from the market or become no longer actively prescribed. We review hepatotoxicity associated with contemporary antiretroviral drugs, with emphasis on data from the past 3 years. Although less robust data exists for side effects of contemporary antiretroviral medications recently approved for the management of HIV (i.e., doravirine, ibalizumab, fostemsavir, cabotegravir), the risks of substantial hepatotoxicity appears to be minimal with these agents. Although newer antiretroviral drugs are better tolerated than their earlier counterparts, they are not completely devoid of adverse drug reactions, including hepatotoxicity. Monitoring patients on antiretroviral therapy for treatment-emergent liver injury should continue to be part of routine clinical care.
Identifiants
pubmed: 34545037
doi: 10.1097/COH.0000000000000706
pii: 01222929-202111000-00002
doi:
Substances chimiques
Anti-HIV Agents
0
Pharmaceutical Preparations
0
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
279-285Informations de copyright
Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.
Références
Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. Department of Health and Human Services. Available at https://clinicalinfo.hiv.gov/en/how-cite/default/files/inline-files/AdultandAdolescentGL.pdf . [Accessed 28 March 2021]
Núñez M. Hepatotoxicity of antiretrovirals: incidence, mechanisms and management. J Hepatol 2006; 44: (1 Suppl): S132–S139.
Qin F, Jiang J, Qin C, et al. Liver damage in patients living with HIV on antiretroviral treatment with normal baseline liver function and without HBV/HCV infection: an 11-year retrospective cohort study in Guangxi, China. BMJ Open 2019; 9:e023140.
Dieterich D. Managing antiretroviral-associated liver disease. J Acquir Immune Defic Syndr 2003; 34: (Suppl 1): S34–S39.
Soni S, Churchill DR, Gilleece Y. Abacavir-induced hepatotoxicity: a report of two cases. AIDS 2008; 22:2557–2558.
Mitsumoto F, Murata M, Kato Y, et al. Hepatitis B virus-related immune reconstitution inflammatory syndrome in two patients coinfected with human immunodeficiency virus diagnosed with a liver biopsy. Intern Med 2014; 53:2165–2170.
Sulkowski MS. Management of hepatic complications in HIV-infected persons. J Infect Dis 2008; 197: (Suppl 3): S279–S293.
Gish RG, Trinh H, Leung N, et al. Safety and antiviral activity of emtricitabine (FTC) for the treatment of chronic hepatitis B infection: a two-year study. J Hepatol 2005; 43:60–66.
Lim SG, Ng TM, Kung N, et al. A double-blind placebo-controlled study of emtricitabine in chronic hepatitis B. Arch Intern Med 2006; 166:49–56.
Terrault NA, Lok AS, McMahon BJ, et al. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology 2018; 67:1560–1599.
Mondou E, Sorbel J, Anderson J, et al. Posttreatment exacerbation of hepatitis B virus (HBV) infection in long-term HBV trials of emtricitabine. Clin Infect Dis 2005; 41:e45–e47.
Mayer KH, Molina JM, Thompson MA, et al. Emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV preexposure prophylaxis (DISCOVER): primary results from a randomised, double-blind, multicentre, active-controlled, phase 3, noninferiority trial. Lancet 2020; 396:239–254.
van Leth F, Phanuphak P, Ruxrungtham K, et al. Comparison of first-line antiretroviral therapy with regimens including nevirapine, efavirenz, or both drugs, plus stavudine and lamivudine: a randomised open-label trial, the 2NN study. Lancet 2004; 363:1253–1263.
Cohen CJ, Andrade-Villanueva J, Clotet C, et al. Rilpivirine versus efavirenz with two background nucleoside or nucleotide reverse transcriptase inhibitors in treatment-naïve adults infected with HIV-1 (THRIVE): a phase 3, randomized, noninferiority trial. Lancet 2011; 378:229–237.
Nelson M, Amaya G, Clumeck N, et al. Efficacy and safety of rilpivirine in treatment-naïve, HIV-1-infected patients with hepatitis B virus/hepatitis C virus coinfections enrolled in Phase III randomized, double-blind ECHO and THRIVE trials. J Antimicrob Chemother 2012; 67:2020–2028.
Bagella P, De Socio GVL, Ricci E, et al. Durability, safety and efficacy of rilpivirine in clinical practice: results from the SCOLTA project. Infect Drug Resist 2018; 11:615–623.
Casado JL, Mena A, Banon S, et al. Liver toxicity and risk of discontinuation in HIV/hepatitis C virus-coinfected patients receiving an etravirine-containing antiretroviral regimen: influence of liver fibrosis. HIV Med 2016; 17:62–67.
Molina JM, Squires K, Sax PE, et al. Doravirine versus ritonavir-boosted darunavir in antiretroviral-naïve adults with HIV-1 (DRIVE-FORWARD): 96-week results of a randomized, double-blind, noninferiority, phase 3 trial. Lancet HIV 2020; 7:e16–e26.
Orkin C, Squires KE, Molina JM, et al. Doravirine/lamivudine/tenofovir disoproxil fumarate (TDF) versus efavirenz/emtricitabine/TDF in treatment-naïve adults with human immunodeficiency virus type 1 infection: week 96 results of the randomized, double-blind, phase 3 DRIVE-AHEAD noninferiority trial. Clin Infect Dis 2021; 73:33–42.
Johnson M, Kumar P, Molina JM, et al. Switching to doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/TDF) maintains HIV-1 virologic suppression through 48 weeks: results of the DRIVE-SHIFT trial. J Acquir Immune Defic Syndr 2019; 81:463–472.
Flexner C. HIV-protease inhibitors. N Engl J Med 1998; 338:1281–1292.
Sulkowski MS, Thomas DL, Chaisson RE, Moore RD. Hepatotoxicity associated with antiretroviral therapy in adults infected with human immunodeficiency virus and the role of hepatitis C or B virus infection. JAMA 2000; 283:74–80.
Tsiodras S, Mantzoros C, Hammer S, Samore M. Effects of protease inhibitors on hyperglycemia, hyperlipidemia, and lipodystrophy: a 5-year cohort study. Arch Intern Med 2000; 160:2050–2056.
Sulkowski MS. Drug-induced liver injury associated with antiretroviral therapy that includes HIV-1 protease inhibitors. Clin Infect Dis 2004; 38: (Suppl 2): S90–S97.
Bentue-Ferrer D, Arvieux C, Tribut O, et al. Clinical pharmacology, efficacy and safety of atazanavir: a review. Expert Opin Drug Metab Toxicol 2009; 5:1455–1468.
Taramasso L, Lorenzini P, Di Biagio A, et al. Incidence and risk factors for liver enzyme elevation among naïve HIV-1 infected patients receiving ART in the ICONA cohort. J Antimicrob Chemother 2019; 74:3295–3304.
Evotaz (atazanavir sulfate/cobicistat). Prescribing information (USA). Princeton, NJ: Bristol-Myers Squibb Company; Revised 2020. https://packageinserts.bms.com/pi/pi_evotaz.pdf . [Accessed 8 April 2021]
Gallant J, Moyle G, Berenguer J, et al. Atazanavir plus cobicistat: week 48 and week 144 subgroup analyses of a phase 3, randomized, double-blind, active-controlled trial. Curr HIV Res 2017; 15:216–224.
Prezcobix (darunavir/cobicistat). Prescribing Information (USA). Titusville, NJ: Janssen Therapeutics; Revised 2020. [Accessed 8 April 2021]
Yancheva N, Tzonev R. A case of late presentation of darunavir-related cholestatic hepatitis. Int J STD AIDS 2019; 30:620–622.
Pelchen-Matthews A, Larsen JF, Shepherd L, et al. The occurrence of hypersensitivity reaction and hepatotoxicity in individuals receiving integrase strand transfer inhibitors: Results from the EuroSIDA study. Centre of Excellence for Health, Immunity and Infections (CHIP); John Wiley & Sons ltd.: Hoboken, NJ, USA. 2020.
Taramasso L, Lorenzini P, Di Biagio A, et al. Incidence and risk factors for liver enzyme elevation among naive HIV-1-infected patients receiving ART in the ICONA cohort. J Antimicrob Chemother 2019; 74:3295–3304.
Alejos B, Suárez-García I, Rava M, et al. Effectiveness and safety of first-line antiretroviral regimens in clinical practice: a multicentre cohort study. J Antimicrob Chemother 2020; 75:3004–3014.
Christensen ES, Jain R, Roxby AC. Abacavir/dolutegravir/lamivudine (Triumeq)-induced liver toxicity in a human immunodeficiency virus-infected patient. Open Forum Infect Dis 2017; 4:ofx122.
Wang B, Abbott L, Childs K, et al. Dolutegravir-induced liver injury leading to sub-acute liver failure requiring transplantation: a case report and review of literature. Int J STD AIDS 2018; 29:414–417.
Nhean S, Yoong D, Wong DK, et al. Probably hepatotoxicity with dolutegravir: report of two cases and review of the literature. AIDS 2019; 33:1261–1263.
Sax PE, DeJesus E, Crofoot G, et al. Bictegravir versus dolutegravir, each with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection: a randomised, double-blind, phase 2 trial. Lancet HIV 2017; 4:e154–e160.
Gallant J, Lazzarin A, Mills A, et al. Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled noninferiority trial. Lancet 2017; 390:2063–2072.
Sax PE, Pozniak A, Montes ML, et al. Coformulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection (GS-US-380-1490): a randomized, double-blind, multicentre, phase 3, noninferiority trial. Lancet 2017; 290:2073–2082.
Orkin C, DeJesus E, Sax PE, et al. Fixed-dose combination bictegravir, emtricitabine and tenofovir alafenamide versus dolutegravir-containing regimens for initial treatment of HIV-1 infection: week 144 results from two randomized, double-blind, multicentre, phase 3, noninferiority trials. Lancet HIV 2020; 7:e389–e400.
Rizzardini G, Overton ET, Orkin C, et al. Long-acting injectable cabotegravir + rilpivirine for HIV maintenance therapy: week 48 pooled analysis of phase 3 ATLAS and FLAIR trials. J Acquir Immune Defic Syndr 2020; 85:498–506.
Selzentry (maraviroc). Prescribing Information (USA). Research Triangle Park, NC: ViiV Healthcare; Revised 2016. [Accessed 3 March 2021]
Ayoub A, Alston S, Goodrich J, et al. Hepatic safety and tolerability in the maraviroc clinical development program. AIDS 2010; 24:2743–2750.
Rizza SA, Bhatia R, Zeuli J, Temesgen Z. Ibalizumab for the treatment of multidrug-resistant HIV-1 infection. Drugs Today (Barc) 2019; 55:25–34.
Emu B, Fessel J, Schrader S, et al. Phase 3 study of ibalizumab for multidrug-resistant HIV-1. N Engl J Med 2018; 379:645–654.
FDA, FDA. FDA summary letter: Ibalizumab. 2018; Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761065Orig1s000SumR.pdf . [Accessed 3 March 2021].
Emu B, DeJesus E, Berhe M, et al. 661. Ibalizumab efficacy and safety through 48 weeks of treatment: results of an expanded access protocol (TMB-311). Open Forum Infect Dis 2019; 6: (Suppl 2): S303.
Emu B, Lalezari K, Kumar P, et al. Ibalizumab: 96-week data and efficacy in patients resistant to common antiretrovirals (Abstract 485). CROI 2019 . Seattle, WA. 2019.
Towner W, DeJesus E, Schrader S, et al. 1027: Long-term efficacy, safety, and durability of ibalizumab-based regimens in subgroup of TMB-202 Pparticipants. Open Forum Infect Dis 2020; 7: (Suppl 1): S542–S543.
Rukobia (fostemsavir). Prescribing Information (USA). Research Triangle Park, NC: ViiV Healthcare; Revised 2020. [Accessed 3 March 2021]
Thompson M, Lalezari JP, Kaplan R, et al. Safety and efficacy of the HIV-1 attachment inhibitor prodrug fostemsavir in antiretroviral-experienced study participants: week 48 analysis of AI438011, a Phase IIb, randomized controlled trial. Antivir Ther 2017; 22:215–223.
Thompson M, Mendo Urbina F, Latiff G, et al. Long-term safety and efficacy of fostemsavir in treatment-experienced HIV participants. CROI 2019 . Seattle, WA. 2019.
Kozal M, Aberg J, Pialoux G, et al. Fostemsavir in adults with multidrug-resistant HIV-1 infection. N Engl J Med 2020; 382:1232–1243.
Lataillade M, Lalezari JP, Kozal M, et al. Safety and efficacy of the HIV-1 attachment inhibitor prodrug fostemsavir in heavily treatment-experienced individuals: week 96 results of the phase 3 BRIGHTE study. Lancet HIV 2020; 7:e740–e751.