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Lopinavir/ritonavir, atazanavir/ritonavir, and efavirenz in antiretroviral-naive HIV-1-infected individuals over 144 weeks: An open-label randomized controlled trial

Andersson, Lars-Magnus; Vesterbacka, Jan; Blaxhult, Anders; Flamholc, Leo LU ; Nilsson, Staffan; Ormaasen, Vidar; Sonnerborg, Anders and Gisslen, Magnus (2013) In Scandinavian Journal of Infectious Diseases 45(7). p.543-551
Abstract
Background: The objective of this study was to compare the efficacy of ritonavir boosted atazanavir versus ritonavir boosted lopinavir or efavirenz, all in combination with 2 nucleoside analogue reverse transcriptase inhibitors (NRTIs), over 144 weeks in antiretroviral-naive HIV-1-infected individuals. Methods: A prospective open-label randomized controlled trial was conducted at 29 sites in Sweden and Norway between April 2004 and December 2009. Patients were randomized to receive either efavirenz 600 mg once daily (EFV), or atazanavir 300 mg and ritonavir 100 mg once daily (AZV/r), or lopinavir 400 mg and ritonavir 100 mg twice daily (LPV/r). The primary endpoints were the proportion of patients with HIV-1 RNA <50 copies/ml at 48 and... (More)
Background: The objective of this study was to compare the efficacy of ritonavir boosted atazanavir versus ritonavir boosted lopinavir or efavirenz, all in combination with 2 nucleoside analogue reverse transcriptase inhibitors (NRTIs), over 144 weeks in antiretroviral-naive HIV-1-infected individuals. Methods: A prospective open-label randomized controlled trial was conducted at 29 sites in Sweden and Norway between April 2004 and December 2009. Patients were randomized to receive either efavirenz 600 mg once daily (EFV), or atazanavir 300 mg and ritonavir 100 mg once daily (AZV/r), or lopinavir 400 mg and ritonavir 100 mg twice daily (LPV/r). The primary endpoints were the proportion of patients with HIV-1 RNA <50 copies/ml at 48 and 144 weeks. Results: Of 245 patients enrolled, 243 were randomized and 239 received the allocated intervention: 77 EFV, 81 AZV/r, and 81 LPV/r. Median (interquartile range) CD4 cell counts at baseline were 150 (80-200), 170 (80-220), and 150 (90-216) per microlitre, respectively. At week 48 the proportion (95% confidence interval (CI)) of patients achieving HIV-1 RNA <50 copies/ml was 86 (78-94)% in the EFV arm, 78 (69-87)% in the AZV/r arm and, 69 (59-78)% in the LPV/r arm in the intention-to-treat analysis. There was a significant difference between the EFV and LPV/r arm (p = 0.014). At week 144, the proportion (95% CI) of patients achieving HIV-1 RNA <50 copies/ml was 61 (50-72)%, 58 (47-69)%, 51 (41-63)%, respectively (p = 0.8). Patients with CD4 cell counts of <= 200/mu l or HIV-1 RNA > 100,000 copies/ml at baseline had similar response rates in all arms. Conclusion: EFV was superior to LPV/r at week 48, but there were no significant differences between the 3 arms in the long-term (144 weeks) follow-up. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Combination antiretroviral therapy, HIV-1, treatment-naive patients, randomized controlled trial
in
Scandinavian Journal of Infectious Diseases
volume
45
issue
7
pages
543 - 551
publisher
Informa Healthcare
external identifiers
  • wos:000320380900008
  • scopus:84879084363
ISSN
1651-1980
DOI
10.3109/00365548.2012.756985
language
English
LU publication?
yes
id
29e5b41c-a99d-4ff7-9340-2e255f07e7e0 (old id 3921093)
date added to LUP
2013-08-01 07:34:03
date last changed
2019-07-09 02:10:17
@article{29e5b41c-a99d-4ff7-9340-2e255f07e7e0,
  abstract     = {Background: The objective of this study was to compare the efficacy of ritonavir boosted atazanavir versus ritonavir boosted lopinavir or efavirenz, all in combination with 2 nucleoside analogue reverse transcriptase inhibitors (NRTIs), over 144 weeks in antiretroviral-naive HIV-1-infected individuals. Methods: A prospective open-label randomized controlled trial was conducted at 29 sites in Sweden and Norway between April 2004 and December 2009. Patients were randomized to receive either efavirenz 600 mg once daily (EFV), or atazanavir 300 mg and ritonavir 100 mg once daily (AZV/r), or lopinavir 400 mg and ritonavir 100 mg twice daily (LPV/r). The primary endpoints were the proportion of patients with HIV-1 RNA &lt;50 copies/ml at 48 and 144 weeks. Results: Of 245 patients enrolled, 243 were randomized and 239 received the allocated intervention: 77 EFV, 81 AZV/r, and 81 LPV/r. Median (interquartile range) CD4 cell counts at baseline were 150 (80-200), 170 (80-220), and 150 (90-216) per microlitre, respectively. At week 48 the proportion (95% confidence interval (CI)) of patients achieving HIV-1 RNA &lt;50 copies/ml was 86 (78-94)% in the EFV arm, 78 (69-87)% in the AZV/r arm and, 69 (59-78)% in the LPV/r arm in the intention-to-treat analysis. There was a significant difference between the EFV and LPV/r arm (p = 0.014). At week 144, the proportion (95% CI) of patients achieving HIV-1 RNA &lt;50 copies/ml was 61 (50-72)%, 58 (47-69)%, 51 (41-63)%, respectively (p = 0.8). Patients with CD4 cell counts of &lt;= 200/mu l or HIV-1 RNA &gt; 100,000 copies/ml at baseline had similar response rates in all arms. Conclusion: EFV was superior to LPV/r at week 48, but there were no significant differences between the 3 arms in the long-term (144 weeks) follow-up.},
  author       = {Andersson, Lars-Magnus and Vesterbacka, Jan and Blaxhult, Anders and Flamholc, Leo and Nilsson, Staffan and Ormaasen, Vidar and Sonnerborg, Anders and Gisslen, Magnus},
  issn         = {1651-1980},
  keyword      = {Combination antiretroviral therapy,HIV-1,treatment-naive patients,randomized controlled trial},
  language     = {eng},
  number       = {7},
  pages        = {543--551},
  publisher    = {Informa Healthcare},
  series       = {Scandinavian Journal of Infectious Diseases},
  title        = {Lopinavir/ritonavir, atazanavir/ritonavir, and efavirenz in antiretroviral-naive HIV-1-infected individuals over 144 weeks: An open-label randomized controlled trial},
  url          = {http://dx.doi.org/10.3109/00365548.2012.756985},
  volume       = {45},
  year         = {2013},
}