Abstract
| Original language | English |
|---|---|
| Pages (from-to) | 1229 - 1238 |
| Number of pages | 10 |
| Journal | AIDS |
| Volume | 30 |
| Issue number | 8 |
| DOIs | |
| Publication status | Published - May 15 2016 |
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Keywords
- darunavir
- emtricitabine
- HIV-1
- maraviroc
- nucleos(t)ide-sparing regimen
- tenofovir
- treatment-naive
ASJC Scopus subject areas
- Immunology and Allergy
- Immunology
- Infectious Diseases
Cite this
Once-daily maraviroc versus tenofovir/emtricitabine each combined with darunavir/ritonavir for initial HIV-1 treatment. / Stellbrink, Hans-Jürgen; Le Fevre, Eric; Carr, Andrew; Saag, Michael S.; Mukwaya, Geoffrey; Nozza, Silvia; Valluri, Srinivas Rao; Vourvahis, Manoli; Rinehart, Alex R.; McFadyen, Lynn; Fichtenbaum, Carl; Clark, Andrew; Craig, Charles; Fang, Annie F.; Heera, Jayvant.
In: AIDS, Vol. 30, No. 8, 15.05.2016, p. 1229 - 1238.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Once-daily maraviroc versus tenofovir/emtricitabine each combined with darunavir/ritonavir for initial HIV-1 treatment
AU - Stellbrink, Hans-Jürgen
AU - Le Fevre, Eric
AU - Carr, Andrew
AU - Saag, Michael S.
AU - Mukwaya, Geoffrey
AU - Nozza, Silvia
AU - Valluri, Srinivas Rao
AU - Vourvahis, Manoli
AU - Rinehart, Alex R.
AU - McFadyen, Lynn
AU - Fichtenbaum, Carl
AU - Clark, Andrew
AU - Craig, Charles
AU - Fang, Annie F.
AU - Heera, Jayvant
PY - 2016/5/15
Y1 - 2016/5/15
N2 - Objective: The aim of this study was to evaluate the efficacy of maraviroc along with darunavir/ritonavir, all once daily, for the treatment of antiretroviral-naive HIV-1 infected individuals. Design: MODERN was a multicentre, double-blind, noninferiority, phase III study in HIV-1 infected, antiretroviral-naive adults with plasma HIV-1 RNA at least 1000copies/ml and no evidence of reduced susceptibility to study drugs. Methods: At screening, participants were randomized 1:1 to undergo either genotypic or phenotypic tropism testing. Participants with CCR5-tropic HIV-1 were randomized 1:1 to receive maraviroc 150mg once daily or tenofovir/emtricitabine once daily each with darunavir/ritonavir once daily for 96 weeks. The primary endpoint was the proportion of participants with HIV-1 RNA less than 50copies/ml (Food and Drug Administration snapshot algorithm) at Week 48. A substudy evaluated bone mineral density, body fat distribution and serum bone turnover markers. Results: Seven hundred and ninety-seven participants were dosed (maraviroc, n=396; tenofovir/emtricitabine, n=401). The Data Monitoring Committee recommended early study termination due to inferior efficacy in the maraviroc group. At Week 48, the proportion of participants with HIV-1 RNA less than 50copies/ml was 77.3% for maraviroc and 86.8% for tenofovir/emtricitabine [difference of-9.54% (95% confidence interval:-14.83 to-4.24)]. More maraviroc participants discontinued for lack of efficacy, which was not associated with non-R5 tropism or resistance. Discontinuations for adverse events, Category C events, Grade 3/4 adverse events and laboratory abnormalities were similar between groups. Conclusion: A once-daily nucleos(t)ide-sparing two-drug regimen of maraviroc and darunavir/ritonavir was inferior to a three-drug regimen of tenofovir/emtricitabine and darunavir/ritonavir in antiretroviral-naive adults.
AB - Objective: The aim of this study was to evaluate the efficacy of maraviroc along with darunavir/ritonavir, all once daily, for the treatment of antiretroviral-naive HIV-1 infected individuals. Design: MODERN was a multicentre, double-blind, noninferiority, phase III study in HIV-1 infected, antiretroviral-naive adults with plasma HIV-1 RNA at least 1000copies/ml and no evidence of reduced susceptibility to study drugs. Methods: At screening, participants were randomized 1:1 to undergo either genotypic or phenotypic tropism testing. Participants with CCR5-tropic HIV-1 were randomized 1:1 to receive maraviroc 150mg once daily or tenofovir/emtricitabine once daily each with darunavir/ritonavir once daily for 96 weeks. The primary endpoint was the proportion of participants with HIV-1 RNA less than 50copies/ml (Food and Drug Administration snapshot algorithm) at Week 48. A substudy evaluated bone mineral density, body fat distribution and serum bone turnover markers. Results: Seven hundred and ninety-seven participants were dosed (maraviroc, n=396; tenofovir/emtricitabine, n=401). The Data Monitoring Committee recommended early study termination due to inferior efficacy in the maraviroc group. At Week 48, the proportion of participants with HIV-1 RNA less than 50copies/ml was 77.3% for maraviroc and 86.8% for tenofovir/emtricitabine [difference of-9.54% (95% confidence interval:-14.83 to-4.24)]. More maraviroc participants discontinued for lack of efficacy, which was not associated with non-R5 tropism or resistance. Discontinuations for adverse events, Category C events, Grade 3/4 adverse events and laboratory abnormalities were similar between groups. Conclusion: A once-daily nucleos(t)ide-sparing two-drug regimen of maraviroc and darunavir/ritonavir was inferior to a three-drug regimen of tenofovir/emtricitabine and darunavir/ritonavir in antiretroviral-naive adults.
KW - darunavir
KW - emtricitabine
KW - HIV-1
KW - maraviroc
KW - nucleos(t)ide-sparing regimen
KW - tenofovir
KW - treatment-naive
UR - http://www.scopus.com/inward/record.url?scp=84957621037&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84957621037&partnerID=8YFLogxK
U2 - 10.1097/QAD.0000000000001058
DO - 10.1097/QAD.0000000000001058
M3 - Article
VL - 30
SP - 1229
EP - 1238
JO - AIDS
JF - AIDS
SN - 0269-9370
IS - 8
ER -