Implementation of an intensive adherence intervention in patients with second-line antiretroviral therapy failure in four west African countries with little access to genotypic resistance testing: a prospective cohort study
Serge Paul Eholie
(1, 2, 3)
,
Raoul Moh
(1, 2, 3)
,
A. Benalycherif
(4)
,
Delphine Gabillard
(1, 3)
,
F. Ello
(2, 3)
,
Eugene Messou
(1, 2, 3, 5)
,
J. Zoungrana
(6)
,
I. Diallo
(7)
,
M. Diallo
(8)
,
G. Bado
(6)
,
M. Cisse
,
A. I. Maiga
(9)
,
A. Anzian
(5)
,
T. D. Toni
(10)
,
M. Congo-Ouedraogo
(7)
,
C. Toure-Kane
(11)
,
M. Seydi
(8)
,
D. K. Minta
(12)
,
A. Sawadogo
(6)
,
L. Sangare
(7)
,
J. Drabo
(7)
,
Sophie Karcher
(1, 3)
,
Jerome Le Carrou
(1, 3)
,
L. A. de Monteynard
(13)
,
G. Peytavin
(14)
,
A. Gabassi
(15, 16)
,
P. M. Girard
(4, 17)
,
M. L. Chaix
(15, 16)
,
Xavier Anglaret
(1, 3)
,
R. Landman
(4, 18)
1
BPH -
Bordeaux population health
2 UFHB - Université Félix Houphouët-Boigny
3 Programme PAC-CI
4 IMEA - Institut de médecine et d'épidémiologie appliquée [AP-HP Hôpital Bichat-Claude Bernard]
5 CePReF - Centre de Prise en charge, de Recherche et de Formation
6 CHUSS - Centre Hospitalier Universitaire Souro Sanou [Bobo-Dioulasso]
7 CHUYO - Centre Hospitalier Universitaire Yalgado Ouédraogo [Ouagadougou, Burkina Faso]
8 CRCF - Centre Régional de recherche et de Formation à la prise en charge Clinique de Fann
9 CHU Bamako - Centre Hospitalier Universitaire Gabriel Touré [Bamako]
10 CHU de Treichville - Centre Hospitalier Universitaire de Treichville [Abidjan, Côte d'Ivoire]
11 Hôpital Aristide-Le-Dantec
12 Hôpital du point G
13 ANRS - Agence Nationale de Recherches sur le Sida et les Hépatites Virales
14 AP-HP - Hôpital Bichat - Claude Bernard [Paris]
15 AP-HP - Hopital Saint-Louis [AP-HP]
16 GenCellDis (U944 / UMR7212) - Génomes, biologie cellulaire et thérapeutiques
17 CHU Saint-Antoine [AP-HP]
18 IAME (UMR_S_1137 / U1137) - Infection, Anti-microbiens, Modélisation, Evolution
2 UFHB - Université Félix Houphouët-Boigny
3 Programme PAC-CI
4 IMEA - Institut de médecine et d'épidémiologie appliquée [AP-HP Hôpital Bichat-Claude Bernard]
5 CePReF - Centre de Prise en charge, de Recherche et de Formation
6 CHUSS - Centre Hospitalier Universitaire Souro Sanou [Bobo-Dioulasso]
7 CHUYO - Centre Hospitalier Universitaire Yalgado Ouédraogo [Ouagadougou, Burkina Faso]
8 CRCF - Centre Régional de recherche et de Formation à la prise en charge Clinique de Fann
9 CHU Bamako - Centre Hospitalier Universitaire Gabriel Touré [Bamako]
10 CHU de Treichville - Centre Hospitalier Universitaire de Treichville [Abidjan, Côte d'Ivoire]
11 Hôpital Aristide-Le-Dantec
12 Hôpital du point G
13 ANRS - Agence Nationale de Recherches sur le Sida et les Hépatites Virales
14 AP-HP - Hôpital Bichat - Claude Bernard [Paris]
15 AP-HP - Hopital Saint-Louis [AP-HP]
16 GenCellDis (U944 / UMR7212) - Génomes, biologie cellulaire et thérapeutiques
17 CHU Saint-Antoine [AP-HP]
18 IAME (UMR_S_1137 / U1137) - Infection, Anti-microbiens, Modélisation, Evolution
Résumé
BACKGROUND: The decision about whether to switch to third-line antiretroviral therapy (ART) in patients with treatment failure on second-line therapy is difficult in settings with little access to genotypic resistance testing. In this study, we used a standardised algorithm including a wide range of adherence-enhancing interventions followed by a new viral load measurement to decide whether to switch to third-line therapy in this situation. The decision, made on the basis of effectiveness of the adherence reinforcement to drive viral resuppression, did not use genotypic resistance testing. METHODS: In this prospective cohort study, adults in four west African countries with treatment failure of a boosted protease inhibitor ART regimen were offered nine adherence reinforcement interventions, and followed up for 64 weeks. We measured viral load at week 12 and used the results to decide ART treatment at week 16: if successful resuppression (plasma HIV-1 RNA <400 copies per mL or had decreased by >/=2 log10 copies per mL compared with baseline), patients continued the same second-line regimen; otherwise they switched to a third-line regimen based on ritonavir-boosted darunavir and raltegravir. The primary endpoint was virological success at week 64 (plasma HIV-1 RNA <50 copies per mL). After study termination we did genotypic resistance testing on frozen plasma samples collected at baseline, and retrospectively determined the appropriateness of the week 16 decision on the basis of the baseline genotypic susceptibility score. FINDINGS: Between March 28, 2013, and May 11, 2015, of the 198 eligible participants, five died before week 16. Of the 193 remaining, 130 (67%) reached viral resuppression and continued with second-line ART, and 63 (33%) switched to third-line ART at week 16. Post-study genotypic resistance testing showed that the baseline genotypic susceptibility score was calculable in 166 patients, of whom 57 (34%) had a score less than 2. We retrospectively concluded that the week 16 decision was appropriate in 145 (75%) patients. At week 64, four patients (2%) were lost to follow-up, ten (5%) had died, and 101 (52%) had a viral load less than 50 copies per mL. INTERPRETATION: Poor adherence is the first problem to tackle in patients for whom second-line ART is failing when resistance tests are not routinely available and is effectively a manageable problem. Lack of access to genotypic resistance testing should not be an obstacle to the prescription of third-line ART in patients who do not achieve viral resuppression after adherence reinforcement. FUNDING: French Agency for Research on AIDS and Viral Hepatitis.
Domaines
Santé publique et épidémiologieFormat du dépôt | Fichier |
---|---|
Type de dépôt | Article dans une revue |
Titre |
en
Implementation of an intensive adherence intervention in patients with second-line antiretroviral therapy failure in four west African countries with little access to genotypic resistance testing: a prospective cohort study
|
Résumé |
en
BACKGROUND: The decision about whether to switch to third-line antiretroviral therapy (ART) in patients with treatment failure on second-line therapy is difficult in settings with little access to genotypic resistance testing. In this study, we used a standardised algorithm including a wide range of adherence-enhancing interventions followed by a new viral load measurement to decide whether to switch to third-line therapy in this situation. The decision, made on the basis of effectiveness of the adherence reinforcement to drive viral resuppression, did not use genotypic resistance testing. METHODS: In this prospective cohort study, adults in four west African countries with treatment failure of a boosted protease inhibitor ART regimen were offered nine adherence reinforcement interventions, and followed up for 64 weeks. We measured viral load at week 12 and used the results to decide ART treatment at week 16: if successful resuppression (plasma HIV-1 RNA <400 copies per mL or had decreased by >/=2 log10 copies per mL compared with baseline), patients continued the same second-line regimen; otherwise they switched to a third-line regimen based on ritonavir-boosted darunavir and raltegravir. The primary endpoint was virological success at week 64 (plasma HIV-1 RNA <50 copies per mL). After study termination we did genotypic resistance testing on frozen plasma samples collected at baseline, and retrospectively determined the appropriateness of the week 16 decision on the basis of the baseline genotypic susceptibility score. FINDINGS: Between March 28, 2013, and May 11, 2015, of the 198 eligible participants, five died before week 16. Of the 193 remaining, 130 (67%) reached viral resuppression and continued with second-line ART, and 63 (33%) switched to third-line ART at week 16. Post-study genotypic resistance testing showed that the baseline genotypic susceptibility score was calculable in 166 patients, of whom 57 (34%) had a score less than 2. We retrospectively concluded that the week 16 decision was appropriate in 145 (75%) patients. At week 64, four patients (2%) were lost to follow-up, ten (5%) had died, and 101 (52%) had a viral load less than 50 copies per mL. INTERPRETATION: Poor adherence is the first problem to tackle in patients for whom second-line ART is failing when resistance tests are not routinely available and is effectively a manageable problem. Lack of access to genotypic resistance testing should not be an obstacle to the prescription of third-line ART in patients who do not achieve viral resuppression after adherence reinforcement. FUNDING: French Agency for Research on AIDS and Viral Hepatitis.
|
Sous-Titre |
fr
Lancet HIV
|
Auteur(s) |
Serge Paul Eholie
1, 2, 3
, Raoul Moh
1, 2, 3
, A. Benalycherif
4
, Delphine Gabillard
1, 3
, F. Ello
2, 3
, Eugene Messou
1, 2, 3, 5
, J. Zoungrana
6
, I. Diallo
7
, M. Diallo
8
, G. Bado
6
, M. Cisse
, A. I. Maiga
9
, A. Anzian
5
, T. D. Toni
10
, M. Congo-Ouedraogo
7
, C. Toure-Kane
11
, M. Seydi
8
, D. K. Minta
12
, A. Sawadogo
6
, L. Sangare
7
, J. Drabo
7
, Sophie Karcher
1, 3
, Jerome Le Carrou
1, 3
, L. A. de Monteynard
13
, G. Peytavin
14
, A. Gabassi
15, 16
, P. M. Girard
4, 17
, M. L. Chaix
15, 16
, Xavier Anglaret
1, 3
, R. Landman
4, 18
1
BPH -
Bordeaux population health
( 476572 )
- Université de Bordeaux - Case 11 - 146 rue Léo Saignat 33076 Bordeaux cedex
- France
2
UFHB -
Université Félix Houphouët-Boigny
( 218070 )
- Abidjan
- Côte d’Ivoire
3
Programme PAC-CI
( 44344 )
- Côte d’Ivoire
4
IMEA -
Institut de médecine et d'épidémiologie appliquée [AP-HP Hôpital Bichat-Claude Bernard]
( 557817 )
- IMEA – FONDATION INTERNATIONALE LÉON MBA,
Hôpital Bichat, 75018 Paris
- France
5
CePReF -
Centre de Prise en charge, de Recherche et de Formation
( 183623 )
- 23 BP 2485 Abidjan 23
- Côte d’Ivoire
6
CHUSS -
Centre Hospitalier Universitaire Souro Sanou [Bobo-Dioulasso]
( 520020 )
- 01 BP 676 Avenue du gouverneur William Ponty Bobo-Dioulasso
- Burkina Faso
7
CHUYO -
Centre Hospitalier Universitaire Yalgado Ouédraogo [Ouagadougou, Burkina Faso]
( 340177 )
- 03 BP, 7022 Ouagadougou 03
- Burkina Faso
8
CRCF -
Centre Régional de recherche et de Formation à la prise en charge Clinique de Fann
( 195137 )
- Avenue Cheikh Anta Diop, BP 45690 Dakar/Fann
- Sénégal
9
CHU Bamako -
Centre Hospitalier Universitaire Gabriel Touré [Bamako]
( 323634 )
- Bamako
- Mali
10
CHU de Treichville -
Centre Hospitalier Universitaire de Treichville [Abidjan, Côte d'Ivoire]
( 493937 )
- 18 BP 1954 Abidjan 18.
- Côte d’Ivoire
11
Hôpital Aristide-Le-Dantec
( 302167 )
- Dakar
- Sénégal
12
Hôpital du point G
( 559114 )
- France
13
ANRS -
Agence Nationale de Recherches sur le Sida et les Hépatites Virales
( 567516 )
- France
14
AP-HP - Hôpital Bichat - Claude Bernard [Paris]
( 300156 )
- 46 Rue Henri Huchard, 75018 Paris
- France
15
AP-HP -
Hopital Saint-Louis [AP-HP]
( 506757 )
- 1 Avenue Claude Vellefaux, 75010 Paris
- France
16
GenCellDis (U944 / UMR7212) -
Génomes, biologie cellulaire et thérapeutiques
( 1005063 )
- Hôpital Saint-Louis - Bâtiment Jean Bernard - 16 rue de la Grange aux Belles, 75010 Paris
- France
17
CHU Saint-Antoine [AP-HP]
( 454982 )
- 184, rue du Faubourg Saint-Antoine
75571 Paris cedex 12
- France
18
IAME (UMR_S_1137 / U1137) -
Infection, Anti-microbiens, Modélisation, Evolution
( 1005021 )
- Faculté de médecine Paris Diderot Paris 7 - site Bichat - 16 rue Henri Huchard 75890 Paris Cedex 18
- France
|
Licence |
Paternité - Pas d'utilisation commerciale
|
Langue du document |
Anglais
|
Nom de la revue |
|
Comité de lecture |
Oui
|
Date de publication |
2019
|
Volume |
6
|
Numéro |
11
|
Page/Identifiant |
e750-e759
|
Vulgarisation |
Non
|
Audience |
Internationale
|
Domaine(s) |
|
Financement |
|
DOI | 10.1016/s2352-3018(19)30228-0 |
PII | S2352-3018(19)30228-0 |
Pubmed Id | 31601544 |
Origine :
Fichiers produits par l'(les) auteur(s)
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