Liver Enzyme Elevation During Darunavir-Based Antiretroviral Treatment in HIV-1–Infected Patients With or Without Hepatitis C Coinfection: Data from the ICONA Foundation Cohort

REFERENCES

• Soriano V, Barreiro P, Nunez M. Management of chronic hepatitis B and C in HIV-coinfected patients. J Antimicrob Chemother. 2006;57:815–818.
   PubMed Web of Science ®Google Scholar
• Nunez M, Lana R, Mendoza JL, Carbonero L, Soriano V. Risk factors for severe hepatic injury after introduction of highly active antiretroviral therapy. J Acquir Immune Defic Syndr. 200127: 426–431.
   Google Scholar
• Nunez M, Soriano V. Hepatotoxicity of antiretrovirals: Incidence, mechanisms and management. Drug Saf. 2005;28:53–66.
   PubMed Web of Science ®Google Scholar
• Puoti M, Torti C, Ripamonti D, et al, for the HIV-HCV Co-Infection Study Group. Severe hepatotoxicity during combination antiretroviral treatment: Incidence, liver histology, and outcome. J Acquir Immune Defic Syndr. 2003;32:259–326.
   PubMed Web of Science ®Google Scholar
• Saves M, Vandentorren S, Daucourt V, et al. Severe hepatic cytolysis: Incidence and risk factors in patients treated by antiretroviral combinations. Aquitaine Cohort, France, 1996-1998. Groupe d’Epidemiologie Clinique de Sida en Aquitaine (GECSA). AIDS. 1999;13:F115–F121.
   PubMed Web of Science ®Google Scholar
• Saves M, Vandentorren S, Daucourt V, et al, for the NN Study Team. 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.
   PubMed Web of Science ®Google Scholar
• Sulkowski M. Drug-induced liver injury associated with antiretroviral therapy that includes HIV-1 protease inhibitors. Clin Infect Dis. 2004;38:590–597.
   Web of Science ®Google Scholar
• Meraviglia P, Schiavini M, Castagna A, et al. Lopinavir/ ritonavir treatment in HIV antiretroviral-experienced patients: Evaluation of risk factors for liver enzyme elevation. HIV Med. 2004;5:334–343.
   PubMed Web of Science ®Google Scholar
• Ena J, Amador C, Benito C, Fenoll V, Pasquau F. Risk and determinants of developing severe liver toxicity during therapy with nevirapine- and efavirenz-containing regimens in HIV-infected patients. Int J STD AIDS. 2003;14:776–781.
   PubMed Web of Science ®Google Scholar
• Martinez E, Blanco JL, Arnaiz JA, et al. Hepatotoxicity in HIV-1-infected patients receiving nevirapine-containing antiretroviral therapy. AIDS. 200115: 1261–1268.
   Google Scholar
• Dieterich DT, Robinson PA, Love J, Stern JO. Drug-induced liver injury associated with the use of nonnucleosid reverse transcriptase inhibitors. Clin Infect Dis. 2004;38(Suppl 2):580–589.
   Google Scholar
• Cicconi P, Cozzi Lepri A, Philips A, et al. Is the increased risk of liver enzyme elevation in patients co-infected with HIV and hepatitis virus greater in those taking antiretroviral therapy ? AIDS. 2007;21:599–606
   Google Scholar
• Fontana R, Seeff L, Andrade R, et al. Standardization of nomenclature and causality assessment in drug-induced liver injury: Summary of a clinical research workshop. Hepatology. 2010; 52:730–742.
   PubMedGoogle Scholar
• Sabin CA Pitfalls of assessing hepatotoxicity in trials and observational cohorts. Clin Infect Dis. 2004;38\(Suppl. 2):S56–64
   PubMed Web of Science ®Google Scholar
• Llibre JM, Imaz A, Clotet B. From TMC114 to darunavir: Five years of data on efficacy. AIDS Rev. 2013;15:112–121.
   PubMed Web of Science ®Google Scholar
• Berhan A, Berhan Y. Virologic response to tipranavir-ritonavir or darunavir-ritonavir based regimens in antiretroviral therapy experienced HIV-1 patients: A meta-analysis and meta-regression of randomized controlled clinical trials. PLoS One. 2013;8:e60814.
   PubMed Web of Science ®Google Scholar
• Mills AM, Nelson M, Jayaweera D, et al. Once-daily darunavir/ritonavir vs lopinavir/ritonavir in treatment-naive, HIV-1 infected patients: 96-week analysis. AIDS. 2009;23:1679–1688.
   PubMed Web of Science ®Google Scholar
• Banhegyi D, Katlama C, da Cunha CA, et al. Week 96 efficacy, virology and safety of darunavir/ritonavir versus lopinavir/ritonavir in treatment-experienced patients in TITAN. Curr HIV Res. 2012;10:171–181.
   PubMed Web of Science ®Google Scholar
• Arasteh K, Yeni P, Pozniak A, et al. Efficacy and safety of darunavir/ritonavir in treatment experienced HIV-1 patients in the POWER 1, 2 and 3 trials at week 96. Antiviral Ther. 2009;14:859–864.
   PubMed Web of Science ®Google Scholar
• FDA alerts doctors to Prezista’s possible link to liver damage, deaths. AIDS Read. 2008,18:235.
   Google Scholar
• Panel on Antiretroviral Guidelines for Adults and Adoles-cents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. December 2, 2013. http://www.aidsinfo.nih.gov/guidelines. Accessed March 10, 2014.
   Google Scholar
• D’Arminio Monforte A, Pezzotti P, et al. Determinants of initiation of antiretroviral therapy (HAART) in an Italian cohort of HIV-positive patients naive from antiretrovirals (ICoNA Study). AIDS. 1998; 12:99. [Database can be found at http://www.icona.org]
   Google Scholar
• Uberti-Foppa C, De Bona A, Morsica G et al. Pretreat-ment of chronic active hepatitis C in patients coinfected with HIV and hepatitis C virus reduces the hepatotoxicity associated with subsequent antiretroviral therapy. J Acquir Immune Defic Syndr. 2003;33:146–152.
   PubMed Web of Science ®Google Scholar
• Labarga P, Soriano V, Vispo ME, et al. Hepatotoxicity of antiretroviral drugs is reduced after successful treatment of chronic hepatitis C in HIV-infected patients. J Infect Dis. 2007;196:670–676.
   PubMed Web of Science ®Google Scholar
• den Brinker M, Wit FW, Wertheim-van Dillen PM, et al. Hepatitis B and C virus co-infection and the risk for hepatotoxicity of highly active antiretroviral therapy in HIV-1 infection. AIDS. 2000;14:2895–2902.
   PubMed Web of Science ®Google Scholar
• Sulkowski M, Thomas D, Chasson 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.
   PubMed Web of Science ®Google Scholar
• Sulkowski MS, Thomas DL, Mehta SH, Chaisson RE, Moore RD. Hepatotoxicity associated with nevirapine or efavirenz containing antiretroviral therapy: Role of hepatitis C and B infections. Hepatology. 2002;35:182–189.
   PubMed Web of Science ®Google Scholar
• Servin-Abad L, Molina E, Baracco G, et al. Liver enzymes elevation after HAART in HIVHCV co-infection. J Viral Hepal. 2005;12:429–434.
   PubMed Web of Science ®Google Scholar
• Bonnet F, Lawson-Ayayi S, Tiebaut R, et al. A cohort study of nevirapine tolerance in clinical practice: French Aquitanie Cohort, 1997-1999. Clin Infect Dis. 2002; 35:1231–1237.
   PubMed Web of Science ®Google Scholar
• Stone SF, Lee S, Keane NM, et al. Association of increased hepatitis C virus (HCV)-specific IgG and soluble CD26 dipeptidyl peptidase IV enzyme activity with hepatotoxicity after highly active antiretroviral therapy in human immu-nodeficiency virus-HCV-coinfected patients. J Infect Dis. 2002;186:1498–1502.
   PubMed Web of Science ®Google Scholar
• Ofotokun I, Smithson SE, Lu C, Easley KA, Lennox JL. Liver enzymes elevation and immune reconstitution among treatment-naïve HIV-infected patients instituting antiretro-viral therapy. Am J Med Sci. 2007;334:334–341.
   PubMed Web of Science ®Google Scholar
• Rachlis A, Clotet B, Baxter J, et al. Safety, tolerability, and efficacy of darunavir (TMC114) with low dose ritonavir in treatment-experienced, hepatitis B or C co-infected patients in Power 1 and 3. HIV Clin Trials. 2007;84:213–220
   Web of Science ®Google Scholar
• Jain MK. Drug-induced liver injury associated with HIV medications. Clin Liver Dis. 2007;11:615–639.
   PubMedGoogle Scholar
• Soriano V, Puoti M, Garcia-Gasco P, et al. Antiretroviral drugs and liver injury. AIDS. 2008;22:1–13.
   PubMed Web of Science ®Google Scholar
• Sulkowski M, Thomas D, Chaisson R, et al. Hepatotoxic-ity associated with antiretroviral therapy in adults infected with HIV and the role of hepatitis C or B virus infection. JAMA. 2000;283:74–80.
   PubMed Web of Science ®Google Scholar
• Molina JM, Andrade-Villanueva J, Echevarria J, et al. Once daily atazanavir/ritonavir compared with twice daily lopinavir/ritonavir, each in combination with tenofovir and emtricitabine, for management of antiretroviral-naive HIV-1-infected patients: 96 week efficacy and safety results of the castle Study. J Acquir Immune Defic Syndr. 2010;53:323–332.
   PubMed Web of Science ®Google Scholar
• Ha B, Wine B, Rodriguez-Alcantra F, Shaefer M. Hepatic safety profile of fosamprenavir-containing regimens in HIV-infected patients with or without hepatitis B or C co-infection. HIV Clin Trials. 2012;13:171–177.
   PubMed Web of Science ®Google Scholar
• Mikl J, Sulkowski MS, Benhamou Y, et al. Hepatic safety profile analyses of tipranavir in Phase II and III clinical trials. BMC Infect Dis. 2009;9:203.
   PubMed Web of Science ®Google Scholar