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Efficacy and safety of rilpivirine in treatment-naive, HIV-1-infected patients with hepatitis B virus/hepatitis C virus coinfection enrolled in the Phase III randomized, double-blind ECHO and THRIVE trials

NELSON, Mark ; AMAYA, Gerardo ; VANVEGGEL, Simon ; BOVEN, Katia ; CLUMECK, Nathan ; DA CUNHA, Clovis Arns ; JAYAWEERA, Dushyantha ; JUNOD, Patrice ; TAISHENG LI ; TEBAS, Pablo ; STEVENS, Marita ; BUELENS, Annemie

Journal of antimicrobial chemotherapy, 2012-08, Vol.67 (8), p.2020-2028 [Periódico revisado por pares]

Oxford: Oxford University Press

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Efficacy and safety of rilpivirine in treatment-naive, HIV-1-infected patients with hepatitis B virus/hepatitis C virus coinfection enrolled in the Phase III randomized, double-blind ECHO and THRIVE trials
Autor: NELSON, Mark ; AMAYA, Gerardo ; VANVEGGEL, Simon ; BOVEN, Katia ; CLUMECK, Nathan ; DA CUNHA, Clovis Arns ; JAYAWEERA, Dushyantha ; JUNOD, Patrice ; TAISHENG LI ; TEBAS, Pablo ; STEVENS, Marita ; BUELENS, Annemie
Assuntos: Adolescent ; Adult ; Aged ; Alanine transaminase ; Alanine Transaminase - blood ; Animals ; Antibiotics. Antiinfectious agents. Antiparasitic agents ; Antibodies ; Antiviral Agents - administration & dosage ; Antiviral Agents - adverse effects ; Aspartate aminotransferase ; Aspartate Aminotransferases - blood ; Benzoxazines - administration & dosage ; Benzoxazines - adverse effects ; Biological and medical sciences ; Chemotherapy ; Clinical outcomes ; Clinical trials ; Coinfection - drug therapy ; Coinfection - virology ; Data processing ; Double-Blind Method ; Drug-Related Side Effects and Adverse Reactions - epidemiology ; Efavirenz ; Female ; Hepatitis ; Hepatitis B ; Hepatitis B - drug therapy ; Hepatitis B Surface Antigens - blood ; Hepatitis B virus ; Hepatitis C ; Hepatitis C - drug therapy ; Hepatitis C Antibodies - blood ; Hepatitis C virus ; HIV ; HIV Infections - complications ; HIV Infections - virology ; HIV-1 - isolation & purification ; Human immunodeficiency virus ; Human viral diseases ; Humans ; Immunodeficiencies ; Immunodeficiencies. Immunoglobulinopathies ; Immunopathology ; Infection ; Infectious diseases ; Inhibitor drugs ; Liver ; Liver - drug effects ; Liver - physiology ; Liver Function Tests ; Male ; Medical sciences ; Middle Aged ; Nitriles - administration & dosage ; Nitriles - adverse effects ; non-nucleoside reverse transcriptase inhibitors ; nucleosides ; Nucleotides ; Original Research ; Pharmacology. Drug treatments ; Placebos - administration & dosage ; Pyrimidines - administration & dosage ; Pyrimidines - adverse effects ; Rilpivirine ; RNA ; RNA-directed DNA polymerase ; surface antigens ; Treatment Outcome ; Viral diseases ; Viral diseases of the lymphoid tissue and the blood. Aids ; Viral hepatitis ; Young Adult
É parte de: Journal of antimicrobial chemotherapy, 2012-08, Vol.67 (8), p.2020-2028
Notas: ObjectType-Article-2
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Members of the ECHO and THRIVE Study Groups are listed in the Acknowledgements section.
Descrição: The efficacy and hepatic safety of the non-nucleoside reverse transcriptase inhibitors rilpivirine (TMC278) and efavirenz were compared in treatment-naive, HIV-infected adults with concurrent hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection in the pooled week 48 analysis of the Phase III, double-blind, randomized ECHO (NCT00540449) and THRIVE (NCT00543725) trials. Patients received 25 mg of rilpivirine once daily or 600 mg of efavirenz once daily, plus two nucleoside/nucleotide reverse transcriptase inhibitors. At screening, patients had alanine aminotransferase/aspartate aminotransferase levels ≤5× the upper limit of normal. HBV and HCV status was determined at baseline by HBV surface antigen, HCV antibody and HCV RNA testing. HBV/HCV coinfection status was known for 670 patients in the rilpivirine group and 665 in the efavirenz group. At baseline, 49 rilpivirine and 63 efavirenz patients [112/1335 (8.4%)] were coinfected with either HBV [55/1357 (4.1%)] or HCV [57/1333 (4.3%)]. The safety analysis included all available data, including beyond week 48. Eight patients seroconverted during the study (rilpivirine: five; efavirenz: three). A higher proportion of patients achieved viral load <50 copies/mL (intent to treat, time to loss of virological response) in the subgroup without HBV/HCV coinfection (rilpivirine: 85.0%; efavirenz: 82.6%) than in the coinfected subgroup (rilpivirine: 73.5%; efavirenz: 79.4%) (rilpivirine, P = 0.04 and efavirenz, P = 0.49, Fisher's exact test). The incidence of hepatic adverse events (AEs) was low in both groups in the overall population (rilpivirine: 5.5% versus efavirenz: 6.6%) and was higher in HBV/HCV-coinfected patients than in those not coinfected (26.7% versus 4.1%, respectively). Hepatic AEs were more common and response rates lower in HBV/HCV-coinfected patients treated with rilpivirine or efavirenz than in those who were not coinfected.
Editor: Oxford: Oxford University Press
Idioma: Inglês

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Efficacy and safety of rilpivirine in treatment-naive, HIV-1-infected patients with hepatitis B virus/hepatitis C virus coinfection enrolled in the Phase III randomized, double-blind ECHO and THRIVE trials

NELSON, Mark ; AMAYA, Gerardo ; VANVEGGEL, Simon ; BOVEN, Katia ; CLUMECK, Nathan ; DA CUNHA, Clovis Arns ; JAYAWEERA, Dushyantha ; JUNOD, Patrice ; TAISHENG LI ; TEBAS, Pablo ; STEVENS, Marita ; BUELENS, Annemie

Oxford: Oxford University Press

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