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Rilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naive adults infected with HIV-1 (ECHO): a phase 3 randomised double-blind active-controlled trial

Summary Background Efavirenz with tenofovir-disoproxil-fumarate and emtricitabine is a preferred antiretroviral regimen for treatment-naive patients infected with HIV-1. Rilpivirine, a new non-nucleoside reverse transcriptase inhibitor, has shown similar antiviral efficacy to efavirenz in a phase 2b... Full description

Journal Title: The Lancet (British edition) 2011, Vol.378 (9787), p.238-246
Main Author: Molina, Jean-Michel, Dr, Prof
Other Authors: Cahn, Pedro, MD , Grinsztejn, Beatriz, MD , Lazzarin, Adriano, Prof , Mills, Anthony, MD , Saag, Michael, Prof , Supparatpinyo, Khuanchai, Prof , Walmsley, Sharon, Prof , Crauwels, Herta, PhD , Rimsky, Laurence T, PhD , Vanveggel, Simon, MSc , Boven, Katia, MD
Format: Electronic Article Electronic Article
Language: English
Subjects:
HIV
Quelle: Alma/SFX Local Collection
Publisher: Kidlington: Elsevier Ltd
ID: ISSN: 0140-6736
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title: Rilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naive adults infected with HIV-1 (ECHO): a phase 3 randomised double-blind active-controlled trial
format: Article
creator:
  • Molina, Jean-Michel, Dr, Prof
  • Cahn, Pedro, MD
  • Grinsztejn, Beatriz, MD
  • Lazzarin, Adriano, Prof
  • Mills, Anthony, MD
  • Saag, Michael, Prof
  • Supparatpinyo, Khuanchai, Prof
  • Walmsley, Sharon, Prof
  • Crauwels, Herta, PhD
  • Rimsky, Laurence T, PhD
  • Vanveggel, Simon, MSc
  • Boven, Katia, MD
subjects:
  • Abridged Index Medicus
  • Acquired Immunodeficiency Syndrome - drug therapy
  • Acquired Immunodeficiency Syndrome - ethnology
  • Acquired Immunodeficiency Syndrome - virology
  • Adenine - administration & dosage
  • Adenine - adverse effects
  • Adenine - analogs & derivatives
  • Adenine - therapeutic use
  • Adult
  • Aged
  • Algorithms
  • Anti-HIV Agents - administration & dosage
  • Anti-HIV Agents - adverse effects
  • Anti-HIV Agents - therapeutic use
  • Antibiotics. Antiinfectious agents. Antiparasitic agents
  • Antiretroviral drugs
  • Antiviral agents
  • Benzoxazines - administration & dosage
  • Benzoxazines - adverse effects
  • Benzoxazines - therapeutic use
  • Biological and medical sciences
  • Clinical trials
  • Deoxycytidine - administration & dosage
  • Deoxycytidine - adverse effects
  • Deoxycytidine - analogs & derivatives
  • Deoxycytidine - therapeutic use
  • Dosage and administration
  • Double-Blind Method
  • Dreams
  • Drug Administration Schedule
  • Drug therapy
  • Efavirenz
  • Emtricitabine
  • Exanthema
  • Female
  • General aspects
  • HIV
  • HIV Reverse Transcriptase - antagonists & inhibitors
  • HIV-1 - drug effects
  • HIV-1 - genetics
  • Human immunodeficiency virus
  • Human immunodeficiency virus 1
  • Human viral diseases
  • Humans
  • Infectious diseases
  • Internal Medicine
  • Lipids
  • Male
  • Medical sciences
  • Middle Aged
  • Mutation
  • Nitriles - administration & dosage
  • Nitriles - adverse effects
  • Nitriles - therapeutic use
  • non-nucleoside reverse transcriptase inhibitors
  • nucleosides
  • Nucleotides
  • Organophosphonates - administration & dosage
  • Organophosphonates - adverse effects
  • Organophosphonates - therapeutic use
  • Patient outcomes
  • Pharmacology. Drug treatments
  • Pyrimidines - administration & dosage
  • Pyrimidines - adverse effects
  • Pyrimidines - therapeutic use
  • Regression analysis
  • Reverse Transcriptase Inhibitors - therapeutic use
  • Rilpivirine
  • RNA-directed DNA polymerase
  • Tenofovir
  • Treatment Outcome
  • Viral diseases
  • Viral diseases of the lymphoid tissue and the blood. Aids
  • Viral Load - drug effects
ispartof: The Lancet (British edition), 2011, Vol.378 (9787), p.238-246
description: Summary Background Efavirenz with tenofovir-disoproxil-fumarate and emtricitabine is a preferred antiretroviral regimen for treatment-naive patients infected with HIV-1. Rilpivirine, a new non-nucleoside reverse transcriptase inhibitor, has shown similar antiviral efficacy to efavirenz in a phase 2b trial with two nucleoside/nucleotide reverse transcriptase inhibitors. We aimed to assess the efficacy, safety, and tolerability of rilpivirine versus efavirenz, each combined with tenofovir-disoproxil-fumarate and emtricitabine. Methods We did a phase 3, randomised, double-blind, double-dummy, active-controlled trial, in patients infected with HIV-1 who were treatment-naive. The patients were aged 18 years or older with a plasma viral load at screening of 5000 copies per mL or greater, and viral sensitivity to all study drugs. Our trial was done at 112 sites across 21 countries. Patients were randomly assigned by a computer-generated interactive web response system to receive either once-daily 25 mg rilpivirine or once-daily 600 mg efavirenz, each with tenofovir-disoproxil-fumarate and emtricitabine. Our primary objective was to show non-inferiority (12% margin) of rilpivirine to efavirenz in terms of the percentage of patients with confirmed response (viral load
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 0140-6736
fulltext: fulltext
issn:
  • 0140-6736
  • 1474-547X
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titleRilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naive adults infected with HIV-1 (ECHO): a phase 3 randomised double-blind active-controlled trial
sourceAlma/SFX Local Collection
creatorMolina, Jean-Michel, Dr, Prof ; Cahn, Pedro, MD ; Grinsztejn, Beatriz, MD ; Lazzarin, Adriano, Prof ; Mills, Anthony, MD ; Saag, Michael, Prof ; Supparatpinyo, Khuanchai, Prof ; Walmsley, Sharon, Prof ; Crauwels, Herta, PhD ; Rimsky, Laurence T, PhD ; Vanveggel, Simon, MSc ; Boven, Katia, MD
creatorcontribMolina, Jean-Michel, Dr, Prof ; Cahn, Pedro, MD ; Grinsztejn, Beatriz, MD ; Lazzarin, Adriano, Prof ; Mills, Anthony, MD ; Saag, Michael, Prof ; Supparatpinyo, Khuanchai, Prof ; Walmsley, Sharon, Prof ; Crauwels, Herta, PhD ; Rimsky, Laurence T, PhD ; Vanveggel, Simon, MSc ; Boven, Katia, MD ; on behalf of the ECHO study group ; ECHO study group
descriptionSummary Background Efavirenz with tenofovir-disoproxil-fumarate and emtricitabine is a preferred antiretroviral regimen for treatment-naive patients infected with HIV-1. Rilpivirine, a new non-nucleoside reverse transcriptase inhibitor, has shown similar antiviral efficacy to efavirenz in a phase 2b trial with two nucleoside/nucleotide reverse transcriptase inhibitors. We aimed to assess the efficacy, safety, and tolerability of rilpivirine versus efavirenz, each combined with tenofovir-disoproxil-fumarate and emtricitabine. Methods We did a phase 3, randomised, double-blind, double-dummy, active-controlled trial, in patients infected with HIV-1 who were treatment-naive. The patients were aged 18 years or older with a plasma viral load at screening of 5000 copies per mL or greater, and viral sensitivity to all study drugs. Our trial was done at 112 sites across 21 countries. Patients were randomly assigned by a computer-generated interactive web response system to receive either once-daily 25 mg rilpivirine or once-daily 600 mg efavirenz, each with tenofovir-disoproxil-fumarate and emtricitabine. Our primary objective was to show non-inferiority (12% margin) of rilpivirine to efavirenz in terms of the percentage of patients with confirmed response (viral load <50 copies per mL intention-to-treat time-to-loss-of-virological-response [ITT-TLOVR] algorithm) at week 48. Our primary analysis was by intention-to-treat. We also used logistic regression to adjust for baseline viral load. This trial is registered with ClinicalTrials.gov , number NCT00540449. Findings 346 patients were randomly assigned to receive rilpivirine and 344 to receive efavirenz and received at least one dose of study drug, with 287 (83%) and 285 (83%) in the respective groups having a confirmed response at week 48. The point estimate from a logistic regression model for the percentage difference in response was −0·4 (95% CI −5·9 to 5·2), confirming non-inferiority with a 12% margin (primary endpoint). The incidence of virological failures was 13% (rilpivirine) versus 6% (efavirenz; 11% vs 4% by ITT-TLOVR). Grade 2–4 adverse events (55 [16%] on rilpivirine vs 108 [31%] on efavirenz, p<0·0001), discontinuations due to adverse events (eight [2%] on rilpivirine vs 27 [8%] on efavirenz), rash, dizziness, and abnormal dreams or nightmares were more common with efavirenz. Increases in plasma lipids were significantly lower with rilpivirine. Interpretation Rilpivirine showed non-inferior efficacy compared with efavirenz, with a higher virological-failure rate, but a more favourable safety and tolerability profile. Funding Tibotec.
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ispartofThe Lancet (British edition), 2011, Vol.378 (9787), p.238-246
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0Molina, Jean-Michel, Dr, Prof
1Cahn, Pedro, MD
2Grinsztejn, Beatriz, MD
3Lazzarin, Adriano, Prof
4Mills, Anthony, MD
5Saag, Michael, Prof
6Supparatpinyo, Khuanchai, Prof
7Walmsley, Sharon, Prof
8Crauwels, Herta, PhD
9Rimsky, Laurence T, PhD
10Vanveggel, Simon, MSc
11Boven, Katia, MD
12on behalf of the ECHO study group
13ECHO study group
title
0Rilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naive adults infected with HIV-1 (ECHO): a phase 3 randomised double-blind active-controlled trial
1The Lancet (British edition)
addtitleLancet
descriptionSummary Background Efavirenz with tenofovir-disoproxil-fumarate and emtricitabine is a preferred antiretroviral regimen for treatment-naive patients infected with HIV-1. Rilpivirine, a new non-nucleoside reverse transcriptase inhibitor, has shown similar antiviral efficacy to efavirenz in a phase 2b trial with two nucleoside/nucleotide reverse transcriptase inhibitors. We aimed to assess the efficacy, safety, and tolerability of rilpivirine versus efavirenz, each combined with tenofovir-disoproxil-fumarate and emtricitabine. Methods We did a phase 3, randomised, double-blind, double-dummy, active-controlled trial, in patients infected with HIV-1 who were treatment-naive. The patients were aged 18 years or older with a plasma viral load at screening of 5000 copies per mL or greater, and viral sensitivity to all study drugs. Our trial was done at 112 sites across 21 countries. Patients were randomly assigned by a computer-generated interactive web response system to receive either once-daily 25 mg rilpivirine or once-daily 600 mg efavirenz, each with tenofovir-disoproxil-fumarate and emtricitabine. Our primary objective was to show non-inferiority (12% margin) of rilpivirine to efavirenz in terms of the percentage of patients with confirmed response (viral load <50 copies per mL intention-to-treat time-to-loss-of-virological-response [ITT-TLOVR] algorithm) at week 48. Our primary analysis was by intention-to-treat. We also used logistic regression to adjust for baseline viral load. This trial is registered with ClinicalTrials.gov , number NCT00540449. Findings 346 patients were randomly assigned to receive rilpivirine and 344 to receive efavirenz and received at least one dose of study drug, with 287 (83%) and 285 (83%) in the respective groups having a confirmed response at week 48. The point estimate from a logistic regression model for the percentage difference in response was −0·4 (95% CI −5·9 to 5·2), confirming non-inferiority with a 12% margin (primary endpoint). The incidence of virological failures was 13% (rilpivirine) versus 6% (efavirenz; 11% vs 4% by ITT-TLOVR). Grade 2–4 adverse events (55 [16%] on rilpivirine vs 108 [31%] on efavirenz, p<0·0001), discontinuations due to adverse events (eight [2%] on rilpivirine vs 27 [8%] on efavirenz), rash, dizziness, and abnormal dreams or nightmares were more common with efavirenz. Increases in plasma lipids were significantly lower with rilpivirine. Interpretation Rilpivirine showed non-inferior efficacy compared with efavirenz, with a higher virological-failure rate, but a more favourable safety and tolerability profile. Funding Tibotec.
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0Abridged Index Medicus
1Acquired Immunodeficiency Syndrome - drug therapy
2Acquired Immunodeficiency Syndrome - ethnology
3Acquired Immunodeficiency Syndrome - virology
4Adenine - administration & dosage
5Adenine - adverse effects
6Adenine - analogs & derivatives
7Adenine - therapeutic use
8Adult
9Aged
10Algorithms
11Anti-HIV Agents - administration & dosage
12Anti-HIV Agents - adverse effects
13Anti-HIV Agents - therapeutic use
14Antibiotics. Antiinfectious agents. Antiparasitic agents
15Antiretroviral drugs
16Antiviral agents
17Benzoxazines - administration & dosage
18Benzoxazines - adverse effects
19Benzoxazines - therapeutic use
20Biological and medical sciences
21Clinical trials
22Deoxycytidine - administration & dosage
23Deoxycytidine - adverse effects
24Deoxycytidine - analogs & derivatives
25Deoxycytidine - therapeutic use
26Dosage and administration
27Double-Blind Method
28Dreams
29Drug Administration Schedule
30Drug therapy
31Efavirenz
32Emtricitabine
33Exanthema
34Female
35General aspects
36HIV
37HIV Reverse Transcriptase - antagonists & inhibitors
38HIV-1 - drug effects
39HIV-1 - genetics
40Human immunodeficiency virus
41Human immunodeficiency virus 1
42Human viral diseases
43Humans
44Infectious diseases
45Internal Medicine
46Lipids
47Male
48Medical sciences
49Middle Aged
50Mutation
51Nitriles - administration & dosage
52Nitriles - adverse effects
53Nitriles - therapeutic use
54non-nucleoside reverse transcriptase inhibitors
55nucleosides
56Nucleotides
57Organophosphonates - administration & dosage
58Organophosphonates - adverse effects
59Organophosphonates - therapeutic use
60Patient outcomes
61Pharmacology. Drug treatments
62Pyrimidines - administration & dosage
63Pyrimidines - adverse effects
64Pyrimidines - therapeutic use
65Regression analysis
66Reverse Transcriptase Inhibitors - therapeutic use
67Rilpivirine
68RNA-directed DNA polymerase
69Tenofovir
70Treatment Outcome
71Viral diseases
72Viral diseases of the lymphoid tissue and the blood. Aids
73Viral Load - drug effects
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titleRilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naive adults infected with HIV-1 (ECHO): a phase 3 randomised double-blind active-controlled trial
authorMolina, Jean-Michel, Dr, Prof ; Cahn, Pedro, MD ; Grinsztejn, Beatriz, MD ; Lazzarin, Adriano, Prof ; Mills, Anthony, MD ; Saag, Michael, Prof ; Supparatpinyo, Khuanchai, Prof ; Walmsley, Sharon, Prof ; Crauwels, Herta, PhD ; Rimsky, Laurence T, PhD ; Vanveggel, Simon, MSc ; Boven, Katia, MD
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1Acquired Immunodeficiency Syndrome - drug therapy
2Acquired Immunodeficiency Syndrome - ethnology
3Acquired Immunodeficiency Syndrome - virology
4Adenine - administration & dosage
5Adenine - adverse effects
6Adenine - analogs & derivatives
7Adenine - therapeutic use
8Adult
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10Algorithms
11Anti-HIV Agents - administration & dosage
12Anti-HIV Agents - adverse effects
13Anti-HIV Agents - therapeutic use
14Antibiotics. Antiinfectious agents. Antiparasitic agents
15Antiretroviral drugs
16Antiviral agents
17Benzoxazines - administration & dosage
18Benzoxazines - adverse effects
19Benzoxazines - therapeutic use
20Biological and medical sciences
21Clinical trials
22Deoxycytidine - administration & dosage
23Deoxycytidine - adverse effects
24Deoxycytidine - analogs & derivatives
25Deoxycytidine - therapeutic use
26Dosage and administration
27Double-Blind Method
28Dreams
29Drug Administration Schedule
30Drug therapy
31Efavirenz
32Emtricitabine
33Exanthema
34Female
35General aspects
36HIV
37HIV Reverse Transcriptase - antagonists & inhibitors
38HIV-1 - drug effects
39HIV-1 - genetics
40Human immunodeficiency virus
41Human immunodeficiency virus 1
42Human viral diseases
43Humans
44Infectious diseases
45Internal Medicine
46Lipids
47Male
48Medical sciences
49Middle Aged
50Mutation
51Nitriles - administration & dosage
52Nitriles - adverse effects
53Nitriles - therapeutic use
54non-nucleoside reverse transcriptase inhibitors
55nucleosides
56Nucleotides
57Organophosphonates - administration & dosage
58Organophosphonates - adverse effects
59Organophosphonates - therapeutic use
60Patient outcomes
61Pharmacology. Drug treatments
62Pyrimidines - administration & dosage
63Pyrimidines - adverse effects
64Pyrimidines - therapeutic use
65Regression analysis
66Reverse Transcriptase Inhibitors - therapeutic use
67Rilpivirine
68RNA-directed DNA polymerase
69Tenofovir
70Treatment Outcome
71Viral diseases
72Viral diseases of the lymphoid tissue and the blood. Aids
73Viral Load - drug effects
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6Supparatpinyo, Khuanchai, Prof
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jtitleThe Lancet (British edition)
delivery
delcategoryRemote Search Resource
fulltextfulltext
addata
au
0Molina, Jean-Michel, Dr, Prof
1Cahn, Pedro, MD
2Grinsztejn, Beatriz, MD
3Lazzarin, Adriano, Prof
4Mills, Anthony, MD
5Saag, Michael, Prof
6Supparatpinyo, Khuanchai, Prof
7Walmsley, Sharon, Prof
8Crauwels, Herta, PhD
9Rimsky, Laurence T, PhD
10Vanveggel, Simon, MSc
11Boven, Katia, MD
aucorp
0on behalf of the ECHO study group
1ECHO study group
formatjournal
genrearticle
ristypeJOUR
atitleRilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naive adults infected with HIV-1 (ECHO): a phase 3 randomised double-blind active-controlled trial
jtitleThe Lancet (British edition)
addtitleLancet
date2011
risdate2011
volume378
issue9787
spage238
epage246
pages238-246
issn0140-6736
eissn1474-547X
codenLANCAO
abstractSummary Background Efavirenz with tenofovir-disoproxil-fumarate and emtricitabine is a preferred antiretroviral regimen for treatment-naive patients infected with HIV-1. Rilpivirine, a new non-nucleoside reverse transcriptase inhibitor, has shown similar antiviral efficacy to efavirenz in a phase 2b trial with two nucleoside/nucleotide reverse transcriptase inhibitors. We aimed to assess the efficacy, safety, and tolerability of rilpivirine versus efavirenz, each combined with tenofovir-disoproxil-fumarate and emtricitabine. Methods We did a phase 3, randomised, double-blind, double-dummy, active-controlled trial, in patients infected with HIV-1 who were treatment-naive. The patients were aged 18 years or older with a plasma viral load at screening of 5000 copies per mL or greater, and viral sensitivity to all study drugs. Our trial was done at 112 sites across 21 countries. Patients were randomly assigned by a computer-generated interactive web response system to receive either once-daily 25 mg rilpivirine or once-daily 600 mg efavirenz, each with tenofovir-disoproxil-fumarate and emtricitabine. Our primary objective was to show non-inferiority (12% margin) of rilpivirine to efavirenz in terms of the percentage of patients with confirmed response (viral load <50 copies per mL intention-to-treat time-to-loss-of-virological-response [ITT-TLOVR] algorithm) at week 48. Our primary analysis was by intention-to-treat. We also used logistic regression to adjust for baseline viral load. This trial is registered with ClinicalTrials.gov , number NCT00540449. Findings 346 patients were randomly assigned to receive rilpivirine and 344 to receive efavirenz and received at least one dose of study drug, with 287 (83%) and 285 (83%) in the respective groups having a confirmed response at week 48. The point estimate from a logistic regression model for the percentage difference in response was −0·4 (95% CI −5·9 to 5·2), confirming non-inferiority with a 12% margin (primary endpoint). The incidence of virological failures was 13% (rilpivirine) versus 6% (efavirenz; 11% vs 4% by ITT-TLOVR). Grade 2–4 adverse events (55 [16%] on rilpivirine vs 108 [31%] on efavirenz, p<0·0001), discontinuations due to adverse events (eight [2%] on rilpivirine vs 27 [8%] on efavirenz), rash, dizziness, and abnormal dreams or nightmares were more common with efavirenz. Increases in plasma lipids were significantly lower with rilpivirine. Interpretation Rilpivirine showed non-inferior efficacy compared with efavirenz, with a higher virological-failure rate, but a more favourable safety and tolerability profile. Funding Tibotec.
copKidlington
pubElsevier Ltd
pmid21763936
doi10.1016/S0140-6736(11)60936-7