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Protease Inhibitors or NNRTIs as First-Line HIV-1 Treatment in West Africa (PIONA) : A Randomized Controlled Trial

, ; Jespersen, Sanne; Hønge, Bo Langhoff; Krarup, Henrik; Medstrand, Patrik LU ; Sørensen, Allan; Medina, Candida; Té, David da Silva; Correira, Faustino Gomes and Erikstrup, Christian, et al. (2018) In Journal of acquired immune deficiency syndromes (1999) 79(3). p.386-393
Abstract

BACKGROUND: Nonnucleoside reverse transcriptase inhibitors (NNRTIs) are recommended as part of first-line treatment for HIV-1 in Africa. However, NNRTI-based regimens are more prone to resistance development than protease inhibitors (PIs) in a context in which drug interruptions are frequent. The aim of this study was to compare the efficacy and tolerability of NNRTIs with PIs in HIV-1-infected patients in Guinea-Bissau.

METHODS: This open-label randomized, 2-arm superiority trial compared the use of 2 NRTIs plus either one NNRTI (efavirenz or nevirapine) or one PI (lopinavir/ritonavir) in treatment-naive HIV-1-infected adults in the Bissau HIV Cohort (ClinicalTrials.gov, NCT0019235). The primary endpoint was HIV-1 RNA <400... (More)

BACKGROUND: Nonnucleoside reverse transcriptase inhibitors (NNRTIs) are recommended as part of first-line treatment for HIV-1 in Africa. However, NNRTI-based regimens are more prone to resistance development than protease inhibitors (PIs) in a context in which drug interruptions are frequent. The aim of this study was to compare the efficacy and tolerability of NNRTIs with PIs in HIV-1-infected patients in Guinea-Bissau.

METHODS: This open-label randomized, 2-arm superiority trial compared the use of 2 NRTIs plus either one NNRTI (efavirenz or nevirapine) or one PI (lopinavir/ritonavir) in treatment-naive HIV-1-infected adults in the Bissau HIV Cohort (ClinicalTrials.gov, NCT0019235). The primary endpoint was HIV-1 RNA <400 copies per milliliter after 12 months of treatment.

RESULTS: Between May 5, 2011, and April 26, 2013, 400 patients were included in the study. In an intention-to-treat analysis, the proportions of patients with viral suppression were similar in the NNRTI [65/197 (33.0%)] and PI [68/203 (33.5%)] arms (P = 0.92). No PI resistance was detected, but high-level NNRTI resistance was seen in 17/30 (56.7%) of NNRTI vs. 3/26 (11.5%) of PI-treated patients, P < 0.01. After 1 year of follow-up, 65 patients died (16.3%) and 93 were lost to follow-up (23.3%). There was no difference in mortality (hazard ratio 0.84, 95% confidence interval: 0.51 to 1.36) or frequency of clinical adverse events between treatment arms [NNRTI: 73/197 (37.1%); and PI: 69/203 (34.0%); P = 0.52].

CONCLUSIONS: In patients at an HIV clinic in Guinea-Bissau, treatment with PIs led to less development of resistance compared with NNRTIs but was not superior in terms of viral suppression, CD4 cell increment, mortality, or severe adverse events.

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Journal of acquired immune deficiency syndromes (1999)
volume
79
issue
3
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8 pages
external identifiers
  • scopus:85054897565
ISSN
1944-7884
DOI
10.1097/QAI.0000000000001820
language
English
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yes
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27b8bf25-301b-434e-bce8-c17ec99c625f
date added to LUP
2018-10-30 10:00:27
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2019-11-13 05:19:00
@article{27b8bf25-301b-434e-bce8-c17ec99c625f,
  abstract     = {<p>BACKGROUND: Nonnucleoside reverse transcriptase inhibitors (NNRTIs) are recommended as part of first-line treatment for HIV-1 in Africa. However, NNRTI-based regimens are more prone to resistance development than protease inhibitors (PIs) in a context in which drug interruptions are frequent. The aim of this study was to compare the efficacy and tolerability of NNRTIs with PIs in HIV-1-infected patients in Guinea-Bissau.</p><p>METHODS: This open-label randomized, 2-arm superiority trial compared the use of 2 NRTIs plus either one NNRTI (efavirenz or nevirapine) or one PI (lopinavir/ritonavir) in treatment-naive HIV-1-infected adults in the Bissau HIV Cohort (ClinicalTrials.gov, NCT0019235). The primary endpoint was HIV-1 RNA &lt;400 copies per milliliter after 12 months of treatment.</p><p>RESULTS: Between May 5, 2011, and April 26, 2013, 400 patients were included in the study. In an intention-to-treat analysis, the proportions of patients with viral suppression were similar in the NNRTI [65/197 (33.0%)] and PI [68/203 (33.5%)] arms (P = 0.92). No PI resistance was detected, but high-level NNRTI resistance was seen in 17/30 (56.7%) of NNRTI vs. 3/26 (11.5%) of PI-treated patients, P &lt; 0.01. After 1 year of follow-up, 65 patients died (16.3%) and 93 were lost to follow-up (23.3%). There was no difference in mortality (hazard ratio 0.84, 95% confidence interval: 0.51 to 1.36) or frequency of clinical adverse events between treatment arms [NNRTI: 73/197 (37.1%); and PI: 69/203 (34.0%); P = 0.52].</p><p>CONCLUSIONS: In patients at an HIV clinic in Guinea-Bissau, treatment with PIs led to less development of resistance compared with NNRTIs but was not superior in terms of viral suppression, CD4 cell increment, mortality, or severe adverse events.</p>},
  author       = {,  and Jespersen, Sanne and Hønge, Bo Langhoff and Krarup, Henrik and Medstrand, Patrik and Sørensen, Allan and Medina, Candida and Té, David da Silva and Correira, Faustino Gomes and Erikstrup, Christian and Østergaard, Lars and Wejse, Christian and Laursen, Alex Lund},
  issn         = {1944-7884},
  language     = {eng},
  number       = {3},
  pages        = {386--393},
  series       = {Journal of acquired immune deficiency syndromes (1999)},
  title        = {Protease Inhibitors or NNRTIs as First-Line HIV-1 Treatment in West Africa (PIONA) : A Randomized Controlled Trial},
  url          = {http://dx.doi.org/10.1097/QAI.0000000000001820},
  volume       = {79},
  year         = {2018},
}