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

Mark Nelson, Gerardo Amaya, Nathan Clumeck, Clovis Arns da Cunha, Dushyantha Jayaweera, Patrice Junod, Taisheng Li, Pablo Tebas, Marita Stevens, Annemie Buelens, Simon Vanveggel, Katia Boven, on behalf of the ECHO and THRIVE Study Groups, Court Pedersen

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Resumé

OBJECTIVES: 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. METHODS: 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. RESULTS: 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
OriginalsprogEngelsk
TidsskriftJournal of Antimicrobial Chemotherapy
Vol/bind67
Udgave nummer8
Sider (fra-til)2020-2028
ISSN0305-7453
DOI
StatusUdgivet - 2012

Fingeraftryk

Rilpivirine
Coinfection
Hepatitis B virus
Hepacivirus
HIV-1
Safety
Reverse Transcriptase Inhibitors
Hepatitis C Antibodies
Virus Diseases
Hepatitis B Surface Antigens
Viral Load
Alanine Transaminase

Citer dette

Nelson, Mark ; Amaya, Gerardo ; Clumeck, Nathan ; Arns da Cunha, Clovis ; Jayaweera, Dushyantha ; Junod, Patrice ; Li, Taisheng ; Tebas, Pablo ; Stevens, Marita ; Buelens, Annemie ; Vanveggel, Simon ; Boven, Katia ; on behalf of the ECHO and THRIVE Study Groups ; Pedersen, Court. / 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. I: Journal of Antimicrobial Chemotherapy. 2012 ; Bind 67, Nr. 8. s. 2020-2028.
@article{7cba89e0171c49218863bf3ff7afcf47,
title = "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",
abstract = "OBJECTIVES: 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. METHODS: 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. RESULTS: 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",
author = "Mark Nelson and Gerardo Amaya and Nathan Clumeck and {Arns da Cunha}, Clovis and Dushyantha Jayaweera and Patrice Junod and Taisheng Li and Pablo Tebas and Marita Stevens and Annemie Buelens and Simon Vanveggel and Katia Boven and {on behalf of the ECHO and THRIVE Study Groups} and Court Pedersen",
year = "2012",
doi = "10.1093/jac/dks130",
language = "English",
volume = "67",
pages = "2020--2028",
journal = "Journal of Antimicrobial Chemotherapy",
issn = "0305-7453",
publisher = "Heinemann",
number = "8",

}

Nelson, M, Amaya, G, Clumeck, N, Arns da Cunha, C, Jayaweera, D, Junod, P, Li, T, Tebas, P, Stevens, M, Buelens, A, Vanveggel, S, Boven, K, on behalf of the ECHO and THRIVE Study Groups & Pedersen, C 2012, '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', Journal of Antimicrobial Chemotherapy, bind 67, nr. 8, s. 2020-2028. https://doi.org/10.1093/jac/dks130

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; Clumeck, Nathan; Arns da Cunha, Clovis; Jayaweera, Dushyantha; Junod, Patrice; Li, Taisheng; Tebas, Pablo; Stevens, Marita; Buelens, Annemie; Vanveggel, Simon; Boven, Katia; on behalf of the ECHO and THRIVE Study Groups ; Pedersen, Court.

I: Journal of Antimicrobial Chemotherapy, Bind 67, Nr. 8, 2012, s. 2020-2028.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - 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

AU - Nelson, Mark

AU - Amaya, Gerardo

AU - Clumeck, Nathan

AU - Arns da Cunha, Clovis

AU - Jayaweera, Dushyantha

AU - Junod, Patrice

AU - Li, Taisheng

AU - Tebas, Pablo

AU - Stevens, Marita

AU - Buelens, Annemie

AU - Vanveggel, Simon

AU - Boven, Katia

AU - on behalf of the ECHO and THRIVE Study Groups

AU - Pedersen, Court

PY - 2012

Y1 - 2012

N2 - OBJECTIVES: 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. METHODS: 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. RESULTS: 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

AB - OBJECTIVES: 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. METHODS: 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. RESULTS: 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

U2 - 10.1093/jac/dks130

DO - 10.1093/jac/dks130

M3 - Journal article

VL - 67

SP - 2020

EP - 2028

JO - Journal of Antimicrobial Chemotherapy

JF - Journal of Antimicrobial Chemotherapy

SN - 0305-7453

IS - 8

ER -